| May 30, 26 |
K261154510(k) |
CoLink® & CoLag® Non-Sterile Screws |
In2Bones USA, LLC |
Orthopedic |
HWC |
| May 29, 26 |
K252396510(k) |
Cryo Sport 2.0 (AVA 501) |
Avanutri Equipamentos DE Saúde |
Physical Medicine |
IRP |
| May 29, 26 |
K252802510(k) |
Peak Flow Meter (PF-10(BR-PEF231)) |
Shenzhen Bi-Rich Medical Devices Co., Ltd. |
Anesthesiology |
BZH |
| May 29, 26 |
K252821510(k) |
Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T) |
Philips Medizin Systeme Böblingen GmbH |
Cardiovascular |
DQA |
| May 29, 26 |
K252840510(k) |
M12 Telemetry System |
Global Instrumentation, LLC |
Cardiovascular |
MHX |
| May 29, 26 |
K252859510(k) |
ZEUS Platform (FG0501US) |
iRhythm Technologies, Inc. |
Cardiovascular |
DQK |
| May 29, 26 |
K252947510(k) |
HistoSonics® Planning Tool |
HistoSonics, Inc. |
Radiology |
QTZ |
| May 29, 26 |
K252965510(k) |
Oxygen Concentrator (OX-5A, OX-5C) |
Oxytek Medical Technology Co., Ltd. |
Anesthesiology |
CAW |
| May 29, 26 |
K253103510(k) |
Nexus DRF Digital X-ray Imaging System |
Varex Imaging Corporation |
Radiology |
JAA |
| May 29, 26 |
K253119510(k) |
CoSense ETCO Monitor |
Capnia, Inc. |
Anesthesiology |
CCJ |
| May 29, 26 |
K254076510(k) |
BD Touchless Plus Unisex Pre-Lubricated Urethral Catheter Kit |
C.R. Bard, Inc. |
Gastroenterology, Urology |
FCM |
| May 29, 26 |
K254300510(k) |
eufy Wearable Breast Pump (T600P, T6000, T6001, T6002, T6003, T6004, T6005, T6006, T6007, T6008, T6009) |
Anker Innovations Limited |
Obstetrics/Gynecology |
HGX |
| May 29, 26 |
K260077510(k) |
OrthoGrid Hip AI® 4.0 |
OrthoGrid Systems, Inc. |
Radiology |
QIH |
| May 29, 26 |
K260138510(k) |
LUNE PureHygiene |
Enamel Pure |
General, Plastic Surgery |
GEX |
| May 29, 26 |
K260262510(k) |
Injection Needle |
Mirco-Tech (Nanjing) Co., Ltd. |
Gastroenterology, Urology |
FBK |
| May 29, 26 |
K260489510(k) |
LASEmaR 1500 |
Eufoton S.R.L. |
General, Plastic Surgery |
GEX |
| May 29, 26 |
K260507510(k) |
Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo Plus |
INTEROJO, Inc. |
Ophthalmic |
LPL |
| May 29, 26 |
K261038510(k) |
Xpert PFP |
Newclip Technics |
Orthopedic |
HRS |
| May 29, 26 |
K261060510(k) |
Navigated LLIF Impactable Tracker |
Tyber Medical, LLC |
Neurology |
OLO |
| May 29, 26 |
K261159510(k) |
Exceed® Biplanar Expandable Interbody System |
Spine Wave, Inc. |
Orthopedic |
MAX |
| May 29, 26 |
K261202510(k) |
ENTire IRE System |
Entire Medical , Ltd. |
General, Plastic Surgery |
GEI |
| May 29, 26 |
K261369510(k) |
GI Genius Module 300 (GGM300-US);ColonPRO US (CPRO403S-US) |
Cosmo Artificial Intelligence - Ai, Ltd. |
Gastroenterology, Urology |
QNP |
| May 28, 26 |
K251840510(k) |
Zimmer® Persona® Personalized Knee System |
Zimmer, Inc. |
Orthopedic |
MBH |
| May 28, 26 |
K252702510(k) |
Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602N |
Bioptimal International Pte. , Ltd. |
Cardiovascular |
DQO |
| May 28, 26 |
K252712510(k) |
STIMPOD NMS460 Nerve Stimulator |
Algiamed Technologies USA, Inc. |
Neurology |
GZJ |
| May 28, 26 |
K252823510(k) |
Dukal Crepe Paper Sterilization Wrap |
Dukal, LLC |
General Hospital |
FRG |
| May 28, 26 |
K253530510(k) |
Trexon Monofilament Synthetic Absorbable Suture |
Medtronic |
General, Plastic Surgery |
GAM |
| May 28, 26 |
K253894510(k) |
BMD Titanium Spinal Fusion System |
Global Biomedica s.r.o. |
Orthopedic |
MAX |
| May 28, 26 |
K253931510(k) |
Arthrex Bioabsorbable PushLock Suture Anchors |
Arthrex, Inc. |
Orthopedic |
MAI |
| May 28, 26 |
K254092510(k) |
Bellalun 2D (VDMS-1000S) |
Vieworks Co., Ltd. |
Radiology |
MUE |
| May 28, 26 |
K260213510(k) |
BD BACTEC FXI Culture System |
BD Diagnostic Systems |
Microbiology |
MDB |
| May 28, 26 |
K260295510(k) |
Helio Kids; Apex P |
Motion Composites |
Physical Medicine |
IOR |
| May 28, 26 |
K260423510(k) |
Disposable Endoscopic Distal Attachments |
Yangzhou Fartley Medical Instrument Technology Co., Ltd. |
Gastroenterology, Urology |
FDF |
| May 28, 26 |
K260895510(k) |
Ulike Clear Zero (YC10 BU) |
Guangxi Ulike Medical Technology Co., Ltd. |
Neurology |
NFO |
| May 28, 26 |
K261037510(k) |
780 nm SPY Portable Handheld Imaging (SPY-PHI) System |
Stryker Endoscopy |
Radiology |
IZI |
| May 28, 26 |
K261405510(k) |
ANDI 2.2 |
Imeka Solutions, Inc. |
Radiology |
QIH |
| May 27, 26 |
K252930510(k) |
AQUA Laminoplasty Systems |
ZheJiang Decans Medical Devices Co., Ltd. |
Orthopedic |
NQW |
| May 27, 26 |
K253130510(k) |
Dione PEEK Screw System |
ZheJiang Decans Medical Devices Co., Ltd. |
Orthopedic |
MBI |
| May 27, 26 |
K253212510(k) |
XR-Series (XR-10, XR-20) Automated Hematology Analyzers |
Sysmex America, Inc. |
Hematology |
GKZ |
| May 27, 26 |
K253971510(k) |
Visby Medical Flu and COVID-19 Test |
Visby Medical, Inc. |
Microbiology |
SIA |
| May 27, 26 |
K254075510(k) |
Synapse Lung Nodule AI |
Fujifilm Corporation |
Radiology |
OEB |
| May 27, 26 |
K254102510(k) |
Glucommander |
Glytec, LLC |
Anesthesiology |
NDC |
| May 27, 26 |
K254104510(k) |
ResScan Essentials |
Resmed Corp |
Anesthesiology |
BZD |
| May 27, 26 |
K254265510(k) |
Helion Viewer Suite |
Videomed Srl ( a Baxter Healthcare Corp company) |
Radiology |
LLZ |
| May 27, 26 |
K260123510(k) |
EPIQ Series Diagnostic Ultrasound System |
Philips Ultrasound, LLC |
Radiology |
IYN |
| May 27, 26 |
K260142510(k) |
StimelMD (SSMD) system |
Motion Informatics ltd. |
Physical Medicine |
IPF |
| May 27, 26 |
K260207510(k) |
Multimodality Simulation Workspace (MM Sim) (v1.0.0) |
Philips Medical Systems Nederland B.V. |
Radiology |
MUJ |
| May 27, 26 |
K260367510(k) |
Portable Dental X-ray System Model PDX nova |
PDX Co., Ltd. |
Dental |
EHD |
| May 27, 26 |
K260646510(k) |
RENASYS EDGE (66803126) |
Smith & Nephew Medical, Ltd. |
General, Plastic Surgery |
OMP |
| May 27, 26 |
K260680510(k) |
EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems |
Philips Ultrasound, LLC |
Radiology |
IYN |
| May 27, 26 |
K261374510(k) |
LigaPASS System |
Medicrea International S.A.S |
Orthopedic |
OWI |
| May 26, 26 |
K252790510(k) |
Digital ClarusScope System and Digital NeuroPEN System |
Clarus Medical, LLC |
Orthopedic |
HRX |
| May 26, 26 |
K252797510(k) |
JAZBI Resorbable Bone Void Filler |
Sdip Innovations Pty, Ltd. |
Orthopedic |
MQV |
| May 26, 26 |
K252833510(k) |
VIVA combo RF System |
Starmed Co., Ltd. |
General, Plastic Surgery |
GEI |
| May 26, 26 |
K253629510(k) |
Momcozy Nasal Aspirator (BN007) |
Shenzhen Root Innovation Technology Co., Ltd. |
General, Plastic Surgery |
BTA |
| May 26, 26 |
K254157510(k) |
CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody |
Medos International SARL |
Neurology |
OLO |
| May 26, 26 |
K260318510(k) |
4K NIR/ICG Imaging System |
Zhejiang Healnoc Technology Co., Ltd. |
Gastroenterology, Urology |
GCJ |
| May 26, 26 |
K260398510(k) |
LOGIQ e |
GE Medical Systems Ultrasound and Primary Care Diagnostics |
Radiology |
IYN |
| May 24, 26 |
K260183510(k) |
MediBot Needle Driver Uno |
Parallel Robotics, LLC |
Gastroenterology, Urology |
GCJ |
| May 22, 26 |
DEN250057510(k) |
PCWP Analysis Software |
Cardiosense, Inc. |
Cardiovascular |
SIF |
| May 22, 26 |
K252735510(k) |
C-beam |
Pulmera, Inc. |
Radiology |
OWB |
| May 22, 26 |
K252772510(k) |
Arc Adjustable Radial Cuff Compression Device |
Tz Medical, Inc. |
Cardiovascular |
DXC |
| May 22, 26 |
K252784510(k) |
eXaSkin Plus |
Anatomical Geometry S.L. |
Radiology |
MUJ |
| May 22, 26 |
K252887510(k) |
DePuy ATTUNE Knee System |
DePuy Orthopaedics, Inc. |
Orthopedic |
OIY |
| May 22, 26 |
K252915510(k) |
AiSteth® |
Ai Health Highway India Pvt., Ltd. |
Cardiovascular |
DQD |
| May 22, 26 |
K252917510(k) |
ATLAAS (Atraumatic Left Atrial Appendage System) (AD) |
Genesee Biomedical, Inc. |
General, Plastic Surgery |
PZX |
| May 22, 26 |
K253060510(k) |
Sterile Latex Powder Free Surgical Gloves |
Protect Gloves Company Limited |
General, Plastic Surgery |
KGO |
| May 22, 26 |
K253359510(k) |
Zenith Distal Access Long Sheath |
Suzhou Zenith Vascular SciTech Limited |
Cardiovascular |
QJP |
| May 22, 26 |
K253569510(k) |
Atmo Gas Capsule System |
Atmo Biosciences, Ltd. |
Gastroenterology, Urology |
NYV |
| May 22, 26 |
K253773510(k) |
Guanhong Sharps Container (GHW-1F1); Guanhong Sharps Container (GHW-1F4); Guanhong Sharps Container (GH-6FA); Guanhong Sharps Container (GHW-2FR); Guanhong Sharps Container (GHW-8FR); Guanhong Sharps Container (GH-3FS); Guanhong Sharps Container (GHW-15FS); Guanhong Sharps Container (GHW-27FS); Guanhong Sharps Container (GH-5FSW); Guanhong Sharps Container (GHW-3FT); Guanhong Sharps Container (GHW-4FT); Guanhong Sharps Container (GHW-5FT); Guanhong Sharps Container (GHW-8FT); Guanhong |
Taizhou Huangyan Guanhong Plastic Steel Products Factory |
General Hospital |
MMK |
| May 22, 26 |
K253949510(k) |
SonoPort Series Digital Color Doppler Ultrasound System (SonoPort 1, SonoPort 1 Exp, SonoPort 1 Pro, SonoPort 1 Elite, SonoPort 1 Plus, SonoPort 2, SonoPort 2 Exp, SonoPort 2 Pro, SonoPort 2 Elite, SonoPort 2 Plus, SonoPort 3, SonoPort 3 Exp, SonoPort 3 Pro, SonoPort 3 Elite, SonoPort 3 Plus, SonoPort 4, SonoPort 4 Exp, SonoPort 4 Pro, SonoPort 4 Elite, SonoPort 4 Plus, SonoPort 5, SonoPort 5 Exp, SonoPort 5 Pro, SonoPort 5 Elite, SonoPort 5 Plus, SonoPort 6, SonoPort 6 Exp, SonoPort 6 |
CHISON Medical Technologies Co., Ltd. |
Radiology |
IYN |
| May 22, 26 |
K254129510(k) |
Spectrum-2 |
Neko Health AB |
Cardiovascular |
MUD |
| May 22, 26 |
K254137510(k) |
InQwire Amplatz Guide Wire |
Merit Medical Ireland, Ltd. |
Cardiovascular |
DQX |
| May 22, 26 |
K260113510(k) |
uMR Astra |
Shanghai United Imaging Healthcare Co., Ltd. |
Radiology |
LNH |
| May 22, 26 |
K260189510(k) |
MagVenture Accelerated TMS (aTMS) Therapy System |
Tonica Elektronik A/S |
Neurology |
OBP |
| May 22, 26 |
K260324510(k) |
Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning |
Canon Medical Informatics, Inc. |
Radiology |
QIH |
| May 22, 26 |
K260329510(k) |
Ion-C Navigation Instruments |
SurGenTec, LLC |
Neurology |
OLO |
| May 22, 26 |
K260560510(k) |
Apollo TMS Therapy System;Apollo light TMS Therapy System |
Mag & More GmbH |
Neurology |
OBP |
| May 22, 26 |
K260695510(k) |
da Vinci Firefly Imaging System |
Intuitive Surgical |
Gastroenterology, Urology |
NAY |
| May 22, 26 |
K261098510(k) |
TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN 2012)TetraSens Pediatric (SEN 2013)TetraSensitive (SEN 2016)TetraHub (SEN 2017) |
Senzime AB |
Anesthesiology |
KOI |
| May 22, 26 |
K261280510(k) |
BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test Panel |
Vivachek Biotech (Hangzhou) Co., Ltd. |
Clinical Toxicology |
NFT |
| May 21, 26 |
DEN250028510(k) |
DeepView AI® System |
Spectralmd, Inc. |
General, Plastic Surgery |
SHY |
| May 21, 26 |
K251920510(k) |
Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face Mask |
Dcstar, Inc. |
Anesthesiology |
BZD |
| May 21, 26 |
K252746510(k) |
Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL) |
Drägerwerk AG Co. Kgaa |
Anesthesiology |
BSZ |
| May 21, 26 |
K253112510(k) |
Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe) |
Hlb Lifescience Co., Ltd. |
General Hospital |
FMF |
| May 21, 26 |
K253191510(k) |
DCMhotbond zircon |
Dental Creativ Management GmbH |
Dental |
EIH |
| May 21, 26 |
K253245510(k) |
Boston 2910 (Boston 2910) |
Boston Aesthetics, Inc. |
General, Plastic Surgery |
GEX |
| May 21, 26 |
K253352510(k) |
Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Color Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Color Soft (Hydrophilic) Contact Lenses |
Pegavision Corporation |
Ophthalmic |
LPL |
| May 21, 26 |
K253720510(k) |
uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita Elite, uSONIQUE Grace, uSONIQUE Grace Elite |
Wuhan United Imaging Healthcare Co.,Ltd |
Radiology |
IYN |
| May 21, 26 |
K253816510(k) |
MuCover (proposed name) Oral Wound Dressing |
MoleculeX Co., Ltd. |
Unknown |
OLR |
| May 21, 26 |
K253956510(k) |
ProGrip advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030) |
Sofradim Production |
General, Plastic Surgery |
FTL |
| May 21, 26 |
K254131510(k) |
BAC |
DeepHealth, Inc. |
Radiology |
QIH |
| May 21, 26 |
K254141510(k) |
Manual Wheelchair (DY01903(2)) |
Guangdong Dayang Medical Technology Co., Ltd. |
Physical Medicine |
IOR |
| May 21, 26 |
K254244510(k) |
Wearable Breast Pump (Model S39) |
Shenzhen TPH Technology Co., Ltd. |
Obstetrics/Gynecology |
HGX |
| May 21, 26 |
K260066510(k) |
PanopticAI Vital Signs (1.6.1-22) |
PanopticAI Technologies Limited |
Cardiovascular |
QME |
| May 21, 26 |
K260068510(k) |
pjur NATURE Touch, 100 ml |
Pjur Group Luxembourg S.A. |
Obstetrics/Gynecology |
NUC |
| May 21, 26 |
K260234510(k) |
MSK Go |
Smart Alfa Teknoloji San. Ve Tic. A.S. |
Radiology |
QIH |
| May 21, 26 |
K260580510(k) |
Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS) |
Olympus Medical Systems Corp. |
Gastroenterology, Urology |
PKL |
| May 21, 26 |
K260582510(k) |
ROSA® Shoulder System |
Orthosoft Inc. (d/b/a) Zimmer CAS |
Neurology |
OLO |
| May 21, 26 |
K260618510(k) |
Ulthera® System |
Ulthera, Inc. |
General, Plastic Surgery |
OHV |
| May 21, 26 |
K260649510(k) |
OES ELITE Cystoscope and Accessories; Obturator, 17 Fr. (WA2C17BO); Obturator, 19.8 Fr. (WA2C19BO); Obturator, 21 Fr. (WA2C21BO); Obturator, 21 Fr., for sheath with ramp (WA2C21RO); Obturator, 21 Fr., long (WA2C21LO); Obturator, 21 Fr., for straight sheath (WA2C21SO); Obturator, 22.5 Fr. (WA2C22BO); Obturator, 25 Fr. (WA2C25BO); Obturator, optical, 19.8 Fr. (WA2C19BV); Obturator, optical, 21 Fr. (WA2C21BV); Obturator, optical, 21 Fr., for straight sheath (WA2C21SV); Obturator, optical, |
Olympus Winter & Ibe GmbH |
Gastroenterology, Urology |
FAJ |
| May 21, 26 |
K260962510(k) |
Sphincterotome |
Taewoong Medical Co., Ltd. |
Gastroenterology, Urology |
KNS |
| May 21, 26 |
K261291510(k) |
Nisus NPWT Canister 500-mL (CPC-500) |
Cork Medical |
General, Plastic Surgery |
OMP |
| May 21, 26 |
K261315510(k) |
Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia Pro.specta VA40 Family |
Siemens Medical Solutions USA, Inc. |
Radiology |
KPS |
| May 21, 26 |
K261325510(k) |
Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU) |
Shenzhen Ulike Smart Electronics Co., Ltd. |
General, Plastic Surgery |
OHT |
| May 21, 26 |
K261359510(k) |
Stelo Glucose Biosensor System |
Dexcom, Inc. |
Clinical Chemistry |
SAF |
| May 20, 26 |
K252707510(k) |
Zenith Aspiration Catheter; Disposable Aspiration Tubing Set |
Suzhou Zenith Vascular SciTech Limited |
Cardiovascular |
NRY |
| May 20, 26 |
K252717510(k) |
MAASTRO Rectal Applicator Set |
Varian Medical Systems |
Radiology |
JAQ |
| May 20, 26 |
K253134510(k) |
LAGIS Endoscopic Instruments- Scissors (EI-330S EI-330S-T EI-330MS EI-330MS-T) |
Lagis Enterprise Co., Ltd. |
General, Plastic Surgery |
GEI |
| May 20, 26 |
K253570510(k) |
Blood Pressure Monitor (W06LT) |
Shenzhen Jamr Technology Co., Ltd. |
Cardiovascular |
DXN |
| May 20, 26 |
K253596510(k) |
Aquilion ONE (TSX-308A/TSX-306A) V2.0 |
Canon Medical Systems Corporation |
Radiology |
JAK |
| May 20, 26 |
K253774510(k) |
Elos Accurate® Denture Fixation System |
Elos Medtech Pinol A/S |
Dental |
NHA |
| May 20, 26 |
K253911510(k) |
Derma-2 |
Neko Health AB |
Obstetrics/Gynecology |
LHQ |
| May 20, 26 |
K260098510(k) |
ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C /ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC) |
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. |
Cardiovascular |
MHX |
| May 20, 26 |
K260304510(k) |
WAVE PTA Balloon Catheter |
WAVE Medical AG |
Cardiovascular |
LIT |
| May 20, 26 |
K260351510(k) |
Numen Helia Coil Embolization System; NumenFR Detachment System |
MicroPort NeuroTech (Shanghai) Co., Ltd. |
Neurology |
HCG |
| May 20, 26 |
K260594510(k) |
IPL Hair Removal Device (FL-B505AG, FL-B505AP, FL-B505AM, FL-B507AG, FL-B507AP, FL-B507AM, FL-B508AG, FL-B508AP, FL-B508AM, FL-B509AG, FL-B509AP, FL-B509AM, FL-B510G, FL-B510P, FL-B510M, FL-B511G, FL-B511P, FL-B511M, FL-B512AG, FL-B512AP, FL-B512AM, FL-B513AG, FL-B513AP, FL-B513AM) |
Shenzhen Xiazhifeng Electronic Co., Ltd. |
General, Plastic Surgery |
OHT |
| May 20, 26 |
K260717510(k) |
Mobility Scooter (Air Carbon) |
Suzhou Sweetrich Vehicle Industry Technology Co., Ltd. |
Physical Medicine |
INI |
| May 20, 26 |
K261286510(k) |
The Circadia C300 System (C300) |
Circadia Health, Inc. |
Cardiovascular |
DRT |
| May 19, 26 |
K251270510(k) |
Taperloc® Complete Hip Stem |
Biomet, Inc. |
Orthopedic |
LPH |
| May 19, 26 |
K252985510(k) |
Laport |
Sejong Medical Co., Ltd. |
Gastroenterology, Urology |
GCJ |
| May 19, 26 |
K253309510(k) |
SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy system family of the Dental diode laser ( ILaser III Pro) |
Shenzhen Soga Technology Co., Ltd. |
General, Plastic Surgery |
NVK |
| May 19, 26 |
K253722510(k) |
LIAISON PLEX Gastrointestinal Flex Assay |
Luminex Corporation |
Microbiology |
PCH |
| May 19, 26 |
K254024510(k) |
MR5 Activ Pro |
Multi Radiance Medical, Inc. |
Physical Medicine |
NHN |
| May 19, 26 |
K260146510(k) |
FITBONE® TRANSPORT AND LENGTHENING SYSTEM |
Orthofix Srl |
Orthopedic |
HSB |
| May 19, 26 |
K260268510(k) |
OrthoEasy Pal; OrthoEasy Pal Long Neck |
Bernhard Förster GmbH (Bernhard Foerster Ltd.) |
Dental |
OAT |
| May 19, 26 |
K260577510(k) |
FilmArray TF Control Panel M527 |
Maine Molecular Quality Controls, Inc. |
Microbiology |
PMN |
| May 19, 26 |
K261071510(k) |
DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g) |
DiaDent Group International |
Dental |
EBF |
| May 19, 26 |
K261299510(k) |
Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses |
Pegavision Corporation |
Ophthalmic |
LPL |
| May 19, 26 |
P250020PMA |
Belotero Volume (+) Lidocaine |
Merz North America, Inc. |
General, Plastic Surgery |
LMH |
| May 19, 26 |
P250027PMA |
Guardant360® Liquid CDx |
Guardant Health, Inc. |
Pathology |
PQP |
| May 18, 26 |
K252047510(k) |
STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices |
ETHICON, Inc. |
General, Plastic Surgery |
NEW |
| May 18, 26 |
K253295510(k) |
Coude Sleeved IC; Coude Plus Sleeved IC |
Hollister Incorporated |
Gastroenterology, Urology |
EZD |
| May 18, 26 |
K253454510(k) |
HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization Wrap |
O&M Halyard, Inc. |
General Hospital |
FRG |
| May 18, 26 |
K253831510(k) |
CMN Capillary Function with Virtual Expert for MRI, CT and CBCT |
Cercare Medical A/S |
Radiology |
LLZ |
| May 18, 26 |
K254109510(k) |
G-CEM UNIVERSAL |
GC America, Inc. |
Dental |
EMA |
| May 18, 26 |
K260100510(k) |
MOSES Raydar |
Boston Scientific Corporation |
General, Plastic Surgery |
GEX |
| May 18, 26 |
K260522510(k) |
RhinAer+ Stylus |
Aerin Medical, Inc. |
General, Plastic Surgery |
GEI |
| May 16, 26 |
K260840510(k) |
BluEX Cervical Expandable Cage System |
L&K BIOMED Co., Ltd. |
Orthopedic |
ODP |
| May 15, 26 |
K250781510(k) |
Embryo Predict |
Alife Health |
Obstetrics/Gynecology |
PBH |
| May 15, 26 |
K252377510(k) |
NxStage System One with NxView |
Fresenius Medical Care Renal Therapies Group, LLC |
Gastroenterology, Urology |
KDI |
| May 15, 26 |
K252423510(k) |
NovaLine Tubing Set for Hemodialysis (BL 124) |
Bain Medical Equipment (Guangzhou) Co., Ltd. |
Gastroenterology, Urology |
FJK |
| May 15, 26 |
K252563510(k) |
Neurophet SCALE PET |
Neurophet., Inc. |
Radiology |
QIH |
| May 15, 26 |
K252624510(k) |
KARL STORZ Laryngoscopes and Accessories |
KARL STORZ Endoscopy-America, Inc. |
Ear, Nose, Throat |
EQN |
| May 15, 26 |
K252643510(k) |
Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled |
Teleflex Medical Sdn. Bhd. |
Anesthesiology |
CAH |
| May 15, 26 |
K253235510(k) |
Introcan Safety® Deep Access XL IV Catheter |
B.Braun Medical, Inc. |
General Hospital |
FOZ |
| May 15, 26 |
K253642510(k) |
Jada System (Jada-2002) |
Organon, LLC |
Obstetrics/Gynecology |
OQY |
| May 15, 26 |
K253716510(k) |
uSONIQUE Genesis, uSONIQUE Genesis Pro, uSONIQUE Genesis Elite, uSONIQUE Genesis Super, uSONIQUE Pulse, uSONIQUE Pulse Pro, uSONIQUE Pulse Elite, uSONIQUE Pulse Super, uSONIQUE Venus, uSONIQUE Venus Pro, uSONIQUE Venus Elite, uSONIQUE Venus Super |
Wuhan United Imaging Healthcare Co.,Ltd |
Radiology |
IYN |
| May 15, 26 |
K253756510(k) |
cobas liat CT/NG nucleic acid test |
Roche Molecular Systems, Inc. |
Microbiology |
QEP |
| May 15, 26 |
K253759510(k) |
cobas liat CT/NG/MG nucleic acid test |
Roche Molecular Systems, Inc. |
Microbiology |
QEP |
| May 15, 26 |
K253935510(k) |
medXion NEXUS |
medXion Technologies, Inc. |
Radiology |
OAS |
| May 15, 26 |
K254028510(k) |
Digital Color Doppler Ultrasound System (Autra RS, Autra 90, Autra Senior, Autra CV, e-Autra, Autra 75, Autra 85W, Autra 65, Autra 55, Autra 65i, Autra 90 Elite, Autra 85 Elite, Autra 80 Elite, Autra 75 Elite, Autra 85 CV, Autra 80W, Autra 65 Elite, Autra 55 Elite, Autra 55i, Autra 90 CV, Autra 85, Autra 80, Autra 80 CV, Autra 75 Pro, Autra 75W, Autra 70 Elite, Autra 70, Autra T) |
Sonoscape Medical Corp. |
Radiology |
IYN |
| May 15, 26 |
K254050510(k) |
Manual Tissue Removal Device |
Suzhou AcuVu Medical Technology Co., Ltd. |
Obstetrics/Gynecology |
HIH |
| May 15, 26 |
K254120510(k) |
SubtleHD-CT (1.x) |
Subtle Medical, Inc. |
Radiology |
QIH |
| May 15, 26 |
K260059510(k) |
NOVEOS Specific IgE (sIgE); Capture Reagent F018, Brazil Nut (Bertholletia excelsa); Capture Reagent F036, Coconut (Cocos nucifera); Capture Reagent F040, Tuna (Thunnus sp.); Capture Reagent F041, Salmon (Salmo salar); Capture Reagent F075, Egg Yolk (Gallus gallus); Capture Reagent F201, Pecan Nut (Carya illinoensis); Capture Reagent F203, Pistachio Nut (Pistacia vera); Capture Reagent F290, Oyster (Ostrea edulis) |
Hycor Biomedical |
Immunology |
DHB |
| May 15, 26 |
K260134510(k) |
Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021) |
Shenzhen Root Innovation Technology Co., Ltd. |
General, Plastic Surgery |
BTA |
| May 15, 26 |
K260506510(k) |
Ventana® P/T Lumbar Interbody System |
Spinal Elements, Inc. |
Orthopedic |
MAX |
| May 15, 26 |
K260536510(k) |
Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement |
Depuy Ireland UC |
Orthopedic |
KWL |
| May 15, 26 |
K260771510(k) |
TruSelect 2.6 Microcatheter |
Boston Scientific Corporation |
Cardiovascular |
KRA |
| May 15, 26 |
K260989510(k) |
Varion Thoracolumbar Fixation System |
Kyocera Medical Technologies Inc. (KMTI) |
Orthopedic |
NKB |
| May 15, 26 |
K261264510(k) |
Stellaris Elite vision enhancement system; Posterior and Combined Procedure Pack(s): 23 ga. Posterior Elite Pack (SE5423); 23 ga. Bi-Blade Vitreous Cutter Posterior Stellaris Elite Pack (SE5423B); 25 ga. Posterior Elite Pack (SE5425); 25 ga. Bi-Blade Vitreous Cutter Posterior Stellaris Elite Pack (SE5425B); 27 ga. Bi-Blade Vitreous Cutter Posterior Stellaris Elite Pack (SE5427B); 23 ga. Bi-Blade+ Vitreous Cutter Posterior Stellaris Elite Pack (SE5423BB+); 25 ga. Bi-Blade+ |
Bausch and Lomb |
Ophthalmic |
HQC |
| May 15, 26 |
K261273510(k) |
Neurophet AQUA |
Neurophet., Inc. |
Radiology |
QIH |
| May 15, 26 |
K261289510(k) |
UNiD Spine Analyzer (SW3002) |
Medicrea International S.A.S. (Medtronic) |
Radiology |
QIH |
| May 15, 26 |
P260004PMA |
Signatera CDx |
Natera, Inc. |
Pathology |
PQP |
| May 14, 26 |
K252601510(k) |
Pelvic Muscle Trainer (PC22A); Pelvic Muscle Trainer (PC22A-L); Pelvic Muscle Trainer (PC22E); Pelvic Muscle Trainer (PC22E-L) |
Hunan Accurate Bio-Medical Technology Co., Ltd. |
Gastroenterology, Urology |
KPI |
| May 14, 26 |
K252652510(k) |
Disposable Syringes with Accessories for Power Injectors (900103T); Disposable Syringes with Accessories for Power Injectors (900103H); Disposable Syringes with Accessories for Power Injectors (801800H); Disposable Syringes with Accessories for Power Injectors (800099T); Disposable Syringes with Accessories for Power Injectors (800099H); Disposable Syringes with Accessories for Power Injectors (800096T); Disposable Syringes with Accessories for Power Injectors (800096H); Disposable Syr |
Fortis Biosolutions Company Limited |
Cardiovascular |
DXT |
| May 14, 26 |
K252776510(k) |
ARIES Anterior Cervical Plate Systems |
ZheJiang Decans Medical Devices Co., Ltd. |
Orthopedic |
KWQ |
| May 14, 26 |
K253078510(k) |
ART.1-US |
Seetreat Pty, Ltd. |
Radiology |
MUJ |
| May 14, 26 |
K253372510(k) |
ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing Abutments |
Hiossen, Inc. |
Dental |
NHA |
| May 14, 26 |
K253676510(k) |
CORUS Posterior Cervical Stabilization System 3D (CORUS PCSS 3D) |
Providence Medical Technology, Inc. |
Unknown |
MRW |
| May 14, 26 |
K253883510(k) |
Bonalive Maxillofacial |
Bonalive , Ltd. |
Dental |
LYC |
| May 14, 26 |
K254013510(k) |
SubtleHD-PET (1.x) |
Subtle Medical, Inc. |
Radiology |
LLZ |
| May 14, 26 |
K254048510(k) |
Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T) |
Shenzhen Urion Technology Co., Ltd. |
Cardiovascular |
DXN |
| May 14, 26 |
K254133510(k) |
ENTity USB Videoscope System |
Optim, LLC |
Ear, Nose, Throat |
EOB |
| May 14, 26 |
K260085510(k) |
RAYMO Mobile X-ray System (Model: RAYMO) |
DRGEM Corporation |
Radiology |
IZL |
| May 14, 26 |
K260111510(k) |
Palmtop Ultrasound Diagnostic System (MT10P/MT10) |
Mytech Intelligence (Shenzhen) Co., Ltd. |
Radiology |
IYN |
| May 14, 26 |
K260485510(k) |
Any-Etch |
Mediclus Co., Ltd. |
Dental |
KLE |
| May 14, 26 |
K260565510(k) |
SmartClip Delivery Catheter (ADR-1715) |
Elucent Medical |
Ear, Nose, Throat |
EOQ |
| May 14, 26 |
K260892510(k) |
Suction Pump (SU-90) |
Shenzhen HugeMed Medical Technical Development Co., Ltd. |
General, Plastic Surgery |
BTA |
| May 14, 26 |
K261134510(k) |
Dormiva Anti-Snoring Mouth Guard |
Koncept Innovators, Inc. |
Dental |
LRK |
| May 14, 26 |
K261224510(k) |
MatriDerm |
Medskin Solutions Dr. Suwelack AG |
Unknown |
KGN |
| May 14, 26 |
K261241510(k) |
TriMed Compression Screws |
TriMed, Inc. |
Orthopedic |
HWC |
| May 14, 26 |
K261317510(k) |
BriefCase-Triage |
Aidoc Medical , Ltd. |
Radiology |
QAS |
| May 13, 26 |
K252591510(k) |
Automatic Micro Needle System (CODE-X) |
Woorhi Mechatronics Co., Ltd. |
General, Plastic Surgery |
QAI |
| May 13, 26 |
K252638510(k) |
VeraPro S100 Multi-Use Syringe (018808); VeraPro S100 LV1 Low Viscosity Single-Use Syringe (018811); VeraPro AMT Auto-Manifold and Transducer (018814); VeraPro AngioTouch FLX165 Hand Controller Kit (018806); VeraPro AngioTouch HiFi165 Hand Controller Kit (018804) |
Acist Medical Systems, Inc. |
Cardiovascular |
DXT |
| May 13, 26 |
K252653510(k) |
ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module; ACIST Pro Cart; Single Transducer Cable; Triple Transducer Cable |
Acist Medical Systems, Inc. |
Cardiovascular |
DXT |
| May 13, 26 |
K253061510(k) |
Portable Neuromodulation Stimulator (PoNS) |
Helius Medical, Inc. |
Neurology |
QCF |
| May 13, 26 |
K253181510(k) |
SURGIMAGE SIM 1000H Fluorescence Imaging Platform |
Surgimage Corporation |
Radiology |
IZI |
| May 13, 26 |
K253241510(k) |
Electric Wheelchair (Y207BL) |
Jiangsu Intco Medical Products Co., Ltd. |
Physical Medicine |
ITI |
| May 13, 26 |
K254073510(k) |
StatSeal Disc |
Merit Medical Systems, Inc. |
Unknown |
FRO |
| May 13, 26 |
K254125510(k) |
Electric Breast Pump (HL-3058 II Pro) |
Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. |
Obstetrics/Gynecology |
HGX |
| May 13, 26 |
K260032510(k) |
Morph |
BeauBrain Healthcare, Inc. |
Radiology |
QIH |
| May 13, 26 |
K261363510(k) |
Y-Knotless Flex Anchors |
CONMED Corporation |
Orthopedic |
MBI |
| May 12, 26 |
K252731510(k) |
Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant |
Promimic AB |
Dental |
DZE |
| May 12, 26 |
K254192510(k) |
Senhance Ultrasonic System |
Asensus Surgical |
Gastroenterology, Urology |
NAY |
| May 12, 26 |
K260051510(k) |
CorVision® (91-205-Z0014) |
CorVent® Medical, Inc. |
Anesthesiology |
MOD |
| May 12, 26 |
K260235510(k) |
CellDx-Tissue |
Datar Cancer Genetics Private Limited |
Pathology |
PZM |
| May 12, 26 |
K260378510(k) |
Rayvolve |
AZmed |
Radiology |
QBS |
| May 12, 26 |
K260415510(k) |
myLEDmask 2 (MJ-144) |
Light Tree Ventures Europe B.V. |
General, Plastic Surgery |
OHS |
| May 12, 26 |
K260473510(k) |
Electric nasal aspirator (BC027, BC030, BC033, BC035, BC035B) |
Shenzhen Kingboom Technology Co., Ltd. |
General, Plastic Surgery |
BTA |
| May 12, 26 |
K260725510(k) |
BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10) |
Hindernis DE Mexico, S.A.P.I. DE C.V. |
General, Plastic Surgery |
FYA |
| May 12, 26 |
K260837510(k) |
VersaLift Expandable System |
Life Spine, Inc. |
Orthopedic |
MAX |
| May 12, 26 |
K260850510(k) |
OSTEOMNI SPINAL CAGES SYSTEM |
Osteomni, Inc. |
Orthopedic |
ODP |
| May 12, 26 |
K261196510(k) |
Promisemed VeriEcto Automatic Biopsy Needles |
Promisemed Hangzhou Meditech Co., Ltd. |
Gastroenterology, Urology |
KNW |
| May 11, 26 |
K250964510(k) |
Protable Phlegm Suction Unit (JMA D01) |
Jiangsu Jumao X-Care Medical Equipment Co., Ltd. |
General, Plastic Surgery |
JCX |
| May 11, 26 |
K252655510(k) |
Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT) |
Shenzhen Imdk Medical Technology Co., Ltd. |
Cardiovascular |
DQA |
| May 11, 26 |
K252880510(k) |
Pytheas Your Guided Trajectory |
Pytheas Navigation Sas |
Neurology |
OLO |
| May 11, 26 |
K252953510(k) |
Velmeni for Dentists (V4D) Endo-Perio |
Velmeni, Inc. |
Radiology |
MYN |
| May 11, 26 |
K253696510(k) |
CFlex Cystoscope - Standard Deflection (0570-0455); CFlex Cystoscope - Reverse Deflection (0570-0456); CystoView Monitor (0570-0465) |
Verathon Medical (Canada) Ulc |
Gastroenterology, Urology |
FAJ |
| May 11, 26 |
K254178510(k) |
SAYA 86 Radial Access Guide Catheter |
Asahi Intecc Co., Ltd. |
Cardiovascular |
QJP |
| May 11, 26 |
K254228510(k) |
KARL STORZ Trocars with Valve Seals |
Karl Storz SE & CO. KG |
Gastroenterology, Urology |
GCJ |
| May 11, 26 |
K260196510(k) |
ETHICON Circular Stapler (CDH21mm); ETHICON Circular Stapler (CDH25mm); ETHICON Circular Stapler (CDH29mm); ETHICON Circular Stapler (CDH33mm); ETHICON Circular Stapler - XL Sealed (ECS21mm); ETHICON Circular Stapler - XL Sealed (ECS25mm); ETHICON Circular Stapler - XL Sealed (ECS29mm); ETHICON Circular Stapler - XL Sealed (ECS33mm) |
Ethicon Endo-Surgery, LLC |
General, Plastic Surgery |
GDW |
| May 11, 26 |
K260805510(k) |
Dual Core |
Vericom Co., Ltd. |
Dental |
EBF |
| May 11, 26 |
K260842510(k) |
HardyDisk AST Gepotidacin 10µg (GEP10) |
Hardy Diagnostics |
Microbiology |
JTN |
| May 11, 26 |
K260846510(k) |
Diagnostic Ultrasound System (MU9);Diagnostic Ultrasound System (MU9S);Diagnostic Ultrasound System (MU9T);Diagnostic Ultrasound System (MU9 Exp);Diagnostic Ultrasound System (MU9 Pro);Diagnostic Ultrasound System (MU9 Super);Diagnostic Ultrasound System (MU9P);Diagnostic Ultrasound System (MU9A);Diagnostic Ultrasound System (MU7);Diagnostic Ultrasound System (MU7S);Diagnostic Ultrasound System (MU7T);Diagnostic Ultrasound System (MU7 Exp);Diagnostic Ultrasound System (MU7 Pro);Diagnos |
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. |
Radiology |
IYN |
| May 11, 26 |
K261214510(k) |
PICO SHINING (PICO-K; PICOFY) |
Speclipse, Inc. |
General, Plastic Surgery |
GEX |
| May 11, 26 |
P250026PMA |
Atellica IM free PSA II (fPSAII) |
Siemens Healthcare Diagnostics, Inc. |
Immunology |
MTG |
| May 9, 26 |
K260385510(k) |
aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; aprevo® cervical interbody system; corra cervical plating system |
Carlsmed, Inc. |
Orthopedic |
MAX |
| May 9, 26 |
K261145510(k) |
Avanti Distal Elbow ORIF System |
Avanti Orthopaedics, LLC |
Orthopedic |
HRS |
| May 8, 26 |
DEN250013510(k) |
Modius Spero |
Neurovalens Limited |
Neurology |
SHX |
| May 8, 26 |
K250814510(k) |
Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB |
Zeus Scientific |
Immunology |
OBE |
| May 8, 26 |
K252617510(k) |
MiroCam® Capsule Endoscope System |
Intromedic Co., Ltd. |
Gastroenterology, Urology |
NEZ |
| May 8, 26 |
K252621510(k) |
DeepSkin (DEP100) |
El Global Trade, Ltd. |
Neurology |
NFO |
| May 8, 26 |
K253013510(k) |
Disposable Stone Retrieval Balloon Catheter |
Zhejiang Soudon Medical Technology Co., Ltd. |
Gastroenterology, Urology |
GCA |
| May 8, 26 |
K253237510(k) |
Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode) |
Elde Medikal Sanayi ve Ticaret Anonim Sirketi |
Neurology |
GXY |
| May 8, 26 |
K253396510(k) |
AYON Body Contouring System (AYON SYSTEM) |
Apyx Medical Corporation |
General, Plastic Surgery |
QPB |
| May 8, 26 |
K253679510(k) |
Hydro Irrigation System |
Stryker Instruments |
Neurology |
GWG |
| May 8, 26 |
K253991510(k) |
Fitbone Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA |
Orthofix Srl |
Orthopedic |
HSB |
| May 8, 26 |
K254215510(k) |
Arthrex Beaming System |
Arthrex, Inc. |
Orthopedic |
HWC |
| May 8, 26 |
K260321510(k) |
HipGuide (V 1.0.0.0) |
Orthopedic Driven Imaging, LLC |
Radiology |
LLZ |
| May 8, 26 |
K260419510(k) |
LingOral Dental Design System |
Hangzhou ChohoTech Co., Ltd. |
Dental |
PNN |
| May 8, 26 |
K260788510(k) |
Smylio Aligners |
Smylio, Inc. |
Dental |
NXC |
| May 8, 26 |
K260792510(k) |
AerFrame Patient Immobilization System (AFPIS) |
Stabilix, LLC |
Radiology |
IYE |
| May 7, 26 |
K253647510(k) |
Evita (V800); Evita (V600) |
Draegerwerk AG & CO Kgaa |
Anesthesiology |
CBK |
| May 7, 26 |
K253739510(k) |
SCRIPT Rods, CREO Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline System |
Globus Medical, Inc. |
Orthopedic |
NKB |
| May 7, 26 |
K253826510(k) |
Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI Flex Needle |
Galvanize Therapeutics, Inc. |
General, Plastic Surgery |
OAB |
| May 7, 26 |
K253837510(k) |
SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex Module |
Heidelberg Engineering GmbH |
Ophthalmic |
OBO |
| May 7, 26 |
K253992510(k) |
Veritas Reverse Total Shoulder System |
Restor3D |
Orthopedic |
PHX |
| May 7, 26 |
K254183510(k) |
MR Conditional Cup Electrodes |
Technomed Europe |
Neurology |
GXY |
| May 7, 26 |
K254276510(k) |
Lynx Aspiration Catheter System |
QApel Medical, Inc. |
Cardiovascular |
NRY |
| May 7, 26 |
K260460510(k) |
Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue |
Institut Straumann AG |
Dental |
NHA |
| May 7, 26 |
K260974510(k) |
CO2 Laser Machine (Monica-I,Monica-II) |
Nanjing Bestview Laser S&T Co., Ltd. |
General, Plastic Surgery |
GEX |
| May 7, 26 |
P250039PMA |
LIAISON Biotrin Parvovirus B19 IgM Plus, LIAISON Biotrin Control Parvovirus B19 IgM Plus |
DiaSorin, Inc. |
Microbiology |
MYM |
| May 6, 26 |
K252552510(k) |
Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303) |
Shenzhen Changkun Technology Co., Ltd. |
Gastroenterology, Urology |
KPI |
| May 6, 26 |
K253027510(k) |
Anchor with Fiber Wire and Disposable Inserter |
Ortobio S.A. |
Orthopedic |
MBI |
| May 6, 26 |
K253152510(k) |
BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000) |
Biozen, LLC |
Cardiovascular |
DXN |
| May 6, 26 |
K253855510(k) |
KardiaPSI Balloon Catheter |
Intervention Tech, Inc. ; dba Corvention |
Cardiovascular |
OZT |
| May 6, 26 |
K260376510(k) |
Denture Base |
Shandong Huge Dental Material Corporation |
Dental |
EBI |
| May 6, 26 |
K260747510(k) |
YP-710T Series NIBP Cuff;YP-840T Series Disposable Cuff |
Nihon Kohden Corporation |
Cardiovascular |
DXQ |
| May 6, 26 |
K260775510(k) |
Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape |
Teleflex Medical, LLC |
General, Plastic Surgery |
GAT |
| May 6, 26 |
K261112510(k) |
CastleLoc-P Anterior Cervical Plate System |
L&K BIOMED Co., Ltd. |
Orthopedic |
KWQ |
| May 5, 26 |
K252558510(k) |
Lumify Diagnostic Ultrasound System |
Philips Ultrasound, LLC |
Radiology |
IYN |
| May 5, 26 |
K254200510(k) |
Air Compression Leg Massager (LF-FT001, LF-FT002-1, LF-FT003, LF-FT003-1, LF-FT004-1, LF-FT005-1, LF-FT006-1, LF-FT007, LF-FT008, LF-FT009, LF-FT010, LF-FT011, LF-FT012, LF-FT013, LF-FT014, LF-FT015, LF-FT016, UM-01, UM-02, UM-03, UM-03-1, UM-04-1, UM-05-1, UM-06-1, UM-07, UM-08, UM-09, UM-10, UM-11, UM-12, UM-13, UM-14, UM-15, UM-16, AI-01, AI-02, AI-03, AI-04, AI-05, AI-06, AI01, AI02, AI03, AI-07, AI-08, AI-09, AI-10, AI-11, AI-12, AI-13, AI-14) |
Wenzhou Lingfeng Electronic Technology Co., Ltd. |
Physical Medicine |
IRP |
| May 5, 26 |
K254202510(k) |
MectaLIF 3D Metal Anterior |
Medacta International S.A. |
Orthopedic |
OVD |
| May 5, 26 |
K260742510(k) |
Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK) |
Shenzhen Ulike Smart Electronics Co., Ltd. |
General, Plastic Surgery |
OHT |
| May 5, 26 |
K261130510(k) |
AccelFix Spinal Fixation System |
L&K BIOMED Co., Ltd. |
Orthopedic |
NKB |
| May 5, 26 |
K261132510(k) |
Healium Intelliscan LX192LC |
Healium Intelliscan Corporation |
Radiology |
IYN |
| May 4, 26 |
K252543510(k) |
AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04) |
Amsino International, Inc. |
General Hospital |
FPA |
| May 4, 26 |
K252622510(k) |
Male Latex Condom HA |
Okamoto USA, Inc. |
Obstetrics/Gynecology |
HIS |
| May 4, 26 |
K252954510(k) |
MammoSightAI |
Neurocareai, Inc. (Dba Savelife.Ai) |
Radiology |
QFM |
| May 4, 26 |
K253251510(k) |
Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece: Quad (810-b and Blend-b) |
Leaseir Technologies, Slu |
General, Plastic Surgery |
GEX |
| May 4, 26 |
K254019510(k) |
Wound Geni NPWT System |
Bechtel Medical, Inc. |
General, Plastic Surgery |
OMP |
| May 4, 26 |
K254115510(k) |
ArteraAI Breast |
Artera, Inc. |
Pathology |
SHW |
| May 4, 26 |
K260256510(k) |
Q-Switched Nd: YAG Laser Systems |
Shanghai Apolo Medical Technology Co., Ltd. |
General, Plastic Surgery |
GEX |
| May 4, 26 |
K260688510(k) |
Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C) |
Shenzhen Kaiyan Medical Equipment Co., Ltd. |
General, Plastic Surgery |
OLI |
| May 4, 26 |
K260716510(k) |
Neowise |
Cefla S.C. |
Radiology |
LLZ |
| May 1, 26 |
DEN240075510(k) |
Prolystica Pass Thru Disinfectant Wipes |
Steris |
General Hospital |
SHM |
| May 1, 26 |
K252073510(k) |
VOCO Profluorid Varnish + BioMin |
Voco GmbH |
Dental |
LBH |
| May 1, 26 |
K252439510(k) |
Tutamen Self Adhesive Electrodes |
Dongguan Tutamen Metalwork Co., Ltd. |
Neurology |
GXY |
| May 1, 26 |
K252475510(k) |
ABL90 FLEX PLUS System |
Radiometer Medicals Aps |
Clinical Chemistry |
JGS |
| May 1, 26 |
K252488510(k) |
ABL90 FLEX PLUS System |
Radiometer Medicals Aps |
Clinical Chemistry |
CGA |
| May 1, 26 |
K252635510(k) |
ArthroTAK Tendon Anchor Kit |
ArthroTAK, LLC |
Orthopedic |
MBI |
| May 1, 26 |
K253030510(k) |
Capnostream35 Portable Respiratory Monitor (PM35MN) |
Covidien, LLC |
Anesthesiology |
CCK |
| May 1, 26 |
K253326510(k) |
Oxiplex |
Fziomed, Inc. |
Orthopedic |
QVL |
| May 1, 26 |
K253663510(k) |
Zeta Navigation System |
Zeta Surgical, Inc. |
Neurology |
HAW |
| May 1, 26 |
K253887510(k) |
Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401) |
Philips Medizin Systeme |
Cardiovascular |
DQA |
| May 1, 26 |
K253966510(k) |
PERLA® TL Posterior Thoraco-lumbar Fixation System |
Spineart SA |
Orthopedic |
NKB |
| May 1, 26 |
K254077510(k) |
OSSIOfiber® Threaded Trimmable Fixation Nail |
OSSIO , Ltd. |
Orthopedic |
HWC |
| May 1, 26 |
K254139510(k) |
BioCode® Respiratory Pathogen Panel (RPP) |
Applied BioCode, Inc. |
Microbiology |
OCC |
| May 1, 26 |
K254154510(k) |
FX V135 EASYTECH® Shoulder System |
FX Shoulder Solutions, Inc. |
Orthopedic |
PKC |
| May 1, 26 |
K254234510(k) |
Phototherapy System (DUV-COMBO) |
Choyang Medics Co., Ltd. |
General, Plastic Surgery |
FTC |
| May 1, 26 |
K260314510(k) |
Ancora-SB |
Aspero Medical, Inc. |
Gastroenterology, Urology |
FDA |
| May 1, 26 |
K260819510(k) |
Any-Com Seal |
Mediclus Co., Ltd. |
Dental |
EBC |
| May 1, 26 |
K260910510(k) |
EndoTool IV Cloud 1.0 |
Glooko, Inc. |
Anesthesiology |
NDC |
| May 1, 26 |
K261045510(k) |
Verifine Safety Lancets |
Promisemed Hangzhou Meditech Co., Ltd. |
General, Plastic Surgery |
FMK |
| May 1, 26 |
K261074510(k) |
BIOMONITOR IV (471155) |
Biotronik, Inc. |
Cardiovascular |
MXD |