| Jul 31, 26 |
K252812510(k) |
UniPearls® Embolic Microspheres |
Suzhou Haowei Medical Technology Co., Ltd. |
Cardiovascular |
KRD |
| Jul 31, 26 |
K253555510(k) |
Flexitouch® Plus Advanced Pneumatic Compression System |
Tactile Medical |
Cardiovascular |
JOW |
| Jul 31, 26 |
K253655510(k) |
Angled Screwdriver MED (M-SD090) |
W&H Dentalwerk Bürmoos GmbH |
Dental |
DZI |
| Jul 31, 26 |
K253800510(k) |
0909FCE, 0909FCE-HS |
Rayence Co., Ltd. |
Radiology |
MQB |
| Jul 31, 26 |
K253835510(k) |
Affinity |
Hermes Medical Solutions AB |
Radiology |
QIH |
| Jul 31, 26 |
K254042510(k) |
WatchPAT SW |
Itamar Medical , Ltd. |
Anesthesiology |
MNR |
| Jul 31, 26 |
K260607510(k) |
Shield System (Siemens 30x40) |
Radiaction , Ltd. |
Radiology |
OWB |
| Jul 31, 26 |
K260852510(k) |
MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.Pure |
Siemens Healthineers AG |
Radiology |
LNH |
| Jul 31, 26 |
K260936510(k) |
RadioViewAI |
Neurocareai, Inc. (Dba Savelife.Ai) |
Radiology |
LLZ |
| Jul 31, 26 |
K261183510(k) |
EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190) |
Olympus Medical Systems Corporation |
Gastroenterology, Urology |
ODG |
| Jul 31, 26 |
K261187510(k) |
Hearing Aid Feature |
Samsung Electronics Co., Ltd. |
Ear, Nose, Throat |
SCR |
| Jul 31, 26 |
K261331510(k) |
I-Genius (100019400) |
Esaote, S.p.A. |
Radiology |
LNH |
| Jul 31, 26 |
K261335510(k) |
VitalFlow Set with Balance Biosurface |
Medtronic, Inc. |
Cardiovascular |
QJZ |
| Jul 31, 26 |
K261451510(k) |
ZSAlign Cervical Interbody System |
ZSFab, Inc. |
Orthopedic |
OVE |
| Jul 31, 26 |
K261482510(k) |
LightStim for Wrinkles (1984); LightStim for Acne (2038) |
Led Intellectual Properties, LLC |
General, Plastic Surgery |
OHS |
| Jul 31, 26 |
K261494510(k) |
Smart Wireless Stethoscope (STEMO310);Smart Wireless Stethoscope (STEMO710);Smart Wireless Stethoscope (STEMO720);Smart Wireless Stethoscope (STEMO730) |
Shanghai Hulu Devices Co., Ltd. |
Cardiovascular |
DQD |
| Jul 31, 26 |
K261809510(k) |
Interwedge® Standalone Lateral |
Foundation Surgical Group |
Orthopedic |
OVD |
| Jul 31, 26 |
K261810510(k) |
Vertiwedge® Intraosseous System |
Foundation Surgical Group |
Orthopedic |
MQP |
| Jul 31, 26 |
K261824510(k) |
da Vinci Surgical System, Model IS5000 |
Intuitive Surgical, Inc. |
Gastroenterology, Urology |
NAY |
| Jul 31, 26 |
K261854510(k) |
xvision Spine system |
Augmedics, Ltd. |
Neurology |
SBF |
| Jul 31, 26 |
K261912510(k) |
SnØreNegatØr |
DnB Innovations, LLC |
Dental |
LRK |
| Jul 31, 26 |
K262251510(k) |
ACTIFY Total Knee System, ACTIFY 3D Total Knee System (ACTIFY MC Tibial Insert) |
Globus Medical, Inc. |
Orthopedic |
JWH |
| Jul 31, 26 |
K262253510(k) |
Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03) |
Orthalign, Inc. |
Neurology |
ONN |
| Jul 31, 26 |
K262681510(k) |
NanoCeram Resin |
3BFAB TEKNOLOJI A.S. |
Dental |
EBI |
| Jul 30, 26 |
K251959510(k) |
TnR Cranial Implant |
T&R BIOFAB CO., Ltd. |
Neurology |
GXP |
| Jul 30, 26 |
K252042510(k) |
Sync AV II Temporary Pacing Catheter |
Swift Sync, Inc. |
Cardiovascular |
LDF |
| Jul 30, 26 |
K254038510(k) |
Motivista (CT-155) |
Click Therapeutics, Inc. |
Neurology |
SAP |
| Jul 30, 26 |
K260161510(k) |
SmartGuide Disposable Guides and Grids |
UC-CARE , Ltd. |
Radiology |
ITX |
| Jul 30, 26 |
K260566510(k) |
SMARTVERTIGO Vestibular Assessment System |
VertigoDx, Inc. |
Neurology |
GWN |
| Jul 30, 26 |
K260620510(k) |
SeptAlign (SPLN001) |
Spirair, Inc. |
Ear, Nose, Throat |
NHB |
| Jul 30, 26 |
K260624510(k) |
Arthrex Radial Head Replacement System |
Arthrex, Inc. |
Orthopedic |
KWI |
| Jul 30, 26 |
K260980510(k) |
cmAngio® V2.0 |
Curemetrix, Inc. |
Radiology |
QIH |
| Jul 30, 26 |
K261288510(k) |
Handheld Ultrasound Scanner |
IMGFAX CO., LTD. |
Radiology |
IYN |
| Jul 30, 26 |
K261389510(k) |
PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1) |
Salter Labs |
Anesthesiology |
CCL |
| Jul 30, 26 |
K261410510(k) |
Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit)) |
Suite 201, National Innovation Centre |
Neurology |
OLO |
| Jul 30, 26 |
K261448510(k) |
neXus Ultrasonic Surgical Aspirator System |
Misonix, LLC |
Unknown |
LFL |
| Jul 30, 26 |
K261835510(k) |
LOGIQ Focus |
GE Medical Systems Ultrasound and Primary Care Diagnostics |
Radiology |
IYN |
| Jul 30, 26 |
K262239510(k) |
Obsidian® Press Over Zirconia |
Prismatik Dentalcraft, Inc. |
Dental |
EIH |
| Jul 30, 26 |
K262330510(k) |
dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS Sentinelle Breast 16ch 1.5TdS Sentinelle Breast 16ch 3.0T |
Philips Medical Systems Nederland B.V. |
Radiology |
MOS |
| Jul 30, 26 |
K262369510(k) |
AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved Down |
Stryker Endoscopy |
Orthopedic |
MBI |
| Jul 30, 26 |
P250036PMA |
PGDx elio tissue complete CDx |
Personal Genome Diagnostics, Inc. |
Medical Genetics |
PQP |
| Jul 29, 26 |
K251908510(k) |
Emanate Tray |
Emanate Biomedical |
Unknown |
OLR |
| Jul 29, 26 |
K253526510(k) |
NAMIC Dilator and Sheath |
Medline Industries, LP |
Cardiovascular |
DYB |
| Jul 29, 26 |
K260588510(k) |
Cleerly LABS |
Cleerly, Inc. |
Radiology |
LLZ |
| Jul 29, 26 |
K261058510(k) |
CraniUS Plate |
CraniUS, LLC |
Neurology |
GWO |
| Jul 29, 26 |
K261205510(k) |
SPINEART Navigation Instrument System |
Spineart SA |
Neurology |
OLO |
| Jul 29, 26 |
K261210510(k) |
Cleerly Plaque |
Cleerly, Inc. |
Radiology |
QIH |
| Jul 29, 26 |
K261766510(k) |
CPS Locator 3D Plus Delivery Catheter |
CenterPoint Systems, LLC |
Cardiovascular |
DQY |
| Jul 29, 26 |
K261770510(k) |
Suture Button Repair System |
Skeletal Dynamics, Inc. |
Orthopedic |
MBI |
| Jul 29, 26 |
K261829510(k) |
Profoject Dual-Safety Pen Needles |
CMT Health PTE., Ltd. |
General Hospital |
FMI |
| Jul 29, 26 |
K262200510(k) |
Stone Clear (BWSC-LP9-02) |
Sonomotion, Inc. |
Gastroenterology, Urology |
QNA |
| Jul 29, 26 |
K262240510(k) |
SSPC NXT Delivery Catheter |
CenterPoint Systems, LLC |
Cardiovascular |
DQY |
| Jul 28, 26 |
DEN250042510(k) |
CaRi-Heart |
Caristo Diagnostics , Ltd. |
Cardiovascular |
SIU |
| Jul 28, 26 |
K253450510(k) |
BodyTom Elite (NL4000) |
NeuroLogica Corp., a Samsung Company |
Radiology |
JAK |
| Jul 28, 26 |
K253651510(k) |
Revi System |
Bluewind Medical , Ltd. |
Gastroenterology, Urology |
QXM |
| Jul 28, 26 |
K260303510(k) |
See-Mode Augmented Reporting Tool, Breast (SMART-B) |
See-Mode Technologies Pty, Ltd. |
Radiology |
QDQ |
| Jul 28, 26 |
K260326510(k) |
Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) |
Datex-Ohmeda, Inc. |
General Hospital |
FMZ |
| Jul 28, 26 |
K260558510(k) |
Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Latex Powder Free Surgical Gloves with Colloidal Oatmeal Tested for Use with Chemotherapy Drugs and Fentanyl Citrate |
Hartalega NGC Sdn. Bhd. |
General, Plastic Surgery |
KGO |
| Jul 28, 26 |
K261399510(k) |
ELISIO-HX |
Nipro Medical Corporation |
Gastroenterology, Urology |
QAX |
| Jul 28, 26 |
K261412510(k) |
V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound System; V7/XV7/XH7/H7/cV7/V7 ONE/XV7 ONE/H7 ONE/XH7 ONE/cV7 ONE Diagnostic Ultrasound System; V6/XV6/XH6/H6/cV6/V6 ONE/XV6 ONE/H6 ONE/XH6 ONE/cV6 ONE Diagnostic Ultrasound System; V5/XV5/XH5/H5/cV5 Diagnostic Ultrasound System; V4/XV4/XH4/H4/cV4 Diagnostic Ultrasound System; |
Samsung Medison Co., Ltd. |
Radiology |
IYN |
| Jul 28, 26 |
K261427510(k) |
uMI Panvivo (uMI Panvivo M) |
Shanghai United Imaging Healthcare Co., Ltd. |
Radiology |
KPS |
| Jul 28, 26 |
K261430510(k) |
TruLift Expandable System |
Life Spine, Inc. |
Orthopedic |
MAX |
| Jul 28, 26 |
K261511510(k) |
Xpert Ankle |
Newclip Technics |
Orthopedic |
HRS |
| Jul 27, 26 |
K250419510(k) |
Intimate Rose Pelvic Wand (Purple); Intimate Rose Bendable Pelvic Wand (Orange); Intimate Rose Temperature Pelvic Wand (Yellow) |
Plus EV Holdings, Inc. D/B/A Intimate Rose |
Physical Medicine |
OSD |
| Jul 27, 26 |
K260529510(k) |
Air Compression Massager (HY-1165) |
Xiamen High Top Electronic Technology Co., Ltd. |
Physical Medicine |
IRP |
| Jul 27, 26 |
K260835510(k) |
ARCHIMEDES Biodegradable Stent (Medium) |
Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) |
Gastroenterology, Urology |
FGE |
| Jul 27, 26 |
K261105510(k) |
Powered Aventus Thrombectomy System |
Inquis Medical |
Cardiovascular |
QEZ |
| Jul 27, 26 |
K261211510(k) |
Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic Ultrasound System |
Philips Ultrasound, LLC |
Radiology |
IYN |
| Jul 27, 26 |
K261310510(k) |
FlexTract Deflectable-Rotational Dilator Sheath Set |
Merit Medical Systems, Inc. |
Cardiovascular |
DRE |
| Jul 27, 26 |
K261759510(k) |
Euphora Rapid Exchange (RX) Balloon Dilatation Catheter |
Medtronic Ireland |
Cardiovascular |
LOX |
| Jul 27, 26 |
K262201510(k) |
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter |
Shockwave Medical, Inc. |
Cardiovascular |
PPN |
| Jul 27, 26 |
K262474510(k) |
ND Needle Guidance System |
Accurate Access, LLC |
Radiology |
ITX |
| Jul 26, 26 |
K253576510(k) |
CorVista System® with PCWP Add-On |
Analytics For Life, Inc. |
Cardiovascular |
DQK |
| Jul 26, 26 |
K261367510(k) |
Corsano CardioWatch 287-2 System |
Corsano Health B.V. |
Cardiovascular |
MSX |
| Jul 25, 26 |
K253206510(k) |
METICULY Patient-specific CMF solution |
Meticuly Co., Ltd. |
Dental |
JEY |
| Jul 25, 26 |
K260382510(k) |
MONARCH Platform (MON-000008) |
Auris Health, Inc. |
Ear, Nose, Throat |
EOQ |
| Jul 24, 26 |
K252370510(k) |
GEN 4 JOY Wheelchair |
Free Wheelchair Mission |
Physical Medicine |
IOR |
| Jul 24, 26 |
K253277510(k) |
Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P |
Ge Medical Systems Information Technologies, Inc. |
Cardiovascular |
MHX |
| Jul 24, 26 |
K253452510(k) |
Accuro 3S |
Rivanna Medical, Inc. |
Radiology |
IYO |
| Jul 24, 26 |
K253541510(k) |
EZ-Close (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device) |
Medical Impact |
Gastroenterology, Urology |
GCJ |
| Jul 24, 26 |
K253703510(k) |
RemunityPRO+ Pump for Remodulin® (treprostinil) Injection |
Deka R&D Corp |
General Hospital |
FRN |
| Jul 24, 26 |
K253943510(k) |
Tiger 2 System |
Zavation Medical Products, LLC |
Orthopedic |
NKB |
| Jul 24, 26 |
K254180510(k) |
PerfusiX-Imaging |
LIMIS Development B.V. |
Gastroenterology, Urology |
OWN |
| Jul 24, 26 |
K260192510(k) |
DIANA |
ROPCA ApS |
Radiology |
QIH |
| Jul 24, 26 |
K260259510(k) |
DiscreetDuo Flow Wearable Breast Pump (Model S3) |
Shenzhen TPH Technology Co., Ltd. |
Obstetrics/Gynecology |
HGX |
| Jul 24, 26 |
K260362510(k) |
QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration) |
MANTIZ Co., Ltd. |
Orthopedic |
NKB |
| Jul 24, 26 |
K260598510(k) |
5 Wavelength LED Facemask (TN2508) |
iSMART Developments, Ltd. |
General, Plastic Surgery |
OHS |
| Jul 24, 26 |
K260948510(k) |
Air Compression Massager (EP30B001 I) |
Wavepulse (Xiamen) Healthcare Technology Co., Ltd. |
Physical Medicine |
IRP |
| Jul 24, 26 |
K261014510(k) |
Accuro® 3S Needle Guide Kit |
Rivanna Medical, Inc. |
Radiology |
ITX |
| Jul 24, 26 |
K261024510(k) |
TMINI Miniature Robotic System |
THINK Surgical, Inc. |
Neurology |
OLO |
| Jul 24, 26 |
K261027510(k) |
NOVEOS Specific IgE (sIgE); Capture Reagent F014, Soybean (Glycine max); Capture Reagent F017, Hazelnut (Corylus avellana); Capture Reagent F352, Ara h 8 PR-10, Peanut; Capture Reagent F423, Ara h 2, Peanut; Capture Reagent F447, Ara h 6, Peanut |
Hycor Biomedical |
Immunology |
DHB |
| Jul 24, 26 |
K261221510(k) |
SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories) |
Olympus Surgical Technologies America |
General, Plastic Surgery |
GEX |
| Jul 24, 26 |
K261267510(k) |
Careflux H60;Careflux H70;Careflux V500 |
Fresenius Medical Care Renal Therapies Group, LLC |
Gastroenterology, Urology |
KDI |
| Jul 24, 26 |
K261274510(k) |
EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip ProCore® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes |
Cook Ireland, Ltd. |
Ear, Nose, Throat |
KTI |
| Jul 24, 26 |
K261312510(k) |
Temporary Keratoprosthesis (QuickSet TKP) |
Eyekon Medical, Inc. |
Ophthalmic |
MLP |
| Jul 24, 26 |
K261349510(k) |
SwiftMR |
Airs Medical, Inc. |
Radiology |
QIH |
| Jul 24, 26 |
K261364510(k) |
Atellica CH Acetaminophen 2 (ACTM) |
Siemens Healthcare Diagnostics, Inc. |
Clinical Toxicology |
LDP |
| Jul 24, 26 |
K261488510(k) |
OBSIDIO Conformable Embolic |
Boston Scientific Corporation |
Cardiovascular |
KRD |
| Jul 24, 26 |
K261781510(k) |
Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ60 |
Thermo Fisher Scientific (Oxoid Ltd.) |
Microbiology |
JTN |
| Jul 24, 26 |
K261849510(k) |
VERAFEYE Imaging Catheter (VF-VIC-002) |
Luma Vision Limited |
Cardiovascular |
OBJ |
| Jul 24, 26 |
K262121510(k) |
Ion-L Navigated Instruments |
SurGenTec, LLC |
Neurology |
OLO |
| Jul 24, 26 |
K262152510(k) |
VS-370CF, VS-370CT |
VISION MEDICAL Co., Ltd. |
Gastroenterology, Urology |
FCX |
| Jul 24, 26 |
K262165510(k) |
FARADRIVE Steerable Sheath (M004PF21M402) |
Boston Scientific Corporation |
Cardiovascular |
DRA |
| Jul 24, 26 |
K262290510(k) |
REMEDY POLY+PLUS SNAP FIT Acetabular Cup |
Osteoremedies, LLC |
Orthopedic |
KWL |
| Jul 24, 26 |
K262294510(k) |
dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS HiRes Hand/Wrist 16CH 3.0T;dS Small Extremity 16Ch 1.5T;dS Small Extremity 16Ch 3.0T |
Philips Medical Systems Nederland B.V. |
Radiology |
MOS |
| Jul 24, 26 |
K262383510(k) |
LumenCare Azure |
Nucletron B.V. |
Radiology |
JAQ |
| Jul 24, 26 |
K262462510(k) |
TheraSphere 360 Y-90 Management Platform |
Boston Scientific Corporation |
Radiology |
LLZ |
| Jul 24, 26 |
P250029PMA |
SimpleScreen CRC |
Freenome, LLC |
Medical Genetics |
PHP |
| Jul 23, 26 |
K251576510(k) |
Total Flow Medical Femoral Arterial (TFA) cannula |
Total Flow Medical Limited |
Cardiovascular |
SFF |
| Jul 23, 26 |
K253041510(k) |
3d Cage Cervical |
Fims Co., Ltd. |
Orthopedic |
ODP |
| Jul 23, 26 |
K253044510(k) |
RXiBreeze PAP System (RXiBreeze 20C) |
Resvent Medical Technology Co., Ltd. |
Anesthesiology |
BZD |
| Jul 23, 26 |
K253932510(k) |
FACEGYM Pro Device (HD-109) |
Shenzhen Kaiyan Medical Equipment Co., Ltd. |
Neurology |
NFO |
| Jul 23, 26 |
K254096510(k) |
VELMENI for DENTISTS (V4D) 3D |
Velmeni, Inc. |
Radiology |
QIH |
| Jul 23, 26 |
K261081510(k) |
Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro) |
Beijing Konted Medical Technology Co.,Ltd |
Radiology |
IYN |
| Jul 23, 26 |
K261082510(k) |
Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G) |
Microlife Corporation |
Cardiovascular |
DXN |
| Jul 23, 26 |
K261136510(k) |
Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D) |
Guangzhou Daxin Health Technology Co., Ltd. |
Cardiovascular |
DXN |
| Jul 23, 26 |
K261272510(k) |
ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/ MOZI-X1/ MOZI-X12/ DF-41E Diagnostic ultrasound system |
Esonic Technology (Wuhan) Co., Ltd. |
Radiology |
IYN |
| Jul 23, 26 |
K261644510(k) |
Perfadex Plus |
Xvivo Perfusion AB |
Gastroenterology, Urology |
KDN |
| Jul 23, 26 |
K261694510(k) |
CORE 300 Digital Stethoscope |
Eko Health, Inc. |
Cardiovascular |
DQD |
| Jul 23, 26 |
K261734510(k) |
Klassic Infection Spacer System |
Total Joint Orthopedics, Inc. |
Orthopedic |
JWH |
| Jul 23, 26 |
K261748510(k) |
Dental Cone-beam Computed Tomography (mDX-15P Series) |
Hefei Meyer Optoelectronic Technology, Inc. |
Radiology |
OAS |
| Jul 23, 26 |
K261853510(k) |
Gepotidacin GEP 10 µg |
Liofilchem, Inc. |
Microbiology |
JTN |
| Jul 23, 26 |
K262116510(k) |
TRUE METRIX Self Monitoring Blood Glucose System |
Trividia Health, Inc. |
Clinical Chemistry |
NBW |
| Jul 23, 26 |
K262143510(k) |
ImageGrid StreamVue |
Candelis, Inc. |
Radiology |
LLZ |
| Jul 22, 26 |
K253840510(k) |
STEDI Scan Device |
Stroke DX |
Cardiovascular |
QAF |
| Jul 22, 26 |
K254296510(k) |
Ossiclear (Ossiclear System) |
Sounduct |
Ear, Nose, Throat |
LXB |
| Jul 22, 26 |
K260721510(k) |
Tornier Perform Advanced Glenoid |
Tornier, Inc. |
Orthopedic |
KWS |
| Jul 22, 26 |
K260804510(k) |
Anovo Surgical System (6Ne) |
Momentis Surgical , Ltd. |
General, Plastic Surgery |
SCV |
| Jul 22, 26 |
K260964510(k) |
NanoZoomer S540MD Slide Scanner System |
Hamamatsu Photonics K.K. |
Pathology |
PSY |
| Jul 22, 26 |
K261113510(k) |
Op.n Spine Navigation and Robotic Guidance |
Ecential Robotics |
Neurology |
OLO |
| Jul 22, 26 |
K261179510(k) |
AlphaTriPart - Monopolar MIC Instruments |
Gimmi GmbH |
General, Plastic Surgery |
GEI |
| Jul 22, 26 |
K262075510(k) |
Lapidus Screw Kit |
Relja Innovations, LLC |
Orthopedic |
HWC |
| Jul 22, 26 |
K262086510(k) |
PreludeSYNC Radial Compression Device |
Merit Medical Systems, Inc. |
Cardiovascular |
DXC |
| Jul 22, 26 |
K262094510(k) |
E3D-C Interbody System |
Evolution Spine |
Orthopedic |
OVE |
| Jul 22, 26 |
K262211510(k) |
Lancet |
Tianjin Huahong Technology Co., Ltd. |
General, Plastic Surgery |
QRL |
| Jul 21, 26 |
DEN250068510(k) |
OTTAVA Robotic Surgical System |
Auris Health, Inc., part of Johnson & Johnson MedTech |
General, Plastic Surgery |
SIR |
| Jul 21, 26 |
K253770510(k) |
CardIQ Suite |
GE Medical Systems SCS |
Radiology |
JAK |
| Jul 21, 26 |
K253814510(k) |
Raney Clips Kit |
Beijing Honghugaoxiang Science and Technology Development CO |
Neurology |
HBO |
| Jul 21, 26 |
K260500510(k) |
ResolutionMD |
ResolutionMD, Inc. |
Radiology |
LLZ |
| Jul 21, 26 |
K260591510(k) |
NOVEOS Specific IgE (sIgE);Capture Reagent F010, Sesame Seed (Sesamum indicum);Capture Reagent F020, Almond (Amygdalus communis);Capture Reagent F078, Bos d 8 Casein, Milk; Capture Reagent F080, Lobster (Homarus gammarus);Capture Reagent F422, Ara h 1, Peanut |
Hycor Biomedical |
Immunology |
DHB |
| Jul 21, 26 |
K261406510(k) |
Versalock Proximal Tibial Plating System |
GM Dos Reis Industria e Comercio Ltda. |
Orthopedic |
HRS |
| Jul 21, 26 |
K261728510(k) |
One-Fil LC |
Mediclus Co., Ltd. |
Dental |
EJK |
| Jul 21, 26 |
K261738510(k) |
Medical Thulium Fiber Laser Systems (UroFiber 150Q) |
Rhein Laser Technologies Co., Ltd. |
General, Plastic Surgery |
GEX |
| Jul 21, 26 |
K261775510(k) |
Uv Phototherapy (KN-4001A,KN-4001B,KN-4001AB) |
Xuzhou Kernel Medical Equipment Co., Ltd. |
Unknown |
|
| Jul 21, 26 |
K262014510(k) |
PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam Gloves |
O&M Halyard, Inc. |
General Hospital |
LZA |
| Jul 20, 26 |
K254231510(k) |
Inno-Hook Disposable Clip Appliers (Ligating Clips) and Inno-Hook Ligating Clips |
Taiwan Surgical Corporation |
General, Plastic Surgery |
FZP |
| Jul 20, 26 |
K254285510(k) |
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Aqua Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Violet Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Dark Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Dark Violet Blue |
Hartalega NGC Sdn. Bhd. |
General Hospital |
LZA |
| Jul 20, 26 |
K260516510(k) |
BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR) |
MacroLux Medical Technology Co., Ltd. |
Gastroenterology, Urology |
FGB |
| Jul 20, 26 |
K261011510(k) |
Sleep Apnea Feature (v2.0) |
Samsung Electronics Co., Ltd. |
Anesthesiology |
QZW |
| Jul 20, 26 |
K261535510(k) |
Hi-D Imaging 4TAVR |
Hi-D Imaging AG |
Radiology |
QIH |
| Jul 20, 26 |
K261573510(k) |
ENDOSCOPE HOLDER (182214) |
Aktormed GmbH |
Gastroenterology, Urology |
QZB |
| Jul 20, 26 |
K261632510(k) |
Thunderbolt System |
Responsive Arthroscopy, Inc. |
Orthopedic |
MBI |
| Jul 17, 26 |
DEN250040510(k) |
SportSuite Vision Software |
Stryker Endoscopy |
Orthopedic |
SIT |
| Jul 17, 26 |
K251952510(k) |
Virasight |
Virasoft Corporation |
Pathology |
PSY |
| Jul 17, 26 |
K253011510(k) |
Catalyft PL Expandable Interbody System |
Medtronic Sofamor Danek USA, Inc. |
Orthopedic |
MAX |
| Jul 17, 26 |
K253694510(k) |
Natural Cycles |
Natural Cycles Nordic AB |
Obstetrics/Gynecology |
PYT |
| Jul 17, 26 |
K253963510(k) |
Cubresa BrainPET |
Cubresa, Inc. |
Radiology |
OUO |
| Jul 17, 26 |
K254006510(k) |
Drivewire 35 Guidewire |
Rapid Medical Ltd. |
Cardiovascular |
MOF |
| Jul 17, 26 |
K260694510(k) |
ZEISS CLINIC 360 |
Carl Zeiss Meditec, AG |
Radiology |
NFJ |
| Jul 17, 26 |
K261046510(k) |
Dental Zirconia Blank & Coloring Liquid |
Hunan Qinghao Puzhong Technology Co., Ltd. |
Dental |
EIH |
| Jul 17, 26 |
K261475510(k) |
BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit |
Biofire Defense, LLC |
Microbiology |
PMN |
| Jul 17, 26 |
K261614510(k) |
LED LCD Monitor (OEV-271H) |
Lg Electronics.Inc |
Gastroenterology, Urology |
GCJ |
| Jul 17, 26 |
K261658510(k) |
LoFric Origo Pro Coudé |
Wellspect AB |
Gastroenterology, Urology |
EZD |
| Jul 17, 26 |
K261675510(k) |
CHZL Red Light Therapy Hair Growth Cap (Model(s):CHZL-120BK-L52D,CHZL-120BK-L53D,CHZL-120BK-L54D) |
Shenzhen Chuanghong Zhilian Technology Co., Ltd. |
Physical Medicine |
OAP |
| Jul 17, 26 |
K261693510(k) |
Diode laser hair removal machine (QDTM-04) |
Beijing Nubway S&T Co., Ltd. |
General, Plastic Surgery |
GEX |
| Jul 17, 26 |
K261984510(k) |
AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test Cup |
Assure Tech., LLC |
Clinical Toxicology |
NFT |
| Jul 17, 26 |
K262061510(k) |
Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer; AVS® AS PEEK Spacer; Monterey AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System; SANTORINI Corpectomy Cage System; MOJAVE Interbody System; VLIFT VERTEBRAL BODY REPLACEM |
Stryker Spine |
Orthopedic |
ODP |
| Jul 16, 26 |
K260002510(k) |
Socrates Aspiration System (Socrates 70 Aspiration Catheter) |
Scientia Vascular, Inc. |
Cardiovascular |
NRY |
| Jul 16, 26 |
K260021510(k) |
cobas® BV/CV |
Roche Molecular Systems, Inc. |
Microbiology |
PQA |
| Jul 16, 26 |
K261271510(k) |
Cable-Ready® Cable Grip System |
Pioneer Surgical Technology, Inc. |
Orthopedic |
JDQ |
| Jul 16, 26 |
K261309510(k) |
Palisades Buttress Plate System |
Bethesda Medical Devices, LLC |
Orthopedic |
KWQ |
| Jul 16, 26 |
K261674510(k) |
Skin Air Cooling System (QALF-01) |
Beijing Nubway S&T Co., Ltd. |
General, Plastic Surgery |
GEX |
| Jul 16, 26 |
K261706510(k) |
Endomat Select (UP220) |
KARL STORZ SE & CO. KG |
Obstetrics/Gynecology |
HIG |
| Jul 16, 26 |
K262032510(k) |
TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB ) |
TriMed, Inc. |
Orthopedic |
HRS |
| Jul 15, 26 |
K252822510(k) |
Atlas Spine HiRISE Expandable Cervical-p Corpectomy Implant |
Atlas Spine, Inc. |
Orthopedic |
PLR |
| Jul 15, 26 |
K253606510(k) |
NanoZoomer S20MD Slide scanner system; NanoZoomer S360MD Slide scanner system |
Hamamatsu Photonics K.K. |
Pathology |
PSY |
| Jul 15, 26 |
K260050510(k) |
WRAP System |
Huneo, LLC |
Anesthesiology |
MNR |
| Jul 15, 26 |
K260206510(k) |
SkeletonPlanner |
UPlanner B.V. - Presurgeo |
Radiology |
QIH |
| Jul 15, 26 |
K260338510(k) |
ThinkSono Guidance |
ThinkSono GmbH |
Radiology |
QJU |
| Jul 15, 26 |
K260739510(k) |
Profoject Pen Needles (Model A; Model B) |
CMT Health PTE., Ltd. |
General Hospital |
FMI |
| Jul 15, 26 |
K260851510(k) |
Better Diagnostics Dental Assist (BDDA) Version 1.0 |
Better Diagnostics AI Corp. |
Radiology |
MYN |
| Jul 15, 26 |
K261353510(k) |
Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor System |
Kyocera Medical Technologies, Inc. |
Orthopedic |
OVD |
| Jul 15, 26 |
K261407510(k) |
XPREEN LED Light Therapy Masks (XPRE322, XPRE326, XPRE327, XPRE342, XPRE368, XPRE422, XPRE434, XPRE451, XPRE455, XPRE457, XPRE448, XPRE335, XPRE350, XPRE420, XPRE436, XPRE339, XPRE445) |
Dongguan Miqiang Technology Co., Ltd. |
General, Plastic Surgery |
OHS |
| Jul 15, 26 |
K262006510(k) |
EnSite X EP System |
Abbott Medical |
Cardiovascular |
DQK |
| Jul 15, 26 |
K262030510(k) |
Aventus Thrombectomy System |
Inquis Medical |
Cardiovascular |
QEZ |
| Jul 15, 26 |
P250025PMA |
TorEx Lung Perfusion System |
Traferox Technologies, Inc. |
Gastroenterology, Urology |
PHO |
| Jul 14, 26 |
K253662510(k) |
LIXI (LXOSFM1) |
Luwi, LLC |
Obstetrics/Gynecology |
MSC |
| Jul 14, 26 |
K253667510(k) |
Accoat Guide Wire |
Sp Medical A/S |
Cardiovascular |
DQX |
| Jul 14, 26 |
K260578510(k) |
Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Cup MRI/CT-set (Models 72704/21-1010US, 72704/21-1010US, 72704/23-1010US, 72704/25-1010US, 72704/27-1010US) Ambu® NeurolineTM Cup MRI/CT-mini set (Models 72704/21-0301US, 72704/23-0301US, 72704/25-0301US, 72704/27-0301US) |
Ambu A/S |
Neurology |
GXY |
| Jul 14, 26 |
K261020510(k) |
Symmetrix L Spinal System |
Medtronic Sofamor Danek USA, Inc. |
Orthopedic |
MAX |
| Jul 14, 26 |
K261232510(k) |
IERO Mobility Scooter (IERO-01) |
Jochu Technology Co., Ltd. |
Physical Medicine |
INI |
| Jul 14, 26 |
K261249510(k) |
Universal Seal (5-12 mm) |
Intuitive Surgical, Inc. |
Gastroenterology, Urology |
GCJ |
| Jul 14, 26 |
K261284510(k) |
Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System |
Alphatec Spine, Inc. |
Orthopedic |
NKB |
| Jul 14, 26 |
K261633510(k) |
VisuBreath |
Affirm Medical Technologies II, LLC |
Anesthesiology |
CCK |
| Jul 13, 26 |
K253504510(k) |
Volnewmer |
Classys, Inc. |
General, Plastic Surgery |
GEI |
| Jul 13, 26 |
K254044510(k) |
Hearing assist |
Meta Platform Technologies, LLC |
Ear, Nose, Throat |
SCR |
| Jul 13, 26 |
K260199510(k) |
SLIM Microcatheter |
Balt USA, LLC |
Cardiovascular |
QJP |
| Jul 13, 26 |
K260208510(k) |
Ultra-Fine SAFETY Insulin Syringe |
embecta Medical II, LLC |
General Hospital |
FMF |
| Jul 13, 26 |
K261085510(k) |
Rapid Vessel Occlusion (Rapid VO) |
iSchemaview |
Radiology |
QAS |
| Jul 13, 26 |
K261199510(k) |
Wearable Breast Pump (Model S32A) |
Shenzhen TPH Technology Co., Ltd. |
Obstetrics/Gynecology |
HGX |
| Jul 13, 26 |
K261640510(k) |
Merit MAK Nitinol/Gold-Tungsten Guide Wire |
Merit Medical Ireland , Ltd. |
Cardiovascular |
DQX |
| Jul 10, 26 |
K253480510(k) |
Capenergy C Equipments RF C200 and C400 Drakarian |
Capenergy Medical S.L. |
General, Plastic Surgery |
PBX |
| Jul 10, 26 |
K253514510(k) |
Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric Tube - 20 French (0092100); Blakemore Esophageal-Nasogastric Tube - 16 French (0092300) |
C.R. Bard, Inc. |
Gastroenterology, Urology |
KNT |
| Jul 10, 26 |
K253670510(k) |
SmartCT (R3.0 (L10)) |
Philips Medical Systems B.V. |
Radiology |
OWB |
| Jul 10, 26 |
K254037510(k) |
LungFlow Airway Catheter |
Free Flow Medical, Inc. |
Ear, Nose, Throat |
EOQ |
| Jul 10, 26 |
K254295510(k) |
Sofia Lyme FIA; Sofia 2 Campylobacter FIA |
Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) |
Microbiology |
LSR |
| Jul 10, 26 |
K260880510(k) |
SedLine Sedation Monitor |
Masimo Corporation |
Neurology |
OLW |
| Jul 10, 26 |
K260902510(k) |
Cochlear Osia® 3(I) Sound Processor;Cochlear Osia® 3 Sound Processor;Cochlear Osia® 3 Charger;Cochlear Osia® 3 Aqua+;Cochlear Osia® Fitting Software 3;Cochlear Osia® Smart App;Cochlear Osia® System |
Cochlear Americas |
Ear, Nose, Throat |
PFO |
| Jul 10, 26 |
K261031510(k) |
POSEIDON ST |
Signus Medinzintechnik GmbH |
Orthopedic |
MQP |
| Jul 10, 26 |
K261041510(k) |
ClearSafe Closed System |
MedSource Labs, LLC |
General Hospital |
FOZ |
| Jul 10, 26 |
K261149510(k) |
Electric Wheelchair (DY611A-2, DY612A-1) |
Zhejiang Lumbre Electric Appliance Co., Ltd. |
Physical Medicine |
ITI |
| Jul 10, 26 |
K261212510(k) |
Flowflex Plus RSV + Flu A/B + COVID Rapid Test |
ACON Laboratories, Inc. |
Microbiology |
SCA |
| Jul 10, 26 |
K261306510(k) |
AI Contouring (VA10A) |
Varian Medical Systems |
Radiology |
QKB |
| Jul 10, 26 |
K261624510(k) |
Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire® 0° Polyethylene Insert; Trident ® Crossfire ® 10° Polyethylene Insert;System 12 Crossfire® 10° Insert; Trident® 0° Constrained Acetabular Insert; Trident® Constrained Acetabular Liner;Trident® All Poly Constrained Acetabular Insert; Crossfire® Eccentric Insert 10°; Artisan® Bone Plug;UHR® Universal Head Bipolar Component |
Howmedica Osteonics Corp., Dba Stryker Orthopaedics |
Orthopedic |
LPH |
| Jul 10, 26 |
K261949510(k) |
NYES Tuff Cuff L3 Disposable Gowns |
New York Embroidery Studio |
General, Plastic Surgery |
FYA |
| Jul 10, 26 |
K261978510(k) |
WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System |
Boston Scientific Corporation |
General, Plastic Surgery |
ESW |
| Jul 10, 26 |
K262120510(k) |
Avara Viewer |
Avara Software |
Radiology |
LLZ |
| Jul 9, 26 |
K252978510(k) |
ScioCardio ECG Analysis Platform |
Synergen Technology Labs, LLC |
Cardiovascular |
DQK |
| Jul 9, 26 |
K253899510(k) |
3D-Anywhere |
Provect.AI |
Radiology |
LLZ |
| Jul 9, 26 |
K253901510(k) |
Millipede88 Access Catheter |
Perfuze, Ltd. |
Cardiovascular |
QJP |
| Jul 9, 26 |
K260157510(k) |
LifeLens Physiological Monitor |
LifeLens Technologies, Inc. |
Cardiovascular |
DSH |
| Jul 9, 26 |
K260539510(k) |
MedSource QuickSafe Safety IV Catheter; MedSource PurSafe Safety IV Catheter |
MedSource Labs, LLC |
General Hospital |
FOZ |
| Jul 9, 26 |
K260723510(k) |
HYDROS Robotic System (HY1000);HYDROS Handpiece (HH1000);HYDROS TRUS Probe (HU1000) |
Procept Biorobotics |
General, Plastic Surgery |
PZP |
| Jul 9, 26 |
K261166510(k) |
DIA-CEM |
DiaDent Group International |
Dental |
EMA |
| Jul 9, 26 |
K261177510(k) |
PINKSLIP Water-Based Personal Lubricant and Moisturizer |
PINKSLIP, LLC |
Obstetrics/Gynecology |
NUC |
| Jul 9, 26 |
K261471510(k) |
Zeta TMS Navigation System |
Zeta Surgical, Inc. |
Neurology |
QFF |
| Jul 9, 26 |
K261569510(k) |
UbiqVue 2AYe Cardiac System (UX2253) |
Lifesignals, Inc. |
Cardiovascular |
DRG |
| Jul 9, 26 |
K261962510(k) |
SmartGuard Technology; Predictive Low Glucose Technology |
Medtronic MiniMed |
Clinical Chemistry |
QJI |
| Jul 9, 26 |
K261968510(k) |
Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982) |
Smith & Nephew, Inc. |
Orthopedic |
MBI |
| Jul 9, 26 |
K261988510(k) |
Monodek (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical Suture |
Teleflex Medical, LLC |
General, Plastic Surgery |
NEW |
| Jul 9, 26 |
P250016PMA |
Belotero® Intense (+) Lidocaine |
Merz North America, Inc. |
General, Plastic Surgery |
LMH |
| Jul 8, 26 |
K253751510(k) |
CXRDetectAI |
Neurocareai, Inc. (Dba Savelife.Ai) |
Radiology |
QFM |
| Jul 8, 26 |
K254130510(k) |
C.A. Medical Interbody Fusion System |
C.A. Medical, LLC |
Orthopedic |
ODP |
| Jul 8, 26 |
K260160510(k) |
VITEK REVEAL GN AST Assay and VITEK REVEAL AST System |
bioMerieux, Inc. |
Microbiology |
SAN |
| Jul 8, 26 |
K260278510(k) |
ThermAffyx(TM) Patient Safety System |
Stihler Electronic GmbH |
Cardiovascular |
DWJ |
| Jul 8, 26 |
K260700510(k) |
BlueDop Vascular Expert |
BlueDop Medical, Ltd. |
Cardiovascular |
DPW |
| Jul 8, 26 |
K260750510(k) |
Virtual Cone (1.0) |
Varian Medical Systems, Inc. |
Radiology |
MUJ |
| Jul 8, 26 |
K260917510(k) |
cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the cobas 5800/6800/8800 systems |
Roche Molecular Systems, Inc. |
Microbiology |
QEP |
| Jul 8, 26 |
K261191510(k) |
Alians Elbow S |
Newclip Technics |
Orthopedic |
HRS |
| Jul 8, 26 |
K261396510(k) |
Electric Wheelchair |
Ningbo Resshidi Medical Devices Co., Ltd. |
Physical Medicine |
ITI |
| Jul 8, 26 |
K262300510(k) |
Denture Base Resin V2 |
Formlabs Ohio, Inc. |
Dental |
EBI |
| Jul 7, 26 |
K253942510(k) |
Pulmonex II Xenon System (132-503) |
Mirion Technologies (Capintec), Inc. |
Radiology |
IYT |
| Jul 7, 26 |
K260973510(k) |
InferOperate Suite |
Beijing Infervision Healthcare Medical Technology Co., Ltd. |
Radiology |
QIH |
| Jul 7, 26 |
K261163510(k) |
Mobility Scooter (R200) |
Yongkang Ruihe Metal Product Co., Ltd. |
Physical Medicine |
INI |
| Jul 7, 26 |
K261164510(k) |
Electric wheelchair (XW-LY007 ) |
Yongkang Ruihe Metal Product Co., Ltd. |
Physical Medicine |
ITI |
| Jul 7, 26 |
K261812510(k) |
HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens; HOYA Illumina (sorafilcon A) Toric Daily Disposable Soft Contact Lens; HOYA Illumina (sorafilcon A) Multifocal Daily Disposable Soft Contact Lens |
HOYA Lamphun , Ltd. |
Ophthalmic |
MVN |
| Jul 7, 26 |
K262045510(k) |
Luja Soft |
Coloplast A.S. |
Gastroenterology, Urology |
EZD |
| Jul 6, 26 |
DEN250037510(k) |
TESSA Spatial Surgery System; INTELLIO Tablet (72205455) |
Smith & Nephew, Inc. |
Orthopedic |
SIQ |
| Jul 6, 26 |
K253317510(k) |
Cytrans Elashield |
GC America, Inc. |
Dental |
LYC |
| Jul 6, 26 |
K260122510(k) |
Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep) |
SteriLance Medical (Suzhou), Inc. |
General, Plastic Surgery |
QRL |
| Jul 6, 26 |
K261009510(k) |
MobileLink Acetabular Cup System 40mm ID Inserts (various) |
Waldemar Link GmbH & Co. KG |
Orthopedic |
LZO |
| Jul 6, 26 |
K261465510(k) |
INDIRA CLOUD VIEWER |
INDIGO TECHNOLOGIES |
Radiology |
LLZ |
| Jul 6, 26 |
K261529510(k) |
Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04) |
Hartman Medical Group, LLC |
Cardiovascular |
DYB |
| Jul 6, 26 |
K261909510(k) |
Plum Vagiceuticals Vaginal Moisturizing Suppositories |
PCCA, Inc. |
Obstetrics/Gynecology |
NUC |
| Jul 2, 26 |
DEN250034510(k) |
Claria System |
Claria Medical, Inc. |
Obstetrics/Gynecology |
SIM |
| Jul 2, 26 |
K252243510(k) |
Fastplex BCR-ABL (p210) %IS digital PCR Kit |
Suzhou Precigenome, Ltd. Co; |
Medical Genetics |
OYX |
| Jul 2, 26 |
K252463510(k) |
SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E) |
Edan Instruments, Inc. |
Cardiovascular |
DPS |
| Jul 2, 26 |
K253463510(k) |
ILR ECG Analyzer (IM007) |
Implicity, Inc. |
Cardiovascular |
DQK |
| Jul 2, 26 |
K253704510(k) |
iPredict-DR |
iHealthscreen, Inc. |
Ophthalmic |
PIB |
| Jul 2, 26 |
K253884510(k) |
Koios DS (3.8) |
Koios Medical, Inc. |
Radiology |
POK |
| Jul 2, 26 |
K260527510(k) |
FACE4D Aligner |
Avinent Implant System S.L.U. |
Dental |
NXC |
| Jul 2, 26 |
K260528510(k) |
OncoStudio |
Oncosoft. Inc., |
Radiology |
QKB |
| Jul 2, 26 |
K260596510(k) |
Collagen Wound Powder |
Ventris Medical |
Unknown |
KGN |
| Jul 2, 26 |
K260755510(k) |
OptraSCAN System |
Optrascan, Inc. |
Hematology |
NOT |
| Jul 2, 26 |
K261129510(k) |
OrthoFit |
Spident Co., Ltd. |
Dental |
DYH |
| Jul 2, 26 |
K261587510(k) |
Insufflation Retention Device (IRD) (11173-325-101) |
BPEndo, LLC |
Gastroenterology, Urology |
FDF |
| Jul 2, 26 |
K261825510(k) |
Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter |
Abbott |
Cardiovascular |
DQY |
| Jul 2, 26 |
K261847510(k) |
iTero Lumina Pro |
Align Technology , Ltd. |
Dental |
NTK |
| Jul 2, 26 |
K261867510(k) |
Xpert Carba-R |
Cepheid® |
Microbiology |
POC |
| Jul 2, 26 |
K261880510(k) |
FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01 |
Fujifilm Corporation |
Gastroenterology, Urology |
FET |
| Jul 2, 26 |
K261897510(k) |
HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* H300W Sterilization Wrap with ASSURE-DRY* Technology |
O&M Halyard, Inc. |
General Hospital |
FRG |
| Jul 1, 26 |
K252483510(k) |
Enteral Syringe (20ml, 60ml) |
Chirana T.Injecta,A.S. |
Gastroenterology, Urology |
PNR |
| Jul 1, 26 |
K253420510(k) |
Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody Sy |
SeaSpine Orthopedics Corporation |
Orthopedic |
MAX |
| Jul 1, 26 |
K253434510(k) |
OSSTM Orthopedic Salvage System |
Biomet, Inc. |
Orthopedic |
JDI |
| Jul 1, 26 |
K253527510(k) |
Tri-Staple 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple 2.0 Black Circular Reload 25mm Extra Thick (SIGCIR25XT) |
Covidien, LLC |
General Hospital |
GAG |
| Jul 1, 26 |
K253802510(k) |
KHEIRON® Spinal Fixation System, including patient specific K-ROD |
S.M.A.I.O |
Orthopedic |
NKB |
| Jul 1, 26 |
K254056510(k) |
THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S (TB-0520FCS) |
Olympus Medical Systems Corp. |
General, Plastic Surgery |
GEI |
| Jul 1, 26 |
K260556510(k) |
Veritas Shoulder System |
Restor3D |
Orthopedic |
PHX |
| Jul 1, 26 |
K261021510(k) |
EasyWhip Family |
Winter Innovations, Inc. |
General, Plastic Surgery |
GAT |
| Jul 1, 26 |
K261054510(k) |
RibPlate System |
Stryker Leibinger GmbH & Co KG |
Orthopedic |
HRS |
| Jul 1, 26 |
K261147510(k) |
Neodent Implant System - NeoConvert Fit |
JJGC Indústria e Comércio de Materiais Dentários S.A. |
Dental |
NHA |
| Jul 1, 26 |
K261473510(k) |
Chromix |
Termosalud S.L. |
General, Plastic Surgery |
OHS |
| Jul 1, 26 |
K261474510(k) |
DENTCA Tru Flexible |
Dentca, Inc. |
Dental |
EBI |
| Jul 1, 26 |
K261485510(k) |
Tetric plus Fill;Tetric plus Flow |
Ivoclar Vivadent, Inc. |
Dental |
EBF |
| Jul 1, 26 |
K261852510(k) |
OTS Hip |
Ortoma AB |
Neurology |
OLO |
| Jul 1, 26 |
K261889510(k) |
Trevo Trak 21 Microcatheter |
Stryker Neurovascular |
Cardiovascular |
QJP |
| Jul 1, 26 |
K262228510(k) |
Transcend Bulk Fill Flowable Composite |
Ultradent Products, Inc. |
Dental |
EBF |