| Sep 6, 26 |
K260396510(k) |
KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100, MetaStim 100A) |
Fidelity BioPharma Co. |
Neurology |
OBP |
| Sep 6, 26 |
K261131510(k) |
Electrical Muscle Stimulator (AST-105DJ, AST-105EJ, AST- 105BJ, AST-105GJ, AST-303J, AST-309J, AST-310J;AST-300Q, AST-300Q-A, AST-500B; AST-500G, AST-500F; AST-500N; AST- 500C, AST- 500K, AST-500A; AST-300E, AST-500M, AST- 500U, AST- 500D; AST- 500E.) |
Shenzhen Osto Medical Technology Co.,Ltd |
Neurology |
NUH |
| Sep 5, 26 |
K254135510(k) |
LipoSurg ARTIST |
NOUVAG AG |
General, Plastic Surgery |
QPB |
| Sep 5, 26 |
K261684510(k) |
FreezeSpray TA |
Cryosurgery, Inc. |
Unknown |
MLY |
| Sep 4, 26 |
K253529510(k) |
Peerbridge COR MDx (Cor MDx) |
Peerbridge Health, Inc. |
Cardiovascular |
MWJ |
| Sep 4, 26 |
K253836510(k) |
FCT iStream Phase 2 |
Fujifilm Corporation |
Radiology |
JAK |
| Sep 4, 26 |
K253909510(k) |
NeoPEX Pre-Mixed Obturation Paste |
NuSmile, Ltd. |
Dental |
KIF |
| Sep 4, 26 |
K254262510(k) |
Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIA |
Ortho Clinical Diagnostics Inc. (QuidelOrtho) |
Microbiology |
PSZ |
| Sep 4, 26 |
K254264510(k) |
Sofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIA |
Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) |
Microbiology |
QVF |
| Sep 4, 26 |
K260035510(k) |
Digital Indeflator INFLANTE |
UAB Telemedicina |
Cardiovascular |
MAV |
| Sep 4, 26 |
K260331510(k) |
IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13) |
Siemens Healthcare Diagnostics Products, Ltd. |
Immunology |
DHB |
| Sep 4, 26 |
K260525510(k) |
NextMR Spine |
MRI2CT, Inc. |
Radiology |
QIH |
| Sep 4, 26 |
K260756510(k) |
TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221) |
Sentinel Medical Technologies, |
Gastroenterology, Urology |
EZL |
| Sep 4, 26 |
K261057510(k) |
ActivaScrew Cannulated COM |
Bioretec, Ltd. |
Orthopedic |
HWC |
| Sep 4, 26 |
K261935510(k) |
Surgical and Prosthetic Trays |
Dentsply Sirona, Inc. |
General Hospital |
KCT |
| Sep 4, 26 |
K262060510(k) |
3D-RD-S |
Radiopharmaceutical Imaging & Dosimetry, LLC |
Radiology |
LLZ |
| Sep 4, 26 |
K262130510(k) |
ATTUNE Revision Knee System |
Depuy Orthopaedics, Inc. |
Orthopedic |
JWH |
| Sep 4, 26 |
K262235510(k) |
ApexCut Blade with Automated EM Tracking (187BL4012EM);ApexCut Blade with Automated EM Tracking (187BL4040EM);ApexCut Blade with Automated EM Tracking (187BL4060EM);ApexCut Blade with Automated EM Tracking (187BL2975EM);ApexCut Blade with Automated EM Tracking (187BL3590EM);ApexCut Blade with Automated EM Tracking (187BL4000LEM) |
Medtronic Xomed, Inc. |
Neurology |
PGW |
| Sep 4, 26 |
K262277510(k) |
70 NeuGlide Catheter |
Piraeus Medical, Inc. |
Cardiovascular |
QJP |
| Sep 4, 26 |
K262292510(k) |
Gastric Alimetry |
Alimetry , Ltd. |
Gastroenterology, Urology |
MYE |
| Sep 4, 26 |
K262828510(k) |
KHEIRON® Spinal Fixation System, including patient specific K-ROD |
S.M.A.I.O |
Orthopedic |
NKB |
| Sep 3, 26 |
DEN250044510(k) |
STEMI AI ECG Model |
Powerful Medical, Inc. |
Unknown |
SHS |
| Sep 3, 26 |
K251794510(k) |
Tenax® Laser Resistant Endotracheal Tube |
Bryan Medical, Inc. |
Anesthesiology |
BTR |
| Sep 3, 26 |
K253673510(k) |
Mcare System (MW-20) |
Marani Health, Inc. |
Obstetrics/Gynecology |
LQK |
| Sep 3, 26 |
K253989510(k) |
HARU Orgasm by jack herer water based lubricant (WL-OJ); HARU Orgasm water based lubricant (WL-OR); HARU STEAMY water based lubricant (WL-ST) |
Maxigen Biotech, Inc. |
Obstetrics/Gynecology |
NUC |
| Sep 3, 26 |
K254000510(k) |
Happy Health Blood Pressure Monitor |
Happy Health, Inc. |
Cardiovascular |
DXN |
| Sep 3, 26 |
K254035510(k) |
Mayumi Thrombectomy System |
MicroVention, Inc., d/b/a Terumo Neuro |
Cardiovascular |
QEZ |
| Sep 3, 26 |
K260503510(k) |
Triton 1 System |
Neptune Medical, Inc. |
Gastroenterology, Urology |
FDF |
| Sep 3, 26 |
K261281510(k) |
CROSSLEAD Standard 035 and CROSSLEAD Stiff 035 |
Filmecc Co., Ltd. |
Cardiovascular |
DQX |
| Sep 3, 26 |
K261622510(k) |
Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52, SCF593/62); Philips Avent Natural Care Warming Hands-free Wearable Electric Breast Pump (Model: SCF594/52, SCF594/62) |
Philips Consumer Lifestyle B.V. |
Obstetrics/Gynecology |
HGX |
| Sep 3, 26 |
K261647510(k) |
Tempo Plating System; Ultra Compression Screw System |
Pace Surgical |
Orthopedic |
HRS |
| Sep 3, 26 |
K261800510(k) |
Helo Max Thrombectomy System (HEL2090) |
Endovascular Engineering |
Cardiovascular |
QEW |
| Sep 3, 26 |
K262243510(k) |
Profisil Free |
Kettenbach GmbH & Co. KG |
Dental |
LBH |
| Sep 3, 26 |
K262315510(k) |
NeuroBlate System |
Monteris Medical |
General, Plastic Surgery |
ONO |
| Sep 3, 26 |
K262460510(k) |
Rezum System |
Boston Scientific |
Gastroenterology, Urology |
KNS |
| Sep 3, 26 |
K262769510(k) |
Permatage XT Settable Nonabsorbable Hemostatic Bone Putty (OS-PER-1001XT) |
Orthocon, Inc. |
Unknown |
MTJ |
| Sep 2, 26 |
K253065510(k) |
Aevumed SUPERCYNCH Button System |
Aevumed, Inc. |
Orthopedic |
MBI |
| Sep 2, 26 |
K253948510(k) |
Momentum Acetabular Cup System |
United Orthopedic Corporation |
Orthopedic |
LZO |
| Sep 2, 26 |
K254026510(k) |
3.8mm Slim ProVu Video Bronchoscope (090-02-0038U); 5.0mm Regular ProVu Video Bronchoscope (090-02-0050U); 6.0mm Large ProVu Video Bronchoscope (090-02-0060U); ProVu Video Bronchoscope 8 display (040-07-0082U) |
Flexicare Medical Limited. |
Ear, Nose, Throat |
EOQ |
| Sep 2, 26 |
K254090510(k) |
I-View® |
Hologic, Inc. |
Radiology |
MUE |
| Sep 2, 26 |
K254198510(k) |
Trexo Theo |
Trexo Robotics, Inc. |
Physical Medicine |
PHL |
| Sep 2, 26 |
K260432510(k) |
Ruby Intravascular Catheter |
Venocare, Inc. |
General Hospital |
FOZ |
| Sep 2, 26 |
K261311510(k) |
HYALOMATRIX |
Anika Therapeutics, Inc. |
Unknown |
QSZ |
| Sep 2, 26 |
K261313510(k) |
Vivid Explorer/Vivid Advanced/Vivid Focus |
GE Medical Systems Ultrasound and Primary Care Diagnostics |
Radiology |
IYN |
| Sep 2, 26 |
K261589510(k) |
1927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02) |
Zhengzhou PZ Laser Slim Technology Co., Ltd. |
General, Plastic Surgery |
GEX |
| Sep 2, 26 |
K261749510(k) |
Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate |
Cardinalhealth |
Unknown |
|
| Sep 2, 26 |
K262153510(k) |
Pivot Insulin Delivery System |
Modular Medical, Inc. |
General Hospital |
LZG |
| Sep 2, 26 |
K262364510(k) |
Ellian Enigma RF Device |
Ellian Corp |
General, Plastic Surgery |
GEI |
| Sep 2, 26 |
K262420510(k) |
Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000) |
Serpex Medical |
General, Plastic Surgery |
GEH |
| Sep 2, 26 |
K262809510(k) |
ArthroTAK Tendon Anchor Kit |
ArthroTAK, LLC |
Orthopedic |
MBI |
| Sep 1, 26 |
K253961510(k) |
SK Knee System |
Just Medical Devices (Tianjin) Co., Ltd. |
Orthopedic |
JWH |
| Sep 1, 26 |
K260613510(k) |
AMI Plasma Cartridge, AMI |
Sequitur Health Corp. |
Clinical Chemistry |
JID |
| Sep 1, 26 |
K260656510(k) |
Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSignal SpO2 MM 3.0M |
GE Healthcare Finland Oy |
Cardiovascular |
MHX |
| Sep 1, 26 |
K260758510(k) |
MAGNETOM Free.Max; MAGNETOM Free.Star |
Siemens Shenzhen Magnetic Resonance , Ltd. |
Radiology |
LNH |
| Sep 1, 26 |
K260884510(k) |
UNIDRIVE Select System |
Karl Storz SE & CO. KG |
Gastroenterology, Urology |
GCJ |
| Sep 1, 26 |
K261811510(k) |
PRIMED Chemotherapy Drug Tested Gowns (PM4-99450: PRIMED Chemotherapy Drug Tested Isolation Gown, Purple, AAMI Level 2; PM4-99460: PRIMED Chemotherapy Drug Tested Isolation Gown, Blue, AAMI Level 3) |
PRIMED Medical Products, Inc. |
General, Plastic Surgery |
QSO |
| Sep 1, 26 |
K262269510(k) |
CO2 Laser System (MBT- CO2 Laser) |
Beijing Mega Beauty Technology Co., Ltd. |
General, Plastic Surgery |
GEX |
| Sep 1, 26 |
K262451510(k) |
Arthrex DynaNite Staples |
Arthrex, Inc. |
Orthopedic |
JDR |
| Sep 1, 26 |
K262774510(k) |
Wearable breast pump (Model: XN/MD-2249BS, ZFHF) |
Guangdong Horigen Mother & Baby Products Co., Ltd. |
Obstetrics/Gynecology |
HGX |
| Sep 1, 26 |
K262783510(k) |
RadiForce MX247W |
Eizo Corporation |
Radiology |
PGY |