Search FDA 510(k) Devices

5,413 clearances indexed · Search by device name, K-number, manufacturer or product code

Filters: 2023–2023 ×
3,347 results
841–864 of 3,347
Cleared Oct 05, 2023
ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD
K232395 · JWY
Biom?rieux
Microbiology · 57d
Cleared Oct 05, 2023
cmAngio® V1.0
K232367 · QIH
Curemetrix, Inc.
Radiology · 58d
Cleared Oct 05, 2023
LifeStyles NRL Textured Condom
K232279 · HIS
Suretex Limited
Obstetrics & Gynecology · 66d
Cleared Oct 05, 2023
All-Suture Anchor
K231078 · MBI
Riverpoint Medical, LLC
Orthopedic · 171d
Cleared Oct 05, 2023
DeepTek CXR Analyzer v1.0
K231001 · MYN
Deeptek Medical Imaging Pvt, Ltd.
Radiology · 181d
Cleared Oct 05, 2023
MFG-05
K230780 · KPI
Zimmer Medizinsysteme GmbH
Gastroenterology & Urology · 197d
Cleared Oct 05, 2023
OsteoCentric Dental Implant System
K230242 · DZE
OsteoCentric Technologies
Dental · 248d
Cleared Oct 05, 2023
MESORAM® Hypodermic Needle (710301)
K230070 · FMI
Promamedical, Inc.
General Hospital · 268d
Cleared Oct 05, 2023
Oxygen Concentrator (Model: KSW-5, KSN-5, KSOC-5)
K223740 · CAW
Jiangsu Konsung Bio-Medical Science...
Anesthesiology · 295d
Cleared Oct 05, 2023
Evidence MultiSTAT DOA Urine MultiPlex
K221550 · DJG
Randox Laboratories Limited
Toxicology · 492d
Cleared Oct 05, 2023
Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT
K220451 · DJG
Randox Laboratories Limited
Chemistry · 595d
Cleared Oct 04, 2023
The IQoolTM System
K232844 · DWJ
Braincool AB
Cardiovascular · 20d
Cleared Oct 04, 2023
Nautilus VF ECMO Oxygenator
K232767 · BYS
Mc3, Inc.
Cardiovascular · 23d
Cleared Oct 04, 2023
Electrode Handpieces (VCT, RFTV, BMDT series)
K232763 · GEI
RF Medical Co., Ltd.
General & Plastic Surgery · 26d
Cleared Oct 04, 2023
Momentum Spine
K232023 · LDK
Momentum Health, Inc.
Physical Medicine · 89d
Cleared Oct 04, 2023
Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with...
K231567 · LZA
Better Care Plastic Technology Co., Ltd.
General Hospital · 126d
Cleared Oct 04, 2023
VUNO Med-DeepBrain
K231398 · QIH
Vuno, Inc.
Radiology · 142d
Cleared Oct 04, 2023
EFAI NeuroSuite CT ICH Assessment System
K231025 · QAS
Ever Fortune.Ai, Co., Ltd.
Radiology · 176d
Cleared Oct 04, 2023
Copioumed Chemotherapy Isolation Gown
K230135 · FYC
Copioumed International, Inc.
General Hospital · 259d
Not Cleared Oct 04, 2023
DuraGraft
DEN230002 · QEJ
Marizyme, Inc.
Gastroenterology & Urology · 274d
Cleared Oct 03, 2023
enspire 300 Series Automated Endoscope Reprocessor
K232918 · NZA
STERIS Corporation
General Hospital · 14d
Cleared Oct 03, 2023
SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500)
K232914 · MED
STERIS Corporation
General Hospital · 14d
Cleared Oct 03, 2023
dS Breast Coil 7ch 1.5T
K232762 · MOS
Invivo Corporation (Business Trade...
Radiology · 25d
Cleared Oct 03, 2023
endo.digital Platform
K232722 · QCC
DreaMed Diabetes, Ltd.
Chemistry · 28d