FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
26929–26952 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 18, 2018
FMS VUE II Fluid Management and Tissue Debridement System
K171237 · HRX
Medos International SARL
Orthopedic · 266d
Cleared Jan 18, 2018
PulsioFlex Monitoring System
K172259 · DXG
Pulsion Medical Systems SE
Cardiovascular · 175d
Cleared Jan 18, 2018
AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low...
K172319 · MLR
STERIS Corporation
General Hospital · 170d
Cleared Jan 18, 2018
BAROnova Retrieval Kit, BAROnova Overtube, BAROnova Endoscope Cap
K172575 · FED
Baronova, Inc.
Gastroenterology & Urology · 143d
Cleared Jan 18, 2018
Lumilisse IPL Hair Remover
K172791 · OHT
Conair Corporation
General & Plastic Surgery · 125d
Cleared Jan 18, 2018
Flex Robotic System and Flex Transabdominal Drive
K172796 · HET
Medrobotics Corporation
Obstetrics & Gynecology · 125d
Cleared Jan 18, 2018
Nurture Rest
K172962 · OUW
Neonatal Loving Kare, Inc.
General Hospital · 114d
Cleared Jan 18, 2018
Navigated INFINITY™ Instruments
K173338 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 87d
Cleared Jan 18, 2018
Tritanium® TL Curved Posterior Lumbar Cage
K173476 · MAX
Stryker
Orthopedic · 70d
Cleared Jan 18, 2018
Barrx SB RFA Endoscopic Catheter
K173559 · KNS
Covidien, LLC
Gastroenterology & Urology · 62d
Cleared Jan 18, 2018
Stryker AIM Light Source and SafeLight cable
K173866 · OWN
Stryker
General & Plastic Surgery · 29d
Cleared Jan 17, 2018
Endotracheal tube
K170234 · BTR
Zhanjiang Star Enterprise Co., Ltd.
Anesthesiology · 357d
Cleared Jan 17, 2018
epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test
K171247 · CDS
Epocal, Inc.
Chemistry · 264d
Cleared Jan 17, 2018
Ortho System
K171634 · PNN
3Shape A/S
Dental · 229d
Cleared Jan 17, 2018
PROPEL Device
K172164 · DZJ
Propel Orthodontics, LLC
Dental · 183d
Cleared Jan 17, 2018
OBA-MCP, Orthodontic Bracket Adhesive with MCP
K173020 · DYH
Pulpdent Corporation
Dental · 111d
Cleared Jan 17, 2018
Medline Disposable Electronic Thermometer Probe Cover
K173113 · FLL
Medline Industries, Inc.
General Hospital · 110d
Cleared Jan 17, 2018
NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall)
K173479 · FMI
Novo Nordisk, Inc.
General Hospital · 65d
Cleared Jan 17, 2018
ThermiX Temperature Control Radiofrequency System, Accessories - RF Electrodes
K173582 · GEI
Thermigen, L.L.C
General & Plastic Surgery · 58d
Cleared Jan 17, 2018
Kinsa QuickCare Thermometer
K173730 · FLL
Kinsa, Inc.
General Hospital · 42d
Cleared Jan 17, 2018
OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (Paper DFU), OptiCross 6 HD,...
K173820 · OBJ
Boston Scientific Corporation
Cardiovascular · 30d
Cleared Jan 17, 2018
ARIA Radiation Therapy Management
K173838 · IYE
Varian Medical Systems, Inc.
Radiology · 30d
Cleared Jan 17, 2018
Unity Total Knee System
K173884 · JWH
Corin U.S.A. Limited
Orthopedic · 27d
Cleared Jan 16, 2018
K2M Navigation Instruments
K171556 · OLO
K2m
Orthopedic · 231d