Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
74497–74520 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 06, 2002
RETRO REPAIR KIT, MODEL PRRK5
K022644 · NFK
Spire Biomedical, Inc.
Gastroenterology & Urology · 90d
Cleared Nov 06, 2002
BIRD AVEA VENTILATOR
K022674 · CBK
Bird Products Corp.
Anesthesiology · 86d
Cleared Nov 06, 2002
AMEDICA DRUG SCREEN COCAINE TEST
K022954 · DIO
Amedica Biotech, Inc.
Toxicology · 62d
Cleared Nov 06, 2002
AMEDICA DRUG SCREEN THC TEST
K022955 · LDJ
Amedica Biotech, Inc.
Toxicology · 62d
Cleared Nov 06, 2002
AMEDICA DRUG SCREEN OPIATES TEST
K023047 · DJG
Amedica Biotech, Inc.
Toxicology · 55d
Cleared Nov 06, 2002
INDWELLING FECAL MANAGEMENT SYSTEM-NON-STERILE
K023344 · KNT
Bowel Management Systems, LLC
Gastroenterology & Urology · 30d
Cleared Nov 06, 2002
ESPRIT VENTILATOR WITH RESPIRATORY MECHANICS
K023350 · CBK
Respironics California, Inc.
Anesthesiology · 30d
Cleared Nov 06, 2002
ARCPM 1050 RESIN-HIPS
K023357 · LPH
Biomet Orthopedics, Inc.
Orthopedic · 30d
Cleared Nov 06, 2002
8F LAUNCHER GUIDE CATHETER
K023402 · DQY
Medtronic Vascular
Cardiovascular · 27d
Cleared Nov 06, 2002
HEARTONE EVENT RECORDER AND TRANSMITTER
K023418 · DXH
Aerotel Medical Systems (1998) , Ltd.
Cardiovascular · 26d
Cleared Nov 06, 2002
DRAPES WITH ABSORBENT REINFORCEMENT
K023425 · KKX
Allegiance Healthcare Corp.
General Hospital · 26d
Cleared Nov 06, 2002
STERI-MATE STERILIZABLE HANDPIECE
K023697 · ELC
Dentsply International
Dental · 2d
Cleared Nov 05, 2002
COZART RAPISCAN ORAL FLUID DRUG TEST - OPIATE/METHADONE
K020920 · DJG
Cozart Bioscience , Ltd.
Toxicology · 229d
Cleared Nov 05, 2002
THERMAGE THERMACOOL TC SYSTEM
K021402 · GEI
Thermage, Inc.
General & Plastic Surgery · 187d
Cleared Nov 05, 2002
SIEMENS VIRTUAL SIMULATION (VSIM)
K022036 · MUJ
Siemens Medical Solutions USA, Inc.
Radiology · 134d
Cleared Nov 05, 2002
CLARUS STRAIGHT FIRING LASER FIBER, MODEL 1150, CLARUS SIDE FIRING LASER...
K022610 · GEX
Clarus Medical, LLC
General & Plastic Surgery · 91d
Cleared Nov 05, 2002
WMT-TCP BONE GRAFT SUBSTITUTE
K022629 · MQV
Wrightmedicaltechnologyinc
Orthopedic · 90d
Cleared Nov 05, 2002
BLASTOMERE BIOPSY PIPETTE, MODELS H-55530 AND H-55540
K022643 · MQH
Swemed Lab International AB
Obstetrics & Gynecology · 89d
Cleared Nov 05, 2002
CURAD
K022645 · KMF
Beiersdorf AG
General & Plastic Surgery · 89d
Cleared Nov 05, 2002
RANDOX C-REACTIVE PROTEIN CALIBRATOR
K022682 · JIS
Randox Laboratories, Ltd.
Chemistry · 85d
Cleared Nov 05, 2002
INSTANT-VIEW LH OVULATION PREDICTING TEST
K022829 · CEP
Alfa Scientific Designs, Inc.
Chemistry · 71d
Cleared Nov 05, 2002
PROMOTOR
K023106 · MQL
Ceres Fertility, Inc.
Obstetrics & Gynecology · 48d
Cleared Nov 05, 2002
CERANUM 82
K023197 · EJT
Sb Lucius, Inc.
Dental · 41d
Cleared Nov 05, 2002
EXTRA LARGE BODY COIL
K023442 · MOS
GE Medical Systems
Radiology · 21d