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.

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

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175,820 results
40465–40488 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 22, 2013
AERODR SYSTEM WITH P-31
K130936 · MQB
Konica Minolta Medical & Graphic, Inc.
Radiology · 140d
Cleared Aug 22, 2013
SIM
K130951 · KPN
Simavita Pty Limited
Gastroenterology & Urology · 139d
Cleared Aug 22, 2013
CENTRAL VENOUS PRESSURE SYSTEM - MESPERE VENUS 1000
K131085 · PFA
Mespere Lifesciences, Inc.
Cardiovascular · 126d
Cleared Aug 22, 2013
LEGACY3 6MM LENGTH IMPLANTS
K131097 · DZE
Implant Direct Sybron Manufacturing, LLC
Dental · 126d
Cleared Aug 22, 2013
OPTI CCA-TS2
K131126 · CHL
Opti Medical Systems, Inc.
Chemistry · 122d
Cleared Aug 22, 2013
GMK FULL PE TIBIAL COMPONENTS
K131310 · JWH
Medacta International
Orthopedic · 107d
Cleared Aug 22, 2013
CLEARFIL SE BOND 2 KIT
K131432 · KLE
Kuraray Noritake Dental, Inc.
Dental · 97d
Cleared Aug 22, 2013
PALTOP DENTAL IMPLANT - STERILE ACCESSORIES
K131451 · DZE
Paltop Advanced Dental Solutions, Ltd.
Dental · 94d
Cleared Aug 22, 2013
CRYOBALLOON FOCAL ABLATION SYSTEM
K131523 · GEH
C2 Therapeutics
General & Plastic Surgery · 86d
Cleared Aug 22, 2013
MYOSURE TISSUE REMOVAL DEVICE (1 PACK AND 3 PACK)
K131581 · HIH
Hologic, Inc.
Obstetrics & Gynecology · 83d
Cleared Aug 22, 2013
FLOWER SMALL AND MEDIUM IMPLANT SET
K131657 · HRS
Flower Orthopedics Corporation
Orthopedic · 77d
Cleared Aug 22, 2013
3B RESMART CPAP AND AUTO CPAP SYSTEMS, BMC RESMART CPAP AND AUTO CPAP SYSTEMS
K131707 · BZD
3B Medical, Inc.
Anesthesiology · 72d
Cleared Aug 22, 2013
MYOSURE TISSUE REMOVAL DEVICE (1 PACK), MYOSURE TISSUE REMOVAL DEVICE (3 PACK)
K131736 · HIH
Hologic, Inc.
Obstetrics & Gynecology · 70d
Cleared Aug 22, 2013
AVENIR CEMENTED HIP STEM
K131884 · LZO
Zimmer GmbH
Orthopedic · 58d
Cleared Aug 22, 2013
SYMBOTEX(TM) COMPOSITE MESH
K131969 · FTL
Sofradim Production
General & Plastic Surgery · 55d
Cleared Aug 22, 2013
ARTHROCARE COBLATOR IQ DLR SPINEWAND, ARTHROCARE COBLATOR IQ DLG SPINEWAND
K132099 · GEI
ArthroCare Corporation
General & Plastic Surgery · 45d
Cleared Aug 22, 2013
SURGIQUEST AIRSEAL IFS
K132169 · GCJ
Surgiquest, Inc.
General & Plastic Surgery · 38d
Cleared Aug 22, 2013
INSUFLOW SYNERGY XL PORT
K132204 · HIF
Lexion Medical, LLC
Obstetrics & Gynecology · 37d
Cleared Aug 22, 2013
MOUNTAINEER OCT SPINAL SYSTEM
K132332 · KWP
Medos International SARL
Orthopedic · 27d
Cleared Aug 22, 2013
SAS FLUALERT A & B, SAS INFLUENZA A TEST
K132352 · GNX
Sa Scientific , Ltd.
Microbiology · 24d
Cleared Aug 21, 2013
LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITOR
K130454 · MKJ
Physio-Control, Inc.
Cardiovascular · 180d
Cleared Aug 21, 2013
SWING-OFF SCREW
K130627 · HWC
Advanced Interventional Technology, LLC
Orthopedic · 166d
Cleared Aug 21, 2013
CARESENS N LINK BLOOD GLUCOSE MONITORING SYSTEM
K130696 · NBW
I-Sens, Inc.
Chemistry · 160d
Cleared Aug 21, 2013
CORVIEW
K131158 · LLZ
Marrek, Inc.
Radiology · 119d