FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
40297–40320 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 02, 2013
ARTHROCARE TURBINATOR WAND
K122652 · GEI
ArthroCare Corporation
General & Plastic Surgery · 305d
Cleared Jul 02, 2013
REVERSE MEDICAL MICRO VASCULAR PLUG (MVP) SYSTEM
K123803 · KRD
Reverse Medical Corporation
Cardiovascular · 204d
Cleared Jul 02, 2013
MDK MULTI-APPLICATIONS PLATFORM
K130256 · GEX
Quanta System Spa
General & Plastic Surgery · 151d
Cleared Jul 02, 2013
PROCELLERA
K130350 · FRO
Vomaris Innovations, Inc.
General & Plastic Surgery · 140d
Cleared Jul 02, 2013
SENSUS
K130919 · GZJ
Neurometrix, Inc.
Neurology · 90d
Cleared Jul 02, 2013
CORRECT PLUS 1
K130920 · ELW
Pentron Clinical
Dental · 90d
Cleared Jul 02, 2013
DIGITAL FLAT PANEL X-RAY DETECTOR/1417WCA
K130935 · MQB
Rayence Co., Ltd.
Radiology · 89d
Cleared Jul 02, 2013
VIDA PTV DILATATON CATHETER
K131002 · OMZ
C.R. Bard, Inc.
Cardiovascular · 83d
Cleared Jul 02, 2013
Y-KNOT FLEX ALL-SUTURE ANCHOR, W/ TWO #2 (5 METRIC) HI-FI SUTURES, 1.8MM
K131035 · MBI
Linvatec Corporation D/B/A Conmed...
Orthopedic · 81d
Cleared Jul 02, 2013
AFFIX SPINOUS PROCESS PLATE SYSTEM
K131238 · PEK
Nuvasive, Inc.
Orthopedic · 62d
Cleared Jul 02, 2013
MOBIS II
K131372 · MAX
Signus Medizintechnik GmbH
Orthopedic · 50d
Cleared Jul 02, 2013
BLOWFISH TRANSBRONCHIAL MICRO-INFUSION CATHETER
K131401 · EOQ
Mercator Medsystems, Inc.
Ear, Nose, Throat · 48d
Cleared Jul 01, 2013
ELLEX 2RT
K122202 · HQF
Ellex Medical Pty, Ltd.
Ophthalmic · 341d
Cleared Jul 01, 2013
COOK HOLMIUM LASER FIBER
K124030 · GEX
Cook Incorporated
General & Plastic Surgery · 185d
Cleared Jul 01, 2013
HEATER-COOLER UNIT HCU 40
K130300 · DWC
Maquet Cardiopulmonary, AG
Cardiovascular · 144d
Cleared Jul 01, 2013
PIPELINE TOTAL HIP SYSTEM (LINE EXTENSION)
K130353 · LPH
Pipeline Orthopedics
Orthopedic · 139d
Cleared Jul 01, 2013
ERA MICRO 23 FEMALE ABUTMENT, ERA MICRO 30 FEMALE ABUTMENT
K130408 · NHA
Sterngold Dental, LLC
Dental · 132d
Cleared Jul 01, 2013
ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY
K131705 · GDW
Covidien, Formerly US Surgical A...
General & Plastic Surgery · 20d
Cleared Jul 01, 2013
CIRONA DVT FOOT GARMENT
K131743 · JOW
Devon Medical, Inc.
Cardiovascular · 18d
Cleared Jun 28, 2013
CODA BALLOON CATHETER
K122917 · DQY
Cook, Inc.
Cardiovascular · 276d
Cleared Jun 28, 2013
IMMUNOCAP ALLERGEN i3, COMMON WASP VENOM (YELLOW JACKET), AND IMMUNOCAP...
K123275 · DHB
Phadia AB
Immunology · 252d
Cleared Jun 28, 2013
REVITIVE IX
K123354 · IPF
Actegy , Ltd.
Physical Medicine · 240d
Cleared Jun 28, 2013
NIRVANA D PERSONAL LUBRICANT (TBD)
K123427 · NUC
Church & Dwight Co., Inc.
Obstetrics & Gynecology · 233d
Cleared Jun 28, 2013
SOLUSMOBILE BLOOD GLUCOSE MANAGMENT SYSTEM
K123559 · NBW
Biotest Medical Corp.
Chemistry · 221d