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
39865–39888 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 23, 2013
GYNECARE TVT EXACT CONTINENCE SYSTEM
K132054 · OTN
Ethicon, Inc.
Gastroenterology & Urology · 51d
Cleared Aug 23, 2013
QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN
K132268 · NEW
Surgical Specialties Corporation Dba...
General & Plastic Surgery · 32d
Cleared Aug 23, 2013
AUTOBAND LIGATOR
K132535 · MND
Endochoice, Inc.
Gastroenterology & Urology · 10d
Cleared Aug 22, 2013
POWDERED VINYL EXAMINATION GLOVES
K122100 · LYZ
Wang Tong Xinghua Co., Ltd.
General Hospital · 402d
Cleared Aug 22, 2013
GIO DIGITAL PRESSURE GUAGES
K122627 · CAP
Galemed Corp.
Anesthesiology · 359d
Cleared Aug 22, 2013
WET PLATINUM PERSONAL LUBRICANT
K130012 · NUC
Trigg Laboratories, Inc.
Obstetrics & Gynecology · 232d
Cleared Aug 22, 2013
DISPOSABLE NEUTRAL ELECTRODE GP202
K130027 · GEI
Cathay Manufacturing Corp.
General & Plastic Surgery · 231d
Cleared Aug 22, 2013
PROMOLUX, PROMOLUX HI, WEROPRESS, PREMECO PCS
K130076 · EBI
Merz Dental GmbH
Dental · 220d
Cleared Aug 22, 2013
LATEX SURGEON'S GLOVES (POWDERED AND POWDER FREE)
K130301 · KGO
Elimedical Devices (Fujian), Inc.
General Hospital · 196d
Cleared Aug 22, 2013
PROGIGY SUPPORT CATHETER
K130714 · DQY
Radius Medical, LLC
Cardiovascular · 160d
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