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
38689–38712 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 10, 2014
FLEXMAP 3D
K133302 · NSU
Luminex Corp.
Pathology · 77d
Cleared Jan 10, 2014
AXIUM DETACHABLE COIL SYSTEM
K133310 · HCG
Micro Therapeutics, Inc. d/b/a ev3...
Neurology · 74d
Cleared Jan 10, 2014
ANSPACH EG1 HIGH SPEED SYSTEM, G1 ATTACHMENTS
K133604 · HBC
The Anspach Effort, Inc.
Neurology · 46d
Cleared Jan 09, 2014
LEIBINGER ADVANCE INTERNAL MIDFACE DISTRACTION SYSTEM
K121235 · JEY
Stryker
Dental · 625d
Cleared Jan 09, 2014
CRYOLOCK
K122982 · MQK
Biotech, Inc.
Obstetrics & Gynecology · 470d
Cleared Jan 09, 2014
ACTIM PROM
K123986 · OAM
Alere Scarborough, Inc.
Chemistry · 379d
Cleared Jan 09, 2014
CASCADE HEMODIALYSIS/APHERESIS CATHETER
K130851 · MSD
Health Line International Corporation
Gastroenterology & Urology · 288d
Cleared Jan 09, 2014
SONOPULSE/ SONOPULSE III
K130888 · IMI
Ibramed- Industria Brazileria DE...
Physical Medicine · 286d
Cleared Jan 09, 2014
RX DAYTONA PLUS CHEMISTRY ANALYZER
K131554 · JJE
Randox Laboratories, Ltd.
Chemistry · 224d
Cleared Jan 09, 2014
BAUSCH & LOMB INJECTOR SYSTEM
K131958 · MSS
Bausch & Lomb
Ophthalmic · 196d
Cleared Jan 09, 2014
ISO-GARD MASK
K132729 · CBN
Teleflexmedical, Inc.
Anesthesiology · 128d
Cleared Jan 09, 2014
FASTEP S10 HCG SERUM/URINE COMBO TEST
K132834 · JHI
Polymed Therapeutics, Inc.
Chemistry · 121d
Cleared Jan 09, 2014
TAMPAX M PLASTIC TAMPONS, UNSCENTED
K133244 · HEB
The Procter & Gamble Company
Obstetrics & Gynecology · 79d
Cleared Jan 09, 2014
ITOTAL CRUCIATE RETAINING, IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEMS, IDUO...
K133256 · JWH
Conformis, Inc.
Orthopedic · 78d
Cleared Jan 09, 2014
MEDOS HILITE 7000 & 7000 LT OXYGENATOR
K133261 · DTZ
Medos Medizintechnik AG
Cardiovascular · 78d
Cleared Jan 09, 2014
MIDLINE (TM)
K133286 · OVD
Centinel Spine, Inc.
Orthopedic · 76d
Cleared Jan 09, 2014
ALAMO C
K133321 · ODP
Alliance Partners, LLC
Orthopedic · 72d
Cleared Jan 09, 2014
RAMPART-L
K133371 · MAX
Spineology, Inc.
Orthopedic · 69d
Cleared Jan 09, 2014
HAMMERLOCK 2
K133520 · HTY
Biomedical Enterprises, Inc.
Orthopedic · 55d
Cleared Jan 08, 2014
ORTHODONTIC MINISCREW FOR ABSOLUTE ANCHORAGE
K130476 · OAT
Dental Morelli
Dental · 317d
Cleared Jan 08, 2014
ENDOVASCULAR LASER VENOUS SYSTEM KIT WITH 2 RING RADIAL EMITTING FIBER
K130681 · GEX
Biolitec Sia
General & Plastic Surgery · 301d
Cleared Jan 08, 2014
SAFESEPT NEEDLE FREE TRANSSEPTAL TROCAR GUIDEWIRE
K130843 · DRC
Oscor, Inc.
Cardiovascular · 287d
Cleared Jan 08, 2014
V-PATCH SYSTEM
K131000 · DSI
Intelesens Limited
Cardiovascular · 273d
Cleared Jan 08, 2014
ULTRASONIC MESH NEBULIZER
K132247 · CAF
Foshan Gaunying Electronics Co., Ltd.
Anesthesiology · 173d