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
37945–37968 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 07, 2014
LOCKING BONE PLATE STYLE 14, METAFIX LOCKING SCREW 3.8, MERETE CANNULATED PCS...
K140069 · HRS
Merete Medical GmbH
Orthopedic · 84d
Cleared Apr 07, 2014
FRAGMENT PLATE SYSTEM
K140372 · HRS
Skeletal Dynamics, LLC
Orthopedic · 52d
Cleared Apr 04, 2014
A1C GEAR SYSTEM
K130014 · LCP
Sakae Corporation
Chemistry · 457d
Cleared Apr 04, 2014
CLOUDEKG
K130878 · DXH
Makromed, Inc.
Cardiovascular · 371d
Cleared Apr 04, 2014
AFTAMED MOUTHWASH
K130959 · OLR
Bioplax Limited
General & Plastic Surgery · 364d
Cleared Apr 04, 2014
CLEARMRI HELIOS-RG8 COIL ACCESSORY KIT
K132381 · LNH
Clearmri Solutions, Inc.
Radiology · 247d
Cleared Apr 04, 2014
I.B.S SNAP-OFF SCREW / SOLAFIX SNAP-OFF SCREW
K132911 · HWC
In2bones Sas
Orthopedic · 199d
Cleared Apr 04, 2014
NOBELPROCERA ANGULATED SCREW CHANNEL ABUTMENT REPLACE
K133377 · NHA
Nobel Biocare AB
Dental · 151d
Cleared Apr 04, 2014
BARD RITECATH INTERMITTENT CATHETER
K133470 · EZD
C.R. Bard, Inc.
Gastroenterology & Urology · 143d
Cleared Apr 04, 2014
ARIA RADIATION THERAPY MANAGEMENT
K133572 · IYE
Varian Medical Systems, Inc.
Radiology · 135d
Cleared Apr 04, 2014
MEDINAUT KYPHOPLASTY SYSTEM
K133669 · NDN
Imedicom
Orthopedic · 126d
Cleared Apr 04, 2014
TORNIER INSITE(TM) FT PEEK KNOTLESS SUTURE ANCHOR
K133777 · MBI
Tornier, Inc.
Orthopedic · 113d
Cleared Apr 04, 2014
TRIBALL INCENTIVE SPIROMETER
K133873 · BWF
Besmed Health Business Corp
Anesthesiology · 105d
Cleared Apr 04, 2014
NORDICBRAINEX
K133910 · LLZ
Nordicneurolab
Radiology · 102d
Cleared Apr 04, 2014
ARTUS C. DIFFICILE QS-RGQ MDX KIT
K133936 · OZN
QIAGEN GmbH
Microbiology · 102d
Cleared Apr 04, 2014
TSP HIP FRACTURE PLATING SYSTEM
K140018 · JDO
Biomet, Inc.
Orthopedic · 91d
Cleared Apr 04, 2014
US ENDOSCOPY DISTAL ATTACHMENT CAP
K140315 · OCX
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 53d
Cleared Apr 04, 2014
8MP COLOR LCD MONITOR, RADIFORCE RX850
K140702 · PGY
Eizo Corporation
Radiology · 15d
Cleared Apr 03, 2014
KOBOLD SECURE LOCK TRANSFER GUIDE TUBE SET
K130757 · JAQ
Spencer Fillmore
Radiology · 379d
Cleared Apr 03, 2014
MEDICALYTE(R) BICARBONATE POWDER (36.83X), MEDICALYTE(R) BICARBONATE POWDER...
K131202 · KPO
Dialysis Medical Solutions, LLC
Gastroenterology & Urology · 339d
Cleared Apr 03, 2014
FLEXIBLE COOAGEN NERVE CUFF
K131541 · JXI
Collagen Matrix, Inc.
Neurology · 309d
Cleared Apr 03, 2014
PERCLOT TOPICAL
K132105 · QSY
Cryolife, Inc.
General & Plastic Surgery · 269d
Cleared Apr 03, 2014
VITALCONNECT PLATFORM BY VITAL CONNECT INC.
K132447 · DRG
Vitalconnect, Inc.
Cardiovascular · 240d
Cleared Apr 03, 2014
ZOLL CODE WRITER
K132488 · DXJ
ZOLL Medical Corporation
Cardiovascular · 238d