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
38641–38664 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 16, 2014
DYNESYS TOP-LOADING SPINAL SYSTEM
K133164 · NQP
Zimmer Spine, Inc.
Orthopedic · 91d
Cleared Jan 16, 2014
STARLIGHT
K133250 · OAN
Orthomerica Products, Inc.
Neurology · 86d
Cleared Jan 16, 2014
HEM-7311
K133379 · DXN
Omron Healthcare, Inc.
Cardiovascular · 73d
Cleared Jan 16, 2014
SYNAPSE SYSTEM
K133698 · KWP
Synthes USA Products, LLC
Orthopedic · 44d
Cleared Jan 16, 2014
Q-FIX SUTURE ANCHOR, 1.8MM
K133727 · MBI
ArthroCare Corporation
Orthopedic · 41d
Cleared Jan 16, 2014
POWERGLIDE MIDLINE CATHETER
K133856 · FOZ
C.R. Bard, Inc.
General Hospital · 28d
Cleared Jan 15, 2014
ONE STEP SINGLE/MULTI-DRUG TEST CUP
K131110 · DKZ
Co-Innovation Biotech Co., Ltd.
Toxicology · 271d
Cleared Jan 15, 2014
BIOPHOTAS CELLUMA
K131113 · ILY
Biophotas, Inc.
Physical Medicine · 268d
Cleared Jan 15, 2014
U2 TIBIAL BASEPLATE- CMA TYPE, TIBIAL INSERT AND AUGMENT
K131864 · JWH
United Orthopedic Corporation
Orthopedic · 205d
Cleared Jan 15, 2014
STRAUMANN CARES BONE LEVEL SCREW RETAINED BARS, STRAUMANN CARES BONE LEVEL...
K132844 · NHA
Straumann USA, LLC
Dental · 126d
Cleared Jan 15, 2014
COMPUTED RADIOGRAPHY SCANNER
K133106 · MQB
3Disc Americas
Radiology · 107d
Cleared Jan 15, 2014
COMPUTED RADIOGRAPHY SCANNER
K133120 · MQB
3Disc Americas
Radiology · 107d
Cleared Jan 15, 2014
ILUMINAGE SKIN SMOOTHING LASER
K133473 · OHS
Cynosure, Inc.
General & Plastic Surgery · 64d
Cleared Jan 14, 2014
TASMIN R
K123758 · MQP
Signus Medizintechnik GmbH
Orthopedic · 403d
Cleared Jan 14, 2014
COSENSE CO MONITOR
K130036 · CCJ
Capnia, Inc.
Anesthesiology · 372d
Cleared Jan 14, 2014
M2 WRIST 2 MRI SYSTEM
K130692 · LNH
Aspect Imaging, Ltd.
Radiology · 307d
Cleared Jan 14, 2014
SYNTHETIC ABSORBABLE SUTURE
K130735 · GAM
Foosin Medical Supplies Inc., Ltd.
General & Plastic Surgery · 302d
Cleared Jan 14, 2014
SYNTHETIC ABSORBABLE SUTURE
K130737 · GAM
Foosin Medical Supplies Inc., Ltd.
General & Plastic Surgery · 302d
Cleared Jan 14, 2014
IMMULITE 2000 AFP, BR-MA, AND OM-MA CALIBRATION VERIFICATION MATERIAL
K132739 · JJX
Siemens Healthcare Diagnostics, Inc.
Immunology · 133d
Cleared Jan 14, 2014
SR VIVODENT S, SR ORTHOTYP S, SR ORTHOLINGUAL S
K132984 · ELM
Ivoclar Vivadent, Inc.
Dental · 112d
Cleared Jan 14, 2014
TIGER SPINE SYSTEM
K133369 · NKB
Corelink, LLC
Orthopedic · 74d
Cleared Jan 14, 2014
SUZHOU BEINUO SURGICAL STAPLERS - CIRCULAR STAPLERS FOR SINGLE USE,...
K133499 · GDW
Suzhou Beinuo Medical Equipment Co. ,...
General & Plastic Surgery · 61d
Cleared Jan 13, 2014
CT PULMONARY ANALYSIS
K130552 · JAK
Qi Imaging, LLC
Radiology · 315d
Cleared Jan 13, 2014
ENTUIT THRIVE LP BALLOON RETENTION GASTROSTOMY FEEDING TUBE
K130674 · KNT
Xeridiem Medical Devices
Gastroenterology & Urology · 306d