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
39457–39480 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 10, 2013
IMMULITE 2000 ACTH CALIBRATION VERIFICATION MATERIAL
K131662 · JJX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 125d
Cleared Oct 10, 2013
BIOLOX(R) DELTA CERAMIC HEADS
K131684 · LZO
Biomet, Inc.
Orthopedic · 122d
Cleared Oct 10, 2013
NXSTAGE CONNECTED HEALTH SYSTEM
K131739 · FKP
Nxstage Medical, Inc.
Gastroenterology & Urology · 119d
Cleared Oct 10, 2013
VITEK 2 AST-ST TIGECYCLINE
K131779 · LON
bioMerieux, Inc.
Microbiology · 115d
Cleared Oct 10, 2013
3B LASER NEEDLE
K131797 · ILY
Livetec GmbH
Physical Medicine · 114d
Cleared Oct 10, 2013
DELTEX MEDICAL CARDIOQ-EDM+
K132139 · DPW
Deltex Medical Limited
Cardiovascular · 91d
Cleared Oct 10, 2013
IMPLANET SPINE SYSTEM
K132303 · OSH
Implanet, S.A.
Orthopedic · 78d
Cleared Oct 10, 2013
INERTIA MIS PEDICLE SCREW SYSTEM
K132412 · MNI
Nexxt Spine, LLC
Orthopedic · 69d
Cleared Oct 10, 2013
BARRICADE EMBOLIZATION COIL SYSTEM
K132482 · HCG
Blockade Medical
Neurology · 63d
Cleared Oct 09, 2013
ESOPHAGEAL TTS STENT
K123205 · ESW
Taewoong Medical Co., Ltd.
Gastroenterology & Urology · 362d
Cleared Oct 09, 2013
ROLLINS 7 OXYGEN MASK
K130379 · CAF
Rollins Medical Solutions, Inc.
Anesthesiology · 237d
Cleared Oct 09, 2013
COMPREHENSIVE CONVERTIBLE GLENOID
K130390 · PHX
Biomet Manufacturing, Inc.
Orthopedic · 236d
Cleared Oct 09, 2013
FEMTO LDV(TM) Z-GENERATION FEMTOSECOND SURGICAL LASER
K131207 · HQF
Surgical Instrument Engineering AG
Ophthalmic · 163d
Cleared Oct 09, 2013
AU BICARBONATE REAGENT
K131546 · KHS
Beckman Coulter Ireland, Inc.
Chemistry · 133d
Cleared Oct 09, 2013
HAMILTON-G5
K131774 · CBK
Hamilton Medical AG
Anesthesiology · 114d
Cleared Oct 09, 2013
CEZANNE II INTERBODY FUSION SYSTEM
K131981 · MAX
Accel Spine
Orthopedic · 103d
Cleared Oct 09, 2013
VIDAS C DIFFICILE GDH
K132010 · MCB
Biomerieux S.A.
Microbiology · 100d
Cleared Oct 09, 2013
SYNERGY ODM
K132667 · NFJ
Topcon Medical Systems, Inc.
Ophthalmic · 43d
Cleared Oct 09, 2013
DISTAL RADIUS VOLAR RIM PLATE STANDARD, DISTAL RADIUS VOLAR RIM PLATE NARROW
K132704 · LXT
Biomet
Orthopedic · 41d
Cleared Oct 09, 2013
PLAYTEX (SCENTED AND UNSCENTED) SPORT FRESH BALANCE TAMPONS
K132819 · HIL
Playtex Manufacturing, Inc.
Obstetrics & Gynecology · 30d
Cleared Oct 08, 2013
MEDDUSA BIPOLAR SYSTEM
K130110 · GEI
Elliquence, LLC
General & Plastic Surgery · 265d
Cleared Oct 08, 2013
R7
K130834 · ELC
Cefla S.C.
Dental · 196d
Cleared Oct 08, 2013
PRONTOSAN WOUND GEL X
K130857 · FRO
B.Braun Medical, Inc.
General & Plastic Surgery · 194d
Cleared Oct 08, 2013
BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFT
K131015 · GXQ
Cook Biotech, Inc.
Neurology · 180d