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
37033–37056 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 18, 2014
GEISTLICH MUCOGRAFT: 15 X 20 MM, 20 X 30 MM, 8 MM DIAMETER
K140518 · NPL
Geistlich Pharma AG
Dental · 140d
Cleared Jul 18, 2014
LEVO TINNITUS MASKING SOFTWARE DEVICE
K140845 · KLW
Otoharmonics Corp
Ear, Nose, Throat · 107d
Cleared Jul 18, 2014
SYNGO.MR NEUROLOGY, SYNGO.MMR GENERAL
K140897 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 102d
Cleared Jul 18, 2014
OPTILITE C1 INACTIVATOR KIT
K141100 · DBA
The Binding Site Group , Ltd.
Immunology · 80d
Cleared Jul 18, 2014
NANOCROSS EITE 0.014 OVER-THE-WIRE PTA BALLOON DILATATION CATHETER
K141118 · LIT
Ev3, Inc.
Cardiovascular · 79d
Cleared Jul 18, 2014
JUGGERLOC BONE TO BONE IMPLANTS/ BONE INSTRUMENTS/ BONE IMPLANT AND...
K141219 · HTN
Biomet Manufacturing Corp
Orthopedic · 67d
Cleared Jul 18, 2014
ELITECH CLINICAL SYSTEMS ENVOY 500 CK REAGENT KIT
K141265 · JHW
Elitechgroup
Chemistry · 64d
Cleared Jul 18, 2014
ILENS (OCUFILCON D) DAILY SOFT CONTACT LENS
K141280 · LPL
Seinoh Optical Co. , Ltd.
Ophthalmic · 63d
Cleared Jul 18, 2014
VARIAX DISTAL RADIUS PLATING SYSTEM
K141430 · HRS
Stryker Leibinger GmbH & Co KG
Orthopedic · 49d
Cleared Jul 18, 2014
ARTHREX PIP DART
K141577 · HTY
Arthrex, Inc.
Orthopedic · 35d
Cleared Jul 18, 2014
POLYSYN SURGICAL SUTURE
K141625 · GAM
Surgical Specialties Corp
General & Plastic Surgery · 31d
Cleared Jul 18, 2014
VOLUSON S6, VOLUSON S8
K141639 · IYN
Ge Healthcare
Radiology · 29d
Cleared Jul 18, 2014
ZONARE ZS3 DIAGNOSTIC ULTRASOUND SYSTEM
K141641 · IYN
Zonare Medical Systems, Inc.
Radiology · 29d
Cleared Jul 18, 2014
THE BELMONT RAPID INFUSER
K141654 · FRN
Belmont Instrument Corporation
General Hospital · 28d
Cleared Jul 17, 2014
TATTOOSTAR EFFECT COMBO
K131757 · GEX
Asclepion Laser Technologies GmbH
General & Plastic Surgery · 395d
Cleared Jul 17, 2014
VERIFY V24 SELF-CONTAINED BIOLOGICAL INDICATOR FOR VAPORIZED VH202...
K140499 · FRC
STERIS Corporation
General Hospital · 140d
Cleared Jul 17, 2014
ACCUCATH BC INTRAVASCULAR CATHETER SYSTEM
K140504 · FOZ
Vascular Pathways, Inc.
General Hospital · 140d
Cleared Jul 17, 2014
VERIFY HPU CHEMICAL INDICATOR/ VERIFY VAPORIZED VH202 PROCESS INDICATOR...
K140515 · JOJ
STERIS Corporation
General Hospital · 139d
Cleared Jul 17, 2014
FINGERTIP PULSE OXIMETER
K140682 · DQA
Beijing Choice Electronic Technololgy...
Anesthesiology · 121d
Cleared Jul 17, 2014
SHILLA GROWTH GUIDANCE SYSTEM
K140750 · PGM
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 114d
Cleared Jul 17, 2014
D2 HEMOSTANTIC DRESSING
K140757 · QSY
Z-Medica, LLC
General & Plastic Surgery · 113d
Cleared Jul 17, 2014
DELWORKS DR SYSTEM
K140825 · MQB
Del Medical, Inc.
Radiology · 107d
Cleared Jul 17, 2014
NUVIS ARTHROSCOPE
K140903 · HRX
Integrated Endoscopy, Inc.
Orthopedic · 99d
Cleared Jul 17, 2014
COBAS C TINA-QUANT CYSTATIN C GEN.2 ASSAY, C.F.A.S. CYSTATIN C CALIBRATOR,...
K141143 · NDY
Roche Diagnostics
Chemistry · 76d