Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
37633–37656 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jul 17, 2014
HEALGEN COC ONE STEP COCAINE TEST STRIP:MORHPINE TEST STRIP (CASSETTE, CUP,...
K141647 · DIO
Healgen Scientific, LLC
Chemistry · 28d
Cleared Jul 16, 2014
G-TL
K133568 · MQL
Vitrolife, Inc.
Obstetrics & Gynecology · 238d
Cleared Jul 16, 2014
CHOICE SPINE LUMBAR SPACER SYSTEM (SABRE, SHARK, HORNET, HARPOON)
K140142 · MAX
Choicespine, LP
Orthopedic · 175d
Cleared Jul 16, 2014
PROCTIGARD
K140558 · PHN
Access Pharmaceuticals, Inc.
Gastroenterology & Urology · 133d
Cleared Jul 16, 2014
PORCINE ANORGANIC BONE MINERAL
K140714 · NPM
Collagen Matrix, Inc.
Dental · 117d
Cleared Jul 16, 2014
BIOSPHERE BIOACTIVE BONE GRAFT PUTTY, 2.5CC, 5CC, 10CC
K140844 · MQV
Synergy Biomedical, Inc.
Orthopedic · 105d
Cleared Jul 16, 2014
SENSITITRE SUSCEPTIBILITY PLATES
K141000 · JWY
Thermo Fisher Scientific
Microbiology · 89d
Cleared Jul 16, 2014
STERLING OVER-THE WIRE PTA BALLOON DILATATION CATHETER
K141112 · LIT
Boston Scientific
Cardiovascular · 77d
Cleared Jul 16, 2014
ACCULIF TL AND PL CAGE
K141217 · MAX
Stryker Corporation
Orthopedic · 65d
Cleared Jul 16, 2014
SOLID STATE X-RAY IMAGING DEVICE, DIGITAL FLAT PANEL X-RAY DETECTOR, 1417WGC
K141563 · MQB
Rayence Co., Ltd.
Radiology · 34d