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
34681–34704 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 29, 2015
Dunamis Force DFX Suture, Size 5, Dunamis Force DFX Suture Size 2
K150327 · GAT
Dunamis, LLC
General & Plastic Surgery · 139d
Cleared Jun 29, 2015
NOVA Dental Implants System
K150363 · DZE
Nova Implants , Ltd.
Dental · 137d
Cleared Jun 29, 2015
Airway with Bite Block and Tongue Depressor 80 mm, Airway with Bite Block and...
K150518 · JXL
Dupaco, Inc.
Neurology · 119d
Cleared Jun 29, 2015
Immunalysis Benzoylecgonine Urine Enzyme Immunoassay, Immunalysis...
K150925 · DIO
Immunalysis Corporation
Toxicology · 84d
Cleared Jun 29, 2015
Stryker ICONIX with Needles
K151201 · MBI
Stryker
Orthopedic · 55d
Cleared Jun 29, 2015
First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test
K151441 · DJR
W.H.P.M., Inc.
Chemistry · 31d
Cleared Jun 29, 2015
AeroDR SYSTEM 2
K151465 · MQB
Konica Minolta, Inc.
Radiology · 28d
Cleared Jun 28, 2015
FILAO NC RX PTCA DILATATION CATHETER
K141933 · LOX
Natec Medical , Ltd.
Cardiovascular · 347d
Cleared Jun 27, 2015
Proteus Digital Health Feedback Device
K150494 · OZW
Proteus Digital Health, Inc.
Gastroenterology & Urology · 122d
Cleared Jun 26, 2015
XENOMEM WOUND MATRIX
K140820 · KGN
Viscus Biologics, LLC
General & Plastic Surgery · 451d
Cleared Jun 26, 2015
JiveX
K142750 · LLZ
Visus Technology Transfer GmbH
Radiology · 275d
Cleared Jun 26, 2015
Nacera Pearl
K143071 · EIH
Doceram Medical Ceramics GmbH
Dental · 242d
Cleared Jun 26, 2015
Plato MICROCATH 27B Microcatheter
K143398 · DQO
Scientia Vascular, LLC
Cardiovascular · 212d
Cleared Jun 26, 2015
ADH 200 Analyzer Software
K143449 · DQK
Adams Meditech, LLC
Cardiovascular · 206d
Cleared Jun 26, 2015
Arrow Epidural Catheter Kit
K143581 · CAZ
Teleflexmedical, Inc.
Anesthesiology · 190d
Cleared Jun 26, 2015
CORA (Coagulation Resonance Analysis) System
K150041 · JPA
Coramed Technologies, LLC
Hematology · 168d
Cleared Jun 26, 2015
Freedom Cementless Femoral Component
K150680 · MBH
Maxx Orthopedics, Inc.
Orthopedic · 101d
Cleared Jun 26, 2015
CapLOX II/TowerLOX Pedicle Screw System
K151116 · MNH
Captiva Spine
Orthopedic · 60d
Cleared Jun 25, 2015
MEDIHONEY WOUND DRESSINGS
K133279 · FRO
Derma Sciences, Inc.
General & Plastic Surgery · 609d
Cleared Jun 25, 2015
CRYOCARE CS SURGICAL SYSTEM
K141110 · GEH
Healthtronics
General & Plastic Surgery · 422d
Cleared Jun 25, 2015
DuraSheath Introducer Sheath System
K142357 · DYB
Contract Medical International, GmbH
Cardiovascular · 304d
Cleared Jun 25, 2015
Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid Tibial
K142814 · JDI
Biomet Manufacturing, LLC
Orthopedic · 269d
Cleared Jun 25, 2015
Ophthalmed Bending Laser Probes
K142830 · HQF
Ophthalmed, LLC
Ophthalmic · 268d
Cleared Jun 25, 2015
Droplet Pen Needles
K143437 · FMI
Htl-Strefa S.A
General Hospital · 206d