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
43153–43176 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 01, 2012
AXSOS DISTAL LATERAL FEMUR TS LONG PLATES
K122308 · HRS
Howmedica Osteonics Corp., Dba...
Orthopedic · 61d
Cleared Oct 01, 2012
ENDOPATH XCEL BLADELESS TROCAR WITH OPTIVIEW TECHNOLOGY ENDOPATH XCEL BLUNT...
K122511 · GCJ
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 45d
Cleared Sep 28, 2012
NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET
K112628 · FJK
Nipro Medical Corporation
Gastroenterology & Urology · 385d
Cleared Sep 28, 2012
BAUSCH & LOMB IOL INJECTOR
K113852 · MSS
Bausch & Lomb, Inc.
Ophthalmic · 274d
Cleared Sep 28, 2012
PEERSCOPE SYSTEM
K120289 · FDF
Peermedical
Gastroenterology & Urology · 241d
Cleared Sep 28, 2012
DIGITAL EYE-FUNDUS CAMERA
K120982 · HKI
Medimaging Integrated Solutions, Inc....
Ophthalmic · 179d
Cleared Sep 28, 2012
EPIC 10
K121286 · GEX
Biolase Technology, Inc.
General & Plastic Surgery · 151d
Cleared Sep 28, 2012
EZ-BLOCKER
K121462 · CBI
Ez-Blocker B.V.
Anesthesiology · 134d
Cleared Sep 28, 2012
SOMNOGUARD SP SOFT
K121761 · LRK
Tomed Dr. Toussaint GmbH
Dental · 105d
Cleared Sep 28, 2012
BESIDE RESPIRATORY PATIENT MONITORING SYSTEM BESIDE RESIRATORY PATIENT...
K121806 · DQA
Covidien
Anesthesiology · 100d
Cleared Sep 28, 2012
BRIGHT RESTORATIVE MATERIALS
K121915 · EBF
Dmp, Ltd.
Dental · 88d
Cleared Sep 28, 2012
WALLFLEXTM BILIARY RX STENT SYSTEM (UNCOVERED, PARTIALLY COVERED, AND FULLY...
K122072 · FGE
Boston Scientific Corporation
Gastroenterology & Urology · 74d
Cleared Sep 28, 2012
GMK NARROW
K122232 · JWH
Medacta International
Orthopedic · 64d
Cleared Sep 28, 2012
14.5-16.0 FRENCH CUFFED CATHETER REMOVAL DEVICE, SYMMETRY SURGICAL SINGEL USE
K122263 · ODY
Symmetry Medical
General Hospital · 63d
Cleared Sep 28, 2012
OVERTUBE ENDOSCOPIC ACCESS SYSTEM
K122270 · FED
Apollo Endosurgery, Inc.
Gastroenterology & Urology · 60d
Cleared Sep 28, 2012
CD HORIZON SPINAL SYSTEM
K122433 · NKB
Medtronic Sofamor Danek, Inc.
Orthopedic · 49d
Cleared Sep 28, 2012
EXACTRAC VERO
K122451 · IYE
Brainlab AG
Radiology · 46d
Cleared Sep 28, 2012
MPACT EXTENSION
K122641 · LZO
Medacta International
Orthopedic · 30d
Cleared Sep 28, 2012
ACUSON
K122825 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 14d
Cleared Sep 27, 2012
FREEDOM ND: YAG LASER SYSTEM
K113843 · PDZ
Lutronic Corporation
General & Plastic Surgery · 274d
Cleared Sep 27, 2012
RAPICIDE OPA-28
K120306 · MED
Minntech Corp.
General Hospital · 239d
Cleared Sep 27, 2012
EASYONE PRO RESPIRATORY TESTING DEVICE
K120635 · BTY
Ndd Medizitechnik AG
Anesthesiology · 210d
Cleared Sep 27, 2012
SUPER SHEATH INTRODUCER SHEATH AND SUPER SHEATH INTRODUCER SHEATH SETS
K121504 · DYB
Togo Medikit Co., Ltd.
Cardiovascular · 129d
Cleared Sep 27, 2012
PMT BONE SCREWS
K121713 · HWC
Providence Medical Technology, Inc.
Orthopedic · 108d