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
30961–30984 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 04, 2016
LumFix Spinal Fixation Sytem
K160731 · MNI
CG Bio Co., Ltd.
Orthopedic · 201d
Cleared Oct 04, 2016
ATTO Mobility Scooter
K160909 · INI
Moving Life, Ltd.
Physical Medicine · 186d
Cleared Oct 04, 2016
ACTABOND Topical Skin Adhesive
K161050 · MPN
Bergen Medical Products, Inc.
General & Plastic Surgery · 173d
Cleared Oct 04, 2016
Arrow Epidural Catheter Kit
K161075 · CAZ
Teleflexmedical, Inc.
Anesthesiology · 169d
Cleared CT Oct 04, 2016
Eyenez Ophthalmic Camera
K161727 · HKI
Eyenez, LLC
Ophthalmic · 104d
Cleared Oct 04, 2016
Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG...
K161854 · PCN
The Binding Site Group , Ltd.
Immunology · 90d
Cleared Oct 04, 2016
PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE...
K161897 · OMP
Kci USA, Inc. (Kinetic Concepts, Inc.)
General & Plastic Surgery · 85d
Cleared Oct 04, 2016
CD HORIZON® Spinal System
K162494 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 27d
Cleared Oct 03, 2016
FilmArray Respiratory Panel EZ (RP EZ)
K152579 · OCC
Biofire Diagnostics, LLC
Microbiology · 389d
Cleared Oct 03, 2016
Dynarex Xeroform Petrolatum Dressing
K152970 · FRO
Dynarex Corporation
General & Plastic Surgery · 361d
Cleared Oct 03, 2016
RS80A Diagnostic Ultrasound System
K153539 · IYN
Samsung Medison Co., Ltd.
Radiology · 298d
Cleared Oct 03, 2016
Volumetric Infusion Controller
K153760 · LDR
DEKA Research & Development
General Hospital · 278d
Cleared Oct 03, 2016
DMi Dental Implant System
K160060 · DZE
Dmi Innovative Medical Technology , Ltd.
Dental · 265d
Cleared Oct 03, 2016
Indiba Diathermia Radiofrequency Device - Activ
K161458 · PBX
Indiba USA, Inc.
General & Plastic Surgery · 130d
Cleared Oct 03, 2016
kneeEOS
K161828 · LLZ
Onefit Medical
Radiology · 90d
Cleared Oct 03, 2016
PreXion3D Excelsior
K161881 · OAS
Prexion Corporation
Radiology · 87d
Cleared Oct 03, 2016
Voluson E6, Voluson E8, Voluson E10
K162269 · IYN
Ge Healthcare
Radiology · 52d
Cleared Oct 03, 2016
SKR 3000
K162504 · MQB
Konica Minolta, Inc.
Radiology · 26d
Cleared Oct 03, 2016
Lumify Ultrasound System
K162549 · IYN
Philips Health Care
Radiology · 20d
Cleared Oct 02, 2016
Esophagus Bougie Set
K161576 · JAQ
Varian Medical Systems, Inc.
Radiology · 117d
Cleared Oct 01, 2016
SeraQuest Herpes Type 1 Specific IgG
K162276 · MXJ
Quest International, Inc.
Microbiology · 50d
Cleared Sep 30, 2016
Xprecia Stride Coagulation System, Xprecia System PT Controls
K151964 · GJS
Siemens Healthcare Diagnostics
Hematology · 442d
Cleared Sep 30, 2016
eCareManager 4.0.1
K153156 · MSX
Visicu, Inc.
Cardiovascular · 333d
Cleared Sep 30, 2016
Electronic Stethoscope DS301
K160023 · DQD
Imediplus, Inc.
Cardiovascular · 268d