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

Filters: Cleared only ×
175,820 results
31345–31368 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 17, 2016
UST-5550-R
K152126 · ITX
Hitachi Aloka Medical America, Inc.
Radiology · 383d
Cleared Aug 17, 2016
Alians Elbow Locking Plating System
K152289 · HRS
Newclip Technics
Orthopedic · 370d
Cleared Aug 17, 2016
WebPAX
K152949 · LLZ
Heart Imaging Technologies, LLC
Radiology · 316d
Cleared Aug 17, 2016
LUOFUCON Silicone Ag foam dressing
K160022 · FRO
Huizhou Foryou Medical Devices Co., Ltd.
General & Plastic Surgery · 225d
Cleared Aug 17, 2016
Accent XL
K160075 · IMI
Alma Lasers, Inc.
Physical Medicine · 216d
Cleared Aug 17, 2016
Sumitomo Proton Therapy System
K160612 · LHN
Sumitomo Heavy Industries, Ltd.
Radiology · 167d
Cleared Aug 17, 2016
Ambu USR, Ambu M
K160766 · FAJ
Ambu A/S
Gastroenterology & Urology · 149d
Cleared Aug 17, 2016
First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First...
K160793 · DJR
W.H.P.M., Inc.
Toxicology · 147d
Cleared Aug 17, 2016
Uroview FD
K161019 · JAA
Pausch Medical GmbH
Radiology · 127d
Cleared Aug 17, 2016
Just Like Me Personal Lubricant
K161385 · NUC
Wtfn-Dba Classic Erotica/Holiday...
Obstetrics & Gynecology · 90d
Cleared Aug 17, 2016
SPEC Model M23
K161396 · KXK
Source Production and Equipment Co.,...
Radiology · 90d
Cleared Aug 17, 2016
PACS CORE/ENCORE
K161518 · LLZ
Compania Mexicana DE Radiologia Cgr,...
Radiology · 76d
Cleared Aug 17, 2016
SUPRIA w/guideShot Option
K161748 · JAK
Hitachi Medical Systems America, Inc.
Radiology · 54d
Cleared Aug 16, 2016
A.R.C. Laser Surgical Fibers and Probes
K161403 · GEX
A.R.C Laser GmbH
General & Plastic Surgery · 88d
Cleared Aug 16, 2016
PerfIC Cath Gel S, PerfIC Cath Gel C, PerfIC Cath Hydro S, PerfIC Cath Hydro C
K161445 · EZD
Adapta Medical, Inc.
Gastroenterology & Urology · 83d
Cleared Aug 16, 2016
MC1 Plus
K161502 · IMI
General Project S.R.L.
Physical Medicine · 76d
Cleared Aug 16, 2016
The Braun ThermoScan® 3 High Speed Compact Ear Thermometer
K161933 · FLL
Kaz USA, Inc., A Helen of Troy Company
General Hospital · 33d
Cleared Aug 15, 2016
Oral Surgery System and Accessories
K152125 · DZI
Bonart Co., Ltd.
Dental · 381d
Cleared Aug 15, 2016
Sydney IVF Gamete Buffer
K153478 · MQL
William A. Cook Australia Pty. , Ltd.
Obstetrics & Gynecology · 257d
Cleared Aug 15, 2016
Tarsa-Link Stand-Alone Wedge Fixation System
K161037 · HRS
Life Spine, Inc.
Orthopedic · 124d
Cleared Aug 15, 2016
PressureWire X Guidewire
K161171 · DXO
St. Jude Medical, Inc.
Cardiovascular · 111d
Cleared CT Aug 15, 2016
Solana Trichomonas Assay
K161182 · OUY
Quidel Corporation
Microbiology · 110d
Cleared Aug 15, 2016
Distal Radius Plating System
K161292 · HRS
Miami Device Solutions, LLC
Orthopedic · 98d
Cleared Aug 15, 2016
Dell UP3216Q with QUBYX PerfectLum bundle
K162196 · PGY
Qubyx Software Technologies, Inc.
Radiology · 10d