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
39937–39960 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 24, 2013
SHEATHLESS EAUCATH CORONARY GUIDE CATHETER
K132556 · DQY
Asahi Intecc Co., Ltd.
Cardiovascular · 71d
Cleared Oct 24, 2013
ACUSON S1000 / S2000 / S3000
K132804 · IYN
Siemens Medical Solutions USA, Inc....
Radiology · 48d
Cleared Oct 24, 2013
RIGHTEST CONTROL SOLUTION
K133003 · JJX
Bionime Corporation
Chemistry · 29d
Cleared Oct 23, 2013
OPTUM TELEHEALTH APPLICATION
K130971 · DRG
Optumhealth Care Solutions, Inc.
Cardiovascular · 198d
Cleared Oct 23, 2013
CALIX LUMBAR SPINAL IMPLANT SYSTEM
K131350 · MAX
X-Spine Systems, Inc.
Orthopedic · 166d
Cleared Oct 23, 2013
DYNAMESH -CICAT
K131530 · FTL
Feg Textiltechnik Forschungs-Und...
General & Plastic Surgery · 148d
Cleared Oct 23, 2013
INNERSENSE ESOPHAGEAL TEMPERATURE PROBE / FEEDING TUBE
K131590 · FPD
Philips Medical Systems
Gastroenterology & Urology · 145d
Cleared Oct 23, 2013
EVOLUTION MP ADAPTIVE PS TIBIAL INSERT
K131679 · JWH
Wrightmedicaltechnologyinc
Orthopedic · 135d
Cleared Oct 23, 2013
RANDOX CSF CONTROLS LEVELS 2 AND 3
K132156 · JJY
Randox Laboratories, Ltd.
Chemistry · 104d
Cleared Oct 23, 2013
MARIGEN WOUND DRESSING
K132343 · KGN
Kerecis Limited
General & Plastic Surgery · 85d
Cleared Oct 23, 2013
RENASYS EZ MAX NEGATIVE PRESSURE WOUND THERAPY DEVICE
K132446 · OMP
Smith & Nephew, Inc.
General & Plastic Surgery · 78d
Cleared Oct 23, 2013
ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY
K132493 · GDW
Covidien, LLC
General & Plastic Surgery · 75d
Cleared Oct 23, 2013
VARIAX 2 SYSTEM
K132502 · HRS
Stryker Trauma AG
Orthopedic · 75d
Cleared Oct 23, 2013
AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR
K132627 · DXN
Honsun (Nantong) Co., Ltd.
Cardiovascular · 62d
Cleared Oct 23, 2013
WMT IMPLANTABLE K-WIRE
K132895 · HTY
Wrightmedicaltechnologyinc
Orthopedic · 37d
Cleared Oct 22, 2013
MEDCOMP VASCU-PICC WITH VALVE
K130897 · LJS
Medcomp ( Medical Components)
General Hospital · 204d
Cleared Oct 22, 2013
RANFAC BONE MARROW ASPIRATION NEEDLE
K131157 · KNW
Ranfac, Corp.
Gastroenterology & Urology · 181d
Cleared Oct 22, 2013
LESSER METATARSAL HEAD IMPLANT SYSTEM
K131187 · KWD
Solana Surgical, LLC
Orthopedic · 179d
Cleared Oct 22, 2013
PERIFLUX 6000
K131253 · LKD
Perimed AB
Anesthesiology · 173d
Cleared Oct 22, 2013
TAUTONA INJECTOR DEVICE
K131963 · FMF
Tautona Group, LLC
General Hospital · 117d
Cleared Oct 22, 2013
SMITH & NEPHEW GLOBAL FEMORAL HEAD TRIALS
K132435 · LZO
Smith & Nephew, Inc.
Orthopedic · 78d
Cleared Oct 22, 2013
VISCOELASTIC INJECTOR
K132494 · MRH
Sight Sciences, Inc.
Ophthalmic · 74d
Cleared Oct 22, 2013
5F & 6F LAUNCHER GUIDE CATHETER, 5F SHERPA ACTIVE NX GUIDE CATHETER, 6F Z4...
K132673 · DQY
Medtronic, Inc.
Cardiovascular · 56d
Cleared Oct 22, 2013
GEM FLOW COUPLER DEVICE AND SYSTEM
K132727 · MVR
Synovis Life Technologies, Inc.
General & Plastic Surgery · 49d