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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
71233–71256 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 10, 2003
LASERSMILE
K030539 · GEX
Biolase Technology, Inc.
General & Plastic Surgery · 232d
Cleared Oct 10, 2003
OMEGA WHOLE-CORTEX MFG SYSTEM, MODELS OMEGA 151, OMEGA 275
K030737 · OLX
Ctf Systems (2001), Inc.
Neurology · 214d
Cleared Oct 10, 2003
CLUED UP MULTIPURPOSE SOLUTION- NO RUB
K030910 · LPN
Clued UP Limited
Ophthalmic · 200d
Cleared Oct 10, 2003
MEDRELIEF SE SERIES, MODELS SE-50, SE-100, SE-200, SE-300
K030998 · IPF
Healthonics, Inc.
Physical Medicine · 193d
Cleared Oct 10, 2003
CUF-COVER (TM)
K031195 · DXQ
Ethox Corp.
Cardiovascular · 177d
Cleared Oct 10, 2003
MODEL 2100 PULSE OXIMETER
K031465 · DQA
Dolphin Medical, Inc.
Anesthesiology · 155d
Cleared Oct 10, 2003
ORIA SPINAL CLIP SYSTEM, LATERAL INTERMEDIATE CONNECTOR, MODEL AL01
K031471 · KWP
Ortho Tec, LLC
Orthopedic · 154d
Cleared Oct 10, 2003
ORION DIAGNOSTICA QUIKREAD CRP KIT AND QUIKREAD CRP CONTROL
K031607 · DCK
Orion Diagnostica, Div. Orion Corp.
Immunology · 141d
Cleared Oct 10, 2003
VIEWPOINT TELEMETRY SYSTEM
K031760 · MHX
Datascope Corp.
Cardiovascular · 126d
Cleared Oct 10, 2003
METHADONE METABOLITE (EDDP) ENZIME IMMUNOASSAY, CAT. NO. 190 (500 TEST KIT),...
K031797 · DJR
Lin-Zhi International, Inc.
Toxicology · 122d
Cleared Oct 10, 2003
CAREMATIX WELLNESS SYSTEM
K031840 · DXN
Carematix, Inc.
Cardiovascular · 116d
Cleared Oct 10, 2003
CARESTATION 126S VIDEOPHONE
K031863 · MWI
Motion Media Technology, Inc.
Cardiovascular · 116d
Cleared Oct 10, 2003
PROVEN REVISION FEMORAL AND PROVEN REVISION TIBIAL INSERT
K031901 · JWH
Stelkast Company
Orthopedic · 112d
Cleared Oct 10, 2003
POWDER FREE VINYL EXAMINATION GLOVE
K032071 · LYZ
Shanghai Foremost Plastic Industrial...
General Hospital · 99d
Cleared Oct 10, 2003
NEUROLAC NERVE GUIDE MODELS NG01-15/03, NG01-020/03, NG01 025/03, NG01-030/03
K032115 · JXI
Polyganics B.V.,
Neurology · 93d
Cleared Oct 10, 2003
RUBBERCARE POWDERED LATEX EXAMINATION GLOVES
K032201 · LYY
Perusahaan Pelindung Getah (M) Sdn Bhd
General Hospital · 84d
Cleared Oct 10, 2003
ONLINE TDM AMIKA
K032279 · KLP
Roche Diagnostics Corp.
Toxicology · 78d
Cleared Oct 10, 2003
FUKUDA DENSHI DYNASCOPE MODEL DS-7100 SERIES PORTABLE PATIENT MONITOR
K032290 · MHX
Fukuda Denshi USA, Inc.
Cardiovascular · 78d
Cleared Oct 10, 2003
MINI V.A.C., V.A.C. FREEDOM, V.A.C. ATS
K032310 · OMP
Kinetic Concepts, Inc.
General & Plastic Surgery · 74d
Cleared Oct 10, 2003
KLS-MARTIN STERNAL PLATING SYSTEM
K032413 · HRS
KLS-Martin L.P.
Orthopedic · 66d
Cleared Oct 10, 2003
MAXTER STERILE POWDERED LATEX SURGICAL GLOVES
K032467 · KGO
Maxter Glove Manufacturing Sdn Bhd
General Hospital · 60d
Cleared Oct 10, 2003
TYTRON C-500IR CLINICAL INFRARED IMAGING SYSTEM
K032471 · LHQ
Titronics Research & Development Co.
Radiology · 60d
Cleared Oct 10, 2003
MODIFICATION TO: MAC-LAB/CARDIOLAB EP/COMBOLAB SYSTEM
K032577 · DQK
Ge Medical Systems Information...
Cardiovascular · 50d
Cleared Oct 10, 2003
GE VOLUSON 730 PRO/EXPERT BT03 ULTRASOUND SYSTEM
K032620 · IYN
General Electric Co.
Radiology · 45d