FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
70105–70128 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 14, 2003
ACON QUICK-CHECK II HOME PREGNANCY TEST DEVICE (CASSETTE)
K032661 · LCX
ACON Laboratories, Inc.
Chemistry · 47d
Cleared Oct 14, 2003
REAADS II ANTI-CARDIOLIPIN IGG SEMI-QUANTITATIVE TEST KIT, MODEL 11139
K032868 · MID
Corgenix, Inc.
Immunology · 29d
Cleared Oct 14, 2003
ACUCAM CONCEPT IV FWT, MODEL 110-0185G1
K032904 · EIA
Dentsply Intl.
Dental · 27d
Cleared Oct 14, 2003
PRECISET DAT AMPHETAMINE CALIBRATORS
K033165 · DLJ
Roche Diagnostics Corp.
Chemistry · 14d
Cleared Oct 14, 2003
COBAS INTEGRA ALP IFCC GEN.2
K033185 · CJE
Roche Diagnostics Corp.
Chemistry · 13d
Cleared Oct 14, 2003
EKOS PERIPHERAL INFUSION SYSTEM
K033214 · QEY
Ekos Corp.
Cardiovascular · 11d
Cleared Oct 10, 2003
INSIGHT MILLENNIUM III
K023209 · IKN
Fasstech
Neurology · 379d
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