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

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174,955 results
90793–90816 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 29, 1997
PORT-A-CATH LOW-PROFILE IMPLANTABLE ACCESS SYSTEMS
K973862 · LJT
Sims Deltec, Inc.
General Hospital · 81d
Cleared Dec 29, 1997
DIGITAL PERSONAL TELEMEDICINE MODULE, DIGITAL PTM 1
K973873 · DRG
American Telecare, Inc.
Cardiovascular · 80d
Cleared Dec 24, 1997
INSYTE, INSYTE-W, INSYTE AUTOGUARD CATHETERS
K971339 · FOZ
Becton Dickinson Vascular Access, Inc.
General Hospital · 258d
Cleared Dec 24, 1997
OMEGA 21 SYSTEM
K973683 · MNH
Ebi Electro Biology
Orthopedic · 89d
Cleared Dec 24, 1997
DURA-GUARD-DURAL REPAIR PATCH
K973706 · GXQ
Bio-Vascular, Inc.
Neurology · 86d
Cleared Dec 24, 1997
VERSYS HIP SYSTEM BEADED HIP PROSTHESIS
K973714 · LPH
Zimmer, Inc.
Orthopedic · 86d
Cleared Dec 24, 1997
POWERFLEX PEC IMPLANT
K973729 · MIC
Hanson Medical, Inc.
General & Plastic Surgery · 85d
Cleared Dec 24, 1997
DURASIL I AND DURASIL II
K973730 · MIB
Hanson Medical, Inc.
General & Plastic Surgery · 85d
Cleared Dec 24, 1997
MICRO-STRIP FOR OPIATE METABOLITES
K973761 · DJG
Microdiagnostics, Inc.
Toxicology · 83d
Cleared Dec 24, 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM ANTITHROMBIN III (AT3) REAGENT
K974110 · JBQ
Beckman Instruments, Inc.
Hematology · 54d
Cleared Dec 24, 1997
OSOM HCG-URINE TEST MODEL 101
K974159 · JHI
Wyntek Diagnostics, Inc.
Chemistry · 71d
Cleared Dec 24, 1997
EVERGREEN NON-STERILE POWDERED LATEX EXAMINATION GLOVE
K974191 · LYY
Yty Industry (Manjung) Sdn Bhd
General Hospital · 44d
Cleared Dec 24, 1997
SYSCOS IDC - G, IDC, BSC, IDC - G
K974262 · MJX
Scantibodies Laboratory, Inc.
Microbiology · 41d
Cleared Dec 24, 1997
BIOSIGN HCG-ONE STEP PREGNANCY TEST, ACCUSIGN HCG-ONE STEP PREGNANCY TEST,...
K974425 · DHA
Princeton BioMeditech Corp.
Chemistry · 30d
Cleared Dec 23, 1997
LEVO MOBIL LCM
K963817 · IPL
Levo USA
Physical Medicine · 456d
Cleared Dec 23, 1997
INDIGO PORTABLE LASER SYSTEM WITH TEMPERATURE FEEDBACK -MODEL IDL 830 (POWER...
K963969 · GEX
Indigo Medical, Inc.
General & Plastic Surgery · 446d
Cleared Dec 23, 1997
COMPOUND SULPHONAMIDES ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K971637 · JTN
Oxoid , Ltd.
Microbiology · 235d
Cleared Dec 23, 1997
3I BIORESORBABLE FIXATION TACK
K972480 · DZL
Implant Innovations, Inc.
Dental · 175d
Cleared Dec 23, 1997
LORAD M-III ELITE (M-III E)
K973631 · IZH
Lorad Corp.
Radiology · 90d
Cleared Dec 23, 1997
N.I.T., INC. NEEDLE GUIDING TEMPLATE
K973638 · IWJ
Avid N.I.T., Inc.
Radiology · 90d
Cleared Dec 23, 1997
FLOSTAT VASCULAR LAB
K973644 · JAF
Biomedix, Inc.
Radiology · 90d
Cleared Dec 23, 1997
DUODERM CONTROL GEL FORMULA BORDER DRESSING
K973688 · FRO
Convatec, Ltd.
General & Plastic Surgery · 88d
Cleared Dec 23, 1997
DUODERM HYDROACTIVE DRESSING
K973689 · FRO
Convatec, Ltd.
General & Plastic Surgery · 88d
Cleared Dec 23, 1997
MEDLITE Q-SWITCHED ND:YAG LASER, MEDLITE IV Q-SWITCHED ND:YAG LASER
K973719 · GEX
Continuum Biomedical, Inc.
General & Plastic Surgery · 84d