FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
91297–91320 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 30, 1997
CONTROL, X-RAY DIAGNOSTIC, GENERATOR, HIGH VOLTAGE, ASSEMBLY, TUBE HOUSING...
K973833 · IZL
Dynarad Corp.
Radiology · 84d
Cleared Dec 29, 1997
EPXPRESS SYSTEM (TIMBERWOLF REVISION) /000391
K971570 · DRR
Quinton Electrophysiology Corp.
Cardiovascular · 244d
Cleared Dec 29, 1997
INTERIM AV SHAPED TEMPORARY PACING CATHETER MODEL INT-AV610
K971775 · LDF
Cardiac Control Systems, Inc.
Cardiovascular · 230d
Cleared Dec 29, 1997
HI-CARE CLOSED SUCTION SYSTEM
K972258 · BSY
Mallinckrodt Medical
Anesthesiology · 195d
Cleared Dec 29, 1997
AESCULAP HILAN MOTOR SYSTEM
K973736 · HWE
Aesculap, Inc.
Orthopedic · 89d
Cleared Dec 29, 1997
UNICATH SP BI-PLANE (MODEL M269 & M289)
K973744 · JAA
Xre Corp.
Radiology · 89d
Cleared Dec 29, 1997
CODMAN HAKIM MICRO PRECISION VALVE
K973774 · JXG
Johnson & Johnson Professionals, Inc.
Neurology · 87d
Cleared Dec 29, 1997
DUODERM HYDROACTIVE GEL
K973806 · MGQ
Convatec, A Bristol-Myers Squibb Co.
General & Plastic Surgery · 84d
Cleared Dec 29, 1997
FLOSTAT VASCULAR REPORT GENERATOR (VRG)
K973857 · JAF
Biomedix, Inc.
Radiology · 81d
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