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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
149233–149256 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 13, 1985
VACCESS 2000 SINGLE LUMEN SUBCLAVIAN CANNULA
K844433 · LFJ
Vas-Cath of Canada , Ltd.
Gastroenterology & Urology · 117d
Cleared Mar 13, 1985
VACCESS 3000 SINGLE LUMEN JUGULAR CANNULA-CATH
K844434 · LFJ
Vas-Cath of Canada , Ltd.
Gastroenterology & Urology · 117d
Cleared Mar 13, 1985
PORTABLE DIAGNOSTIC LABORATORY
K844476 · LIB
Portable Medical Laboratories, Inc.
Chemistry · 114d
Cleared Mar 13, 1985
MOBILCHAIR 360 ELECTRIC-POWERED CHAIR
K844847 · ITI
Davis-Smith Corp.
Physical Medicine · 90d
Cleared Mar 13, 1985
CADD-VT, 5300 AMBULATORY INFUSION PUMP W/3050, 50M
K850183 · FRN
Deltec Systems, Inc.
General Hospital · 54d
Cleared Mar 13, 1985
BIO-TEK AUTOMATED MICROPLATE WASHER EL402
K850249 · JTC
Bio-Tek Instruments, Inc.
Microbiology · 50d
Cleared Mar 13, 1985
PHADEBACT MONOCLONAL GC TEST
K850351 · LIC
Pharmacia, Inc.
Microbiology · 44d
Cleared Mar 13, 1985
BIOTIS CHOCOLATE TELLURITE
K850565 · JSI
Otisville Biotech, Inc.
Microbiology · 29d
Cleared Mar 12, 1985
TSS/FIK
K842501
Zarcon Corp.
Immunology · 259d
Cleared Mar 12, 1985
SITE STRIP
K843200 · NAD
E-Med Corp.
General & Plastic Surgery · 210d
Cleared Mar 12, 1985
SCANHEADS-ACCESS 10PV, BIOSTATIC
K843620 · JOP
Advanced Technology Laboratories, Inc.
Cardiovascular · 179d
Cleared Mar 12, 1985
DIGITAL ELECTRONEUROMETER S-100
K843924 · JXE
Neurotron, Inc.
Neurology · 158d
Cleared Mar 12, 1985
SCANHEADS ACCESS 10 10PV B10
K843953 · JOP
Advanced Technology Laboratories, Inc.
Cardiovascular · 154d
Cleared Mar 12, 1985
PENLON PPV VAPORIZER
K844007 · CAD
Penlon, Inc.
Anesthesiology · 151d
Cleared Mar 12, 1985
PENLON AM1000 ANAESTHESIA MACHINE
K844008 · BSZ
Penlon, Inc.
Anesthesiology · 151d
Cleared Mar 12, 1985
REPRO-MED SYSTEMS INFUSION DEVICE
K844401 · FRN
Repro-Med Systems, Inc.
General Hospital · 119d
Cleared Mar 12, 1985
THERMOPULS E
K844416 · IMJ
Nemectron Medical, Inc.
Physical Medicine · 118d
Cleared Mar 12, 1985
MECRON CEMENTED STRUCTURED STEM HIP PROSTHESIS
K844488 · KWL
Mecron Medical Products, Inc.
Orthopedic · 113d
Cleared Mar 12, 1985
ROPE SYSTEM REVERSE OSMOSIS PERITONEAL SYSTEM
K844630 · FKX
Organon Teknika Corp.
Gastroenterology & Urology · 105d
Cleared Mar 12, 1985
MICRO-STRUCTURED HS3P PROPORTIONAL SERIES HIP STEM
K844817 · JDI
Osteonics Corp.
Orthopedic · 91d
Cleared Mar 12, 1985
PLURA-GARD CHEST DRAINAGE SYSTEM
K844942 · KDQ
Consolidated Medical Equipment, Inc.
General Hospital · 82d
Cleared Mar 12, 1985
KARECO INT'L - DOUGLE-HOOK I.V. STAND
K845031 · FOX
Kareco Intl., Inc.
General Hospital · 75d
Cleared Mar 12, 1985
PRECONNECTED URETHRAL CATHETER TRAY
K850152
Inmed Corp.
General & Plastic Surgery · 56d
Cleared Mar 12, 1985
ALBA HEALTH CARE NON-ADHERING DRESSING
K850241 · FRO
Alba Health Care
General & Plastic Surgery · 49d