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
87409–87432 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 25, 1998
ZOLL STAT*PADZ ADULT MULTI-FUNCTION ELECTRODES MODEL NUMBER 8900-4003
K981802 · MKJ
Bio-Detek, Inc.
Cardiovascular · 188d
Cleared Nov 25, 1998
ACUTRON MENTOR MODEL 961
K981976 · GZJ
Microcurrent Research, Inc.
Neurology · 177d
Cleared Nov 25, 1998
MODIFICATION TO COPALIS CMV TOTAL ANTIBODY ASSAY
K982027 · LFZ
DiaSorin, Inc.
Microbiology · 176d
Cleared Nov 25, 1998
ESCORT-LINK CENTRAL STATION MONITOR MODEL 20500
K982104 · MLD
Medical Data Electronics
Cardiovascular · 163d
Cleared Nov 25, 1998
CRYOPRO MAXI AND CRYOPRO MINI
K982280 · GEH
Cortex Technology Aps
General & Plastic Surgery · 148d
Cleared Nov 25, 1998
SYNTHES SPINE OCCIPITAL-CERVICAL PLATE/ROD AND HOOK SYSTEM
K982322 · KWP
Synthes (Usa)
Orthopedic · 146d
Cleared Nov 25, 1998
EBNA-1 IGM ELISA TEST SYSTEM
K982348 · LSE
Columbia Bioscience, Inc.
Microbiology · 142d
Cleared Nov 25, 1998
EA-D IGM ELISA TEST SYSTEM
K982350 · LSE
Columbia Bioscience, Inc.
Microbiology · 142d
Cleared Nov 25, 1998
VCA IGM ELISA TEST SYSTEM
K982352 · LSE
Columbia Bioscience, Inc.
Microbiology · 142d
Cleared Nov 25, 1998
PLUS BIPOLAR PROSTHESIS COCRMO
K982447 · KWY
Plus Orthopedics
Orthopedic · 133d
Cleared Nov 25, 1998
PREMIER GIARDIA
K982711 · MHI
Meridian Diagnostics, Inc.
Microbiology · 113d
Cleared Nov 25, 1998
CONSENSUS FEMORAL COMPONENT, POROUS, COCR/TI
K983004 · JWH
Hayes Medical, Inc.
Orthopedic · 89d
Cleared Nov 25, 1998
PERIPHERAL AVE STENT SYSTEM
K983008 · FGE
Peripheral Ave
Gastroenterology & Urology · 89d
Cleared Nov 25, 1998
BSM- BONE SUBSTITUTE MATERIAL
K983009 · GXP
Etex Corp.
Neurology · 89d
Cleared Nov 25, 1998
COMPACT KTP LASER
K983020 · GEX
Cosmos Medical Technology
General & Plastic Surgery · 86d
Cleared Nov 25, 1998
SWEEN WOUN'DRES
K983042 · MGQ
Coloplast Corp.
General & Plastic Surgery · 86d
Cleared Nov 25, 1998
AMIELLE
K983045 · KXP
Owen Mumford USA, Inc.
Obstetrics & Gynecology · 85d
Cleared Nov 25, 1998
PNEUMATIC CUTTER SYSTEM
K983050 · ERL
Surgical Laser Technologies, Inc.
Ear, Nose, Throat · 85d
Cleared Nov 25, 1998
MEDISYSTEMS TRANSDUCER PROTECTOR
K983076 · FIB
Medisystems Corp.
Gastroenterology & Urology · 84d
Cleared Nov 25, 1998
DEPUY LUSTER STEM
K983136 · JDI
DePuy Orthopaedics, Inc.
Orthopedic · 78d
Cleared Nov 25, 1998
COMPLETE BRAND LUBRICATING AND REWETTING DROPS
K983150 · LPN
Allergan, Inc.
Ophthalmic · 77d
Cleared Nov 25, 1998
TIELLE PLUS HYDROPOLYMER ADHESIVE DRESSING
K983234 · MGP
Johnson & Johnson Medical, Div. of...
General & Plastic Surgery · 71d
Cleared Nov 25, 1998
SURESKIN PLUS STANDARD, SURESKIN PLUS BORDER, SURESKIN PLUS THIN
K983249 · FRO
Euromed, Inc.
General & Plastic Surgery · 70d
Cleared Nov 25, 1998
SYSTEM U3 FOR TRIMETHOPRIM/SULFAMETHOXAZOLE
K983259 · JWY
Ab Biodisk
Microbiology · 70d