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
93529–93552 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 24, 1997
TOTAL BILIRUBIN REAGENT
K972073 · CIG
Carolina Liquid Chemistries Corp.
Chemistry · 21d
Cleared Jun 24, 1997
VITROS IMMUNODIAGNOSTICS PRODUCTS PROGESTERONE REAGENT PACK (GEM.1070),...
K972133 · JLS
Johnson & Johnson Clinical...
Chemistry · 18d
Cleared Jun 24, 1997
LYPHOCHEK REMEDI CONTROL
K972174 · DIF
Bio-Rad
Toxicology · 15d
Cleared Jun 24, 1997
RIVIERA SUNGLASS4ES
K972194 · HQY
Riviera Optical Co., Ltd.
Ophthalmic · 14d
Cleared Jun 24, 1997
ROCHE SERUM CONTROL NORMAL (HUMAN), ROCHE SERUM CONTROL PATHOLOGICAL (HUMAN)
K972214 · JJY
Roche Diagnostic Systems, Inc.
Chemistry · 12d
Cleared Jun 24, 1997
ABBOTT AXSYM FOLATE
K972232 · CGN
Abbott Laboratories
Chemistry · 8d
Cleared Jun 23, 1997
EDOSSEOUS DENTAL IMPLANT
K970127 · DZE
Sulzer Calcitek, Inc.
Dental · 160d
Cleared Jun 23, 1997
SPLINE ENGAGING SHOULDERED ABUTMENT SYSTEM
K970752 · DZE
Sulzer Calcitek, Inc.
Dental · 112d
Cleared Jun 23, 1997
ARTHROSCOPE
K971083 · HRX
Electro-Biology, Inc.
Orthopedic · 90d
Cleared Jun 23, 1997
SVL-9130 DEFIBRILLATION ELECTRODE
K971149 · MKJ
Survivalink Corp.
Cardiovascular · 87d
Cleared Jun 22, 1997
PRIMED PRIME-PLUS COTTON GAUZE SPONGES
K971075 · EFQ
Primeline Medical Products, Inc.
General & Plastic Surgery · 90d
Cleared Jun 20, 1997
SYNAPTIC 3000
K940954 · GZJ
The Synaptic Corp.
Neurology · 1207d
Cleared Jun 20, 1997
PRELOADED SOFT TISSUE ANCHOR
K963932 · MBI
Linvatec Corp.
Orthopedic · 262d
Cleared Jun 20, 1997
NUCLETRON PLATO EXTERNAL BEAM PLANNING RTS V2 AND RTS 3D V2
K964206 · IYE
Nucletron Corp.
Radiology · 242d
Cleared Jun 20, 1997
LONG MEDIUM PALMAZ-SCHATZ BALLOON EXPANDABLE STENT
K964688 · FGE
Cordis Corp.
Gastroenterology & Urology · 210d
Cleared Jun 20, 1997
PHOTON RADIOSURGERY SYSTEM (PRS)
K964947 · JAD
Photoelectron Corporation
Radiology · 192d
Cleared Jun 20, 1997
TECA. MILLENNIUM
K965065 · GWF
Medelec , Ltd.
Neurology · 184d
Cleared Jun 20, 1997
BSC, SONICATH ULTRA IMAGING CATHETER 3.2F/20MHZ(37410/456221 & BSC, SONICATH...
K970049 · ITX
Cardiovascular Imaging Systems, Inc.
Radiology · 165d
Cleared Jun 20, 1997
GENERAL PURPOSE TRANDUCER COVER
K970513 · ITX
CIVCO Medical Instruments Co., Inc.
Radiology · 129d
Cleared Jun 20, 1997
DISPOSABLE TRANSRECTAL/TRANSVAGINAL/ENDOCAVITY ULTRASOUND NEEDLE INSTRUMENT...
K970514 · ITX
CIVCO Medical Instruments Co., Inc.
Radiology · 129d
Cleared Jun 20, 1997
GENERAL PURPOSE LATEX TRANSDUCER COVERS
K970515 · ITX
CIVCO Medical Instruments Co., Inc.
Radiology · 129d
Cleared Jun 20, 1997
GLORY
K970680 · IZH
Elscint, Inc.
Radiology · 116d
Cleared Jun 20, 1997
ELECT II BLOOD GLUCOSE MONITORING SYSTEM
K970707 · CGA
Selfcare, Inc.
Chemistry · 114d
Cleared Jun 20, 1997
SULLIVAN AUTOSET PORTABLE II NASAL CPAP SYSTEM
K970771 · BZD
Resmed, Ltd.
Anesthesiology · 109d