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
82753–82776 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 27, 2000
LIGHT BOND (QUICK CURE)
K001048 · DYH
Reliance Orthodontic Products, Inc.
Dental · 35d
Cleared Apr 27, 2000
AFFINITY 20 MICRON ARTERIAL BLOOD FILTER WITH CARMEDA BIOACTIVE SURFACE,...
K001138 · DTM
Medtronic Vascular
Cardiovascular · 17d
Cleared Apr 27, 2000
MEDTRONIC AORTOCORONARY SHUNT AND SEPARATELY PACKAGED ARTERIOTOMY CANNULAE
K994171 · DWF
Medtronic Cardiac Surgical Products
Cardiovascular · 139d
Cleared Apr 26, 2000
ONTRAK TESTSTIK FOR METHAMPHETAMINE, CAT. 1986686
K000096 · LAF
Roche Diagnostics Corp.
Toxicology · 104d
Cleared Apr 26, 2000
VITAPORT 3
K000338 · OLV
Nihon Kohden America, Inc.
Neurology · 83d
Cleared Apr 26, 2000
K-ASSAY AT-III
K000361 · JBQ
Kamiya Biomedical Co.
Hematology · 82d
Cleared Apr 26, 2000
REAADS IGA ANTI-PHOSPHATIDYLSERINE SEMI-QUANTITATIVE TEST KIT
K000920 · MID
Corgenix, Inc.
Immunology · 35d
Cleared Apr 26, 2000
EMBOSPHERE MICROSPHERES
K991549 · HCG
Biosphere Medical
Neurology · 359d
Cleared Apr 26, 2000
DELTALOC ANTERIOR CERVICAL PLATE SYSTEM
K993513 · KWQ
Alphatec Mfg., Inc.
Orthopedic · 191d
Cleared Apr 26, 2000
BIOLOK SCREW
K993630 · HWC
Encore Orthopedics, Inc.
Orthopedic · 182d
Cleared Apr 25, 2000
COBE SMARXT OPTIMA XP SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATOR
K000255 · DTZ
Cobe Cardiovascular, Inc.
Cardiovascular · 88d
Cleared Apr 25, 2000
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500
K000649 · GGP
Dade Behring, Inc.
Hematology · 57d
Cleared Apr 25, 2000
MOXIFLOXACIN, 5 UG, BBL SENSI-DISC
K000762 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 48d
Cleared Apr 25, 2000
STERILE WATER OR O.9% SODIUM CHLORIDE, MODEL AL4100 & AL4109
K000964 · JOH
Automatic Liquid Packaging, Inc.
Anesthesiology · 29d
Cleared Apr 25, 2000
LILLIPUT PHOSPHOLYPIDIC INERT SURFACE IN OXYGENATION (PH.I.S.I.O.) INFANT...
K001021 · DTZ
Dideco S.P.A.
Cardiovascular · 26d
Cleared Apr 25, 2000
MODIFICATION TO LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET
K001118 · DFC
DiaSorin, Inc.
Chemistry · 18d
Cleared Apr 25, 2000
DATES-OHMEDA AESTIVA SMARTVENT MRI
K993410 · BSZ
Datex-Ohmeda, Inc.
Anesthesiology · 196d
Cleared Apr 25, 2000
HAEMACURE HEMAMYST SURGICAL APPLICATOR SYSTEM H-AS01
K994023 · FMF
Haemacure Corp.
General Hospital · 151d
Cleared Apr 24, 2000
ERCHINGER HEMORRHOIDAL LIGATORS: SUCTION LIGATORS, MOD. ERCHINGER, RUDD,...
K000297 · FHN
Erchinger Medizintecnik
Gastroenterology & Urology · 84d
Cleared Apr 24, 2000
RESPONSE 2000 HIP STEM
K000392 · LZO
DePuy Orthopaedics, Inc.
Orthopedic · 77d
Cleared Apr 24, 2000
VISION R/F TILTING TABLE
K000412 · IXR
Villa Sistemi Medicali S.P.A.
Radiology · 76d
Cleared Apr 24, 2000
RESPONSE 2000 CEMENTED HIP STEM
K000432 · LZO
DePuy Orthopaedics, Inc.
Orthopedic · 75d
Cleared Apr 24, 2000
REMOTE FETAL MEDICINE ULTRASOUND SYSTEM
K000443 · LLZ
R4 Telemedicine, Inc.
Radiology · 74d
Cleared Apr 24, 2000
SCREENERS METHAMPHETAMINE TEST, DRUGSCREEN DIP METHAMPHETAMINE TEST
K000452 · LAF
Drug Detection Devices, Ltd.
Toxicology · 73d