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
139009–139032 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 16, 1987
STANDARD SCREW DRIVER
K872387 · LRZ
Med-Tool, Inc.
General & Plastic Surgery · 27d
Cleared Jul 16, 1987
1.1 TWIST DRILLS AND 1.2 CORTICAL DRILLS
K872491 · GEG
Micro-Aire Surgical Instruments, Inc.
General & Plastic Surgery · 23d
Cleared Jul 16, 1987
HEARING AID S45 SERIES
K872553 · ESD
Electone, Inc.
Ear, Nose, Throat · 17d
Cleared Jul 16, 1987
HEARING AID 49 SERIES
K872554 · ESD
Electone, Inc.
Ear, Nose, Throat · 17d
Cleared Jul 16, 1987
HEARING AID M35/M36 SERIES
K872556 · ESD
Electone, Inc.
Ear, Nose, Throat · 17d
Cleared Jul 16, 1987
HDL CHOLESTEROL REAGENT
K872575 · CHH
Sigma Chemical Co.
Chemistry · 16d
Cleared Jul 16, 1987
HIGH PRESSURE LIQUID CHROMATOGRAPHY SYSTEM
K872582 · LDM
Millipore Corp.
Chemistry · 16d
Cleared Jul 16, 1987
LEAD GLASS SHIELDS
K872656 · IWR
Viox Corp.
Radiology · 9d
Cleared Jul 15, 1987
ULTRASOUND TRANSDUCER GEL, STERILE
K871565 · JOT
Amedic USA
General & Plastic Surgery · 84d
Cleared Jul 15, 1987
HTF MEDIUM AND MODIFIED HTF MEDIUM-HEPES
K871577 · HDR
Irvine Scientific
Obstetrics & Gynecology · 83d
Cleared Jul 15, 1987
ULTRASOUND TRANSDUCER SHEATHS, STERILE
K871609 · ITX
Amedic USA
Radiology · 82d
Cleared Jul 15, 1987
HCG MAB SOLID PHASE COMPONENT SYSTEM
K871700 · JHI
Bd Becton Dickinson Vacutainer...
Chemistry · 75d
Cleared Jul 15, 1987
CONDUCTIVITY GEL
K871913 · GYB
Futuremed Div. of Future Impex Corp.
Neurology · 58d
Cleared Jul 15, 1987
CONDUCTIVITY GEL
K872045 · GYB
Futuremed Div. of Future Impex Corp.
Neurology · 49d
Cleared Jul 15, 1987
MODEL 3000 OPHTHALMIC SURGICAL SYSTEM
K872312 · HQE
Allergan Humphrey
Ophthalmic · 92d
Cleared Jul 15, 1987
TRANSWORLD 360V, MODEL A1-4040
K872357 · IZO
Transworld X-Ray Corp.
Radiology · 27d
Cleared Jul 15, 1987
PRECISION SCREW DRIVER SET
K872389 · HXX
Med-Tool, Inc.
Orthopedic · 26d
Cleared Jul 15, 1987
CENTRALITE
K872489 · IWE
Diacor, Inc.
Radiology · 22d
Cleared Jul 15, 1987
CURETTE SET, ANTRUM, COAKLEY
K872609 · KAP
Military Engineering, Inc.
Ear, Nose, Throat · 9d
Cleared Jul 14, 1987
GENDER CHOICE INFORMATION KIT, FEMALE AND MALE
K870999 · LHD
Procare C/O Wiley, Rein & Fielding
Obstetrics & Gynecology · 125d
Cleared Jul 14, 1987
CIVCO STEPPER
K871413 · FZX
CIVCO Medical Instruments Co., Inc.
General & Plastic Surgery · 97d
Cleared Jul 14, 1987
KONTOUR ULTRA SOFT SPONGE #SS144.50
K872069 · NAD
Winfield Laboratories, Inc.
General & Plastic Surgery · 46d
Cleared Jul 14, 1987
TAMPAX DEODORANT TAMPON, SUPER
K872261 · HIL
Tambrands, Inc.
Obstetrics & Gynecology · 34d
Cleared Jul 13, 1987
FETALFLEX FETAL ELECTRODE
K871079 · HGP
Epcom Medical Systems, Inc.
Obstetrics & Gynecology · 117d