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
137041–137064 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 11, 1988
WORTH 4 DOT TEST DISTANCE C/W MUSCLE LIGHT
K874251 · HLP
Richmond Products, Inc.
Ophthalmic · 84d
Cleared Jan 11, 1988
SOLOS SINGLE USE TITANIUM TIP
K874334 · HQC
Solos Ophthalmology
Ophthalmic · 81d
Cleared Jan 11, 1988
RAICHEM(TM) ALCOHOL REAGENT
K874382 · DML
Reagents Applications, Inc.
Toxicology · 77d
Cleared Jan 11, 1988
PRESSURE LIMIT CONTROL
K874415 · CBK
Draeger Medical, Inc.
Anesthesiology · 75d
Cleared Jan 11, 1988
FIAGEN(TM) PROLACTIN CATALOGUE NUMBER: 102-201
K874621 · CFT
Cyberfluor, Inc.
Chemistry · 62d
Cleared Jan 11, 1988
FIAGEN(TM) HLH CATALOGUE NUMBER: 102-301
K874624 · CEP
Cyberfluor, Inc.
Chemistry · 62d
Cleared Jan 11, 1988
REVISED LABELING FOR SYVA PHENCYCLIDINE ASSAYS
K874626 · LCL
Syva Co.
Toxicology · 62d
Cleared Jan 11, 1988
BENNETT PORTABLE RADIOGRAPHIC SYSTEM NO. SPR-100A
K874840 · IZL
Bennett X-Ray Corp.
Radiology · 48d
Cleared Jan 11, 1988
GRAM - & GRAM + MIC/COMBO & BREAKPOINT/COMBO PANEL
K874876 · JWY
Baxter Healthcare Corp
Microbiology · 42d
Cleared Jan 11, 1988
BILIRUBIN (TOTAL)
K875069 · CIG
Tech-Co, Inc.
Chemistry · 33d
Cleared Jan 11, 1988
ALBUMIN, BROMCRESOL GREEN DYE-BINDING
K875070 · CIX
Tech-Co, Inc.
Chemistry · 33d
Cleared Jan 07, 1988
DELTA SCRUB
K872823 · GEC
Pacific Biosystems, Inc.
General & Plastic Surgery · 175d
Cleared Jan 07, 1988
MODIFIED MULTICOR AND OMNI-STANICOR PACEMAKERS
K873158 · DXY
Tpl-Cordis, Inc.
Cardiovascular · 150d
Cleared Jan 07, 1988
CARDIOFAX-V ECG-8110A
K873874 · DSI
Nihon Kohden America, Inc.
Cardiovascular · 107d
Cleared Jan 07, 1988
BARD DESAI CATHETER ELECTRODE
K873995 · DRF
C.R. Bard, Inc.
Cardiovascular · 98d
Cleared Jan 07, 1988
INFECTION CONTROL GOGGLE (TSE FONG)/STER/NON-STER
K874296 · FXX
Ulti-Med Intl., Inc.
General Hospital · 79d
Cleared Jan 07, 1988
AUDIOTONE MODEL MSP, IN-THE-EAR HEARING AID
K874385 · ESD
Audiotone, Inc.
Ear, Nose, Throat · 73d
Cleared Jan 07, 1988
PLAYTEX NON & DEODORANT TAMPONS + PRIVATE LABEL
K874509 · HIL
Playtex, Inc.
Obstetrics & Gynecology · 66d
Cleared Jan 07, 1988
POLYFLEX(R) EPICARDIAL 439-04 IMPLANT PACING LEAD
K874531 · DTB
Intermedics, Inc.
Cardiovascular · 65d
Cleared Jan 07, 1988
PROXIMAL FEMORAL REPLACEMENT PROSTHESIS
K874575 · JDG
Dow Corning Wright
Orthopedic · 62d
Cleared Jan 07, 1988
HISTOBRUSH
K874604 · HHT
Spectrum Co.
Obstetrics & Gynecology · 59d
Cleared Jan 07, 1988
REFERENCE HIGH LEVEL ASSAYED CHEM. CONTROL SERUM
K874809 · JJY
Biotrol, USA, Inc.
Chemistry · 48d
Cleared Jan 07, 1988
MULTICHEM HDL PRECIPITATING REAGENT #S0914
K874820 · LBR
Simmler, Inc.
Chemistry · 44d
Cleared Jan 07, 1988
FLEXIE THE COPPER SHANK NEEDLE
K874891 · KCW
Skin Deep, Inc.
General & Plastic Surgery · 37d