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
139681–139704 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 13, 1987
TODD HEWITT W/CNA (LIM BROTH)
K871447 · JSD
Remel Co.
Microbiology · 30d
Cleared May 13, 1987
BUFFALO GREEN MONKEY KIDNEY CELLS
K871613 · KIR
Viromed Laboratories, Inc.
Pathology · 19d
Cleared May 13, 1987
ALKALINE PEPTONE WATER
K871640 · JSD
Bd Becton Dickinson Vacutainer...
Microbiology · 16d
Cleared May 12, 1987
DSP100 CAROTID PHONOANGIOGRAPHY MODULE
K864429 · DQC
Intl. Acoustics, Inc.
Cardiovascular · 181d
Cleared May 12, 1987
40CC PERCUTANEOUS FURL DOU. LUMEN BALLOON CATHETER
K864567 · DSP
Aries Medical, Inc.
Cardiovascular · 174d
Cleared May 12, 1987
40CC SURGICAL DOUBLE LUMEN BALLOON CATHETER
K864568 · DSP
Aries Medical, Inc.
Cardiovascular · 174d
Cleared May 12, 1987
KODAK EKTACHEM DT SLIDES (CA)
K870035 · CID
Eastman Kodak Company
Chemistry · 127d
Cleared May 12, 1987
IONOMETER EF AND ACCESSORIES
K870183 · JGS
Smash Ent., Inc.
Chemistry · 116d
Cleared May 12, 1987
PCTE MICROPOROUS MEMBRANE FILTER
K870196 · KET
Poretics Corp.
Pathology · 112d
Cleared May 12, 1987
T.O.P. 2000 (TOMOGRAPHIC ORIENTATED PLANNING)
K870221 · KPQ
Kermath Mfg. Corp.
Radiology · 111d
Cleared May 12, 1987
AVL MODEL 985 ELECTROLYTE ANALYZER
K870657 · CEM
Avl Scientific Corp.
Chemistry · 83d
Cleared May 12, 1987
NEY-ORO 41
K870677 · EJT
Deringer-Ney, Inc.
Dental · 82d
Cleared May 12, 1987
CONTACT LENS TWEEZERS
K871130 · KYE
S. M. C. Medi-Tech Corp.
Ophthalmic · 53d
Cleared May 12, 1987
HEARTSTART 2000, MANUAL MEDICAL CONTROL MODULE
K871135 · LDD
First Medical Devices Corp.
Cardiovascular · 53d
Cleared May 12, 1987
HEARTSTART 2000, MANUAL DEFIBRILLATOR
K871136 · LDD
First Medical Devices Corp.
Cardiovascular · 53d
Cleared May 12, 1987
PLAYTEX TAMPONS AND DEODORANT TAMPONS
K871197 · HIL
Intl. Playtex, Inc.
Obstetrics & Gynecology · 49d
Cleared May 12, 1987
ACU-PREG-AL SLIDE TEST
K871294 · JHJ
Papibris Scientific, Inc.
Chemistry · 42d
Cleared May 12, 1987
EASY-TEST EMIT GENTAMICIN (GENT) ITEM NO. 16640
K871329 · LCD
Em Diagnostic Systems, Inc.
Toxicology · 39d
Cleared May 12, 1987
CONTOUR SOFT-E SERIES CONDUCTIVE SOLID GEL ELECTRO
K871412 · DRX
Contour Electrodes, Inc.
Cardiovascular · 34d
Cleared May 12, 1987
EASY-TEST CHEM CAL LEVELS 1,2&3/ITEMS 67617 ABC/95
K871638 · JIX
Em Diagnostic Systems, Inc.
Chemistry · 15d
Cleared May 12, 1987
TAMPAX TAMPON, REGULAR
K871642 · HEB
Tambrands, Inc.
Obstetrics & Gynecology · 15d
Cleared May 12, 1987
DELFIA (TM) HTSH KIT
K871644 · JLW
Lkb Instruments, Inc.
Chemistry · 15d
Cleared May 12, 1987
GLUCOSE ENZYME - COLOR REAGENT SET
K871650 · CGA
Biochemical Trade, Inc.
Chemistry · 14d
Cleared May 12, 1987
COLORIMETRIC BUN REAGENT KIT
K871651 · CDL
Biochemical Trade, Inc.
Chemistry · 14d