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
146329–146352 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 23, 1985
MANUAL VENTILATION ACCESSORY
K854036
Siemens Elema AB
Cardiovascular · 57d
Cleared Oct 23, 1985
SYVA MYCOTRANS MYCOPLASMA TRANSPORT SYSTEM
K854061 · JSM
Syva Co.
Microbiology · 19d
Cleared Oct 23, 1985
BCYE (BUFFERED CHARCOAL YEAST EXTRACT) AGAR
K854064 · KZI
Bd Becton Dickinson Vacutainer...
Microbiology · 19d
Cleared Oct 23, 1985
TSK STERIJECT STERILE EPIDURAL NEEDLE
K854149 · BSP
Pharmacia, Inc.
Anesthesiology · 12d
Cleared Oct 23, 1985
PHADIRECT STREP A TEST
K854150 · GTZ
Pharmacia, Inc.
Microbiology · 12d
Cleared Oct 22, 1985
EDC/TITAN GELISO-TOTAL CPK ISOENZYME PROCEDURE
K852392 · CGS
Helena Laboratories
Chemistry · 139d
Cleared Oct 22, 1985
#9431 TELETRACE, TELEPHONE, EKG TRANSMITTER
K852971 · DXH
Medtronic Vascular
Cardiovascular · 99d
Cleared Oct 22, 1985
FIAX TEST KIT FOR MEASLES-G ANTIBODIES FLYORESCENT
K853067 · GRE
Idt, A Division of Whittaker M.A....
Microbiology · 92d
Cleared Oct 22, 1985
XYLENE SUBSTITUTE
K853694 · KEM
Lerner Laboratories, Inc.
Pathology · 48d
Cleared Oct 22, 1985
GRAM STAIN KIT
K853896 · JTS
Sigma Diagnostics, Inc.
Pathology · 32d
Cleared Oct 22, 1985
BIO-TEK EL 401 HANDHELD MICROPLATE WASHER
K853920 · JTC
Bio-Tek Instruments, Inc.
Microbiology · 29d
Cleared Oct 22, 1985
BETA-TSH-IRMA
K853977 · JLW
Leeco Diagnostics, Inc.
Chemistry · 26d
Cleared Oct 22, 1985
ENTAMOEBA HISTOLYTICA-POSITIVE CONTROL(RABBIT)
K854017 · KHW
Lmd Laboratories
Microbiology · 22d
Cleared Oct 22, 1985
XYLENE SUBSTITUTE MONTANT
K854083 · KEM
Lerner Laboratories, Inc.
Pathology · 15d
Cleared Oct 21, 1985
SENSOR TAPE CAT. NO. ST-45
K852407 · DTW
American Omni Medical, Inc.
Cardiovascular · 137d
Cleared Oct 21, 1985
HA-1000 & HA-500 HYDROXYLAPATITE TOOTH ROOT SUBSTI
K852766 · LYC
Orthomatrix, Inc.
Dental · 115d
Cleared Oct 21, 1985
CERAMIC ALLOY NO. DW 179
K852895 · EJH
Williams Gold Refining Co., Inc.
Dental · 104d
Cleared Oct 21, 1985
QVANTIMETRIC 2KAPPA AND LAMBDA TEST KIT
K852999 · DEH
Kallestad Laboratories, Inc.
Immunology · 98d
Cleared Oct 21, 1985
ADVANCED CARDIOVASCULAR SYSTEMS DOUBLE LUMEN BALLO
K853746 · LIT
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 42d
Cleared Oct 21, 1985
SUN KING
K853752 · FTC
American Chase Company, Inc.
General & Plastic Surgery · 42d
Cleared Oct 21, 1985
UV-A SUNTANNING EQUIPMENT
K853911 · FTC
Eurotan Intl.
General & Plastic Surgery · 31d
Cleared Oct 18, 1985
MODEL TT25RF
K844178 · GEX
Inframed, Inc.
General & Plastic Surgery · 357d
Cleared Oct 18, 1985
DR. BRUNO LNAGE MINI PHOTOMETER
K851575
Texas Medical Products, Inc.
Chemistry · 184d
Cleared Oct 18, 1985
QCT-BONE MINERAL PHANTOM
K852509 · KGI
Image Analysis, Inc.
Radiology · 128d