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
159481–159504 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 27, 1982
EMIT D.A.V. METHAQUALONE URINE CALIBRA
K822052 · DLJ
Syva Co.
Toxicology · 14d
Cleared Jul 27, 1982
ZETAPHASE-DIG
K822053 · DON
Biological & Diagnostic Products
Chemistry · 14d
Cleared Jul 27, 1982
EMIT C-REACTIVE PROTEIN AUTOCAROUSEL
K822067 · DCK
Syva Co.
Chemistry · 13d
Cleared Jul 27, 1982
DADE DISP. DISPENSING-SPREADING PIPETS
K822078 · JRC
American Dade
Chemistry · 12d
Cleared Jul 27, 1982
ENZYMATIC CO2
K822079 · KHS
American Monitor Corp.
Chemistry · 12d
Cleared Jul 26, 1982
PNEUMOPULSSOR (PPS II)
K821265 · BYI
Strom Corp.
Anesthesiology · 84d
Cleared Jul 26, 1982
TELEPHONE LINK DATA TRANSMISSION SYS
K821478 · HGM
Advantage Medical Systems, Inc.
Obstetrics & Gynecology · 69d
Cleared Jul 26, 1982
BLOW-SINGER TRACHEOSTOMA VALVE
K821568 · EWL
Bivona Medical Technologies
Ear, Nose, Throat · 60d
Cleared Jul 26, 1982
INFORMED REMOTE FIELD UNIT MODEL IFM1000
K821712 · BTY
Burditt & Calkins-Siemens-Elema
Anesthesiology · 47d
Cleared Jul 26, 1982
XOMED MANDIBULAR TRAY
K821904 · JAZ
Xomed, Inc.
Ear, Nose, Throat · 28d
Cleared Jul 26, 1982
SPORT SUPPORTS
K822022 · IQI
Ginny, Inc.
Physical Medicine · 17d
Cleared Jul 26, 1982
AUTORANGE MODEL 205
K822031 · BXB
Tri W-G, Inc.
Physical Medicine · 14d
Cleared Jul 26, 1982
MODEL M3000XA VENTILATOR SPECIFICA
K822103 · CBK
Thompson Respiration Products, Inc.
Anesthesiology · 10d
Cleared Jul 23, 1982
THERMOFONTE AIR MESSAGE BATH
K821809 · ILJ
Greenfields
Chemistry · 35d
Cleared Jul 22, 1982
ELVI BICLOT 816
K812906 · KQG
Volu Sol Medical Industries
Hematology · 276d
Cleared Jul 22, 1982
OCULAR-BIOMETER 4000
K820042 · IYO
Radionics, Inc.
Radiology · 196d
Cleared Jul 22, 1982
BARRIER ANTIMICROBIAL INCISE DRAPE
K820543 · KKX
Surgikos, Inc.
General Hospital · 142d
Cleared Jul 22, 1982
EF2000
K820953 · IPF
Squire, Sanders & Dempsey
Physical Medicine · 107d
Cleared Jul 22, 1982
MCPARLAND SCALP VEIN CATHETER
K821001 · LFJ
Renal Systems, Inc.
Gastroenterology & Urology · 105d
Cleared Jul 22, 1982
RIA-QUANT FPA TEST KIT
K821151 · DAN
Mallinckrodt Critical Care
Immunology · 87d
Cleared Jul 22, 1982
GLUCOSE(ENZYMATIC) REAGENT SET
K821204 · CGA
Omega Medical Electronics
Chemistry · 86d
Cleared Jul 22, 1982
SGPT-UV REAGENT SET
K821206 · CKA
Omega Medical Electronics
Chemistry · 86d
Cleared Jul 22, 1982
UREA NITROGEN REAGENT SET
K821212 · CDW
Omega Medical Electronics
Chemistry · 86d
Cleared Jul 22, 1982
C-REACTIVE PROTEIN CONTROL
K821412 · DCK
Syva Co.
Chemistry · 71d