Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
160321–160344 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 27, 1982
IMPROVED MEM-RICHTER'S POWDER MODIF.
K821916 · KIT
Dutchland Laboratories, Inc.
Microbiology · 29d
Cleared Jul 27, 1982
WAYMOUTH'S POWDER MEDIUM
K821917 · KIT
Dutchland Laboratories, Inc.
Microbiology · 29d
Cleared Jul 27, 1982
POWDERED RPMI-1603 MEDIUM
K821918 · KIT
Dutchland Laboratories, Inc.
Microbiology · 29d
Cleared Jul 27, 1982
POWDERED RPMI-1634 MEDIUM
K821919 · KIT
Dutchland Laboratories, Inc.
Microbiology · 29d
Cleared Jul 27, 1982
EIA-F8 ENZYMEIMMUNOASSAY KIT FOR QUANT.
K821963 · GGP
Intl. Immunoassay Laboratories, Inc.
Hematology · 26d
Cleared Jul 27, 1982
EMIT D.A.V. METHAQUALONE ASSAY
K822051 · KXS
Syva Co.
Toxicology · 14d
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