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
165673–165696 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 22, 1980
MYCOLOGY CULTURE SYSTEM
K802946 · JSJ
Orion Diagnostica, Inc.
Microbiology · 33d
Cleared Dec 22, 1980
ORICULT DTM
K802947 · JSI
Orion Diagnostica, Inc.
Microbiology · 33d
Cleared Dec 22, 1980
GAMBRO A-V FISTULA NEEDLE SET
K802956 · FIE
Gambro, Inc.
Gastroenterology & Urology · 32d
Cleared Dec 22, 1980
MUELLER HINTON BROTH
K802957 · JTZ
Gibco Laboratories Life Technologies,...
Microbiology · 35d
Cleared Dec 22, 1980
CHEM-ASSAY STANDARD-CONTROLS
K802962 · JJY
National Bio-Technical Laboratories
Chemistry · 31d
Cleared Dec 22, 1980
UNIPOLAR ENDOCARDIAL LASER DRILLED ELEC
K802968 · DTB
Telectronics, Inc.
Cardiovascular · 31d
Cleared Dec 22, 1980
POWERED WHEELCHAIR
K802986 · ITI
Vessa , Ltd.
Physical Medicine · 28d
Cleared Dec 22, 1980
TRYPTICASE SOY AGAR W/5% RABBIT BLD. CEL
K802994 · JSH
Sacks Farms Biological Products
Microbiology · 27d
Cleared Dec 22, 1980
TRYPTICASE SOY AGAR W/5% SHEEP BLD. CELL
K802995 · JSH
Sacks Farms Biological Products
Microbiology · 27d
Cleared Dec 22, 1980
HDL-CHOLESTEROL CONTROL SERUM
K802997 · JJX
Isolab, Inc.
Chemistry · 27d
Cleared Dec 22, 1980
PATIENT CARE DISPOSABLE INFANT SHIRTS
K802998 · KME
American Convertors Div., American...
General Hospital · 27d
Cleared Dec 22, 1980
BETA-TEC QUALITATIVE
K802999 · JHI
Armkel, LLC
Chemistry · 27d
Cleared Dec 22, 1980
ELECATH FLUID-DRAIN ASSEMBLY
K803002 · DQR
Electro-Catheter Corp.
Cardiovascular · 27d
Cleared Dec 22, 1980
AMINO ACID ANALYSER SYSTEM
K803004 · JJF
Lkb Instruments, Inc.
Chemistry · 26d
Cleared Dec 22, 1980
SENSOMAT
K803014 · CBZ
Biochem International, Inc.
Anesthesiology · 24d
Cleared Dec 22, 1980
SERALYZER LDH REAGENT STRIPS, CALIBR
K803019 · CFJ
Miles Laboratories, Inc.
Chemistry · 24d
Cleared Dec 22, 1980
CDC ANAEROBE BLD AGAR W/KANAMYCIN ETC.
K803022 · JSJ
Bd Becton Dickinson Vacutainer...
Microbiology · 26d
Cleared Dec 22, 1980
ENRICHED THIOGLYCOLLATE MEDIUM
K803023 · JSG
Bd Becton Dickinson Vacutainer...
Microbiology · 26d
Cleared Dec 22, 1980
CDC ANAEROBE LAKED BL AGAR W/PARAMOMY.
K803024 · JSJ
Bd Becton Dickinson Vacutainer...
Microbiology · 26d
Cleared Dec 22, 1980
CDC ANAEROBE BLOOD AGAR
K803025 · JSG
Bd Becton Dickinson Vacutainer...
Microbiology · 26d
Cleared Dec 22, 1980
PEPTONE YEAST EXTRACT GLUCOSE BROTH
K803026 · JSC
Bd Becton Dickinson Vacutainer...
Microbiology · 26d
Cleared Dec 22, 1980
CDC ANAEROBE BL AGAR W/PHENYLETHYL ETC.
K803027 · JSJ
Bd Becton Dickinson Vacutainer...
Microbiology
Cleared Dec 22, 1980
TLC SUPPORT PRODUCTS
K803029
Orthopedic Systems, Inc.
Orthopedic · 26d
Cleared Dec 22, 1980
THE BIO-TEK CHROMOSCAN
K803030 · JJQ
Bio-Tek Instruments, Inc.
Microbiology · 24d