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
169297–169320 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 24, 1979
HYPERDERMIC NEEDLE WITH SENSOR #514
K791462 · FMI
Medtech Intl., Inc.
General Hospital · 70d
Cleared Sep 24, 1979
ANTI-NUCLEAR ANTIBODY TEST
K791493 · DHN
Meloy Laboratories, Inc.
Immunology · 53d
Cleared Sep 24, 1979
LUKENS BONE WAX (GAMMA RADIATION)
K791495 · MTJ
Lukens Corp.
General & Plastic Surgery · 52d
Cleared Sep 24, 1979
GOAT ANTI-HUMAN C-REACTIVE PROTEIN
K791560 · DCK
Protos Laboratories
Immunology · 38d
Cleared Sep 24, 1979
TOXOPLASMA ANTIBODY TEST SYSTEM
K791571 · GLZ
Zeus Scientific, Inc.
Microbiology · 42d
Cleared Sep 24, 1979
BETA-CELL
K791607 · JSG
Biologics Intl., Inc.
Chemistry · 41d
Cleared Sep 24, 1979
TRYPTIC SOY AGAR 5% SHEEP BLOOD
K791620 · JSG
American Laboratory Supply, Inc.
Microbiology · 34d
Cleared Sep 24, 1979
MANNITOL SALT AGAR
K791621 · JSI
American Laboratory Supply, Inc.
Microbiology · 34d
Cleared Sep 24, 1979
COLUMBIA AGAR WITH5% SHEEP
K791622 · JSG
American Laboratory Supply, Inc.
Microbiology · 34d
Cleared Sep 24, 1979
MUELLER-HINTON AGAR
K791624 · JTZ
American Laboratory Supply, Inc.
Microbiology · 34d
Cleared Sep 24, 1979
AO TEACHING ATTACHMENT, MODEL TA-1
K791635 · FEA
American Optical Corp.
Gastroenterology & Urology · 34d
Cleared Sep 24, 1979
COULTER ACCU-ZYME II ENZYMATIC REAGENT
K791640 · CDT
Coulter Electronics, Inc.
Chemistry · 34d
Cleared Sep 24, 1979
SGPT REAGENT SET MODIFICATION
K791641 · CKA
American Monitor Corp.
Chemistry · 34d
Cleared Sep 24, 1979
SYSTEM CONTROLLER 720 SERIES
K791661 · KIE
Waters Assoc., Inc.
Toxicology · 34d
Cleared Sep 24, 1979
GLUCOSE OXIDASE REAGENT SET
K791669 · CGA
Macomb Chemical Co.
Chemistry · 27d
Cleared Sep 24, 1979
NADH OXIDATION, AST/SGOT
K791679 · CIT
American Monitor Corp.
Chemistry · 27d
Cleared Sep 24, 1979
CONTRO I
K791695 · JJY
Hi Chem, Inc.
Chemistry · 55d
Cleared Sep 24, 1979
CONTRO II
K791696 · JJY
Hi Chem, Inc.
Chemistry · 55d
Cleared Sep 24, 1979
INORGANIC PHOSPHORUS REAGENT
K791708 · CEO
Gilford Diagnostics
Chemistry · 27d
Cleared Sep 24, 1979
HEEL/ELBOW PROTECTORS
K791709 · FMP
Fibre Formations, Inc.
General Hospital · 28d
Cleared Sep 24, 1979
PROCAST
K791831 · ITG
Medical Specialties, Inc.
Physical Medicine · 6d
Cleared Sep 21, 1979
EMISONIC 4290
K791429 · IYO
Emi Medical, Inc.
Radiology · 57d
Cleared Sep 21, 1979
SELF CHECK
K791762 · DTC
Instromedix, Inc.
Cardiovascular · 24d
Cleared Sep 21, 1979
CONPHAR UMBILICAL CORD CLAMP
K791800 · GDJ
Conphar, Inc.
General & Plastic Surgery · 8d