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
168865–168888 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 13, 1979
RUBELLA BIO-BEAD SCREEN KIT
K791610 · GOL
Litton Bionetics
Microbiology · 84d
Cleared Nov 13, 1979
TOXO BIO-BEAD SCREEN KIT
K791611 · GLZ
Litton Bionetics
Microbiology · 84d
Cleared Nov 13, 1979
CMV BIO-BEAD SCREEN KIT
K791612 · GQH
Litton Bionetics
Microbiology · 84d
Cleared Nov 13, 1979
HSV BIO-BEAD SCREEN KIT
K791614 · GQN
Litton Bionetics
Microbiology · 84d
Cleared Nov 13, 1979
TORCH BIO-BEAD SCREEN KIT
K791618 · GLZ
Litton Bionetics
Microbiology · 85d
Cleared Nov 13, 1979
COMPU-SCAN
K791632 · DSI
Hittman Medical Systems
Cardiovascular · 84d
Cleared Nov 13, 1979
POPE UMBRELLA TUBE
K791680 · ETD
Xomed, Inc.
Ear, Nose, Throat · 78d
Cleared Nov 13, 1979
HTSH NEONATE RIA DIAGNOSTIC KIT
K791747 · JLW
Abbott Laboratories
Chemistry · 64d
Cleared Nov 13, 1979
CORNING GLYCOSYLATED HEMOGLOBIN SET
K791777 · LCP
Corning Medical & Scientific
Chemistry · 64d
Cleared Nov 13, 1979
BIOGUARD INFUSION LINE FILTER
K791822 · FPB
United States Surgical, A Division of...
General Hospital · 60d
Cleared Nov 13, 1979
LAP SPONGES
K791872 · EFQ
Carwild Corp.
General & Plastic Surgery · 53d
Cleared Nov 13, 1979
USCI SAFE-T-CLOTH THERMODILUTION CAT.
K791873 · KRB
C.R. Bard, Inc.
Cardiovascular · 53d
Cleared Nov 13, 1979
BACTO-HATTS
K791897 · GMT
Difco Laboratories, Inc.
Microbiology · 49d
Cleared Nov 13, 1979
CYCLER SETS MOD. #5C4143, 5C4144, 5C4145
K791899 · KDJ
Travenol Laboratories, S.A.
Gastroenterology & Urology · 49d
Cleared Nov 13, 1979
HEART RATE COMPUTER STRIP CHART
K791927 · JOM
Stanford Assoc., Inc.
Cardiovascular · 47d
Cleared Nov 13, 1979
ANTIBODY TO NATIVE DEOXYRIBONUCLEASE KIT
K791928 · DHN
Keith E. Abbott
Immunology · 47d
Cleared Nov 13, 1979
AMS ENTEROBACTERIACEASE CARE
K791932 · JSS
Vitek Systems, Inc.
Microbiology · 47d
Cleared Nov 13, 1979
CONVERSION CONTRACTOR TIMER KIT
K791933 · IZO
Advanced Instrument Development, Inc.
Radiology · 47d
Cleared Nov 13, 1979
ATMOS ENT PATIENT CHAIR #1
K791937 · ETL
Jedmed Instrument Co.
Ear, Nose, Throat · 47d
Cleared Nov 13, 1979
ATMOS ENT PATIENT CHAIR #5
K791938 · ETL
Jedmed Instrument Co.
Ear, Nose, Throat · 47d
Cleared Nov 13, 1979
SHILEY CARDIOPLEGIC SOLUTION DEL SETS
K791947 · DWF
Shiley, Inc.
Cardiovascular · 43d
Cleared Nov 13, 1979
EXTRACORPOREAL'S MODEL EX-85 DIALYZER
K791961 · FJG
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 43d
Cleared Nov 13, 1979
USCI MULLINS TRANSSEPTAL CATHETER INTRO.
K791963 · DYB
C.R. Bard, Inc.
Cardiovascular · 43d
Cleared Nov 13, 1979
TECHNICON FAST-LC SYS. ANTICONVU DRUGS
K791979 · DPE
Technicon Instruments Corp.
Toxicology · 49d