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
163777–163800 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 20, 1981
VEIN-TRAP TM
K811910 · DWQ
Atrium Medical Corp.
Cardiovascular · 19d
Cleared Jul 20, 1981
AMP MARK IV INFUSION PUMP
K811918 · FRN
American Medical Products, Inc.
General Hospital · 18d
Cleared Jul 20, 1981
GUARDIAN, VOLUMETRIC CONTROL DELIVERY
K811933 · FRN
Avi, Inc.
General Hospital · 14d
Cleared Jul 20, 1981
VISITEC NEEDLE RANGE (ORTHOPAEDIC)
K811961
Visitec Co.
Orthopedic · 10d
Cleared Jul 20, 1981
VISITEC NEEDLE RANGE (CARDIOVASCULAR)
K811964 · DRC
Visitec Co.
Cardiovascular · 10d
Cleared Jul 20, 1981
JOHNSON & JOHNSON O.B. TAMPONS
K811983 · HEB
Johnson & Johnson Professionals, Inc.
Obstetrics & Gynecology · 7d
Cleared Jul 20, 1981
ASSURE NATURAL FIT TAMPON
K811992 · HEB
Personal Products Co.
Obstetrics & Gynecology · 7d
Cleared Jul 16, 1981
DOPPLEX-PLB & PXB
K810115 · KNG
Huntleigh Technology, Inc.
Radiology · 181d
Cleared Jul 16, 1981
CONTACT-MICRO COLPOHYSTEROSCOPE
K810569 · HIH
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 135d
Cleared Jul 16, 1981
THE BETA
K810940 · DSI
Burdick Corp.
Cardiovascular · 100d
Cleared Jul 16, 1981
THROMBIN CLOTTING TIME
K811109 · GJA
Bio/Data Corp.
Hematology · 84d
Cleared Jul 16, 1981
EYE CARE TRAY
K811117
American Pharmaseal Div. Ahsc
Ophthalmic · 83d
Cleared Jul 16, 1981
BIOVISION CARDIAC STROBE
K811341 · DPS
Cardiac Imaging
Cardiovascular · 65d
Cleared Jul 16, 1981
TOXOPLASMOSIS TEST KIT
K811562 · GLZ
Immuno-Diagnostic Products, Inc.
Microbiology · 43d
Cleared Jul 16, 1981
CERVICAL DILATOR
K811568 · HDQ
Gynemetrics, Inc.
Obstetrics & Gynecology · 42d
Cleared Jul 16, 1981
ACTIN FS ACTIVATED PTT REAGENT
K811589 · GGW
American Dade
Hematology · 38d
Cleared Jul 16, 1981
PLAYTEX MODIFIED FIBER TAMPONS
K811660 · HIL
Playtex, Inc.
Obstetrics & Gynecology · 34d
Cleared Jul 16, 1981
MODEL 381 HOME OXYGEN SENTRY
K811702 · CCL
Stanley Aviation Corp.
Anesthesiology · 30d
Cleared Jul 16, 1981
H-101 KAPPA,H-102 LAMBDA,H-107 LYSOZME
K811721 · DFH
Immulok, Inc.
Pathology · 28d
Cleared Jul 16, 1981
KALLESTAD'S ENDOPLATE FACTOR B TEST
K811740 · JZH
Kallestad Laboratories, Inc.
Immunology · 27d
Cleared Jul 16, 1981
MAXITHERM
K811743 · DWJ
Cincinnati Sub-Zero
Cardiovascular · 27d
Cleared Jul 16, 1981
REDUCT-ASE TUBES
K811852 · JSH
Microchemical Specialities, Co.
Microbiology · 15d
Cleared Jul 16, 1981
PHOLPHORYL-ASE TUBES
K811853 · JTO
Microchemical Specialities, Co.
Microbiology · 15d
Cleared Jul 16, 1981
GALACTOSID-ASE TUBES
K811854 · JTO
Microchemical Specialities, Co.
Microbiology · 15d