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
175993–176016 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 20, 1976
PHYSIOSCOPE
K760083
Narco Bio-Systems
Radiology · 29d
Cleared Jul 20, 1976
BASIN, STERILE (#3200)
K760085 · FNY
Concord Laboratories, Inc.
General Hospital · 29d
Cleared Jul 20, 1976
TAPE, VASCULAR, 1/4 DACRON
K760087 · DWS
Meadox Medicals, Div. Boston...
Cardiovascular · 29d
Cleared Jul 20, 1976
TEST, IN-VITRO DIAGNOSTIC
K760089
Hoffmann-La Roche, Inc.
Immunology · 29d
Cleared Jul 20, 1976
GRAFT, COOLEY GUIDELINE, STERILE
K760090 · DSY
Meadox Medicals, Div. Boston...
Cardiovascular · 29d
Cleared Jul 20, 1976
GRAFT, MICROVEL GUIDELINE, STERILE
K760091 · DSY
Meadox Medicals, Div. Boston...
Cardiovascular · 29d
Cleared Jul 20, 1976
GRAFT, COOLEY WOVEN VASCULAR, STERILE
K760092 · DSY
Meadox Medicals, Div. Boston...
Cardiovascular · 29d
Cleared Jul 20, 1976
RESPIRIZOR
K760095 · CAF
Campillary Systems
Anesthesiology · 29d
Cleared Jul 20, 1976
PROSTHESIS, TOTAL HIP-FEMORAL
K760106 · JDG
Orthopedic Equipment Co., Inc.
Orthopedic · 26d
Cleared Jul 20, 1976
PROSTHESIS, TOTAL HIP-TEST FEMORAL
K760107 · JDG
Orthopedic Equipment Co., Inc.
Orthopedic · 26d
Cleared Jul 20, 1976
PROSTHESIS, TOTAL HIP-TEST CUP
K760108 · JDG
Orthopedic Equipment Co., Inc.
Orthopedic · 26d
Cleared Jul 20, 1976
PROSTHESIS, TOTAL HIP-RASP
K760109 · HTR
Orthopedic Equipment Co., Inc.
General & Plastic Surgery · 26d
Cleared Jul 20, 1976
THERMOMETER, DIGITAL FEVER (MEDITEMP)
K760118 · FLL
Johnson & Johnson Professionals, Inc.
General Hospital · 25d
Cleared Jul 20, 1976
SAMPLER, FLAMELESS (IL MODEL 555)
K760119 · JXR
Instrumentation Laboratory CO
Chemistry · 25d
Cleared Jul 20, 1976
PULSE CARDULE (MODEL 1859/1860 ECG)
K760120 · DRT
Spacelabs, Inc.
Cardiovascular · 22d
Cleared Jul 20, 1976
AUTOZYME
K760123 · KSK
Bd Becton Dickinson Vacutainer...
Hematology · 22d
Cleared Jul 20, 1976
AUTO CELL DILUENT
K760124 · GIF
Bd Becton Dickinson Vacutainer...
Hematology · 22d
Cleared Jul 20, 1976
LENS, HARD CONTACT
K760126 · HPX
Tru-Form Optics, Inc.
Ophthalmic · 22d
Cleared Jul 20, 1976
SALINE, ISOTONIC BUFFERED, AZIDE-FREE
K760129 · GIF
Harleco
Hematology · 22d
Cleared Jul 20, 1976
PROSTHESIS, VASCULAR BIFURCATED
K760130 · DSY
Usci, Div. C.R. Bard, Inc.
Cardiovascular · 22d
Cleared Jul 20, 1976
AGARO-GEL, PRODUCT # A1266
K760131 · JJN
Sigma Chemical Co.
Chemistry · 22d
Cleared Jul 20, 1976
TEST, RIA, TSH QUANTIMUNE
K760132 · JLW
Bio-Rad
Immunology · 22d
Cleared Jul 20, 1976
PROCEDURE, RED CELL FOLATE ASSAY
K760133 · CGN
Bio-Rad
Chemistry · 22d
Cleared Jul 20, 1976
PROCEDURE, RA, THYROXINE BINDING PROTEIN
K760134 · CEE
Bio-Rad
Chemistry · 22d