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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
138025–138048 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 27, 1987
REFLEX(TM) CA-T CLIP APPLIER
K873309 · FZP
Richard-Allan Medical Ind., Inc.
General & Plastic Surgery · 101d
Cleared Nov 27, 1987
USCI (R) 8F LARGE LUMEN SOFT TIP GUIDE CATHETER
K873438 · DQO
C.R. Bard, Inc.
Cardiovascular · 92d
Cleared Nov 27, 1987
ROTASCREEN EIA
K873740 · LIQ
Mercia Diagnostics , Ltd.
Microbiology · 73d
Cleared Nov 27, 1987
SUPERPULSE AMBULASE (XAM-SP) CO2 SURGICAL LASER
K873760 · GEX
Coherent Medical Group
General & Plastic Surgery · 72d
Cleared Nov 27, 1987
REUMA TEST
K873782 · DHR
Sclavo, Inc.
Immunology · 72d
Cleared Nov 27, 1987
DYNAMARK 1000
K873979 · DXN
Dynamedics, Inc.
Cardiovascular · 58d
Cleared Nov 27, 1987
LAD MODEL 735 LUMINOMETER
K874262 · JJQ
Los Alamos Diagnostics
Chemistry · 38d
Cleared Nov 27, 1987
CONCEPT SUTURE NEEDLE
K874515 · HRX
Concept, Inc.
Orthopedic · 25d
Cleared Nov 25, 1987
O.P.T.(TM) OVULATION PREDICTION TEST
K870584 · CEP
Warner-Lambert Co.
Chemistry · 287d
Cleared Nov 25, 1987
ARTHROBOT 100 UPPER LIMB POSITIONER
K873079 · JEA
Andronic Devices, Ltd.
General & Plastic Surgery · 112d
Cleared Nov 25, 1987
ARTHROBOT 101 UPPER LIMB TRACTION ACCESSORY
K873080 · JEA
Andronic Devices, Ltd.
General & Plastic Surgery · 112d
Cleared Nov 25, 1987
VIDEO ARTHROSCOPE, 1.7MM X 55 MM
K873387 · HXR
Arthropedics, Inc.
General & Plastic Surgery · 152d
Cleared Nov 25, 1987
CANNULA AND GENERAL PURPOSE ASPIRATOR
K873552 · HHI
Cosmedtech, Inc.
Obstetrics & Gynecology · 107d
Cleared Nov 25, 1987
BIOSURE SPECIMEN COLLECTION CONTAINER
K873593 · KDT
Biosure, Inc.
Pathology · 82d
Cleared Nov 25, 1987
FIAX TEST KIT FOR ENA (RNP/SM) ANTIBODIES
K873708 · LLL
Whittaker Bioproducts, Inc.
Immunology · 71d
Cleared Nov 25, 1987
SYSMEX F-800 15 PARAMETER, SEMI-AUTO HEMA ANALYZER
K873734 · GKZ
Toa Medical Electronics USA, Inc.
Hematology · 71d
Cleared Nov 25, 1987
TISSUE CULTURE TUBES
K873889 · KJA
Nunc, Inc.
Pathology · 63d
Cleared Nov 25, 1987
TISSUE CULTURE FLASKS
K873890 · KJA
Nunc, Inc.
Pathology · 63d
Cleared Nov 25, 1987
TISSUE CULTURE DISHES
K873891 · KIZ
Nunc, Inc.
Pathology · 63d
Cleared Nov 25, 1987
CREAT BRAND O-RISE GENERAL ASPIRATOR
K873940 · BTA
Aesthetech Corp.
General & Plastic Surgery · 58d
Cleared Nov 25, 1987
IRMA-COUNT FERRITIN W/MONO. ANTIBODIES RKFE1,2,5
K874031 · DBF
Diagnostic Products Corp.
Immunology · 54d
Cleared Nov 25, 1987
IQ/QCA TOTAL BILIRUBIN
K874261 · CIG
Bd Becton Dickinson Vacutainer...
Chemistry · 36d
Cleared Nov 25, 1987
MULTICHEM (R) TOTAL BILIRUBIN
K874311 · CIG
Simmler, Inc.
Chemistry · 36d
Cleared Nov 25, 1987
BAUSCH & LOMB RENU REWETTING & LUBRICATING DROPS
K874364 · LPN
Bausch & Lomb, Inc.
Ophthalmic · 33d