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
50833–50856 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 23, 2010
EXTRA PTA BALLOON CATHETER WITH EMBOLIC PROTECTION FEATURE
K090364 · LIT
Angioslide, Ltd.
Cardiovascular · 403d
Cleared Mar 23, 2010
D-STORM 810NM, D-STORM 980NM
K093048 · GEX
Light Instruments
General & Plastic Surgery · 174d
Cleared Mar 23, 2010
OPAL BOND MV
K094006 · DYH
Ultradent Products, Inc.
Dental · 85d
Cleared Mar 23, 2010
SPIRAL LAMINAR FLOW VASCULAR ARTERIOVENOUS GRAFT
K094044 · DSY
Tayside Flow Technologies Limited
Cardiovascular · 82d
Cleared Mar 22, 2010
LAPORT
K092584 · GCJ
Mgb Endoskopische Gerate GmbH (Berlin)
General & Plastic Surgery · 210d
Cleared Mar 22, 2010
BELRAY II
K093240 · EHD
Takara Belmont Corp.
Radiology · 158d
Cleared Mar 22, 2010
AUTOLOG AUTOTRANSFUSION SYSTEM
K093535 · CAC
Medtronic, Inc.
Anesthesiology · 126d
Cleared Mar 22, 2010
VPAP III ST-A
K093731 · MNS
Resmed, Ltd.
Anesthesiology · 109d
Cleared Mar 22, 2010
ADVIA CHEMISTRY DRUG CALIBRATOR I MODEL 10376770
K093732 · JIX
Siemens Healthcare Diagnostics
Chemistry · 108d
Cleared Mar 22, 2010
GORE DRYSEAL SHEATH
K093791 · DYB
W.L. Gore & Associates, Inc.
Cardiovascular · 102d
Cleared Mar 22, 2010
HOVEROUND HOVERGLIDE MODEL HOVERGLIDE MK-2
K093946 · ILK
Hoveround Corp.
Physical Medicine · 89d
Cleared Mar 22, 2010
KNEEALIGN SYSTEM WITH REFERENCE SENSOR
K093998 · OLO
Orthalign, Inc.
Orthopedic · 84d
Cleared Mar 22, 2010
18 STANDARD WHEELCHAIR, MODEL MS005-4, 18 RECLINING WHEELCHAIR , MODEL...
K094047 · IOR
Modern Rehabilitation Solutions Co.,...
Physical Medicine · 81d
Cleared Mar 22, 2010
ANGIOSCULPT PTA SCORING BALLOON CATHETER MODEL 2039-XXYY, 2076-XXYY,...
K100303 · PNO
Angioscore, Inc.
Cardiovascular · 47d
Cleared Mar 22, 2010
HEARTWAY POWER CHAIR, P23
K100327 · ITI
Heartway Medical Products Co., Ltd.
Physical Medicine · 46d
Cleared Mar 22, 2010
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K100339 · LYZ
Tangshan Changrong Glove Co., Ltd.
General Hospital · 45d
Cleared Mar 22, 2010
SYSTEMS INTEGRATION MODEL: ENDOALPHA
K100345 · ODA
Olympus Medical Systems Corporation
Gastroenterology & Urology · 45d
Cleared Mar 22, 2010
HOVEROUND TEKNIQUE GT POWER WHEELCHAIR, MODEL# TEKNIQUE GT
K100350 · ITI
Hoveround Corp.
Physical Medicine · 38d
Cleared Mar 19, 2010
MEDPOR CONTAIN IMPLANT
K091120 · NPK
Porex Surgical, Inc.
Dental · 336d
Cleared Mar 19, 2010
NBM-200MP PULSE OXIMETRY DEVICE
K091564 · DQA
Orsense, Ltd.
Anesthesiology · 295d
Cleared Mar 19, 2010
ELECSYS TROPONIN T CALCHECK 5
K092848 · JJX
Roche Diagnostics Corp.
Chemistry · 184d
Cleared Mar 19, 2010
KIMBERLY-CLARK KC100 SURGICAL GOWN, MODEL KC100
K093115 · FYA
Kimberly-Clark Corp.
General Hospital · 168d
Cleared Mar 19, 2010
MISSION CLINICHECK ASSAYED CHEMISTRY CONTROL, LEVEL 1&2, MISSION CLINICAL...
K093492 · JJY
Diamond Diagnostics, Inc.
Chemistry · 129d
Cleared Mar 19, 2010
SMPLE PLATE AND SCREWS
K093983 · HRS
Biomet Trauma (Aka Ebi, Lp)
Orthopedic · 85d