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
60409–60432 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 08, 2007
SPYGLASS IRRIGATION SYSTEM
K063700 · LJH
Medical Scientific, Inc.
Gastroenterology & Urology · 57d
Cleared Feb 08, 2007
MP5 INTELLIVUE PATIENT MONITOR
K063725 · MHX
Philips Medizinsysteme Boeblingen...
Cardiovascular · 55d
Cleared Feb 08, 2007
LISFRANC PLATE
K063820 · HRS
New Deal, S.A.
Orthopedic · 44d
Cleared Feb 08, 2007
POSITIONER
K063839 · IYE
C-Rad Positioning AB
Radiology · 44d
Cleared Feb 08, 2007
POWDERED VINYL PATIENT EXAMINATION GLOVES
K070008 · LYZ
Zibo Hengde Plastic & Rubber Products...
General Hospital · 36d
Cleared Feb 08, 2007
CLASSIC/HYPOTHERMIA, FLEXIBLE, 10-SECOND, LEFT-RIGHT HANDED, BASAL,...
K070028 · FLL
Actherm, Inc.
General Hospital · 36d
Cleared Feb 08, 2007
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, WHITE
K070043 · LYZ
Super Safe Plastic Products Co., Ltd.
General Hospital · 36d
Cleared Feb 08, 2007
MONOCHROME LCD MONITOR, MODEL RADIFORCE GX320
K070122 · LLZ
Eizo Nanao Corporation
Radiology · 23d
Cleared Feb 08, 2007
MODIFICATION TO TTC PLATES
K070160 · HRS
New Deal, S.A.
Orthopedic · 22d
Cleared Feb 08, 2007
MODIFICATION TO LAPIDUS PLATE
K070241 · HRS
New Deal, S.A.
Orthopedic · 14d
Cleared Feb 07, 2007
INFINITI SYSTEM
K060564 · NPQ
AutoGenomics, Inc.
Pathology · 341d
Cleared Feb 07, 2007
PLEXUR P
K061982 · MBP
Osteotech, Inc.
Orthopedic · 209d
Cleared Feb 07, 2007
SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E
K062793 · CBK
Maquet Critical Care AB
Anesthesiology · 142d
Cleared Feb 07, 2007
SUTURTEK SURGICAL STEEL SUTURE, MODELS SC-S13, SC-S14, SC-S15, SC-S16, SC-S17
K063603 · GAQ
Suturtek Incorporated
General & Plastic Surgery · 66d
Cleared Feb 07, 2007
OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2407
K063660 · NUH
Well-Life Healthcare Limited
Neurology · 61d
Cleared Feb 07, 2007
BASAL DORSAL PLATES
K063831 · HRS
Newdeal Sas
Orthopedic · 43d
Cleared Feb 07, 2007
POWDERED VINYL PATIENT GLOVE
K070046 · LYZ
Shijiazhuang Lianhe Shunda Plastic...
General Hospital · 35d
Cleared Feb 07, 2007
SUNIRAY II DIGITAL RADIOGRAPHY SYSTEM
K070219 · MUH
Suni Medical Imaging, Inc.
Radiology · 15d
Cleared Feb 06, 2007
STAODYN MAX PRESET, MODEL 4470
K061516 · GZJ
Compex Technologies, Inc.
Neurology · 250d
Cleared Feb 06, 2007
STARCLOSE HEX-HUB DILATOR
K062554 · DRE
Abbott Vascular, Inc.
Cardiovascular · 160d
Cleared Feb 06, 2007
GLUCO TRACK BLOOD GLUCOSE MONITORING SYSTEM
K062799 · CGA
Apex BioTechnology Corp.
Chemistry · 140d
Cleared Feb 06, 2007
EMMA ANALYZER (KPA) AND (MMHG)
K063167 · CCK
Phasein AB
Anesthesiology · 111d
Cleared Feb 06, 2007
XPER INFORMATION MANAGEMENT/PHYSIOMONITORING 5 SYSTEM AND/OR VASCULAR 5,...
K063840 · MWI
Witt Biomedical Corp
Cardiovascular · 42d
Cleared Feb 06, 2007
EZ-FILL XPRESS EPOXY ROOT CANAL CEMENT SYSTEM
K063856 · KIF
Essential Dental Systems, Inc.
Dental · 40d