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
53809–53832 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 15, 2009
VANISH VARNISH, 5% SODIUM FLUORIDE VARNISH, MODEL 12245, VANISH VARNISH, 5%...
K090519 · LBH
3M Company
Dental · 48d
Cleared Apr 15, 2009
MODIFICATION TO DASH 2500 PATIENT MONITOR
K090702 · MHX
Ge Medical Systems Information...
Cardiovascular · 29d
Cleared Apr 15, 2009
NOVABONE POROUS - SYNTHETIC BONE GRAFT SCAFFOLD
K090731 · MQV
Novabone Products, LLC
Orthopedic · 27d
Cleared Apr 15, 2009
RTX 3371
K090886 · DRG
Tunstall Healthcare
Cardiovascular · 15d
Cleared Apr 15, 2009
DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, MODEL DP-6900
K090912 · ITX
Shenzhen Mindray Bio-Medical...
Radiology · 14d
Cleared Apr 15, 2009
BIOCARDIA MORPH SHEATH GUIDE
K090999 · DYB
Biocardia, Inc.
Cardiovascular · 7d
Cleared Apr 14, 2009
MINICAP IMMUNOTYPING, MODEL: 2300
K082388 · CFF
Sebia
Immunology · 238d
Cleared Apr 14, 2009
CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES
K083216 · LPL
Ciba Vision Corporation
Ophthalmic · 165d
Cleared Apr 14, 2009
EZLASE
K083595 · ILY
Biolase Technology, Inc.
Physical Medicine · 130d
Cleared Apr 14, 2009
ADAPTABLE COMPOSITE RESIN RESTORATIVE MATERIAL
K083841 · EBF
Dentsply International, Inc.
Dental · 111d
Cleared Apr 14, 2009
ALMA LASERS SOPRANO XL MULTI-APPLICATION PLATFORM
K083848 · GEX
Alma Lasers , Ltd.
General & Plastic Surgery · 111d
Cleared Apr 14, 2009
BLUESHINE GOLD SERIES
K090297 · GEX
Blueshine Srl
General & Plastic Surgery · 67d
Cleared Apr 14, 2009
BONOS INJECT
K090460 · NDN
Aap Biomaterials GmbH
Orthopedic · 50d
Cleared Apr 14, 2009
CYNOSURE SMARTCOOL FAMILY COLD AIR DEVICE: SMARTCOOL, SMARTCOOL 6 AND CRYO C
K090618 · GEX
Cynosure, Inc.
General & Plastic Surgery · 36d
Cleared Apr 13, 2009
LIFEBED NETWORK PATIENT VIGILANCE SYSTEM
K083534 · DRT
Hoana Medical, Inc.
Cardiovascular · 136d
Cleared Apr 13, 2009
P.D SOFTWARE
K083672 · MUJ
.Decimal, Inc.
Radiology · 123d
Cleared Apr 13, 2009
PROGUIDE CHRONIC DIALYSIS CATHETER
K090148 · MSD
Merit Medical Systems, Inc.
Gastroenterology & Urology · 82d
Cleared Apr 13, 2009
SWIFT FX
K090244 · BZD
Resmed, Ltd.
Anesthesiology · 70d
Cleared Apr 10, 2009
VIDAS CA 125 II ASSAY
K080561 · LTK
bioMerieux, Inc.
Immunology · 407d
Cleared Apr 10, 2009
WELL LIFE SELF ADHESIVE ELECTRODE / MODELS: CM, FA, PU AND SP
K082065 · GXY
Well-Life Healthcare Limited
Neurology · 262d
Cleared Apr 10, 2009
ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO...
K082759 · LKJ
Phadia US, Inc.
Immunology · 200d
Cleared Apr 10, 2009
DETLOGIX ANNULOPLASTY RING, MODEL: 5100
K083191 · KRH
Edwards Lifesciences, LLC
Cardiovascular · 163d
Cleared Apr 10, 2009
BLOOD TRANSFUSION SET
K083349 · BRZ
Shan Dong Wei Gao Group Medical...
General Hospital · 148d
Cleared Apr 10, 2009
AUTOSUTURE ENDO GIA STAPLERS WITH ENDO GIA SINGLE USE LOADING UNITS
K083519 · GDW
Covidien Lp, Formerly Registered AS...
General & Plastic Surgery · 135d