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
54889–54912 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 10, 2008
EASYRA BILIRUBIN DIRECT AND TOTAL REAGENT, PHOSPHORUS INORGANIC REAGENT AND...
K080810 · CIG
Medica Corp.
Chemistry · 264d
Cleared Dec 10, 2008
DISPOSABLE VINYL SYNTHETIC EXAMINATION GLOVES, POWDERED
K082448 · LYZ
Rich Mountain Medical Products, Inc.
General Hospital · 107d
Cleared Dec 10, 2008
SPECTRANETICS QUICK-CROSS EXTREME SUPPORT CATHETERS
K082561 · DQY
Spectranetics Corp.
Cardiovascular · 97d
Cleared Dec 10, 2008
RZ ENDOSCOPIC (MINIMALLY INVASIVE) INSTRUMENTS AND ACCESSORIES
K082902 · GEI
Rz Medizintechnik GmbH
General & Plastic Surgery · 71d
Cleared Dec 10, 2008
TAIDOC TD-11 SERIES AND CLEVER TD-1112 EAR/SKIN/ SURFACE IR THERMOMETERS &...
K083299 · FLL
Taidoc Technology Corporation
General Hospital · 30d
Cleared Dec 10, 2008
MODIFICATION TO ARTHROCARE ARTHROWANDS
K083306 · GEI
Arthrocare Corp.
General & Plastic Surgery · 30d
Cleared Dec 10, 2008
PASS LP SPINAL SYSTEM
K083308 · MNI
Medicrea Technologies
Orthopedic · 30d
Cleared Dec 09, 2008
RUGALIFT, MODEL# V.2.1
K071573 · NFO
Fatrotek S.R.L.
Neurology · 550d
Cleared Dec 09, 2008
NANOBEAM 940, MODEL 940-900-02
K073681 · ILY
Davaray, Inc.
Physical Medicine · 347d
Cleared Dec 09, 2008
GEL-SPONGE ENT, ABSORBABLE GELATIN SPONGE, USP
K080022 · KHJ
Vascular Solutions, Inc.
Ear, Nose, Throat · 341d
Cleared Dec 09, 2008
ATTAIN COMMAND 6250 LEFT HEART DELIVERY SYSTEMS AND ATTAIN COMMAND 6250 GUIDE...
K080428 · DQY
Medtronic, Inc.
Cardiovascular · 294d
Cleared Dec 09, 2008
AGILIS NXT STEERABLE INTRODUCER, MODEL G408324
K081645 · DYB
St Jude Medical
Cardiovascular · 180d
Cleared Dec 09, 2008
ZOLL R SERIES BLS DEFIBRILLATOR
K081828 · MKJ
ZOLL Medical Corporation
Cardiovascular · 165d
Cleared Dec 09, 2008
BUSSE SURGICAL DRAPE
K082297 · KKX
Busse Hospital Disposables, Inc.
General Hospital · 119d
Cleared Dec 09, 2008
POWDER FREE NITRILE PATIENT EXAMINATION GLOVES WITH CHEMO LABELING CLAIM
K082302 · LZA
Pt. Medisafe Technologies
General Hospital · 119d
Cleared Dec 09, 2008
MODIFICATION TO VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR
K082308 · DXG
Edwards Lifesciences, LLC
Cardiovascular · 118d
Cleared Dec 09, 2008
NOVABONE PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT
K082672 · MQV
Novabone Products, LLC
Orthopedic · 85d
Cleared Dec 09, 2008
TEMPORARY COLD.V AND SELF-CURE DENTINE
K082700 · EBG
Major Prodotti Dentari S.P.A.
Dental · 85d
Cleared Dec 09, 2008
FREEWAY AND RAILRUNNER GUIDEWIRES
K082922 · DQX
Lake Region Mfg., Inc.
Cardiovascular · 69d
Cleared Dec 09, 2008
PK DIEGO POWERED DISSECTOR CONSOLE, MODEL 7033-9050, DIEGO TRIGGER-ENABLED...
K083013 · GEI
Gyrus Acmi, Inc.
General & Plastic Surgery · 61d
Cleared Dec 09, 2008
MEDEGEN PRESSURE RATED EXTENSION SETS
K083472 · FPA
Medegen, Inc.
General Hospital · 15d
Cleared Dec 08, 2008
MAGSTIM DOUBLE 70MM AIR FILM COIL, MODEL 3910-00
K080499 · GWF
The Magstim Company , Ltd.
Neurology · 287d
Cleared Dec 08, 2008
HAV-LOK BUNION CORRECTION SYSTEM
K082384 · HTN
Instratek, Inc.
Orthopedic · 111d
Cleared Dec 08, 2008
MAXTORQUE MINI CANNULATED SCREW SYSTEM
K082574 · HWC
Orthohelix Surgical Designs, Inc.
Orthopedic · 94d