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
42361–42384 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 04, 2013
OLYMPUS MAJ-172 INSTRUMENT TRAY FOR LTF VIDEOSCOPE
K122818 · KCT
Olympus Keymed (Medical & Industrial...
General Hospital · 112d
Cleared Jan 04, 2013
ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER
K122854 · DYB
Arrow International (Subsidiary of...
Cardiovascular · 108d
Cleared Jan 04, 2013
BODY FAT SCALE MODEL SF-371
K122976 · MNW
Shenzhen Belter Health Measurement...
Gastroenterology & Urology · 100d
Cleared Jan 04, 2013
K7C SPACER
K123388 · ODP
K7, LLC
Orthopedic · 63d
Cleared Jan 04, 2013
BIOTENE ORAL BALANCE GEL, BIOTENE DRY MOUTH ORAL RINSE, BIOTENE MOISTURIZING...
K123731 · LFD
Glaxosmithkline Consumer Healthcare...
Dental · 30d
Cleared Jan 03, 2013
COLLADENTAL BARRIER
K100695 · NPL
Collamatrix, Inc.
Dental · 1029d
Cleared Jan 03, 2013
DOPPLEX ABILITY
K121108 · JOM
Huntleigh Healthcare
Cardiovascular · 266d
Cleared Jan 03, 2013
AIRVO HUMIDIFIER MYAIRO HUMIDIFIER
K121975 · BTT
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 182d
Cleared Jan 03, 2013
BIOPHOTAS LIFELIGHT
K122237 · ILY
Biophotas, Inc.
Physical Medicine · 161d
Cleared Jan 03, 2013
PEARL DIABETES MANAGEMENT SYSTEM
K122483 · LZG
Asante Solutions, Inc.
General Hospital · 142d
Cleared Jan 03, 2013
MOORFLPI-2 FULL-FIELD LASER PERFUSION IMAGER
K122943 · DPT
Moor Instruments, Ltd.
Cardiovascular · 101d
Cleared Jan 03, 2013
SOVEREIGN MINI
K123102 · GCJ
Aesculap, Inc.
General & Plastic Surgery · 93d
Cleared Jan 03, 2013
JUNCTIONAL EMERGENCY TREATMENT TOOL MODEL 30-0088
K123194 · DXC
North American Rescue Products, Inc.
Cardiovascular · 84d
Cleared Jan 03, 2013
SUPER STAPLE(TM) CLASSIC
K123363 · JDR
Metric Medical Devices, Inc.
Orthopedic · 63d
Cleared Jan 03, 2013
NEO ERCP GUIDEWIRE
K123439 · OCY
Neometrics, Inc.
Gastroenterology & Urology · 56d
Cleared Jan 03, 2013
TRACKER-17 MICROCATHER, 150 CM LONG AND 15.0 CM FLEXIBLE DISTAL SHAFT,...
K123452 · DQY
Stryker
Cardiovascular · 56d
Cleared Jan 03, 2013
RETRACTA DETACHABLE EMBOLIZATION COIL
K123712 · KRD
Cook Incorporated
Cardiovascular · 30d
Cleared Jan 03, 2013
CG+ ARROW PICC POWERED BY ARROW VPS STYLET
K123759 · LJS
Arrow International, Inc. (Subsidiary...
General Hospital · 27d
Cleared Jan 02, 2013
INTERVENTIONAL WORKSPOT
K121296 · LLZ
Philips Medical Systems Nederland B.V.
Radiology · 247d
Cleared Jan 02, 2013
MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENS
K122273 · MRC
Menicon Co, Ltd.
Ophthalmic · 156d
Cleared Jan 02, 2013
GE INNOVA/INNOVA IGS/DISCOVERY IGS/OPTIMA ANGIOGRAPHIC, FLUOSCOPIC X-RAY...
K122457 · OWB
Ge Healthcare
Radiology · 142d
Cleared Jan 02, 2013
QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN
K123877 · NEW
Surgical Specialties Corp. Dba Angiotech
General & Plastic Surgery · 16d
Cleared Jan 01, 2013
LIAISON DIRECT RENIN LIAISON CONTROL DIRECT RENIN LIAISON ENDOCRINOLOGY DILUENT
K121944 · CIB
DiaSorin, Inc.
Chemistry · 182d
Cleared Jan 01, 2013
DIGITAL FLAT PANEL X-RAY DETECTOR11417PCA
K122919 · MQB
Rayence Co., Ltd.
Radiology · 99d