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
38305–38328 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 01, 2014
REPROCESSED HARMONIC ACE SHEARS WITHOUT ADAPTIVE TISSUE TECHNOLOGY
K133672 · NLQ
Stryker Sustainability Solutions
General & Plastic Surgery · 153d
Cleared May 01, 2014
OCELOT CATHETER, OCELOT PIXL CATHETER, LIGHTBOX CONSOLE
K140185 · PDU
Avinger, Inc.
Cardiovascular · 97d
Cleared May 01, 2014
ORTHOPEDIC FIXATION SYSTEMS
K140216 · HRS
Impact Medical, LLC
Orthopedic · 93d
Cleared May 01, 2014
IMMULITE: 2000 FREE T4 CALIBRATION VERIFICATION MATERIAL, 2000 IGF-I...
K140818 · JJX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 30d
Cleared Apr 30, 2014
BEAUTIFUL IMAGE FACIAL SCULPTING DEVICE
K130065 · NFO
Biosonic Technologies, LLC
Neurology · 475d
Cleared Apr 30, 2014
MOSTDI DENTAL IMPLANT SYSTEM
K132178 · DZE
Mostdi Innovations Sdn Bhd
Dental · 289d
Cleared Apr 30, 2014
MEDTRONIC INPUT PS INTRODUCER
K132617 · DYB
Medtronic, Inc.
Cardiovascular · 252d
Cleared Apr 30, 2014
BIOPURE HX2 REVERSE OSMOSIS WATER PURIFICATION SYSTEM
K133149 · FIP
Mar Cor Purification, Inc.
Gastroenterology & Urology · 195d
Cleared Apr 30, 2014
CO2 MONITORING LINE, CO2 MONITORING LINE WITH FILTER
K133516 · CCK
Flexicare
Anesthesiology · 166d
Cleared Apr 30, 2014
FIAGON NAVIGATION SYSTEM
K133573 · PGW
Fiagon GmbH
Ear, Nose, Throat · 161d
Cleared Apr 30, 2014
SOMATOM PERSPECTIVE
K133590 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 159d
Cleared Apr 30, 2014
COEUR, INC. FRONTLOAD FOR OPTIVANTAGE POWER INJECTOR
K133600 · DXT
Coeur, Inc.
Cardiovascular · 156d
Cleared Apr 30, 2014
CARESCAPE CENTRAL STATION (FORMALLY KNOWN AS CIC PRO)
K133882 · DXJ
Ge Medical Systems Information...
Cardiovascular · 131d
Cleared Apr 30, 2014
ACUSON S1000, S2000, S3000 DIAGNOSTIC ULTRASOUND SYSTEMS
K140959 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 15d
Cleared Apr 29, 2014
NEURODYN COMPACT, NEURODYN II
K131917 · IPF
Ibramed Equipamentos Medicos
Physical Medicine · 307d
Cleared Apr 29, 2014
ELECTRIC HANDPIECE SYSTEM
K132570 · EBW
Ttbio Corp.
Dental · 257d
Cleared Apr 29, 2014
NEUROMATE FRAMELESS GEN II
K132755 · HAW
Renishaw Mayfield Sarl
Neurology · 238d
Cleared Apr 29, 2014
ORIGIO(R) SEQUENTIAL BLAST TM
K133387 · MQL
Origio A/S
Obstetrics & Gynecology · 175d
Cleared Apr 29, 2014
ACCU-CHEK AVIVA PLUS SYSTEM
K133862 · NBW
Roche Diagnostics Corporation
Chemistry · 131d
Cleared Apr 29, 2014
FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETER
K133879 · MUD
Cas Medical Systems, Inc.
Cardiovascular · 130d
Cleared Apr 29, 2014
NEW STETIC DENTAL AMALGAM ALLOY
K140125 · OIV
New Stetic
Dental · 103d
Cleared Apr 29, 2014
COMFORTSOFT SOFT DENTURE LINER SYSTEM
K140146 · EBI
Whip-Mix Corp.
Dental · 97d
Cleared Apr 29, 2014
GENERAL SPINAL SYSTEM
K140229 · MNI
Tianjin Walkman Biomaterial Co., Ltd.
Orthopedic · 89d
Cleared Apr 29, 2014
FAMILY OF DISPOSABLE LENSES
K140368 · HKS
Sensor Medical Technology, LLC
Ophthalmic · 74d