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
49153–49176 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 29, 2010
GUIDED MEDICAL POSITIONING SYSTEM II (GMPS II)
K102905 · DQK
Mediguide, Ltd.
Cardiovascular · 29d
Cleared CT Oct 29, 2010
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
K102906 · DXN
Andon Health Co, Ltd.
Cardiovascular · 28d
Cleared Oct 29, 2010
DX-D 300
K103050 · KPR
Agfa Healthcare N.V.
Radiology · 14d
Cleared Oct 28, 2010
METRO SOFT
K100244 · LPL
Metro Optics of Austin, Inc.
Ophthalmic · 274d
Cleared Oct 28, 2010
DEFINITIVE, FLEXLENS - SILICONE HYDROGEL
K100443 · LPL
X-Cel Contacts, Inc.
Ophthalmic · 253d
Cleared Oct 28, 2010
CVUE ADVANCED DEFINITIVE
K100456 · LPL
Unilens Corp., USA
Ophthalmic · 253d
Cleared Oct 28, 2010
COLLEXA
K100574 · KGN
Innocoll Pharmaceuticals
General & Plastic Surgery · 241d
Cleared Oct 28, 2010
NEXFIN MODEL 2
K101123 · DXN
Bmeye B.V.
Cardiovascular · 189d
Cleared Oct 28, 2010
GENESIS IMPLANT SYSTEM
K101545 · DZE
Keystone Dental
Dental · 147d
Cleared Oct 28, 2010
ULTRASONIC TABLETOP DOPPLER
K102138 · MAA
Edan Instruments, Inc.
Radiology · 90d
Cleared Oct 27, 2010
PATHIAM SYSTEM WITH ISCAN FOR P53 AND KI-67
K092333 · NQN
Bioimagene, Inc.
Pathology · 449d
Cleared Oct 27, 2010
ORGENTEC RHEUMATOID FACTOR EIA
K100499 · DHR
Orgentec Diagnostika GmbH
Immunology · 247d
Cleared Oct 27, 2010
ENDOVASCULAR LAER VEIN SYSTEM KIT
K101712 · GEX
Biolitec, Inc.
General & Plastic Surgery · 131d
Cleared Oct 27, 2010
CENTERVUE DIGITAL RETINOGRAPHY SYSTEM
K101935 · HKI
Centervue S.P.A.
Ophthalmic · 107d
Cleared Oct 27, 2010
ZIECON DISC WITH COLLAR FOR CAD/CAM MODEL ZD810-26, ZIECON BLOCK FOR MOM...
K102538 · EIH
Jyoti Ceramic Industries Private Limited
Dental · 54d
Cleared Oct 27, 2010
FM-02 BONE GRAFT SUBSTITUTE
K102545 · MQV
Orthovita, Inc.
Orthopedic · 54d
Cleared Oct 27, 2010
HI VISION AVIUS DIAGNOSTIC ULTRASOUND SCANNER
K102901 · IYN
Hitachi Medical Systems America, Inc.
Radiology · 27d
Cleared Oct 26, 2010
ELEKTA NEUROMAG WITH MAXFILTER
K091393 · OLX
Elekta Neuromag OY
Neurology · 533d
Cleared Oct 26, 2010
DXH 300 COULTER CELLULAR ANALYSIS SYSTEM, DXH 300C COULTER CELLULAR ANALYSSI...
K100489 · GKZ
Beckman Coulter Cellular
Hematology · 249d
Cleared Oct 26, 2010
AUGEASE VASCULAR AUGMENTATION DEVICE
K101355 · JOW
Augdvt, LLC
Cardiovascular · 165d
Cleared Oct 26, 2010
XPER INFORMATION MANAGEMENT AND FLEX CARDIO PHYSIOMONITORING SYSTEMS
K101571 · MWI
Witt Biomedical Corp
Cardiovascular · 144d
Cleared Oct 26, 2010
OSSEOCONDUCT
K101718 · LYC
Steiner Laboratories Div of Steiner...
Dental · 130d
Cleared Oct 26, 2010
TSC
K101756 · MVL
Kerr Corporation
Dental · 125d
Cleared Oct 26, 2010
LIGHT CURE RETAINER
K101951 · DYH
Reliance Orthodontic Products, Inc.
Dental · 106d