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
48217–48240 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 15, 2011
SYSTEMS INTEGRATION
K102763 · ODA
Olympus Medical Systems Corporation
Gastroenterology & Urology · 144d
Cleared Feb 15, 2011
TRABECULAR METAL FEMORAL CONE AUGMENTS
K103517 · MBH
Zimmer Trabecular Metal Technology, Inc.
Orthopedic · 77d
Cleared Feb 15, 2011
VANTAGE ABI
K103693 · DXN
Summit Doppler Systems, Inc.
Cardiovascular · 60d
Cleared Feb 15, 2011
SIROLASER ADVANCE, SIROLASER XTEND, SIROLASER XTEND UPGRADED, FONALASER
K103753 · GEX
Sirona Dental Systems GmbH
General & Plastic Surgery · 54d
Cleared Feb 15, 2011
PSL ANTERIOR CERVICAL PLATE SYSTEM
K103819 · KWQ
Precision Surgery , Ltd.
Orthopedic · 47d
Cleared Feb 15, 2011
FIXED VARIABLE & CORPECTOMY CERVICAL PLATE SYSTEM
K103838 · KWQ
Precision Surgery , Ltd.
Orthopedic · 47d
Cleared Feb 15, 2011
AFINION ANALYZER
K110056 · LCP
Axis-Shield Poc AS
Chemistry · 36d
Cleared Feb 15, 2011
ATRIUM CENTRILFX MESH
K110110 · FTL
Atrium Medical Corporation
General & Plastic Surgery · 32d
Cleared Feb 15, 2011
AXSOS LOCKED PLATING 4.0MM LOCKING INSERTS
K110176 · HRS
Howmedica Osteonics Corp., Dba...
Orthopedic · 25d
Cleared Feb 15, 2011
PHILIPS ECG LEADWIRE SET
K110287 · DSA
Philips Medical Systems
Cardiovascular · 15d
Cleared Feb 14, 2011
FUSTAR STEERABLE INTRODUCERS
K100184 · DQY
Lifetech Scientific (Shenzhen) Co., Ltd.
Cardiovascular · 389d
Cleared Feb 14, 2011
DIMENSION VISA HBA1C, MODEL K3105A
K102045 · LCP
Siemens Heatlhcare Diagnostics, Inc.
Chemistry · 208d
Cleared Feb 14, 2011
NEODENT GRAFT SCREW
K103084 · DZL
Jjgc Industria E Comercio DE...
Dental · 118d
Cleared Feb 14, 2011
QMIX 2IN1 ENDODONTIC IRRIGATING SOLUTION
K103244 · KJJ
Dentsply Intl., Inc.
Dental · 104d
Cleared Feb 14, 2011
TELIO CS INLAY & TELIO CS ONLAY
K103379 · EBG
Ivoclar Vivadent, Inc.
Dental · 89d
Cleared Feb 14, 2011
SKYLINE ANTERIOR CERVICAL PLATE SYSTEM
K103491 · KWQ
A Johnson & Johnson Company
Orthopedic · 80d
Cleared Feb 11, 2011
ONE TOUCH VERIO BLOOD GLUCOSE MONITORING SYSTEM
K093745 · NBW
Lifescan, Inc.
Chemistry · 434d
Cleared Feb 11, 2011
ROCHE ORAL FLUID OPIATES, DAT QUAL CAL A, DAT CONTROL SET A AND DAT SQ CAL A
K093867 · DJG
Roche Diagnostics
Chemistry · 402d
Cleared Feb 11, 2011
THERMO SCIENTIFIC QMS EVEROLIMUS REAGENTS, CALIBRATORS AND CONTROLS
K100144 · OUF
Microgenics Corp.
Chemistry · 388d
Cleared Feb 11, 2011
ROCHE ORAL FLUID COCAINE
K101160 · DIO
Roche Diagnostics
Chemistry · 291d
Cleared Feb 11, 2011
4CIS VANE SPINE SYSTEM
K101818 · MNH
Solco Biomedical Co., Ltd.
Orthopedic · 226d
Cleared Feb 11, 2011
DIGITAL FLAT PANEL X-RAY DETECTOR MODEL SDX-4336CP
K102321 · MQB
Samsung Mobile Display Co., Ltd.
Radiology · 178d
Cleared Feb 11, 2011
BRIGHT SPINE GALILEO SPINAL SPACER SYSTEM
K102449 · ODP
Bright Spine, Inc.
Orthopedic · 168d
Cleared Feb 11, 2011
AS3700 ANESTHSIA DELIVERY SYSTEM
K102471 · BSZ
Mindray DS USA, Inc.
Anesthesiology · 165d