Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

GEX 2017-04-25

Cutera enlighten III Laser System

Applicant Cutera, Inc.

K-Number K170936

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NHA 2017-04-25

ET US SS Prosthetic system

Applicant Osstem Implant Co., Ltd.

K-Number K160670

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PBZ 2017-04-25

Triton Sponge System

Applicant Gauss Surgical, Inc.,

K-Number K163507

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KIF 2017-04-25

SavDenTM MTA Root Canal Filling Materials

Applicant Tyds Biotech Incorporation

K-Number K162661

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ONN 2017-04-25

XO1 Knee Balancing System

Applicant Xpandortho, Inc.

K-Number K162237

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MAX 2017-04-25

NeoFuse HA Enhanced PLIF/TLIF

Applicant Ht Medical, LLC

K-Number K170511

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GZI 2017-04-25

MyoCycle Home, MyoCycle Pro

Applicant Myolyn, LLC

K-Number K170132

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FET 2017-04-25

Processor VP-7000, Light Source BL-7000

Applicant Fujifilm Medical System U.S.A., Inc.

K-Number K163675

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HRS 2017-04-24

Pantheon Medical Balanced Plating System

Applicant Pantheon Medical

K-Number K162154

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HWC 2017-04-24

Foot and Hand Motion

Applicant Newclip Technics

K-Number K170012

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LJS 2017-04-24

PowerPICC Provena Catheters with SOLO Valve Technology

Applicant C.R. Bard, Inc.

K-Number K162441

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FAD 2017-04-24

C-Flex Ureteral Stent Set

Applicant Cook Incorporated

K-Number K162104

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