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    PHILIPS M5066A AND M5068A

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    Philips and Laerdal brands of HeartStart HS1 Defibrillator Family Model number M5066A, M5067A, and M5068A Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA. The HS1 Defibrillator is intended to treat ventricular fibrillation, the most common cause of sudden cardiac arrest. Using voice prompts, light emitting diodes (LEDs) and buttons, the user is guided through the response. The HS1 uses a SMART biphasic, impedance compensating exponential waveform to deliver a nominal 150 J to adults and nominal 50 J to infants/children.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems North America Co. Phillips·January 16, 2013

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526743687·ACHIMED ACHILLES SUPP SILVER V

    QUANTIMETRIX CORP.

    FDA registration
    QUANTIMETRIX CORP.·7 products·🇺🇸 United States

    Plateau Spacer System

    FDA UDI
    Life Spine, Inc.·00190837050795·10mmx20mmx15mm Plateau-P, 7 Degree Reverse Angle

    Plateau Spacer System

    FDA UDI
    Life Spine, Inc.·00190837009939·

    7 x15mm CitreLock Implant

    FDA UDI
    Acuitive Technologies, Inc.·00810027270238·

    Single Use Biliary Stent V

    FDA UDI
    OLYMPUS MEDICAL SYSTEMS CORP.·04953170186110·Single Use Biliary Stent V

    3M™ Unitek™

    FDA UDI
    3M UNITEK CORPORATION·00652221231468·Unitek Miniature Twin MBT LR 2Bi -17T/2A DHk 02...

    COATED VICRYL PLUS ANTIBACTERIAL SUTURE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code GAM·April 20, 2006

    COATED VICRYL PLUS ANTIBACTERIAL SUTURE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code GAM·April 20, 2006

    COATED VICRYL PLUS ANTIBACTERIAL SUTURE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code GAM·April 20, 2006

    COATED VICRYL PLUS ANTIBACTERIAL SUTURE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code GAM·April 20, 2006

    ECAT PET SCANNER

    FDA 510(k)
    FDA Class 2 ·Radiology

    ENVOY AND VISTA BRITE TIP

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    COATED VICRYL PLUS ANTIBACTERIAL SUTURE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code GAM·April 25, 2006

    Genemed®

    FDA UDI
    SAKURA FINETEK U.S.A., INC.·00615233007810·anti-Herpes Simplex Virus 1 (HSV1) Rabbit Polyc...

    COATED VICRYL PLUS ANTIBACTERIAL SUTURE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code GAM·April 21, 2006

    ZYGOMATIC IMPLANT

    FDA Adverse Event
    Injury ·NORIS MEDICAL LTD·Product code DZE·November 3, 2025

    ZYGOMATIC IMPLANT

    FDA Adverse Event
    Injury ·NORIS MEDICAL LTD·Product code DZE·November 3, 2025