BEUDAMED
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    Cervical Spinal Truss System (CSTS) Interbody Fusion Device

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Ambler Value Line

    FDA UDI
    AMBLER SURGICAL CORP.·00190660214579·Sawyer rectal retractor, 11'', large, 3 1/2'' l...

    TRAUSON BONE SCREW, MODELS HA 3.5 AND 4.5

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CARDIO MED MODEL A102, H104, O101, P103, AND Z100

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CONSTELLATION VISION SYS

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CTR·Product code HQC·October 10, 2014

    GYNECARE TVT OBURATOR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·June 17, 2013

    TELIGEN

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 23, 2011

    Cardio Medical Products, Inc. Defibrillation/Cardioversion/Monophasic or Biphasic Pacing/ECG Electrode Rx Only Single Patient Use Only Manufactured for Cardio Medical Products 385 Franklin Avenue, Suite L Rockaway, New Jersey 07866 www.cardiomedicalproducts.com (800) 227-3633 (973) 586-9624 FAX Defibrillator

    FDA Enforcement
    Class II ·Terminated·Cardio Medical Products·July 17, 2013

    THERMAGE CPT SYSTEM

    FDA Adverse Event
    Injury ·SOLTA MEDICAL, INC·Product code GEI·November 12, 2020

    THERMAGE CPT SYSTEM TIP

    FDA Adverse Event
    Injury ·SOLTA MEDICAL INC·Product code GEI·November 30, 2022

    Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 25, 2020