BEUDAMED
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    Cytosponge Cell Collection Device

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    OIC Pedicle Screw System

    FDA UDI
    ORTHOPAEDIC IMPLANT COMPANY, THE·M69631810200·STRAIGHT PROBE

    DD tempMED

    FDA UDI
    Dental Direkt GmbH·EDDIK110201·DD tempMED are pre-colored dental milling blank...

    AIM™SUPRACONDYLAR NAIL

    FDA UDI
    Biomet Orthopedics, LLC·00887868005275·

    PRINCETON

    FDA UDI
    Princeton Medical Group, Inc.·00810158213623·DILATOR DEBAKEY / GARRETT VASCULAR MALLEABLE 2M...

    OIC Pedicle Screw System

    FDA UDI
    ORTHOPAEDIC IMPLANT COMPANY, THE·M6963181020S0·LENKE PROBE STRAIGHT

    BOSS Instruments

    FDA UDI
    BOSS INSTRUMENTS, LTD., INC.·00888515024199·Volkman Ret, 2 prngs blunt 8"

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B16720031810200·

    Sochi

    FDA UDI
    Altus Spine, LLC·00843210173559·Pre-Curved Rod, 3.5mm x 20mm

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197456531·Burford Rib Spreader, Child, complete 108mm,...

    ENDOSKELETON® TA

    FDA UDI
    TITAN SPINE, LLC·00191375051282·Perforated, Tray, Base

    ATRICURE DISSECTOR

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    VIPER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Free-Lock®

    FDA UDI
    Zimmer, Inc.·00889024035409·

    8800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 7, 2011

    DEPUY ASR XL FEM IMP SIZE 47

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. - 8010379·Product code KXA·June 20, 2013

    TRUPATH BIOPSY DEVICE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FCG·September 23, 2008

    MOZEC¿ NC RX PTCA BALLOON DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·MERIL LIFE SCIENCES PRIVATE LIMITED·Product code LOX·April 28, 2023

    MOZECTM NC RX PTCA BALLOON DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·MERIL LIFE SCIENCES PRIVATE LIMITED·Product code LOX·October 21, 2023

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Product Usage: Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) are indicated for patients with moderate to severe heart failure who remain symptomatic despite stable, optimal heart failure drug therapy and have left ventricular dysfunction and QRS duration > or equal to 120 ms. This family of pulse generators provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Cardiac Resynchronization Therapy (CRT), which treats heart failure by resynchronizing ventricular contractions through biventricular electrical stimulation; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014