BEUDAMED
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    TAUT-INSUFFLATION NEEDLE

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    ROLLO 37X10X12E*31*PRINTER

    FDA UDI
    AB MEDICA GROUP, S.A.·08428763002666·

    Preat Implant Prosthetics

    FDA UDI
    Preat Corporation·00842092156841·Multi-Unit Abutment Digital Analog

    InstaFix Shape Memory Fixation System

    FDA UDI
    OT MEDICAL, LLC·B04140037030·

    Implant Prosthetics

    FDA UDI
    Preat Corporation·00842092134894·Multi-Unit Abutment Digital Analog (10-Pack)

    Implant Prosthetics

    FDA UDI
    Preat Corporation·00842092134900·Multi-Unit Abutment Digital Analog (25-Pack)

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00842528104187·InstaFix Implant Kit, 10x10mm

    Patella Drill Guide/Sizer, Klassic ONE

    FDA UDI
    TOTAL JOINT ORTHOPEDICS, INC.·00810094691813·Patella Drill Guide/Sizer, 3-4

    INSTAFIX 10X10MM STAPLE

    FDA Adverse Event
    Malfunction ·OSTEOMED, LLC·Product code JDR·October 1, 2021

    O-PERM 30

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    PERCLOSE VASCULAR SUTURE DELIVERY DEVICE

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

    INSTAFIX

    FDA Adverse Event
    Malfunction ·OSTEOMED·Product code JDR·July 10, 2019

    INSTAFIX 10X10MM STAPLE

    FDA Adverse Event
    Malfunction ·OSTEOMED, LLC·Product code GDW·October 1, 2021

    LIFEVEST WCD 3000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·February 12, 2013

    RESTORE ULTRA

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·February 24, 2011

    HAKIM PROGRAMMABLE VALVE

    FDA Adverse Event
    Injury ·CODMAN & SHURTLEFF, INC.·Product code JXG·August 12, 2014

    HEARTWARE VENTRICULAR ASSIST SYSTEM - SHOULDER PACK

    FDA Adverse Event
    Malfunction ·HEARTWARE, INC.·Product code DSQ·July 12, 2022

    2027754-2018-00022

    FDA Adverse Event
    Injury ·July 31, 2018

    Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of diagnostic materials such as contrast media. UltraFlow HPC Flow: The device is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuroanatomy. It is not intended for use in the coronary vasculature. Catalog No. 105-5055V02 105-5055V02 105-5055V05 105-5065V02 105-5065V05 105-5066V02 105-5066V05

    FDA Enforcement
    Class I ·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013