BEUDAMED
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    COOK GASTRIC SIZING BALLOON CATHETER

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ANATOMIC PEEK PTC Cervical Fusion System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00643169357495·CAGE 5030841 ANATOMIC PTC 14X11X8MM

    Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)

    FDA UDI
    TENON MEDICAL, INC.·B74240308410·7.5mm Drill

    ACON COC ONE STEP COCAINE TEST STRIP, ACON COC ONE STEP COCAINE TEST DEVICE

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    AVON PATELLAR COMPONENT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    FDA Adverse Event
    Death ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code MAF·October 15, 2010

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR·Product code MGB·June 6, 2022

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Death ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code NIQ·October 7, 2010

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code NIQ·October 10, 2012

    TERUMO ADVANCED PERFUSION SYSTEM 1

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEM CORP·Product code DTQ·March 28, 2013

    TERUMO CDI 540 CALIBRATOR

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP·Product code DRY·March 4, 2011

    ECHELON 14 MICRO CATHETER

    FDA Adverse Event
    Injury ·EV3 NEUROVASCULAR·Product code KRA·April 17, 2008

    1030489-2016-01433

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·May 16, 2016

    StarClose SE Vascular Closure System, Part No. 14679-01, 14679-02. The UDI is 08717648079467. The GMDN is 47411.

    FDA Enforcement
    Class II ·Terminated·Abbott Vascular·February 22, 2017

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012