BEUDAMED
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    AVANT DIGITAL PULSE OXIMETRY SYSTEM, MODELS 4000, 4001

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code MQP·October 30, 2017

    PHOENIX HEMODIALYSIS DELIVERY SYSTEM, GAMBRO CARTRIDGE FOR HEMODIALYSIS BLOOD TUBING SET

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

    BCI 3403 SLEEP SCREENING PULSE OXIMETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    9616240-2006-00341

    FDA Adverse Event
    Malfunction ·Product code FII·June 14, 2006

    9616240-2006-00332

    FDA Adverse Event
    Other ·Product code FII·June 1, 2006

    PHOENIX

    FDA Adverse Event
    Malfunction ·GAMBRO DASCO·Product code FII·May 10, 2006

    9616240-2006-00339

    FDA Adverse Event
    Malfunction ·Product code FII·June 9, 2006

    9616240-2006-00340

    FDA Adverse Event
    Malfunction ·Product code FII·June 9, 2006

    9616240-2006-00350

    FDA Adverse Event
    Malfunction ·Product code FII·June 23, 2006

    9616240-2006-00345

    FDA Adverse Event
    Malfunction ·Product code FII·June 14, 2006

    VERTE-STACK SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·SOFAMOR DANEK DEGGENDORF GMBH·Product code MQP·January 21, 2010

    VERTE-STACK SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·SOFAMOR DANEK DEGGENDORF GMBH·Product code ODP·November 20, 2009

    PHOENIX

    FDA Adverse Event
    Malfunction ·GAMBRO DASCO·Product code FII·May 10, 2006

    PHOENIX

    FDA Adverse Event
    Malfunction ·GAMBRO DASCO·Product code FII·May 10, 2006

    VITALITY 2

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 8, 2013

    VITAL-PORT DETACHED SILICONE CATHETER TITANIUM INFUSION PORT

    FDA Adverse Event
    Injury ·COOK VASCULAR INC.·Product code DWF·March 29, 2011

    EEA XL 25MM SINGLE-USER STAPLER

    FDA Adverse Event
    Injury ·NORTH HAVEN - USS·Product code GDW·May 12, 2008

    LEGION PS OXIN FEM SZ5 LT

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·February 5, 2018

    cobas 8000 analyzer series Operators Manual Roche cobas Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014