BEUDAMED
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    PRECINORM PROTEINS IN URINE/CSF PRECIPATH PROTEINS IN URINE/CSR CONTROLS

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    TAPERLOC POR LAT FMRL 12.5X145

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·January 21, 2019

    M2A-38 CUP NON FLARED SZ 62MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·January 21, 2019

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319700556·McGlamry Metatarsal Elevator 6-3/8" (16cm), bla...

    Mariner Outrigger

    FDA UDI
    Seaspine Orthopedics Corporation·10889981175504·Z-Rod, Dia. 5.5mm, Co-Cr, 280mm

    Medline

    FDA UDI
    MEDLINE INDUSTRIES, INC.·10884389027981·FENESTRATED DRAPE W/TAPE, 18 X 26

    PULMOLAB EX671 EXERCISE TESTING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    AESCULAP ABSORBABLE CRANIOFIX

    FDA 510(k)
    FDA Class 2 ·Neurology

    LAMITRODE TRIPOLE 16

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·April 3, 2013

    4 FR SINGLE LUMEN GROSHONG NXT CLEARVUE BASIC KIT WITH MICRO

    FDA Adverse Event
    Malfunction ·C. R. BARD INC. (BASD)·Product code LJS·February 15, 2011

    16" STG 2 PIWS

    FDA Adverse Event
    Injury ·STERIS CORPORATION·Product code FLE·May 8, 2008

    COMP RVS TRAY CO 44MM

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code KWS·March 16, 2018

    SPINAL ANESTHESIA KIT

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL INC.·Product code BSP·November 6, 2018

    M2A-38 CUP NON FLARED SZ 56MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·June 29, 2018

    Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024

    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. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013