BEUDAMED
    20 results · 22ms · Sources: EU EUDAMED, US FDA

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    BISCEM TRANSLUCENT, BISCEM OPAQUE

    FDA 510(k)
    FDA Class 2 ·Dental

    MATIRA ANTERIOR CERVICAL SYSTEM

    FDA UDI
    Kalitec Direct LLC·B07307K0600010·Tray Insert, Level 1

    Ocata Anterior Cervical System

    FDA UDI
    Kalitec Direct LLC·B07308K0600010·Tray Insert 1, Ocata

    Durable BP Cuff

    FDA UDI
    SUNTECH MEDICAL, INC.·10840935107958·

    NA

    FDA UDI
    Summit Medical, Inc.·00385640001441·

    HUMAN IGG SUBCLASS KIT USE WITH THE BECKMAN IMAGE ANALYZER

    FDA 510(k)
    FDA Class 2 ·Immunology

    MEDTRONIC SOFAMOR DANEK BIPHASIC CALCIUM PHOSPHATE (BCP) BONE VOID FILLER

    FDA 510(k)
    FDA Class 2 ·Dental

    TRIAGE TOX DRUG SCREEN PANEL

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code DIO·March 27, 2017

    BA KIT,WE,P37,INL,1',BE,S37,INL,6'

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828188852·BA KIT,WE,P37,INL,1',BE,S37,INL,6'

    TRIAGE TOX DRUG SCREEN PANEL

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code DIO·May 23, 2017

    TRIAGE TOX DRUG SCREEN PANEL

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code DIO·May 8, 2017

    TRIAGE TOX DRUG SCREEN PANEL

    FDA Adverse Event
    Malfunction ·QUIDEL CARDIOVASCULAR INC.·Product code DIO·October 4, 2019

    MEDICAL COMPRESSOR

    FDA Adverse Event
    Malfunction ·EKOM SPOL. S.R.O.·Product code BTI·April 5, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 4, 2014

    SYNCHROMED II

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·June 13, 2008

    SIG MOD TIB TRAY CEM COCR 3

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JWH·April 6, 2011

    PERSONA PROVISIONAL STEMMED TIBIAL COMPONENT SIZE 6

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code HWT·November 2, 2018

    Titanium Tack Starter Kit, REF 400-270, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental.

    FDA Enforcement
    Class II ·Terminated·BioHorizons Implant Systems Inc·December 26, 2012

    CardioMD III (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015

    STERRAD 100NX Sterilization System, P/N 10104 Product Usage: The STERRAD 100NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100NX process to inactivate microorganisms on a board range of medical devices and surgical instruments.

    FDA Enforcement
    Class II ·Terminated·Advanced Sterilization Products·April 10, 2013