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

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    FREEDOM TOTAL KNEE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DYNASTY(R) COCR LINER

    FDA Adverse Event
    Injury ·MICROPORT ORTHOPEDICS INC.·Product code JDL·February 7, 2019

    CONSERVE(R) TOTAL A-CLASS HEAD

    FDA Adverse Event
    Injury ·MICROPORT ORTHOPEDICS INC.·Product code JDL·February 7, 2019

    COLOR BUFFED (CB) DDH FEMORAL STEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RETROGRADE CARDIOPLEGIA CANNULA, SELF-INFLATING, WITH MALLEABLE OR GUIDEWIRE STYLET

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PASS LP

    FDA Adverse Event
    MEDICREA TECHNOLOGIES·Product code MNI·April 17, 2013

    PASS LP

    FDA Adverse Event
    Injury ·MEDICREA INTERNATIONAL·Product code MNI·April 5, 2012

    PASS LP

    FDA Adverse Event
    Injury ·MEDICREA TECHNOLOGIES·Product code MNI·April 17, 2013

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 29, 2013

    HEARTSTART MRX-EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE·Product code MKJ·April 26, 2011

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·July 21, 2008

    HOSP SS FLEXX METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·February 22, 2011

    HOSP SS FLEXX METER W/O LASER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·May 17, 2011

    HOSP SS FLEXX METER

    FDA Adverse Event
    Death ·LIFESCAN INC.·Product code NBW·April 1, 2011

    TL-HEX TruLok Hexapod System, Double Row Footplates, TL-HEX Sterile, All Sizes: 120 MM, 140 MM, 160 MM, 180 MM, 200 MM. The TL-HEX TrueLock Hexapod System (TL-HEX) consists of rings, foot plates and struts to be used in conjunction with the TruLok external fixation system. The system is a metal bone fixation device for stabilization and correction during the normal healing process. The purpose of the TL-HEX System is to provide a solution for deformity correction and keeping the bone segments aligned during the healing process. The device may only be applied by a physician, who is fully responsible for the surgical and post-operative procedures of the system and is able to manage possible mechanical and software limitations. Indications for use for adults and all pediatric subgroups except newborns include: post-traumatic joint contracture which has resulted in loss of range of motion, fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction, open and closed fracture fixation, pseudoarthrosis of long bones, limb lengthening by epiphyseal or metaphyseal distraction, correction of bony or soft tissue deformities, correction of bony of soft tissue defects, joint arthrodesis, infected fractures or non unions.

    FDA Enforcement
    Class II ·Terminated·Orthofix Srl·June 13, 2018

    Thio Med w/Dex, Hem, Vit K (5ml) 100/PK Product Usage; Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes

    FDA Enforcement
    Class II ·Terminated·Remel Inc·May 29, 2019

    Thio Med w/o Ind, w/Dex (9ml) 100/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes

    FDA Enforcement
    Class II ·Terminated·Remel Inc·May 29, 2019

    Medline E-Z Lubricating Jelly; Bacteriostatic. Water Soluble. Sterile. 2 FL OZ (59 ml). Product Usage: For medical purposes to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices. Single use only. Sterile if unopened, undamaged package.

    FDA Enforcement
    Class II ·Terminated·MEDLINE IND·January 18, 2017

    Thio Med w/o Ind, w/Dex (18ml) 20/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes

    FDA Enforcement
    Class II ·Terminated·Remel Inc·May 29, 2019

    Thio Med w/o Ind, w/Dex (10ml) 100/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes

    FDA Enforcement
    Class II ·Terminated·Remel Inc·May 29, 2019