BEUDAMED
    15 results · 21ms · Sources: EU EUDAMED, US FDA

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    VITROS CHEMISTRY PRODUCTS THC REAGENT, CALIBRATOR KIT 30, FS CALIBRATOR 1, AND DAT PERFORMANCE VERIFIERS I, II, III, IV

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    SURSHIELD SAFETY WINGED BLOOD COLLECTION SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    TROCARS TROTEC WITH AUTOMATIC PROTECTIVE MECHANISM

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    ERBE

    FDA Adverse Event
    Malfunction ·LEONHARD LANG GMBH·Product code GEI·October 21, 2020

    ABRAMS MULTIDENSITY POLYURETHAN FOAM WOUND DRESSING SYSTEM

    FDA Adverse Event
    Other ·DR LEN'S MEDICAL PRODUCTS·Product code FRO·October 11, 2005

    KLS MARTIN

    FDA Adverse Event
    Malfunction ·LEONHARD LANG GMBH·Product code GEI·November 17, 2020

    AED PRO

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·March 27, 2013

    NEXGEN FEMORAL IMPACTOR/EXTRACTOR JAW

    FDA Adverse Event
    Malfunction ·ZIMMER, INC.·Product code MBH·March 22, 2011

    PUMP MMT-722NAP PRDGM INS V2.2 PL EN

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code LZG·June 20, 2008

    ERBE

    FDA Adverse Event
    Injury ·LEONHARD LANG GMBH·Product code GEI·October 23, 2024

    ERBE

    FDA Adverse Event
    Malfunction ·LEONHARD LANG GMBH·Product code GEI·September 20, 2024

    MOZAIK

    FDA Adverse Event
    Injury ·ISOTIS ORTHOBIOLOGICS INC.·Product code MQV·January 7, 2021

    Integra Mozaik Strip 10 cc Product Usage: The product is a bone graft substitute composed of collagen (Type 1) and ceramic (I3-Tricalcium phosphate) matrix in putty and strip forms. The product is intended for use as a bone void filler to fill voids or gaps of the skeletal system in the extremities, spine. and pelvis not intrinsic to the stability of the bony structure. Integra Mozaik is also indicated for use in the treatment of surgically treated osseous defects or osseous defects created from traumatic injury to the bone. Following placement in the bone void or a defect Integra Mozaik is reabsorbed and replaced with bone during the healing process.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·June 20, 2012

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P025; b) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P030; c) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P035; d) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P040; e) TTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P045; f) TTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P050; g) TTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P055

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015