BEUDAMED
    54 results · 26ms · Sources: EU EUDAMED, US FDA

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    REPROCESSED ELECTROPHYSIOLOGY CATHETERS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0120230·Screwdriver, Extended Tab, Fixed Tap Sleeve, As...

    ANCHOR GUIDE LESION LOCALIZATION DEVICE; ANCOR GUIDE HOLDER; RF GENERATOR CABLE

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

    MEDMIRA RAPID H. PYLORI ANTIBODY TEST, MODEL 10714

    FDA 510(k)
    FDA Class 1 ·Microbiology

    STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code MHY·February 16, 2024

    UNK MAMMARY IMPLANT

    FDA Adverse Event
    Injury ·ALLERGAN (COSTA RICA)·Product code FWM·August 2, 2023

    OT VERIO IQ METER

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

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORP.·Product code LZG·April 26, 2011

    M SERIES

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

    UNK MAMMARY IMPLANT

    FDA Adverse Event
    Injury ·ALLERGAN (COSTA RICA)·Product code FWM·March 1, 2024

    HAMILTON MEDICAL AG

    FDA Adverse Event
    Malfunction ·HAMILTON MEDICAL AG·Product code CBK·December 21, 2023

    DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK234SU. For use in laparoscopic procedures.

    FDA Enforcement
    Class II ·Ongoing·Aesculap Inc·March 13, 2024

    DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK236SU. For use in laparoscopic procedures.

    FDA Enforcement
    Class II ·Ongoing·Aesculap Inc·March 13, 2024

    PCRopsis Reagent Buccal, IVD, REF 282001; Extraction-free PCR from bucca; swabs (no transport medium) ,nucleic acid extraction from a variety of biological samples

    FDA Enforcement
    Class II ·Ongoing·Entopsis , Inc.·April 5, 2023

    DISP.TROCAR W. DILATING PIN 10/110MM, Product Code EK224SU. For use in laparoscopic procedures.

    FDA Enforcement
    Class II ·Ongoing·Aesculap Inc·March 13, 2024

    Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic

    FDA Enforcement
    Class I ·Terminated·Abbott Molecular, Inc.·October 20, 2021

    Leica MICROSYSTEMS Proveo 8, Part Number 10449058, surgical microscope system

    FDA Enforcement
    Class II ·Ongoing·Leica Microsystems, Inc.·December 21, 2022

    Leica MICROSYSTEMS Provido, Part Numbers 10448950 (Premium), 10448976 (Standard). Surgical microscope system

    FDA Enforcement
    Class II ·Ongoing·Leica Microsystems, Inc.·December 21, 2022

    Alinity m Resp-4-Plex AMP Kit (Non-US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic

    FDA Enforcement
    Class I ·Terminated·Abbott Molecular, Inc.·October 20, 2021

    Mallinckrodt One-Way Valve, 22F x 22M, a) Part #91346 (1 piece) and b) Part #50412 (pack of 5) Used with ventilators.

    FDA Recall
    Open, Classified ·Mallinckrodt Manufacturing LLC·Product code BZO·August 8, 2023