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

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    Filters Regulation: Us FDA ×

    Introducer Sheath Kits

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Portex

    FDA UDI
    ICU MEDICAL, INC.·15019517110753·

    Prostiva RF Therapy Generator, Prostiva RF Therapy Hand Piece, Prostiva RF Therapy Return Electrode, Prostiva RF Therapy Tubing System, Prostiva RF Therapy Telescope

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    KRONUS, INC.'S ACETYLCHOLINE RECEPTOR ANTIBODY (ACHRAB) ASSAY KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    OT VERIO2 METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·August 17, 2017

    STRATAFIX UNKNOWN

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code NEW·December 20, 2019

    VICRYL POLYGLACTIN 910 MESH UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code FTL·December 20, 2019

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAM·December 20, 2019

    DERMABOND UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code MPN·December 20, 2019

    UNK

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·April 14, 2008

    ONE TOUCH ULTRA 2 METER

    FDA Adverse Event
    Injury ·LIFESCAN, INC.·Product code NBW·November 19, 2008

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 9, 2011

    TRIFUSE

    FDA Adverse Event
    Malfunction ·ICU MEDICAL, INC.·Product code FPA·July 17, 2013

    UNK MAMMARY IMPLANT

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

    LIGACLIP EXTRA TITANIUM CLIPS

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·December 18, 2019

    TRANSPAC¿ IV MONITORING KIT, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP, Item No. 011-42584-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·November 23, 2016

    Light Sheer Desire Diode Laser System with XC Handpiece Accessory options.

    FDA Enforcement
    Class II ·Terminated·Lumenis Limited·May 6, 2015

    Nussloch GmbH ASP6025 Tissue Processor

    FDA Enforcement
    Class II ·Ongoing·Leica Microsystems, Inc.·July 12, 2017

    dS Breast 7ch 1.5T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 4, 2024