BEUDAMED
    22 results · 31ms · Sources: EU EUDAMED, US FDA

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    SFI BAR ABUTMENTS

    FDA 510(k)
    FDA Class 2 ·Dental

    ArgenZ ST 98x20 ML B1B

    FDA UDI
    ARGEN CORPORATION, THE·D818130183·Dental porcelain/ceramic restoration kit

    MUELLER PERFORM PLUS TAPE

    FDA UDI
    Mueller Sports Medicine, Inc.·20074676131836·2" X 15YD PERFORM PLUS TAPE (24 ROLLS)

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00842528125731·1.6MM PRE-BENT 13 HOLE PLT 5MM STP RT

    Tecno

    FDA UDI
    TECNO INSTRUMENTS (PVT) LTD·08964003293413·Dressing Forceps Fully Coated (25 cm)

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197540186·Caspar Rongeur straigth 3x12mm 180mm

    TRILLIANT SURGICAL SUBTALAR IMPLANT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MODEL MC-180MA MULTI-FREQUENCY BODY COMPOSITION ANALYZER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OZO·November 18, 2019

    POWERPACK

    FDA Adverse Event
    Malfunction ·ICC-NEXERGY·Product code IYN·September 3, 2013

    ULTRACLEAN HANDCONTROLLED SUCTION COAGULATOR, MODEL 130182, 130183, 130184, 130185; ULTRACLEAN FOOTCONTROLLED SUCTION

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

    PYXIS ANESTHESIA SYSTEM (PAS)

    FDA Adverse Event
    Malfunction ·CAREFUSION·Product code BRY·May 9, 2011

    HEARTMATE II SYSTEM CONTROLLER

    FDA Adverse Event
    Malfunction ·THORATEC CORP.·Product code DSQ·May 22, 2013

    LIGAMAX-5MM ENDO CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code FZP·August 20, 2008

    MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS

    FDA Adverse Event
    Malfunction ·MENTOR TEXAS·Product code LCJ·October 20, 2020

    MENTOR CPX 4 BREAST TISSUE EXPANDER

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code LCJ·May 24, 2022

    MENTOR CPX 4 BREAST TISSUE EXPANDER

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code LCJ·June 27, 2024

    MENTOR CPX 4 BREAST TISSUE EXPANDER

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code LCJ·December 9, 2022

    Azurion 3 M12; System Code: (1)722063, (2)722221, (3)722229;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.

    FDA Enforcement
    Class II ·Terminated·Ecolab Inc·September 30, 2015