BEUDAMED
    19 results · 27ms · Sources: EU EUDAMED, US FDA

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    APEX KNEE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    REMEL

    FDA UDI
    REMEL, INC.·00848838005862·Arylsulfatase Broth,3 Day (2ml) 20/PK

    SOLIDEA

    FDA UDI
    CALZIFICIO PINELLI SRL·08300496060192·MARILYN 70 SHEER OPEN TOE, SIZE M, MIELE, GRADU...

    Mini-Mono®

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR70601921·Mini-Mono-Brackets Roth 'N' .018" 200 Brackets

    Enteral Feeding

    FDA UDI
    Medela LLC·00020451100104·Bifurcated Enteral Extension Set, 60", Minibore...

    Enteral Feeding

    FDA UDI
    Medela LLC·00020451101156·Bifurcated Enteral Extension Set, 60", Minibore...

    E3 MICROPROB SERIES OF LASERS AND ACCESSORIES

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

    ENDOSCOPIC TUBE SHAFT INSTRUMENTS FOR MONOPLAR COAGULATION

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

    COMPR 12MM IM HMRL

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code MBF·April 1, 2019

    TOTAL ASR ACET IMP SIZE 60

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD - 8010379·Product code KWA·April 16, 2013

    LI-ION BATTERY, NON-STERILE

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code MOQ·September 4, 2014

    CONSERVE(R) PLUS CUP

    FDA Adverse Event
    Injury ·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code KWA·April 15, 2011

    ROD, FIXATION, INTRAMEDULLARY

    FDA Adverse Event
    Injury ·SYNTHES MONUMENT·Product code HSB·February 10, 2017

    DPM Central Station Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 The Central Monitoring Station (CMS) network transfers information between DOM Central Station and other network devices. It also allows information transfer between several CMS. Network connections consist of hardwired network cables and or WLAN connections. The DPM Central Station is used for remote monitor management, storing, printing, reviewing, or processing of information from net worked devices, and it is operated by medical personnel in hospitals or medical institutions.

    FDA Enforcement
    Class II ·Terminated·Mindray DS USA, Inc. d.b.a. Mindray North America·January 9, 2013

    Instructions For Use document of the GPS Trackers.

    FDA Enforcement
    Class II ·Terminated·Blue Ortho·November 4, 2020

    Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022