BEUDAMED
    15 results · 28ms · Sources: EU EUDAMED, US FDA

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    DEPUY PFC SIGMA KNEE PROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526827936·ACHIMED ACHILLES SUPP BLACK V

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526827875·***DISC*LEVAMED ANKLE SUPPORT BLACK V

    Symmetry Surgical

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00887482048771·Symmetry® Forceps, Tissue, 1x2 Teeth, 6 in

    MODIFICATION TO SYNERGY SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PRO OSTEON 200R RESORBABLE BONE GRAFT SUBSTITUTE, MODELS 2RG051, 2RG101, 2RG151, 2RG201, 2RG301, 2RG050, 2RG100, 2RG150,

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SATELLITE SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH·Product code NVR·May 5, 2011

    XMAX MOTOR

    FDA Adverse Event
    Malfunction ·THE ANSPACH EFFORT, INC.·Product code ERL·April 10, 2013

    RHEUMATOID FACTOR REAGENT

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code DHR·April 18, 2011

    S4 PRE-BENT ROD 5.5X40MM

    FDA Adverse Event
    Malfunction ·AESCULAP AG & CO. KG·Product code KWP·June 11, 2008

    UNKNOWN BEARING

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JWH·March 10, 2017

    COSYCOT INFANT WARMER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code FMT·November 25, 2010

    Aurora Series, Aurora 7 lighthead; Models: LED7 (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

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    Cocoon Convective Warming System, Product Code: CWS4000 (110V).

    FDA Enforcement
    Class II ·Terminated·Care Essentials Pty., Ltd.·February 12, 2020