BEUDAMED
    17 results · 21ms · Sources: EU EUDAMED, US FDA

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    EVOS Large Fragment Plating System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Tibial Spacer

    FDA UDI
    ADLER ORTHO SPA·08052693620883·LB H 18 mm TIBIAL SPACER

    Blade Handle

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112366·CHUCK HANDLE #3K 10CM LONG

    Conventional Lead Apron .5mm Large 24 X 42

    FDA UDI
    Flow X Ray Corporation·00843696123420·Conventional Lead Apron .5mm Large 24 X 42, Bur...

    Disposable Blade

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113196·BARD-PARKER BLADE #11 PACK OF 50

    KSEA PERCUTANEOUS FORAMINOSCOPY SET

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CLARREN HELMET (ORTHOMERICA)

    FDA 510(k)
    FDA Class 2 ·Neurology

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES·Product code MIH·April 14, 2014

    G4 PLATINUM PEDIATRIC CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·December 10, 2015

    HANDPIECE MICS

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL CORP.·Product code OLO·January 25, 2018

    VIRTUOSO DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code LWS·August 11, 2011

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·October 27, 2014

    COMP RVRS SHLDR GLNSP STD 36MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWS·July 2, 2013

    BlockAid Cut Resistant Surgical Glove Liners, combine stainless steel and synthetic fibers woven together to form a cut resistant glove material. Blockaid Cut Resistant Surgical Glove Liners are to be worn between two layers of surgical gloves. Item Number: 650126, 650127, 650128, 650129, 650130, 650131

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·February 21, 2018

    ARGENT SURGICAL SYSTEMS***BIOPSY Punches*** Disposable manual instrument for skin biopsy.

    FDA Enforcement
    Class II ·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021