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

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    Circular Fixation with Balanced Cable Transport

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112557·BARRON VACUUM TREPHINE 9.0MM

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112977·CORNEAL TREPHINE BLADE9.0MM

    JOWIRE NEO'S PTCA CATHETER GUIDEWIRES, MODELS AG141000, AG142000, AG143000, AG141002, AG141010, AG14M060 & AG14M050

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ORTHOSTAT BONE HEMOSTAT MATRIX APPLICATOR

    FDA 510(k)
    FDA Unclassified ·Unknown

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM, DEXCOM SHARE SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·February 11, 2016

    DEXCOM G4 PLATINUM CONTINUOUS MONITORING SYSTEM DEXCOM SHARE SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·October 5, 2015

    OT VERIO TEST STRIPS

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 7, 2012

    FOUNDATION KNEE SYSTEM

    FDA Adverse Event
    Other ·ENCORE MEDICAL, L.P.·Product code JWH·October 13, 2008

    IPUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011

    PROLENE POLYPROPYLENE MESH

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code FTL·July 2, 2013

    Barron Radial Vacuum Trephine (1) Complete Trephine Set 9.0mm Dia. Ref. K20-2062 Lot 122336 Opthalmic

    FDA Enforcement
    Class II ·Terminated·Surgical Instrument Service And Savings, Inc.·July 10, 2013

    ASAHI PROWATER

    FDA Adverse Event
    Injury ·ASAHI INTECC CO., LTD.·Product code DQX·June 9, 2019

    ASAHI PROWATER

    FDA Adverse Event
    Injury ·ASAHI INTECC CO., LTD.·Product code DQX·June 9, 2019

    Barron Radial Vacuum Trephine (1) Complete Trephine Set 9.0mm Dia. Ref. K20-2062 Lot 122336 Opthalmic

    FDA Recall
    Terminated ·Surgical Instrument Service And Savings, Inc.·Product code HRH·May 3, 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