BEUDAMED
    19 results · 26ms · Sources: EU EUDAMED, US FDA

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    BEGO Semados® RS/RSX Implant System

    FDA 510(k)
    FDA Class 2 ·Dental

    Dornier MedTech

    FDA UDI
    Dornier MedTech GmbH·04049958004032·Medilas H35 Holmium Laser with wireless footswitch

    MIRABAY

    FDA UDI
    Mirabay Orthodontics Corp.·05061075029827·PURPLE R ULTRA MINI TIE PK1000

    JOBST Elvarex

    FDA UDI
    BSN-Jobst GmbH·04019702452235·Elvarex 2/Thigh High/Slant, Open Toe, E-Version...

    iTotal Identity CR

    FDA UDI
    Conformis, Inc.·M572RCR0201700141·ITOTAL IDENTITY CR TIBIAL INSERT, NO TRIAL, IPO...

    iTotal Identity Posterior Stabilized Knee Replacement System

    FDA UDI
    Conformis, Inc.·M572RPS0201700031·ITOTAL IDENTITY PS TIBIAL INSERT + TRIAL, IPOLY...

    iTotal Identity CR

    FDA UDI
    Conformis, Inc.·M572RCR0201700041·ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY...

    iTotal PS

    FDA UDI
    Conformis, Inc.·M572RPS0201700121·ITOTAL PS IPOLY XE - 17MM INSERT - LEFT or righ...

    XPLAN 2.1

    FDA 510(k)
    FDA Class 2 ·Radiology

    ANIMUS EZSERTER INFUSION SET INSERTER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Inogen Rove 6

    FDA UDI
    Inogen, Inc.·00817131020513·2.1. The Inogen Rove 6™ Portable Oxygen Concent...

    RAD-G

    FDA Adverse Event
    Malfunction ·MASIMO - 15750 ALTON PKWY·Product code DQA·October 17, 2024

    POUNCE VENOUS THROMBECTOMY SYSTEM

    FDA Adverse Event
    Injury ·SURMODICS INC·Product code QEW·May 16, 2024

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·October 6, 2011

    MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT

    FDA Adverse Event
    C.T.M. SHANGHAI·Product code INI·October 27, 2014

    ENRHYTHM DR

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

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    FDA Adverse Event
    Injury ·STAAR SURGICAL CO.·Product code HQL·June 28, 2013

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022

    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