BEUDAMED
    18 results · 18ms · Sources: EU EUDAMED, US FDA

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    R2 ESU CABLE-ADAPTER MODELS 160,161

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Elite Orthopaedics

    FDA UDI
    Elite Orthopaedics, Inc.·00816591013400·Adjustable Elbow Brace, Right

    Elite Orthopaedics

    FDA UDI
    Elite Orthopaedics, Inc.·00816591013394·Adjustable Elbow Brace, Left

    VIENNA RING CT/MR APPLICATOR SET, ROUND POINT TITANIUM NEEDLE SET, TROCAR POINT TITANIUM NEEDLE SET

    FDA 510(k)
    FDA Class 2 ·Radiology

    MDI SCL-70 TEST

    FDA 510(k)
    FDA Class 2 ·Immunology

    CONSERVE(R) PLUS HA CUP

    FDA Adverse Event
    Injury ·MICROPORT ORTHOPEDICS INC.·Product code KWA·May 8, 2014

    UNKNOWN DEPUY ASR FEMORAL HEAD

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KXA·October 23, 2012

    CENTRAL LINE

    FDA Adverse Event
    Injury ·ARROW·Product code DQY·August 10, 2010

    Arthrex Deltoid Ligament Reconstruction Implant System. Intended as a fixation post, a distribution bridge or for distributing suture tension over areas of ligament or tendon repair utilizing titanium buttons.

    FDA Recall
    Terminated ·Arthrex, Inc.·Product code HRS·January 11, 2016

    BioSync Anatomic Cotton Wedge, 20 x 6.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.

    FDA Recall
    Terminated ·Arthrex, Inc.·Product code PLF·April 22, 2016

    BioSync Anatomic Cotton Wedge, 16 x 6.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.

    FDA Recall
    Terminated ·Arthrex, Inc.·Product code PLF·April 22, 2016

    BioSync Anatomic Cotton Wedge, 16 x 5.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.

    FDA Recall
    Terminated ·Arthrex, Inc.·Product code PLF·April 22, 2016

    BioSync Anatomic Cotton Wedge, 20 x 4.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.

    FDA Recall
    Terminated ·Arthrex, Inc.·Product code PLF·April 22, 2016

    BioSync Anatomic Cotton Wedge, 16 x 4.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.

    FDA Recall
    Terminated ·Arthrex, Inc.·Product code PLF·April 22, 2016

    BioSync Anatomic Cotton Wedge, 20 x 5.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.

    FDA Recall
    Terminated ·Arthrex, Inc.·Product code PLF·April 22, 2016

    Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021

    ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022

    Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.

    FDA Enforcement
    Class I ·Terminated·Animas Corporation·April 10, 2013