BEUDAMED
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    Hitachi Echelon MRI System/Oasis MRI, Software. These are software controlled MRI devices. Product Usage: The Echelon and Oasis MR systems are imaging devices, intended to provide the physician with physiological and clinical information that can be useful in diagnosis determination.

    FDA Enforcement
    Class II ·Terminated·Hitachi Medical Systems America Inc·August 29, 2012

    Sapi Med sterile disposable colorectal anoscopes and proctoscopes. REF/Product Description: A.4083/THE BEAK - Surgical proctoscope. Disposable & sterile. Transparent. Self light; A.4519/MPR Short - Multi Purpose Rectoscope. 190mm long. Sterile & Disposable; A.4086/EPOFLIER - Surgical kit made of a 34,3mm wide anoscope and an opened retractor named GULL. Disposable & sterile; A.4084/THE BEAK Diagnostic- Disposable proctoscope. Transparent. Sterile & Self lighting; A.4522/ MPR - Multi Purpose Rectoscope. 220mm long. Sterile & Disposable

    FDA Enforcement
    Class II ·Terminated·Adler MicroMed, Inc.·June 30, 2021

    Infant Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow. Product ID # 5801, 12-8713, 732-E, and 2206. Packaged under the name of Dynarex, Evergreen, Mada and Hospitak. Recalled codes may be identified by examining the patient valve housing immediately below the right-angle exhalation port, where the retention ring should be visible. MPR units with a clear or transparent ring, as well as those where no ring can be seen, should be returned. MPR units with a blue retention ring are not affected and do not need to be returned.

    FDA Recall
    Terminated ·Unomedical·Product code BTM·October 6, 2009

    Philips Healthcare Informatics iSite PACS (Picture Archiving and Communications System), version 3.5.x The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital imaging, measurement, communication and storage.

    FDA Recall
    Terminated ·Philips Healthcare Informatics, Inc.·Product code LLZ·July 3, 2008

    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/14, Stem size 001, prox. Stem dia. 14 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg

    FDA Enforcement
    Class II ·Terminated·Waldemar Link GmbH & Co. KG (Corp. Hq.)·September 4, 2013

    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/20, Stem size 004, prox. Stem dia. 20 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg

    FDA Enforcement
    Class II ·Terminated·Waldemar Link GmbH & Co. KG (Corp. Hq.)·September 4, 2013

    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/22, Stem size 005, prox. Stem dia. 22.5 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg

    FDA Enforcement
    Class II ·Terminated·Waldemar Link GmbH & Co. KG (Corp. Hq.)·September 4, 2013

    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/18, Stem size 003, prox. Stem dia. 18 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg

    FDA Enforcement
    Class II ·Terminated·Waldemar Link GmbH & Co. KG (Corp. Hq.)·September 4, 2013

    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/25, Stem size 006, prox. Stem dia. 25 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg

    FDA Enforcement
    Class II ·Terminated·Waldemar Link GmbH & Co. KG (Corp. Hq.)·September 4, 2013

    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/12, Stem size 00, prox. Stem dia. 12 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg

    FDA Enforcement
    Class II ·Terminated·Waldemar Link GmbH & Co. KG (Corp. Hq.)·September 4, 2013

    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/12, Stem size S-0, prox. Stem dia. 12 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg

    FDA Enforcement
    Class II ·Terminated·Waldemar Link GmbH & Co. KG (Corp. Hq.)·September 4, 2013

    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/25, Stem size 06, prox. Stem dia. 25 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg

    FDA Enforcement
    Class II ·Terminated·Waldemar Link GmbH & Co. KG (Corp. Hq.)·September 4, 2013

    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/14, Stem size S-1, prox. Stem dia. 14 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg

    FDA Enforcement
    Class II ·Terminated·Waldemar Link GmbH & Co. KG (Corp. Hq.)·September 4, 2013

    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/16, Stem size 002, prox. Stem dia. 16 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg

    FDA Enforcement
    Class II ·Terminated·Waldemar Link GmbH & Co. KG (Corp. Hq.)·September 4, 2013

    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/16, Stem size 02, prox. Stem dia. 16 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg

    FDA Enforcement
    Class II ·Terminated·Waldemar Link GmbH & Co. KG (Corp. Hq.)·September 4, 2013

    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/14, Stem size 01, prox. Stem dia. 14 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg

    FDA Enforcement
    Class II ·Terminated·Waldemar Link GmbH & Co. KG (Corp. Hq.)·September 4, 2013

    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/16, Stem size S-2, prox. Stem dia. 16 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg

    FDA Enforcement
    Class II ·Terminated·Waldemar Link GmbH & Co. KG (Corp. Hq.)·September 4, 2013

    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/20, Stem size S-4, prox. Stem dia. 20 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg

    FDA Enforcement
    Class II ·Terminated·Waldemar Link GmbH & Co. KG (Corp. Hq.)·September 4, 2013

    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/22, Stem size 05, prox. Stem dia. 22.5 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg

    FDA Enforcement
    Class II ·Terminated·Waldemar Link GmbH & Co. KG (Corp. Hq.)·September 4, 2013

    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/20, Stem size 04, prox. Stem dia. 20 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg

    FDA Enforcement
    Class II ·Terminated·Waldemar Link GmbH & Co. KG (Corp. Hq.)·September 4, 2013