BEUDAMED
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    1.5T PROCURE ARRAY COIL, 3.0T PROCURE ARRAY COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    Humelock II Cemented Reversible Shoulder

    FDA UDI
    FX SOLUTIONS·03701037302910·HUMERAL CUP 135/145° MOBILITY PE/TA6V Ø40 +6

    LOCATOR R-Tx

    FDA UDI
    Zest Anchors, LLC·00840481120961·LOCATOR R-Tx Abutment For UF(II) Regular/Wide I...

    ZAVATION F3D-Z CIF

    FDA UDI
    Zavation LLC·00197157020927·F3D-Z CIF 16mmx18mmx6mm - 6deg

    Humelock II Cemented Reversible Shoulder

    FDA UDI
    FX SOLUTIONS·03701037308257·TRIAL HUMERAL CUP 135/145° MOBILITY Ø40 +6

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319740835·Foerster Sponge (Ring) Forceps 7" (17.5cm), smo...

    MV INTRADERMIC NEEDLES; MAGIC NEEDLE; MAGIC NEEDLE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    VATEA ENDONTIC IRRIGATION SYSTEM

    FDA 510(k)
    FDA Class 1 ·Dental

    BATT F/PD

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code MOQ·May 31, 2013

    HEART START XL

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE·Product code MKJ·June 16, 2011

    COAGUCHEK XS SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·August 28, 2008

    ARCHITECT C8000 SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING INC·Product code JGS·October 27, 2014

    NEOPUFF INFANT RESUSCITATOR

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTL·October 13, 2016

    PKG, 5MM INSERT, RETENTION GRASPER, 33CM, P/N 0250080697 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    D7120, BG-OX Cartridge, D7120 REF 946-003, and 946-001, cuvettes for the NPT7 series of blood gas analyzers.

    FDA Recall
    Terminated ·Radiometer America Inc·Product code CHL·January 12, 2005

    CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000.

    FDA Enforcement
    Class II ·Terminated·Cardiovascular Systems Inc·May 31, 2017