BEUDAMED
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    ORCHESTRA HYDROPHILIC GUIDEWIRE STANDARD ANGLED, ORCHESTRA HYDROPHILIC GUIDEWIRE STRAIGHT STIFF, ORCHESTRA HYDROPHILIC

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111092374·OP SCISS 7 1/4" STR S/S

    Fine osteotomy Locking HA 4.5 Cortical Bone Screw - L72mm

    FDA UDI
    Laboratoires Bodycad Inc·00688346002928·Button Head Locking HA 4.5 Cortical Self Tappin...

    DISPOSABLE POWDER FREE VINYL EXAM GLOVES WITH VITAMIN E

    FDA 510(k)
    FDA Class 1 ·General Hospital

    TRITANIUM PERI-APATITIE ACETABULAR SOLID-BACKED SHELL, TRITANIUM PERI-APATITE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    O-ARM O2 IMAGING SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC. (LITTLETON)·Product code OWB·June 30, 2016

    CANTATA 2.9 SUPERSELECTIVE MICROCATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRA·September 14, 2017

    INTELLIVUE MX500 PATIENT MONITOR

    FDA Adverse Event
    Death ·PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH·Product code MHX·December 4, 2023

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 1, 2014

    MEDICHOICE

    FDA Adverse Event
    Injury ·DALIAN GOODWOOD MEDICAL CARE LTD.·Product code KXF·May 23, 2013

    RF CONTACTR

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code LPB·June 16, 2011

    K-Wire 1.4mm x 12in Non-Threaded, Part Number 9080-12U; K-Wire Threaded 1.4mm x 18, Part Number 9080-18T; K-Wire Non-Threaded 1.4mm x 18, Part Number 9080-18U; 1.4mm x 24 Threaded Guide Wire, Part Number 9080-24T; K-Wire Non-Threaded 24, Part Number 9080-24U; Blunt K-Wire, 18 inches, Threaded, Part Number 9080B-18T; Blunt K-Wire, 18 inches, Unthreaded, Part Number 9080B-18U; Blunt K-Wire, 24 inches, Unthreaded, Part Number 9080B-24U; 1.4mm x 18 Blunt Threaded Nitinol Guide Wire, Part Number 9080B-N-18T; 1.4mm x 18" Blunt Non-Threaded Nitinol Guide Wire, Part Number 9080B-N-18U; Lodestar K-wire Non-Threaded, 18, Part Number 9080L-18U; 1.4mm x 18 Threaded Nitinol Guide Wire, Part Number 9080-N-18T; 1.4mm x 18 Non-Threaded Nitinol Guide Wire, Part Number 9080-N-18U The guide wire is passed through the cannulated handle of the Dual Stylet Needles and pressed into the bone

    FDA Enforcement
    Class II ·Terminated·Amendia, Inc·December 28, 2016

    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015