BEUDAMED
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    SYNGO MR B19 FOR MAGNETOM AVANTO, SYNGO MR B19 FOR MAGNETOM ESPREE, SYNGO MR B19 FOR MAGNETOM SYMPHONY A TIM SYSTEM, SYN

    FDA 510(k)
    FDA Class 2 ·Radiology

    THE PL-1064 LASER SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MODIFICATION TO INSPECTRA TISSUE SPECTROMETER SYSTEM, MODEL 325

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    U-BLADE SET, TI GAMMA3 10.5X90MM

    FDA Adverse Event
    Injury ·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·November 30, 2012

    PASS LP

    FDA Adverse Event
    Injury ·MEDICREA INTERNATIONAL·Product code MNI·July 12, 2013

    PASS LP

    FDA Adverse Event
    Injury ·MEDICREA INTERNATIONAL·Product code MNI·July 12, 2013

    PASS LP

    FDA Adverse Event
    Injury ·MEDICREA INTERNATIONAL·Product code MNI·July 12, 2013

    ARTICULEZE M HEAD 36MM +1.5

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·May 22, 2013

    PDS II (POLYDIOXANONE) SUTURE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code GAN·June 14, 2011

    SOFTCLIX LANCET DEVICE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·August 15, 2008

    PASS LP

    FDA Adverse Event
    Injury ·MEDICREA INTERNATIONAL·Product code MNI·July 12, 2013

    PASS LP - LIAPASS

    FDA Adverse Event
    Injury ·MEDICREA TECHNOLOGIES·Product code MNI·March 29, 2013

    Berchtold Chromophare F628 Surgical Lights. Product Usage: The medical lights are for usage in hospital treatment rooms. They provide localized lighting focused on the patient s body for detecting and treating disease, injury, and disability. The surgical lights may only be used in rooms used for medical purposes that have been equipped in accordance with VDE 0100-710 or IEC 60364-7-10 in accordance with the regulations.

    FDA Enforcement
    Class II ·Ongoing·Stryker Communications·September 18, 2019

    NEEDLE SPINAL S/SU 22GA 5IN QUINCKE

    FDA Adverse Event
    Malfunction ·BD CARIBE LTD.·Product code BSP·June 21, 2019

    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