BEUDAMED
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    FINAL VARNISH LC

    FDA 510(k)
    FDA Class 2 ·Dental

    Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)

    FDA UDI
    TENON MEDICAL, INC.·B74240308440·Drill Probe

    Kalitec Universal Instruments

    FDA UDI
    Kalitec Direct LLC·B073K0380440·Egg Handle, 1.75" Ratcheting, Quarter Square, C...

    ABSOLUTE HCG PREGNANCY TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE KIT, 50 HOUR, PART NO. 80-8000-13K

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDIC, INC.·Product code KWP·March 15, 2011

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·September 26, 2016

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·July 26, 2016

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·September 11, 2017

    APPLIANCE, FIXATION, SPINAL INTERLAMINAL

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·October 25, 2017

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·April 4, 2016

    LONG NAIL KIT R1.5, LEFT 10X260MM X 125

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·June 16, 2010

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·April 6, 2017

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CAHMBER THREE PIECE FOLDABLE INTRAOCULA

    FDA Adverse Event
    Malfunction ·STAAR SURGICAL COMPANY·Product code HQL·March 28, 2013

    TERUMO ADVANCED PERFUSION SYSTEM 1

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP·Product code DTQ·March 4, 2011

    INDURA

    FDA Adverse Event
    Injury ·RICE CREEK MANUFACTURING·Product code LKK·April 17, 2008

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·February 7, 2020

    8) Signa 3.0T Infinity with EXCITE (K030874 GE 3.0T Signa Infinity TwinSpeed with EXCITE MR System) Signa 3.0T with EXCITE (K030874 GE 3.0T Signa Infinity TwinSpeed with EXCITE MR System) The GE Signa@ Infinity line of products are whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio and short scan times. The Signa@ Infinity System is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images, spectroscopic images, and/or spectra, dynamic images of the internal structures and organs of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. The images produced by the Signa@ Infinity systems reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code LNH·November 9, 2010

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·October 3, 2011

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·September 30, 2011