BEUDAMED
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    CONCERTO DETACHABLE COIL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EPIONE RoboKit Plus

    FDA UDI
    QUANTUM SURGICAL·03760305400253·The EPIONE® RoboKit™ Plus is used during the CT...

    N/A

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036026622·

    Reusable Surgical Optical fiber

    FDA UDI
    QUANTA SYSTEM SPA·08033945937218·Reusable 10X Surgical Optical Fiber ø 550 µm. D...

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K0100460·ASSEMBLY, CADDIE, CURVED RODS WITH STOPS

    8.0 X 90mm Cann Screw Fastener 46mm Var Thd

    FDA UDI
    Osteocentric Technologies, Inc.·00810074306805·8.0 X 90mm Cann Screw Fastener 46mm Var Thd

    Ø7.0 x 46mm x 90mm CANNULATED PARTIAL THREAD SCREW

    FDA UDI
    Osteocentric Technologies, Inc.·00816950027000·Ø7.0 x 46mm x 90mm CANNULATED PARTIAL THREAD SCREW

    COPPERHEAD CERVICAL INTERBODY CAGE

    FDA Adverse Event
    Injury ·EMINENT SPINE·Product code ODP·January 8, 2016

    KNIGHT ENDOSCOPIC SPINE SYSTEM (KESS)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NUVOLASE 532 MEDICAL LASER SYSTEM

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

    FLEXTOME? CUTTING BALLOON?

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - GALWAY·Product code LOX·May 2, 2013

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·September 15, 2014

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·May 4, 2011

    BD Connecta Stopcock Without Extension Tube Catalog No. 394601 (OUS)

    FDA Enforcement
    Class II ·Ongoing·Becton Dickinson & Company·July 27, 2022

    STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System. Model P6500, 510 (k) Numbers: K090036 Cleared 4/05/2010; K101409 cleared 8/2/2010; K102462, cleared 9/2/2010; add to file 2/24/2011. The SYSTEM 1E Liquid Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reuseable critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories.

    FDA Recall
    Terminated ·Steris Corporation Hopkins Facility·Product code MED·December 7, 2011

    Trinica Anterior Lumbar Plate (ALP) system, part 07.01058.001. Non Sterile, Rx only. The Trinica Anterior Lumbar Plate System is a temporary supplemental fixation device consisting of a variety of shapes and sizes of plates and screws. The Trinica Anterior Lumbar Plate System is used as an implant for the correction and stabilization of the spine. This system provides temporary stabilization and augments the development of a solid spinal fusion. Additionally, this system provides the surgeon with the ability to supplement an interbody device with anterior plate fixation. The Trinica Anterior Lumbar Plate System components can be locked into a variety of configurations and each construct may be customized to individual cases. The plates are low profile and anatomically designed to provide optimal fit from either anterior or anterior-lateral approach. This system also features anti-migration locking caps to help secure the fixation screws. All Trinica Anterior Lumbar Plate System implant components are made from titanium alloy (Ti-6AI-4V). The Trinica Anterior Lumbar Plate System is indicated for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels. This system is indicated in the treatment of lumbar or lumbosacral (L1-SI) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), pseudoarthrosis, spondylolisthesis, scoliosis, lordotic deformities of the spine, spinal stenosis, or a failed previous fusion.

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·November 27, 2013

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012