BEUDAMED
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    EMBRYON ULTRASOUND NEEDLE GUIDE

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K0120150·Assembly, Screwdriver, Polyaxial, Lockable

    Battalion

    FDA UDI
    ALPHATEC SPINE, INC.·00840967187501·Battalion, LLIF Trial, 15°, 20 mm Wide, 15 mm X...

    N/A

    FDA UDI
    SYNVASIVE TECHNOLOGY, INC.·00889024367289·Full Length Sling

    Intelliguides

    FDA UDI
    Mios Marketing, LLC·G2710820320150·Zadik Calcaneal Guide, 32mm x 15°

    Omnicurve

    FDA UDI
    STRYKER CORPORATION·07613327638233·10G 15MM FRACTURE KIT

    Intelliguides

    FDA UDI
    Mios Marketing, LLC·G2710810320150·Dwyer Calcaneal Guide, 32mm x 15mm

    Intelliguides

    FDA UDI
    Mios Marketing, LLC·G2710310340150·Talar Osteotmy Guide, 34mm x 15mm

    SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    2027971-2022-032015

    FDA Adverse Event
    Injury ·NOBEL BIOCARE USA, LLC·Product code DZE·January 17, 2022

    EON MINI

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 26, 2013

    SURGICAL STAINLESS STEEL SUTURE

    FDA Adverse Event
    Malfunction ·ETHICON, INC. SAN LORENZO·Product code GAQ·March 28, 2011

    ORTHO PROVUE

    FDA Adverse Event
    Malfunction ·MICRO TYPING SYSTEMS, INC.·Product code KSZ·April 21, 2008

    G3 Opticage Expandable Interbody Fusion Device, Model No. 9180-00, 9180-01, 9180-06, 9180-07, 9180-17, 9101-00, 9101-06 The Opticage Expandable Interbody Fusion Device is a posterior lumbar intervertebral body fusion device and is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Opticage Interbody Fusion Device can be implanted via posterior, transforaminal or lateral approach. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Candidates for surgery should be skeletally mature and have had six months of conservative treatment. These patients may have had primary or secondary surgery, but no previous fusion at the involved levels. The device is not intended to be used as a stand-alone device. It must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine (i.e. facet screw fixation systems, facet compression devices and posterior pedicle screw and rod systems).

    FDA Enforcement
    Class II ·Terminated·Interventional Spine Inc·January 11, 2017

    ANIMAS VIBE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·December 15, 2015

    ANIMAS VIBE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·December 15, 2015

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·March 17, 2015

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·March 17, 2015

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·March 17, 2015