BEUDAMED
    19 results · 33ms · Sources: EU EUDAMED, US FDA

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    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814534·GENUMEDI SAND SIZE II

    INTEGRA ELECTRODE TUNNELING NEEDLE

    FDA 510(k)
    FDA Class 2 ·Neurology

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814657·GENUMEDI SILVER SIZE II

    VTI 20 MHZ Disposable Doppler Probe, Curved Tip, Box

    FDA UDI
    VASCULAR TECHNOLOGY, INCORPORATED·10817122020048·Part Number 102802, VTI 20 MHZ Disposable Doppl...

    PRINCETON

    FDA UDI
    Princeton Medical Group, Inc.·00810158216839·VASCULAR CLAMP/FORCEP DEBAKEY-SATINSKY ATRAUMAT...

    MP3CF ELECTRIC WHEELCHAIR

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    RAPID EXCHANGE TAPERTOME

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

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code NKB·May 1, 2014

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·October 2, 2012

    TRESTLE LUXE¿ Anterior Cervical Plating System, Product code KWQ. 510(k) K102820. The TRESTLE LUXE Anterior Cervical Plating System is a temporary device used to stabilize the cervical spine during bone fusion development. Device implants include a range of plate sizes and bone screws to provide the versatility required for the specific indications noted. Fixation is achieved by means of a rigid plate that is surgically attached to the spine with bone screws. The TRESTLE LUXE Anterior Cervical Plating System is intended for use in the anterior cervical spine (C2-C7). Patients with trauma (including fractures), spondylolisthesis, and pseudoarthrosis, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, tumors, and failed previous fusion.

    FDA Enforcement
    Class II ·Terminated·Alphatec Spine, Inc.·September 5, 2012

    PULSE GEN MODEL 1000

    FDA Adverse Event
    Injury ·LIVANOVA USA, INC.·Product code LYJ·August 6, 2024

    RENAISSANCE 29 P-WASHOBS10/04

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FPO·May 9, 2013

    GREENLIGHT MOXY FIBER OPTIC

    FDA Adverse Event
    Malfunction ·AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)·Product code GEX·September 19, 2014

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 25, 2011

    Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Model # CR2003 Product Usage: The CrAg Lateral Flow Assay is an immunochromatographic test system for the qualitative or semi-quantitative detection of the capsular polysaccharide antigens of Cryptococcus species complex (Cryptococcus neoformans and Cryptococcus gattii) in serum and cerebral spinal fluid (CSF). The CrAg Lateral Flow Assay is a prescription-use laboratory assay which can aid in the diagnosis of cryptococcosis.

    FDA Enforcement
    Class II ·Terminated·Immuno-Mycologics, Inc·July 18, 2018

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code NKB·May 25, 2016

    CardioMD III (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015

    TRESTLE LUXE Anterior Cervical Plating System, Product code KWQ. 510(k) K102820. The TRESTLE LUXE Anterior Cervical Plating System is a temporary device used to stabilize the cervical spine during bone fusion development. Device implants include a range of plate sizes and bone screws to provide the versatility required for the specific indications noted. Fixation is achieved by means of a rigid plate that is surgically attached to the spine with bone screws. The TRESTLE LUXE Anterior Cervical Plating System is intended for use in the anterior cervical spine (C2-C7). Patients with trauma (including fractures), spondylolisthesis, and pseudoarthrosis, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, tumors, and failed previous fusion.

    FDA Recall
    Terminated ·Alphatec Spine, Inc.·Product code KWQ·May 29, 2012

    SOLUS Anterior Lumbar Interbody Fusion Spinal Spacer System, Solus Proximal/Distal Deployment Wrenches, 510(k) K102402. The Alphatec Solus Anterior Lumbar Interbody Fusion (AUF) System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DOD) at one or two contiguous levels from L2-S1 with up to Grade 1 spondyiolisthesis or retrolisthesis at the involved level(s). DOD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The Alphatec Solus implant is intended to be used with autograft. The device is intended for use with supplemental fixation that is in addition to the integrated blades. The Alphatec Solus implant is intended for use with supplemental spinal fixation. Specifically, the Alphatec Solus implant is to be used with the Alphatec's Zodiac Spinal Fixation System, Aspida" Anterior Lumbar Plating System, or the ILLlCO MIS Posterior Fixation System. Intervertebral body fusion device.

    FDA Recall
    Terminated ·Alphatec Spine, Inc.·Product code MAX·March 19, 2012