BEUDAMED
    3 results · 21ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Status: Terminated ×

    IMRIS IMRI 1.5T AND 3T S System Product Usage: The IMRIS intraoperative MRI systems are traditional MRI systems that have been suspended on an overhead rail system. and is designated to operative inside an RF shielded room to facilitate intraoperative and multi room use.

    FDA Enforcement
    Class II ·Terminated·Deerfield Imaging, Inc.·May 16, 2018

    Signify hCG Serum/Urine 30 Test Kit, Abbott List No. 07K09-30, ABI List No. 6026KSI, Lot# 84936, Exp 02/10/2007

    FDA Recall
    Terminated ·Applied Biotech Inc·Product code JHI·May 5, 2006

    Accessories for the Captiva Spine FuseLOX Lumbar Cage. The Trial product is a reuseable component of the Captiva Spine FuseLOX Lumbar product. It is not generally sold as an individually packaged product. Trial products are shipped as a component of the FuseLOX Lumbar Caddy which is placed in the FuseLox Lumbar Sterilization tray. The sterilization tray is distributed on consignment. FPT - F is FuseLOX, P is Plif, and T is Trial. Products subject to recall: FuseLOX Lumbar Trials Trial - 7mm x 25mm Part Number: FPT2507 Lot Number 8110001. Trial - 8mm x 25mm Part Number FPT2508 Lot Number 8110002. Trial - 9mm x 25mm Part Number: FPT2509 Lot Number 8110003. Trial - 10mm x 25mm Part Number: FPT2510 Lot Number 8110004. Trial - 11mm x 25mm Part Number: FPT2511 Lot Number 8110005. Trial - 12mm x 25mm Part Number: FPT2512 Lot Number 8110006. Trial - 13mm x 25mm Part Number FPT2513 Lot Number 8110007. Trial - 14mm x 25mm Part Number FPT2514 Lot Number 8110008. The FuseLOX Lumbar Cage implant is an intervertebral body fusion device indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The FuseLOX Lumbar Cage Implant is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine.

    FDA Recall
    Terminated ·Captiva Spine, Inc 967 Alternate A1A Suite1·Product code MAX·April 27, 2012