BEUDAMED
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    Amplilink (AL) Software 3.2.3 for use with COBAS AMPLICOR, CAP/CA, COBAS TaqMan,and COBAS AmpliPrep/COBAS TaqMan. The software can be used with a Laboratory Information System.

    FDA Recall
    Terminated ·Roche Molecular Systems, Inc.·Product code OYT·April 23, 2012

    VIDAS Lyme IgG and IgM LYT, Ref #30 298, containing 60 LYT STR (reagent strip labels), 2 x 30 LYT SPR (Solid Phase Receptable) pouches, 1 x 1.5 ml LYT C1 (human) (positive control bottle), 1 x 1.5 ml LYT C2 (human) (negative control bottle), and 1 x 1.5 ml LYT S1 (human) (standard bottle). The responsible firm on the kit label is bioMerieux sa, 69280 Marcy l''Etoile France. The responsible firm on the insert is bioMerieux, Inc., Durham, NC.

    FDA Recall
    Terminated ·Biomerieux, Inc.·Product code LSR·October 28, 2003

    Stryker Howmedica Osteonics Triathlon tibial alignment ankle clamp extramedullary (EM) referencing instrument (Cat. No. 6541-2-609), for use in Total Knee Arthroplasty (TKA) when the surgeon elects to use Stryker's Triathlon Total Knee System in conjunction with EM referencing. Non-Sterile Instrument.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code GDJ·July 2, 2013

    Widefield OCT software feature for the Spectralis HRA+OCT and variants

    FDA Enforcement
    Class II ·Terminated·Heidelberg Engineering·May 2, 2018

    The PLEX Elite 9000, a Swept-Source OCT [SS-OCT] - Product Usage: The PLEX Elite 9000 Swept-Source OCT [SS-OCT] is a non- contact, high resolution, wide field of view tomographic and biomicroscopic imaging device intended for in-vivo viewing, axial cross-sectional and three-dimensional imaging of posterior ocular structures. The device is indicated for visualizing posterior ocular structures including, but not limited to, retina, retinal nerve fiber layer, ganglion cell plus inner plexiform layer, macula, optic nerve head, vitreous and choroid. The PLEX Elite SS-OCT angiography is indicated as an aid in the visualization of vascular structures of the retina and choroid.

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec, Inc.·January 8, 2020

    ADVIA Centaur¿ iPTH Calibrator 6 pk; REF: 10492387, 10630628. For in vitro diagnostic use in calibrating Intact PTH assays.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc·June 12, 2013

    Altius M-INI OCT Posterior Spinal Fixation System, Model Number 1200-9216 The AltiusTM OCT and AltiusTM M-INITM OCT Systems when intended to promote fusion of the cervical spine and occipitocervico-thoracic junction (Occiput-T3), these systems are indicated for: DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies); spondylolisthesis; spinal stenosis; fracture/dislocation; atlantoaxial fracture with instability; occipitocervical dislocation; revision of previous cervical spine surgery; and tumors. The occipital bone screws are limited to occipital fixation only

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet Spine, Inc·April 5, 2017

    Target Detachable Coils: TARGET 360 NANO 1 MM X 3 CM MODEL Number: M0035421030 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.

    FDA Enforcement
    Class II ·Terminated·Stryker Neurovascular·July 20, 2016

    RTI Surgical Streamline Occipito-Cervico-Thoracic (OCT) Final Driver, Common Name: Screw Driver

    FDA Enforcement
    Class II ·Terminated·RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)·April 20, 2016

    HemosIL PT-Fibrinogen HS PLUS, IVD --- Instrumentation Laboratory IL Company. A high sensitivity thromboplastin reagent based on recombinant human tissue factor (RTF) for the quantitative determination in human citrated plasma of Prothrombin Time (PT) and Fibrinogen on IL Coagulation Systems. The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy (OAT).

    FDA Recall
    Terminated ·Instrumentation Laboratory Co.·Product code GJS·November 21, 2014

    Streamline OCT Occipito-Cervico-Thoracic System, Crosslink Counter Torque Sleeve. Spinal fixation device instrument.

    FDA Enforcement
    Class II ·Terminated·RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)·June 1, 2016

    ADVIA Centaur iPTH Calibrator 2 pk; REF 10492394. For in vitro diagnostic use in calibrating Intact PTH assays.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc·June 12, 2013

    Target Detachable Coils: TARGET 360 NANO 1 MM X 2 CM MODEL Number: M0035421020 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.

    FDA Enforcement
    Class II ·Terminated·Stryker Neurovascular·July 20, 2016

    Mucolytic Agent 1 pint/473 ml; 1 gallon/3.8 l Product Usage: A mucoliquefying preservative designed for use in the preparation of mucoid cytology specimens. Mucolexx & Mucolytic Agent liquefies mucus and allows for optimal cytologic diagnostic results.

    FDA Enforcement
    Class II ·Terminated·Richard-Allan Scientific Company·May 27, 2015

    Target Detachable Coils: TARGET 360 NANO 1.5 MM X 2 CM MODEL Number: M0035421520 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.

    FDA Enforcement
    Class II ·Terminated·Stryker Neurovascular·July 20, 2016

    Virage OCT Spinal Fixation System. Intended to promote fusion of the Occipital-Cervical-Thoracic spine (Occiput-T3).

    FDA Enforcement
    Class II ·Terminated·Zimmer Spine, Inc.·March 9, 2016

    Ulrich medical neon3 OCT spinal stabilization, REF CS 3917-12, Locking screw for crosslink, screw-to-screw

    FDA Enforcement
    Class II ·Terminated·ulrich medical USA Inc·March 4, 2020

    Target Detachable Coils: TARGET 360 NANO 1.5 MM X 3 CM MODEL Number: M0035421530 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.

    FDA Enforcement
    Class II ·Terminated·Stryker Neurovascular·July 20, 2016

    Target Detachable Coils: TARGET 360 NANO 1.5 MM X 4 CM MODEL Number:M0035421540 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.

    FDA Enforcement
    Class II ·Terminated·Stryker Neurovascular·July 20, 2016

    Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 3 CM MODEL Number:M0035431530 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.

    FDA Enforcement
    Class II ·Terminated·Stryker Neurovascular·July 20, 2016