BEUDAMED
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    Arrow/Teleflex Medical Berman Angiographic Balloon Catheter and Reverse Berman Angiographic Balloon Catheter. The Arrow Berman(TM) Angiographic Catheter is indicated for use in right heart catheterization for cardiac angiography, and measurement of the right heart and pulmonary artery pressures. It can be sued to inject radiopaque media and measure pressures in any chamber or vessel that can be entered from the right heart. The Arrow Berman(TM) Angiographic Catheter is also indicated for use in Balloon Occlusion Femoral Angiography (BOFA) of the ipsilateral leg for adult patients. The Arrow Reverse Berman(TM) Angiographic Catheter is indicated for balloon occlusion pulmonary angiography.

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·April 10, 2013

    Arsenal Spinal Fixation System, Set Screw, Part No. 47027 Product Usage: The Arsenal Spinal Fixation System is intended for posterior, non-cervical, spinal fixation as an adjunct to fusion for the treatment of degenerative disease, deformity, and trauma indications. The Arsenal System consists of a variety of shapes and sizes of rods, screws, hooks, connectors, and bridges that provide temporary internal fixation and stabilization during bone graft healing and/or fusion mass development. The screws, hooks, connectors, and bridges are manufactured from surgical grade titanium alloy (Ti-6AI-4V ELl). The rods are available in commercially pure titanium, titanium alloy, and cobalt chrome (CP Ti Grade 4, Ti-6AI-4V ELl, and Co-28Cr-6Mo).

    FDA Enforcement
    Class II ·Terminated·Alphatec Spine, Inc.·June 14, 2017

    Arsenal Spinal Fixation System, Set Screw, Part No. 47127 Product Usage: Usage: The Arsenal Spinal Fixation System is intended for posterior, non-cervical, spinal fixation as an adjunct to fusion for the treatment of degenerative disease, deformity, and trauma indications. The Arsenal System consists of a variety of shapes and sizes of rods, screws, hooks, connectors, and bridges that provide temporary internal fixation and stabilization during bone graft healing and/or fusion mass development. The screws, hooks, connectors, and bridges are manufactured from surgical grade titanium alloy (Ti-6AI-4V ELI). The rods are available in commercially pure titanium, titanium alloy, and cobalt chrome (CP Ti Grade 4, Ti-6Al-4V ELI, and Co-28Cr-6Mo).

    FDA Enforcement
    Class II ·Terminated·Alphatec Spine, Inc.·November 23, 2016

    Glucose Hexokinase (Liquid) Reagent For the in vitro quantitative determination of Glucose in serum.

    FDA Enforcement
    Class II ·Terminated·JAS Diagnostics Inc.·December 24, 2014

    Glucose Hexokinase Liquid Reagent For the in vitro quantitative determination of Glucose in serum.

    FDA Enforcement
    Class II ·Terminated·JAS Diagnostics Inc.·July 2, 2014

    Drew Scientific DREW 3-PAC Reagent Kit containing: 5L Diluent, 750 mL Enzymatic Cleaner, and 125 mL Lysing Reagent.

    FDA Enforcement
    Class II ·Terminated·JAS Diagnostics Inc.·July 12, 2017

    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

    Drew Scientific Inc. Drew3-PAC. This D3 Reagent Pack includes: diluent reagent 5L, enzymatic cleaner 750 mL, and a lysing reagent 125 mL.

    FDA Enforcement
    Class II ·Terminated·Jas Diagnostics/Drew Scientific·May 4, 2016

    Medtronic Temporary Pacemaker, Model 5348. Single Chamber External Pulse Generator (EPG) Temporary Pacemaker (AAI/VVI). Used in conjunction with a cardiac pacing lead system for temporary atrial or ventricular pacing in a clinical environment. The device is typically connected to temporary transvenous, epicardial or myocardial pacing leads, in a bipolar configuration, using a patient cable (Medtronic Model 5433A or 5433V) or a surgical cable (Medtronic Model 5832 or 5832S).

    FDA Enforcement
    Class II ·Terminated·Medtronic Inc. Cardiac Rhythm Disease Management·June 4, 2014

    Halyard Closed Suction System for Adults, Multi-Access¿Port¿Closed¿Suction¿System¿for¿Adults. Used to aspirate liquids or semisolids from a patient's upper airway. a. HALYARD* MULTI-PORT, DSY, ENDO 10FR; b. HALYARD* MULTI-PORT, DSY, ENDO 12FR; c. HALYARD* MULTI-PORT, DSY, ENDO, MDI 12FR; d. HALYARD* MULTI-PORT, DSY, ENDO 14FR; e. HALYARD* MULTI-PORT, DSY, TRACH 14FR; f. HALYARD* MULTI-PORT, DSY, TRACH, WP 14FR; g. HALYARD* MULTI-PORT, DSY, ENDO, MDI 14FR; h. HALYARD* MULTI-PORT, DSY, ENDO, WP 14FR; i. HALYARD* MULTI-PORT, DSY, ENDO, WP 14FR; j. HALYARD* MULTI-PORT, DSY, ENDO, MDI 14FR; k. HALYARD* MULTI-PORT, DSY, ENDO, MDI 16FR;

    FDA Enforcement
    Class II ·Terminated·Halyard Health, Inc·April 25, 2018

    Halyard Closed Suction System for Adults, Turbo- cleaning¿Closed¿Suction¿System¿for¿Adults,¿Double¿Swivel¿Elbow (DSE). Used to aspirate liquids or semisolids from a patient's upper airway. a. HALYARD* TURBO-CLEANING 14FR DSE 21.3IN/54 CM (GREEN); b. HALYARD* TRACH CARE-72 DSE ENDO 14FR; c. HALYARD* TRACH CARE-72 WET PAK* 14FR; d. HALYARD* TRACH CARE-72 WET PAK* T-PIECE SWVL/FLEX ENDO 14FR; e. HALYARD* TURBO-CLEANING 14FR DSE 12IN/30.5 CM (GREEN); f. HALYARD* TRACH CARE-72 DSE TRACH 14FR; g. HALYARD* TRACH CARE-72 WET PAK* DSE TRACH 14FR; h. HALYARD* TRACH CARE-72 DSE ENDO 10FR; i. HALYARD* TURBO-CLEANING 10FR DSE 12IN/30.5CM (BLACK); j. HALYARD* TRACH CARE-72 DSE MDI BUILT IN ENDO 10FR; k. HALYARD* TRACH CARE-72 DSE MDI BUILT IN ENDO 12FR; l. HALYARD* TURBO-CLEANING 12FR DSE 12IN/30.5CM (WHITE); m. HALYARD* 72 DSE MDI BUILT IN ENDO 12FR; n. HALYARD* 72 DSE TRACH CARE 12FR; o. HALYARD* 14FR DSE 22.2IN/56CM (GREEN); p. HALYARD* TRACH CARE-72 DSE MDI BUILT IN ENDO 14FR; q. HALYARD* TURBO-CLEANING 14FR DSE 12IN/30.5CM (GREEN); r. HALYARD* TRACH CARE-72 DSE MDI BUILT IN TRACH 14FR; s. HALYARD* TC-72 WET PAK* DSE MDI ENDO 14FR; t. HALYARD* TC-72 WET PAK DSE MDI ENDO 14FR; u. HALYARD* TC-72 WET PAK DSE 14FR; v. HALYARD* TURBO-CLEANING 14FR DSE 21.3IN/54CM (GREEN); w. HALYARD* TURBO-CLEANING 12FR DSE 21.3IN/54 CM (WHITE); x. HALYARD* TRACH CARE-72 DSE ENDO 12FR; y. HALYARD* TURBO-CLEANING 12FR DSE 12IN/30.5CM (WHITE); z. HALYARD* TRACH CARE-72 DSE TRACH 12FR; aa. HALYARD* TRACH CARE-72 WET PAK* DSE TRACH 12FR; ab. HALYARD* TURBO-CLEANING 16FR DSE 21.3IN/54CM (ORANGE); ac. HALYARD* TRACH CARE-72 DSE 16FR 21.3IN/54CM; ad. HALYARD* TRACH CARE-72 DSE TRACH 16FR; ae. HALYARD* TRACH CARE-72 DSE ENDO 16FR; af. HALYARD* TRACH CARE-72 DSE MDI BUILT IN ENDO 16FR; ag. HALYARD* TRACH CARE-72 DSE MDI BUILT IN TRACH 16FR; ah. HALYARD* TRACH CARE-72 DSE MDI ENDO 16FR; ai. HALYARD* TRACH CARE-72 DSE 16FR; aj. HALYARD* TRACH CARE-72 WET PAK* DSE ENDO 12FR; ak. HALYARD* TURBO-CLEANING 14FR DSE 21.3IN/54CM (GREEN); al. HALYARD* TURBO-CLEANING 14FR DSE Endo;

    FDA Enforcement
    Class II ·Terminated·Halyard Health, Inc·April 25, 2018