BEUDAMED
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    COULTER LH 780 HEMATOLOGY ANALYZER

    FDA 510(k)
    FDA Class 2 ·Hematology

    Epimed

    FDA UDI
    EPIMED INTERNATIONAL, INC·00818788020314·RX Epidural Needle 16g TW x 6.0"

    INDUO BLOOD GLUCOSE METER

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MODIFICATION TO SYRINGE PREFILLED WITH 0.9% SODIUM CHLORIDE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523173952·Tk C, Cage Trial/Broach, No Stops - 16.1 X 13.5...

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523173990·Tk C, Cage Trial/Broach, No Stops - 16.1 X 13.5...

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523173945·Tk C, Cage Trial/Broach, No Stops - 16.1 X 13.5...

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523173969·Tk C, Cage Trial/Broach, No Stops - 16.1 X 13.5...

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523173983·Tk C, Cage Trial/Broach, No Stops - 16.1 X 13.5...

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523174003·Tk C, Cage Trial/Broach, No Stops - 16.1 X 13.5...

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523173976·Tk C, Cage Trial/Broach, No Stops - 16.1 X 13.5...

    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

    DELTA CERAMIC FEM HD 36/0MM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LZO·June 9, 2022

    EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED

    FDA Adverse Event
    Injury ·COOK IRELAND LTD·Product code FGE·August 11, 2023

    LSLF EXT SET W CLV

    FDA Adverse Event
    Malfunction ·HOSPIRA LTD.·Product code FPA·April 11, 2013

    CAPSUREFIX

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·April 18, 2011

    BRAVO

    FDA Adverse Event
    Malfunction ·ARIZONA DEVICE MANUFACTURING·Product code FFT·June 17, 2008

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018