BEUDAMED
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    SMITH & NEPHEW, INC., PROMOS REVERSE SHOULDER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Stainless Steel Wire

    FDA UDI
    Dentsply International Inc.·D001N0810160·Round 10ft

    PMMA disc

    FDA UDI
    Dentsply International Inc.·D00180810160·

    Stamey

    FDA UDI
    COOK INCORPORATED·00827002148918·Stamey Percutaneous Suprapubic Catheter Set

    SchureMed

    FDA UDI
    SCHUERCH CORPORATION·00810014608969·GETINGE / SHAMPAINE 2" DELUXE

    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

    CD117-APC

    FDA UDI
    Miltenyi Biotec B.V. & Co. KG·04049934134432·A3C6E2 recognizes human CD117, also known as c-...

    GE LOGIQ 700

    FDA 510(k)
    FDA Class 2 ·Radiology

    LSI SOLUTIONS FLEXIBLE SUTURE PLACEMENT DEVICE AND ACCESSORIES PRODUCT

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

    ADULT BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD.·Product code BZE·November 27, 2008

    PINNACLE 100 ACET CUP 52MM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS·Product code LPH·April 26, 2013

    ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-RIO

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL·Product code OLO·August 22, 2014

    2800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 14, 2011

    HOSP SS FLEXX METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·February 22, 2011

    HOSP SS FLEXX METER W/O LASER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·May 17, 2011

    HOSP SS FLEXX METER

    FDA Adverse Event
    Death ·LIFESCAN INC.·Product code NBW·April 1, 2011

    AperFix Femoral Implant Coring Removal Drill, labeled as the following: a. Femoral Removal Coring Reamer 9mm, Model Number CM-7109; b. Femoral Removal Coring Reamer 10mm, Model Number CM-7110; c. Femoral Removal Coring Reamer 11mm, Model Number CM-7111; d. Femoral Removal Coring Reamer 9 mm - Long, Model Number CM-7129; e. Femoral Removal Coring Reamer 10 mm - Long, Model Number CM-7130; f. Femoral Removal Coring Reamer 11 mm - Long, Model Number CM-7131; Orthopedic surgical instrument.

    FDA Enforcement
    Class II ·Terminated·Cayenne Medical Inc.·August 1, 2018