BEUDAMED
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    MICRUS COURIER MICROCATHETERS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Integra®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780088417·Integra® Intrument Tray for Netterville Instrum...

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    FDA UDI
    FX SOLUTIONS·03701037312001·REAMER Ø16 mm / HUDSON

    TiWAVE L Lumbar Cage System

    FDA UDI
    Kalitec Direct LLC·B07323K0101160·Distractor, Smooth Paddle, Lordotic, 16mm

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0101160·Distractor, Smooth Paddle, 16mm

    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

    Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection

    FDA UDI
    XERIDIEM MEDICAL DEVICES, INC.·00827002447820·Entuit Gastrostomy BR Balloon Retention Feeding...

    PLANMED SOPHIE, PLANMED SOPHIE CLASSIC

    FDA 510(k)
    FDA Class 2 ·Radiology

    QUALITROL URINALYSIS WITH MICROSCOPICS CONTROL, LEVELS 1,2 AND 3

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    UNKNOWN NOTTINGHAM SHOULDER

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code MBF·May 17, 2017

    ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION

    FDA Adverse Event
    Injury ·XERIDIEM MEDICAL DEVICES·Product code PIF·May 31, 2024

    COMPREHENSIVE SHOULDER SYSTEM MODULAR HEAD - VARIABLE OFFSET 42MM X 18MM X 46MM

    FDA Adverse Event
    Malfunction ·BIOMET ORTHOPEDICS·Product code HSD·October 19, 2016

    NATURALYTE

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·April 5, 2013

    SOFTCLIX PLUS LANCET DEVICE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·June 10, 2008

    ACUITY

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code OJX·April 15, 2011

    NEOPUFF INFANT RESUSCITATOR

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTL·June 21, 2015

    2.5 mm Reaming Rod W/Ball Tip 650 mm, Sterile

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·November 30, 2016