BEUDAMED
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    MANI NEEDLE & SUTURE PACK (PGA ABSORBABLE)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Premier Barbed Broaches

    FDA UDI
    PREMIER DENTAL PRODUCTS COMPANY·D6919053636·BROACH BARBD 60 PH BX 144

    SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY

    FDA 510(k)
    FDA Class 2 ·Radiology

    PORTALVISION

    FDA 510(k)
    FDA Class 2 ·Radiology

    METASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 48, 42,CODE H

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·June 19, 2018

    TELIGEN

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 11, 2013

    TOTAL CARE SPORT BED

    FDA Adverse Event
    Malfunction ·HILL-ROM INC.·Product code FNL·March 17, 2011

    LOW PROFILE EXTENSION

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code MHY·May 23, 2008

    METASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 54, 48, CODE N

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·March 28, 2019

    9) Signa Excite 1.5 T (Excite II) (K013636 Signa Infinity MR System with EXCITE Technology) Signa Infinity MR System with EXCITE (K013636 Signa Infinity MR System with EXCITE Technology) The GE Signa@ Infinity line of products are whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio and short scan times. The Signa@ Infinity System is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images, spectroscopic images, and/or spectra, dynamic images of the internal structures and organs of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. The images produced by the Signa@ Infinity systems reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code LNH·November 9, 2010

    METASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 50, 44, CODE J

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·February 20, 2018

    METASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 50, 44, CODE J

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·February 20, 2018

    METASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 46/ 40, CODE F

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·June 13, 2018

    METASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 62/56, CODE V

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·January 31, 2018

    Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black; MT20649-PNK, Receiver (mg/dL), Pink; MT20649-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.

    FDA Enforcement
    Class I ·Terminated·Dexcom Inc·April 20, 2016

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012