BEUDAMED
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    6F X 60CM TRIPLE PRO-LINE CT BASIC IR SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694055451·1.6mm Orbital Floor Plate, Preformed, Left, .5m...

    VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EMG SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    AESCULAP SURGICAL INSTRUMENTS

    FDA Adverse Event
    Injury ·CHRISTOPH MIETHKE GMBH & CO. KG·Product code JXG·November 27, 2019

    AESCULAP SURGICAL INSTRUMENTS

    FDA Adverse Event
    Injury ·CHRISTOPH MIETHKE GMBH & CO. KG·Product code JXG·November 27, 2019

    AMISTEM H CEMENTLESS STEM NUMBER 3 STD

    FDA Adverse Event
    Injury ·Product code MEH·March 18, 2015

    INTERSTIM II

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code EZW·June 21, 2013

    RESTORE SENSOR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 29, 2013

    ENRHYTHM DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code DXY·June 16, 2011

    COGNIS

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 1, 2014

    Tearaway Introducer, Model # VS203, VS303, 510 K # 130687, packaged individually in a pouch, 5 pouches per carton, lot # MBZ140, MBZL450, MBZV930 MBZZ490 Product Usage: The 2F and 3F Vascu-Sheath Tearaway Introducer is intended for percutaneous venous access by modified Seldinger Technique in neonates, infants and children.

    FDA Enforcement
    Class II ·Terminated·Medical Components, Inc dba MedComp·June 15, 2016

    Tearaway Introducer, Model # VS203, VS303, 510 K # 130687, packaged individually in a pouch, 5 pouches per carton, lot # MBZ140, MBZL450, MBZV930 MBZZ490 Product Usage: The 2F and 3F Vascu-Sheath Tearaway Introducer is intended for percutaneous venous access by modified Seldinger Technique in neonates, infants and children.

    FDA Recall
    Terminated ·Medical Components, Inc dba MedComp·Product code DYB·May 5, 2016

    Assurity Model Numbers: PM1240, PM2240; Assurity + Model Number: PM2260; Accent Model Numbers: PM1210, PM2210, PM1222, PM2212; Accent MRI Model Numbers: PM1224, PM2218, PM2224 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated in one or more of the following permanent conditions: Syncope, Presyncope, Fatigue, Disorientation, Or any combination of those symptoms. Implantation of a CRT-P is indicated for: Maintaining synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic atrial fibrillation and have NYHA Class II or III heart failure. The reduction of the symptoms of moderate to severe heart failure (NYHA Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction d35% and a prolonged QRS duration

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017

    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015