BEUDAMED
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    AVEA VENTILATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    AVEA VENTILATOR

    FDA Adverse Event
    Malfunction ·CAREFUSION·Product code CBK·July 17, 2015

    Product Name: AVEA Ventilator. All Models. The affected devices are cleared under K073069 pm 1/25/2008 and K103211 on 05/06/2011. This device is a Class II medical Device. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.

    FDA Recall
    Terminated ·Carefusion 211 Inc dba Carefusion·Product code CBK·September 5, 2013

    Product Name: AVEA¿ Ventilator. All Models. The affected devices are cleared under K073069 pm 1/25/2008 and K103211 on 05/06/2011. This device is a Class II medical Device. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.

    FDA Enforcement
    Class I ·Terminated·Carefusion 211 Inc dba Carefusion·October 9, 2013

    DURAVENT

    FDA UDI
    Andreas Fahl Medizintechnik-Vertrieb GmbH·04051948038781·DURAVENT LINGO-PHON 1 IC + 1 ICF, SIZE 11

    Radius Plate PROlock II

    FDA UDI
    I.T.S. GmbH·09120034307997·Radius Plate PROlock II, 11-Hole, Left

    STEREOTACTIC

    FDA UDI
    PMT CORPORATION·00650551149682·LEKSELL UPPER GUIDE BUSHING FOR 3.3MM DRILL

    FEMORAL HEAD DISARTICULATOR KNIFE

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896090040·FEMORAL HEAD DISARTICULATOR KNIFE SMALL SIZE CU...

    Navagio

    FDA UDI
    Kalitec Direct LLC·B07330K0132110·Trial, TLIF, 27L OB CRV 7Deg, 11mm

    HOFFMANN II DYNAMIZATION/DISTRACTION ROD-TO-ROD COUPLING

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MODIFICATION TO: ACUMATCH L-SERIES BIPOLAR ENDOPROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GALAXY G3 MINI 1MM X 2CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·December 5, 2020

    TOTAL ASR FEM IMP SIZE 55

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD - 8010379·Product code KXA·May 9, 2013

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 25, 2011

    PUMP MMT-722NAB PRDGM INS V2.2 BL EN

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code LZG·August 8, 2008

    M2A MAGNUM MODULAR HEAD

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWS·February 3, 2017

    M2A MAGNUM PF CUP

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·February 3, 2017

    SPECTRANETICS 12F GLIDELIGHT LASER SHEATH

    FDA Adverse Event
    Malfunction ·THE SPECTRANETICS CORPORATION·Product code MFA·May 24, 2021

    AMISTEM H, HA COATED STEM SIZE 2 STD

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·September 30, 2016

    Volar Radius Plate with Angular Stability with the following description: Radius Plate PROlock II. Article Numbers: 21031-3, 21031-5, 21032-11, 21032-3, 21032-5, 21033-3, 21033-5, 21034-3, 21034-5, 21035-3, 21036-3.

    FDA Enforcement
    Class II ·Ongoing·I.T.S. GmbH·April 1, 2026