BEUDAMED
    21 results · 11ms · Sources: EU EUDAMED, US FDA

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    Oxygen Sensor Model K54019-2 used in the: G185 & G210 Incubators and G603 Work Chambers Oxygen Sensors supplied for use in the following incubator and work chamber products; G185 Standard 110V, G185 SensorTech 110V, G185 Standard 230V, G185 SensorTech 230V, G210 InviCell Standard, G210 InviCell Standard US, G210 Invicell Plus Optional pH and External Monitoring, G603 Work Chamber 115V, & G603 Work Chamber 230V. [CooperSurgical part numbers K22400-110, K22200-110, K22400-230, K22200-230, K59500, K59700, K60000, 3.641.831.153, & 3.641.832.153].

    FDA Recall
    Terminated ·CooperSurgical, Inc.·Product code FMZ·June 30, 2021

    Oxygen Sensor Model K54019-2 used in the: G185 & G210 Incubators and G603 Work Chambers Oxygen Sensors supplied for use in the following incubator and work chamber products; G185 Standard 110V, G185 SensorTech 110V, G185 Standard 230V, G185 SensorTech 230V, G210 InviCell Standard, G210 InviCell Standard US, G210 Invicell Plus Optional pH and External Monitoring, G603 Work Chamber 115V, & G603 Work Chamber 230V. [CooperSurgical part numbers K22400-110, K22200-110, K22400-230, K22200-230, K59500, K59700, K60000, 3.641.831.153, & 3.641.832.153].

    FDA Enforcement
    Class II ·Terminated·CooperSurgical, Inc.·August 25, 2021

    AngioDynamics Soft Vu Omni Flush Angiographic Catheter Model Number: 10732203

    FDA Enforcement
    Class I ·Terminated·Stryker Sustainability Solutions·July 27, 2016

    ASY, Brat 2 Procedure Set

    FDA Recall
    Terminated ·Cobe Cardiovascular, Inc·Product code CAC·June 22, 2005

    ASY, Brat 2 Pack Procedure Set

    FDA Recall
    Terminated ·Cobe Cardiovascular, Inc·Product code CAC·June 22, 2005

    ASY Brat 2 Procedure Set

    FDA Recall
    Terminated ·Cobe Cardiovascular, Inc·Product code CAC·June 22, 2005

    ASY, Brat Pack Procedure Set

    FDA Recall
    Terminated ·Cobe Cardiovascular, Inc·Product code CAC·June 22, 2005

    ASY Brat 2 Procedure Set

    FDA Recall
    Terminated ·Cobe Cardiovascular, Inc·Product code CAC·June 22, 2005

    ASY Brat 2 Procedure Set, for blood recovery & autotransfusion.

    FDA Recall
    Terminated ·Cobe Cardiovascular, Inc·Product code CAC·June 22, 2005

    CRITIFLO(tm) FLUSH KIT

    FDA Recall
    Terminated ·Becton Dickinson Medical Systems·Product code KRA·July 1, 2005

    CRITIFLO(tm) flush kit.

    FDA Recall
    Terminated ·Becton Dickinson Medical Systems·Product code KRA·July 1, 2005

    TAKHPQ60R continuous flow catheter.

    FDA Recall
    Terminated ·Becton Dickinson Medical Systems·Product code KRA·July 1, 2005

    DTX(tm) Plus DT-DL60 Continuous flush catheter

    FDA Recall
    Terminated ·Becton Dickinson Medical Systems·Product code KRA·July 1, 2005

    DT-DL60-1 W/Bifurcated

    FDA Recall
    Terminated ·Becton Dickinson Medical Systems·Product code KRA·July 1, 2005

    CRITIFLOW(tm) TA4004 continuous flush catheter

    FDA Recall
    Terminated ·Becton Dickinson Medical Systems·Product code KRA·July 1, 2005

    CRITIFLO(tm) TAK0460 continuous flow catheter

    FDA Recall
    Terminated ·Becton Dickinson Medical Systems·Product code KRA·July 1, 2005

    Product is labeled in part - Pouch label: "***ORTHOFIX***Manufactured By: Nanotherapeutics, Inc. 13859 Progress Blvd, Suite 300 Alachua, FL 32615 (386) 462-9663***Description: Origen***DBM Paste***Size***REF:***ID***Expiration***STERILE R***Donated Human Tissue Allograft***SINGLE PATIENT USE ONLY***Rx Only***" Product is labeled in part - Carton label: "***Origen DBM with Bioactive Glass***REF***ID***Expiration***Manufactured for Blackstone Medical, Inc by: Nanotherapeutics, Inc. 13859 Progress Blvd. suite 300 Alachua, FL 32615***Distributed By: Orthofix Inc 1720 Bray Central Drive McKinney, TX 75069***Rx Only***ONE EACH***" Origen DBM with Bioactive Glass Catalog #: 22-2002 (2cc size) 22-2005 (5cc size) 22-2010 (10cc size) "Bone void filler comprised of a gelatin carrier, bioactive glass (45s5), and human demineralized bone matrix (DBM) intended for transplantation." Indicated to be gently placed into bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure (e.g. the extremities and pelvis).

    FDA Recall
    Terminated ·Nanotherapeutics, Inc·Product code MQV·March 10, 2011

    Cannula and Seal; 5mm x 100mm and 12mm x 100mm Model #: CTS02 and CTS22. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.

    FDA Enforcement
    Class II ·Terminated·Stryker Sustainability Solutions·July 1, 2015

    Leksell GammaPlan, Model 5.34. Intended to be used for planning the dosimetry of treatments in stereotactic radiation therapy.

    FDA Recall
    Terminated ·Elekta, Inc.·Product code IWB·October 1, 2005

    Medtronic Model 37711 Restore Neurostimulator. The Restore Neurostimulator is an implanted, rechargeable neurostimulator which provides pain management therapy.

    FDA Recall
    Terminated ·Medtronic Inc, Neurological & Spinal Division·Product code GZB·November 22, 2005