127 results
·
12ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
×
Ebb Complete Tamponade System, BD-OTS Obstetric Catheter, REF CTS-1000, Rx Only, Sterile EO
FDA Enforcement
Class II
·Terminated·Clinical Innovations, LLC·February 4, 2015
Angio WorkStation (XIDF-AWS801) used in conjunction with your Infinix System (INFX-8000V;INFX-8000C;INFX-8000F
FDA Enforcement
Class II
·Terminated·Toshiba American Medical Systems Inc·June 7, 2017
The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY. Intended for use in providing temporary control or reduction of postpartum uterine bleeding.
FDA Enforcement
Class II
·Terminated·Clinical Innovations, LLC·October 21, 2015
Toshiba America Medical Systems Angio WorkStation: XIDF-AWS801v6.00, v6.01, and V6.10 System: INFX-8000V Bi-Plane System
FDA Enforcement
Class II
·Terminated·Toshiba American Medical Systems Inc·July 27, 2016
The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY. Intended for use in providing temporary control or reduction of postpartum uterine bleeding.
FDA Recall
Terminated
·Clinical Innovations, LLC·Product code OQY·January 5, 2015
StemPro¿ MSC SFM CTS"
FDA Enforcement
Class II
·Terminated·Life Technologies Corporation·November 13, 2019
ACL TOP 300 CTS, automated coagulation laboratory instrument.
FDA Enforcement
Class II
·Terminated·Instrumentation Laboratory Co.·July 23, 2014
ACL TOP CTS, automated coagulation laboratory instrument.
FDA Enforcement
Class II
·Terminated·Instrumentation Laboratory Co.·July 23, 2014
ACL TOP 500 CTS, automated coagulation laboratory instrument.
FDA Enforcement
Class II
·Terminated·Instrumentation Laboratory Co.·July 23, 2014
ACL TOP 700 CTS, automated coagulation laboratory instrument.
FDA Enforcement
Class II
·Terminated·Instrumentation Laboratory Co.·July 23, 2014
StemPro MSC SFM CTS"
FDA Recall
Terminated
·Life Technologies Corporation·Product code NDS·June 11, 2019
Siemens Somatom CTs equipped with software syngo CT2010A, syngo CT2010B, syngo CT2011A and CT2012B. Computed tomography x-ray system.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·March 20, 2013
Roche Acetaminophen assay 03255379160-HAcetaminophen (P) 20767174160- cobas c Integra AAcetaminophen150 test
FDA Recall
Terminated
·Roche Diagnostics Corporation·Product code LDP·January 2, 2018
Tibial Array and Femoral Array. Model Number(s): 0150ARR00001 and 0150ARR00002. Manufactured by: MAKO Surgical, Corp. The devices are accessories used with MAKO's Tactile Guidance System (TGS). The Tactile Guidance System is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.
FDA Recall
Terminated
·Mako Surgical Corporation·Product code HAW·May 2, 2008
ACL TOP CTS, automated coagulation laboratory instrument.
FDA Recall
Terminated
·Instrumentation Laboratory Co.·Product code GKP·June 3, 2014
ACL TOP 500 CTS, automated coagulation laboratory instrument.
FDA Recall
Terminated
·Instrumentation Laboratory Co.·Product code GKP·June 3, 2014
ACL TOP 300 CTS, automated coagulation laboratory instrument.
FDA Recall
Terminated
·Instrumentation Laboratory Co.·Product code GKP·June 3, 2014
ACL TOP 700 CTS, automated coagulation laboratory instrument.
FDA Recall
Terminated
·Instrumentation Laboratory Co.·Product code GKP·June 3, 2014
Brilliance 64 CT Model 728231; To produce cross-sectional images of the body.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·August 17, 2016
GIBCO CTS AIM V Serum-Free Media (SFM), Model Number 0870112BK. Tissue and cell culture medium.
FDA Enforcement
Class II
·Terminated·Life Technologies, Corp.·August 1, 2018