921 results
·
11ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
×
AXIOM Artis dBA, Model Number 7555357
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·July 31, 2019
AXIOM Artis dBA, Model Number 7555357
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code OWB·June 12, 2019
CoaguChek XS PT Test; All Catalog/REF Numbers that do NOT end in 160 The CoaguChek XS PT test strips are part of the CoaguChek XS System. The CoaguChek XS System is intended for properly selected and suitably trained users or their caregivers on the prescription or other order of the treating doctor.
FDA Enforcement
Class I
·Terminated·TERRIFIC CARE LLC·February 13, 2019
Axiom Artis dBA, Axiom Artis Modular Angiography X-Ray System, Model number 7555357.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code IZI·September 2, 2008
***REF LS7600***Qty 1*** EC REP*** ConMed Linvatec Xenon Light Source
FDA Enforcement
Class II
·Terminated·Linvatec Corp. dba ConMed Linvatec·October 3, 2012
***REF LS7700***Qty 1*** EC REP*** ConMed Linvatec Xenon Universal Light Source
FDA Enforcement
Class II
·Terminated·Linvatec Corp. dba ConMed Linvatec·October 3, 2012
AXIOM Artis System dBA using software version VB31D with 30x40 cm2 flat detectors. AXIOM Artis is a angiography system developed for single and biplane diagnostic imaging and interventional procedures.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code IZI·August 25, 2008
CareFusion Vital Signs LightWand Stylet. A device inserted into an endotracheal tube to aid in the intubation procedure.
FDA Enforcement
Class II
·Terminated·Vital Signs Colorado Inc.·May 6, 2015
Introduction Pack. A device inserted into an endotracheal tube to aid in the intubation procedure.
FDA Enforcement
Class II
·Terminated·Vital Signs Colorado Inc.·May 6, 2015
Custom Assembly, Custom FCFFM x/8.2 cm Tubing Extension, Model Number: FCA026-001, Manufactured by: Value Plastics dba Nordson MEDICAL, 805 West 71st Street, Loveland, CO 80538, packaged in Bags consisting of 100, 500 or 1,000 stopcocks.
FDA Enforcement
Class II
·Terminated·Value Plastics, Inc.·March 16, 2016
TriFoillmaging Triumph/Triumph II Research CT scanners.
FDA Enforcement
Class II
·Terminated·Northridge Tri-Modality Imaging,·October 12, 2016
NP211H***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA*** To reattach soft tissue to bone in orthopedic surgical procedures
FDA Enforcement
Class II
·Terminated·Linvatec Corp. dba ConMed Linvatec·October 24, 2012
ANTI-BORRELIA (LYME) MICROPLATE EIA Kit, Catalog # 32507 Kit Lot Number 120960. Package Insert Supplement: Calibrator-1206 U/mL, Positive Control-228 - 532 U/mL, and Negative Control-<120 U/mL; Manufactured by Innominata dba GenBio for Bio-Rad. The kit is used as an aid in diagnosis of Lyme disease.
FDA Enforcement
Class II
·Terminated·Innominata Dba Genbio·March 20, 2013
"***PressFT***2.1 w/ One #2 (5 metric) Hi-Fi***Suture***NP211***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA*** To reattach soft tissue to bone in orthopedic surgical procedures
FDA Enforcement
Class II
·Terminated·Linvatec Corp. dba ConMed Linvatec·October 24, 2012
"***PressFT***2.1 w/ Two #0 (3.5 metric) Hi-Fi***Sutures***NP212***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA*** To reattach soft tissue to bone in orthopedic surgical procedures
FDA Enforcement
Class II
·Terminated·Linvatec Corp. dba ConMed Linvatec·October 24, 2012
"***PressFT***2.6 w/ One #2 (5 metric) Hi-Fi***Suture***NP261***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA*** To reattach soft tissue to bone in orthopedic surgical procedures
FDA Enforcement
Class II
·Terminated·Linvatec Corp. dba ConMed Linvatec·October 24, 2012
"***PressFT***2.6 w/ Two #1 (4 metric) Hi-Fi***Sutures***NP262***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA*** To reattach soft tissue to bone in orthopedic surgical procedures
FDA Enforcement
Class II
·Terminated·Linvatec Corp. dba ConMed Linvatec·October 24, 2012
OsteoStim Cervical Allograft (Lordotic Cervical Spacer) H. 7mm; W. 14mm; L. 10mm., Catalog Number: 45-5537 and Catalog Number : LGAL906, Distributed by EBI. (dba Biomet Spine, Biomet Trauma, Biomet Bracing, Biomet Osteobiologics) Parsippany, New Jersey 07054
FDA Recall
Terminated
·Product code MQV·October 23, 2007
"***Press FT***2.6 w/ One #2 (5 metric) Hi-Fi***Suture, HIP***N2***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA*** To reattach soft tissue to bone in orthopedic surgical procedures
FDA Enforcement
Class II
·Terminated·Linvatec Corp. dba ConMed Linvatec·October 24, 2012
"***SENTINEL***Cannulated Drill Bit***S8580***8 X 229mm (9")***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***LOT***2012-03***". This drill bit is an eccentric mono-fluted cutting edge for drilling bone tunnels in ACL and PCL reconstruction.
FDA Enforcement
Class II
·Terminated·Linvatec Corp. dba ConMed Linvatec·November 28, 2012