12 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MODIFICATION TO DEPUY 1 GENTAMICIN BONE CEMENT AND SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENT
FDA 510(k)
FDA Class 2
·Orthopedic
SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code MQP·October 30, 2017
HERMES HDAQ ACQUISITION STATION AND HERMES WORKSTATION, VER. 3.4
FDA 510(k)
FDA Class 2
·Radiology
HYPERFORM OCCLUSION BALLOON SYSTEM, MODEL 104-4470, 104-4471, 104-4770, 104-4771
FDA 510(k)
FDA Class 2
·Cardiovascular
VERTE-STACK SPINAL SYSTEM
FDA Adverse Event
Malfunction
·SOFAMOR DANEK DEGGENDORF GMBH·Product code MQP·January 21, 2010
VERTE-STACK SPINAL SYSTEM
FDA Adverse Event
Malfunction
·SOFAMOR DANEK DEGGENDORF GMBH·Product code ODP·November 20, 2009
TOTAL ASR FEM IMP SIZE 51
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KXA·April 8, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·March 10, 2011
VITALITY VR
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020