23 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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WEARABLE THERAPY GARMENTS
FDA 510(k)
FDA Class 2
·Neurology
EBERLE
FDA UDI
Eberle GmbH & Co. KG·04050052015930·Aggressive Full Radius Resector 4,2
QCT Pro Asynchronous Calibration Module, CliniQCT
FDA UDI
MINDWAYS SOFTWARE, INC.·B052DIASYNC0·The QCT Pro Asynchronous Calibration Module is ...
CoRoent
FDA UDI
Nuvasive, Inc.·00887517637468·CoRoent Ant TLIF PEEK, 14x11x34mm 12°
IMPRUV A.I. CREAM WOUND AND SKIN EMULSION
FDA 510(k)
FDA Unclassified
·Unknown
OSIRIX MD
FDA 510(k)
FDA Class 2
·Radiology
OSSURE LOEP KIT
FDA Adverse Event
Death
·AGNOVOS HEALTHCARE USA, LLC·Product code MQV·December 27, 2018
OSSURE LOEP KIT
FDA Adverse Event
Death
·AGNOVOS HEALTHCARE USA, LLC·Product code MQV·January 18, 2020
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·October 3, 2014
THREADED GUIDE WIRE ASNIS III Ø2.0X150MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS-SELZACH·Product code LXH·June 3, 2013
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·June 27, 2011
OSTEOVATION RMX 10 CC Injectable. REF/UDI: 390-6002/ /00813845021099 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
FDA Enforcement
Class II
·Terminated·Osteomed, LLC·June 10, 2020
ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code PNO·November 20, 2017
ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code PNO·December 19, 2017
ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code PNO·January 8, 2019
ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code PNO·January 22, 2019
ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code PNO·January 29, 2018
ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code DQY·January 26, 2018
ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code PNO·February 12, 2018
ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code PNO·January 29, 2018