23 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Xia 3 Spinal System
FDA 510(k)
FDA Class 2
·Orthopedic
XIA TITANIUM 4.5 BLOCKER
FDA Adverse Event
Malfunction
·STRYKER SPINE-US·Product code NKB·September 3, 2020
HI TORQUE CONNECT GUIDEWIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS5508
FDA 510(k)
FDA Class 2
·Cardiovascular
LEAD EXTRACTION EVOLUTION MECHANICAL DILATOR SHEATH SET
FDA Adverse Event
Injury
·COOK VASCULAR INC·Product code DRE·October 22, 2018
LEAD EXTRACTION EVOLUTION MECHANICAL DILATOR SHEATH SET
FDA Adverse Event
Injury
·COOK VANDERGRIFT INC·Product code DRE·October 22, 2018
LEAD EXTRACTION STEADYSHEATH¿ EVOLUTION® TISSUE STABILIZATION SHEATH
FDA Adverse Event
Injury
·COOK VASCULAR INC·Product code DRE·June 12, 2017
LEAD EXTRACTION STEADYSHEATH¿ EVOLUTION® TISSUE STABILIZATION SHEATH
FDA Adverse Event
Injury
·COOK VASCULAR INC·Product code DRE·January 10, 2018
LEAD EXTRACTION EVOLUTION MECHANICAL DILATOR SHEATH SET
FDA Adverse Event
Injury
·COOK VASCULAR INC·Product code DRE·October 16, 2018
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 5, 2014
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·June 3, 2013
INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code LZG·June 21, 2011
ENDOWRIST
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·May 6, 2023
LEAD EXTRACTION EVOLUTION MECHANICAL DILATOR SHEATH SET
FDA Adverse Event
Injury
·COOK VASCULAR INC.·Product code DRE·December 7, 2018
LEAD EXTRACTION EVOLUTION MECHANICAL DILATOR SHEATH SET
FDA Adverse Event
Injury
·COOK VASCULAR INC·Product code DRE·October 15, 2018
LEAD EXTRACTION EVOLUTION MECHANICAL DILATOR SHEATH SET
FDA Adverse Event
Injury
·COOK VASCULAR INC·Product code DRE·April 13, 2017
LEAD EXTRACTION EVOLUTION MECHANICAL DILATOR SHEATH SET
FDA Adverse Event
Injury
·COOK VANDERGRIFT INC·Product code DRE·December 11, 2019
LEAD EXTRACTION EVOLUTION SHORTIE MECHANICAL DILATOR SHEATH SET
FDA Adverse Event
Injury
·COOK VASCULAR INC·Product code DRE·March 22, 2017
LEAD EXTRACTION EVOLUTION MECHANICAL DILATOR SHEATH SET
FDA Adverse Event
Injury
·COOK VASCULAR INC·Product code DRE·May 11, 2017
R-F IM NAIL 10MMDX48CM LG, 11MMDX42CM, 11MMDX44CM, 11MMDX46CM LG, 11MMDX48CM LG, 12MMDX46CM LG, 12MMDX48CM LG, 13MMDX40CM, 13MMDX42CM, 13MMDX44CM, 13MMDX46CM LG, 13MMDX48CM LG, 14MMDX34CM, 14MMDX36CM, 14MMDX38CM, 14MMDX40CM, 14MMDX42CM, 14MMDX44CM, 14MMDX46CM LG, 14MMDX48CM LG
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 21, 2017