16 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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V2.7 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
SSW CARBIDE
FDA UDI
Ss White Burs, Inc.·D6901411852·RA SL CARBIDE 8 - 5 PACK
LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET
FDA Adverse Event
Injury
·COOK VANDERGRIFT INC·Product code DRE·September 14, 2020
Biogel
FDA UDI
Bosma Enterprises·10818634024029·Biogel PI UltraTouch Surgical 8.5 - 50 Pair/Box
LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET
FDA Adverse Event
Death
·COOK VANDERGRIFT INC·Product code DRE·July 12, 2019
LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET
FDA Adverse Event
Death
·COOK VANDERGRIFT INC·Product code DRE·September 17, 2020
LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET
FDA Adverse Event
Death
·COOK VASCULAR INC·Product code DRE·May 9, 2019
TORSO ARRAY COIL, MODEL 558GE-64
FDA 510(k)
FDA Class 2
·Radiology
NUCLEIC ACID DETECTION IMMUNOASSAY (NADIA) PSA ASSAY
FDA 510(k)
FDA Class 2
·Immunology
ASR UNI FEMORAL IMPL SIZE 51
FDA Adverse Event
Injury
·DEPUY INTL., LTD. - 8010379·Product code KWA·June 3, 2013
PULSE GEN MODEL 102
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code MUZ·June 22, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 3, 2014
TRUEMETRIX
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH, INC.·Product code NBW·November 9, 2017
LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET
FDA Adverse Event
Injury
·COOK VANDERGRIFT INC·Product code DRE·December 1, 2020
LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET
FDA Adverse Event
Injury
·COOK VANDERGRIFT INC·Product code DRE·December 16, 2020
LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET
FDA Adverse Event
Injury
·COOK VANDERGRIFT INC·Product code DRE·August 13, 2019