21 results
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19ms
·
Sources: EU EUDAMED, US FDA
RAPID PROGRAMMER, VERSION 3.3.0
FDA 510(k)
FDA Class 2
·Neurology
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450208328·
QUANTUM BLAST
FDA 510(k)
FDA Class 2
·Physical Medicine
SOF-TACT DIABETES MANAGEMENT SYSTEM; SOF-TACT GLUCOSE TEST STRIP; PRECISION CONTROL SOLUTIONS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TRULIANT TIB IMP CRC INSERT SZ 3.5, 15MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·May 30, 2024
SYNOX SX 45-JBP
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code DTB·May 3, 2013
CHARGING SYSTEM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, NEUROMODULATION·Product code GZB·August 27, 2014
ADAPTA DR
FDA Adverse Event
Death
·MEDTRONIC MED REL, INC.·Product code NVZ·May 18, 2011
METASUL LDH, HEAD, 56, CODE V, TAPER 18/20
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·April 27, 2018
METASUL LDH, HEAD, 56, CODE V, TAPER 18/20
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWY·January 31, 2018
METASUL LDH, HEAD, 40, CODE F, TAPER 18/20
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·June 13, 2018
METASUL LDH, HEAD, 44, CODE J, TAPER 18/20
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KXA·October 24, 2017
METASUL HEAD 28MM L 12/14
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·August 7, 2018
METASUL HEAD 28MM L 12/14
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·August 3, 2018
METASUL, HEAD, M, 32/0, TAPER 12/14
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code LZO·March 12, 2018
METASUL LDH, HEAD, 44, CODE J, TAPER 18/20
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·February 22, 2018
ECHO BI-MTRC MICR RP SO 5X73
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·June 6, 2018
METASUL LDH, HEAD, 44, CODE J, TAPER 18/20
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·June 14, 2018
METASUL LDH, HEAD, 48, CODE N, TAPER 18/20
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·May 18, 2018
Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of diagnostic materials such as contrast media. UltraFlow HPC Flow: The device is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuroanatomy. It is not intended for use in the coronary vasculature. Catalog No. 105-5055V02 105-5055V02 105-5055V05 105-5065V02 105-5065V05 105-5066V02 105-5066V05
FDA Enforcement
Class I
·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016