18 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TRANSFLOW TEST
FDA 510(k)
FDA Class 2
·Anesthesiology
KHEIRON® Spinal Fixation System, including patient specific K-ROD
FDA 510(k)
FDA Class 2
·Orthopedic
OSM3 HEMOXIMETER
FDA 510(k)
FDA Class 1
·Clinical Toxicology
S3 ROLLER PUMP
FDA Adverse Event
Other
·SORIN GROUP DEUTSCHLAND (SORIN GROUP USA, INC. IS DISTRIBUTOR)·Product code DTQ·April 23, 2010
3 TO 1 REDUCTION DRIVE
FDA Adverse Event
Other
·SORIN GROUP DEUTSCHLAND·Product code DTQ·December 14, 2011
S3 ROLLER PUMP MODULE AND CONSOLE
FDA Adverse Event
Malfunction
·SORIN GROUP DEUTSCHLAND (SORIN GROUP USA, INC. IS DISTRIBUTOR·Product code DTQ·March 24, 2010
3-TO-1 REDUCTION DRIVE
FDA Adverse Event
Other
·SORIN GROUP DEUTSCHMAND·Product code DTQ·December 14, 2011
STOCKERT S3 CONSOLE
FDA Adverse Event
Other
·SORIN GROUP DEUTSCHLAND·Product code DTQ·October 6, 2011
STOCKERT S3 CONSOLE
FDA Adverse Event
Other
·SORIN GROUP DEUTSCHLAND·Product code DTQ·October 6, 2011
HI-TORQUE BALANCE MIDDLE WEIGHT
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR·Product code DQX·January 30, 2013
RESERVOIR 1.8ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·July 23, 2014
EASYTRAK 2
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code OJX·January 10, 2011
Vanguard XP Tibial Tray 75 mm Item # 195251
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 18, 2019
SENSOR, LOW LEVEL II
FDA Adverse Event
Malfunction
·SORIN GROUP DEUTSCHLAND·Product code DTQ·April 16, 2010
S3 ROLLER PUMP
FDA Adverse Event
Other
·SORIN GROUP DEUTSCHLAND (SORIN GROUP USA, INC. IS DISTRIBUTOR)·Product code DTQ·April 23, 2010
S3 ROLLER PUMP
FDA Adverse Event
Malfunction
·SORIN GROUP DEUTSCHLAND·Product code DTQ·April 22, 2010
S3 ROLLER PUMP
FDA Adverse Event
SORIN GROUP DEUTSCHLAND·Product code DWB·October 12, 2016
BLOOD CARDIOPLEGIA INSERTS
FDA Adverse Event
Malfunction
·SORIN GROUP DEUTSCHLAND·Product code DTQ·March 24, 2010