23 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LAPAROSCOPE, ROD-LENS VIEWING AND OPERATING ENDOSCOPE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BR2000 BLADES
FDA UDI
Peter Brasseler Holdings, LLC·00887919739036·K5-1990-35
BR2000 BLADES
FDA UDI
Peter Brasseler Holdings, LLC·00887919100232·K5-1990-50
NA
FDA UDI
STERILMED, INC.·10888551007542·SAW BLADE SAGITTAL K9 K2000 SERIES
Tissue Removal System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ECHELON MICRO CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
BONEE NEEDLE FOR BLADDER INJECTION
FDA Adverse Event
Malfunction
·COLOPLAST A/S·Product code FBK·January 8, 2025
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
SPRINT QUATTRO
FDA Adverse Event
Injury
·MPRI·Product code LWS·February 9, 2013
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·January 4, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 23, 2014
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