22 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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REP CHOLESTEROL PROFILE CONTROL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MEGA PLUS MIS SPINE SYSTEM
FDA UDI
BK MEDITECH CO.,LTD.·08809665588876·MIS Fenestrated Screw M, Ø10.5 x 90mm, Ø5.5mm Rod
ENZY-WELL SYPHILIS IGG, MODEL 91106
FDA 510(k)
FDA Class 2
·Microbiology
CONTAFLEX 54 (hioxifilcon D) Spherical Soft Contact Lens for Daily Wear, CONTAFLEX 49 (hioxifilcon B) Spherical Soft Contact Lens for Daily Wear,
FDA 510(k)
FDA Class 2
·Ophthalmic
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
VISI-PRO¿ BALLOON-EXPANDABLE BILIARY STENT SYSTEM
FDA Adverse Event
Injury
·EV3 INC.·Product code FGE·February 8, 2013
ASR ACETABULAR CUPS 56
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code KWA·November 19, 2010
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Injury
·TANDEM DIABETES CARE INC.·Product code LZG·July 11, 2014
COMPREHENSIVE REVERSE MINI BASEPLATE & TAPER ADAPTOR
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·October 25, 2018
COMPREHENSIVE REVERSE ARCOMXL STANDARD HUMERAL BEARING
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·October 25, 2018
COMPREHENSIVE REVERSE COBALT CHROME STANDARD HUMERAL TRAY 44MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·October 25, 2018
COMPREHENSIVE REVERSE VERSA-DIAL GLENOSPHERE STANDARD
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PAO·October 25, 2018
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