20 results
·
38ms
·
Sources: EU EUDAMED, US FDA
OPTI PADS
FDA 510(k)
FDA Class 2
·Ophthalmic
Medtronic Reusable Instruments
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00673978084060·INSTRUMENT 950-940 ANTR IVD 4MM 10MM CP
PMP4 MEDICAL WEB CENTER
FDA 510(k)
FDA Class 2
·Cardiovascular
Atmo Gas Capsule System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
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
UNIPLEX NANOLINE CANNULA
FDA Adverse Event
Malfunction
·PAJUNK GMBH MEDIZINTECHNOLOGIE·Product code BSP·December 22, 2010
OMNIFIT M/S PSL SHELL 56MM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code JDI·February 8, 2013
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Injury
·TANDEM DIABETES CARE INC.·Product code LZG·July 14, 2014
LIGACLIP ROTATING MULTIPLE CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code GDO·October 4, 1996
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
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024