24 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM MULTI-AXIAL SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
WMT MODULAR ULNAR HEAD IMPLANT
FDA 510(k)
FDA Class 2
·Orthopedic
RANDOX MICROALBUMIN
FDA 510(k)
FDA Class 2
·Immunology
WARMTOUCH COMPACT WARMING UNIT
FDA Adverse Event
Malfunction
·COVIDIEN/FORMERLY TYCOHEALTHCARE·Product code DWJ·August 30, 2011
WARMTOUCH COMPACT WARMING UNIT
FDA Adverse Event
Malfunction
·COVIDIEN/FORMERLY TYCO HEALTHCARE·Product code DWJ·January 12, 2011
WARMTOUCH COMPACT WARMING UNIT
FDA Adverse Event
Malfunction
·COVIDIEN/FORMERLY TYCO HEALTHCARE·Product code DWJ·April 28, 2011
WARMTOUCH COMPACT WARMING UNIT
FDA Adverse Event
Malfunction
·COVIDIEN/FORMERLY TYCO HEALTHCARE·Product code DWJ·August 30, 2011
WARMTOUCH COMPACT WARMING UNIT
FDA Adverse Event
Malfunction
·COVIDIEN/FORMERLY TYCO·Product code DWJ·July 29, 2011
WARMTOUCH COMPACT WARMING UNIT
FDA Adverse Event
Malfunction
·COVIDIEN/FORMERLY TYCO HEALTHCARE·Product code DWJ·May 25, 2011
WARM TOUCH COMPACT WARMING UNIT
FDA Adverse Event
Malfunction
·COVIDIEN/ FORMERLY TYCO HEALTHCARE·Product code DWJ·January 6, 2011
WARMTOUCH COMPACT WARMING UNIT
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY TYCOHEALTHCARE·Product code DWJ·September 2, 2011
VIASYS
FDA Adverse Event
Malfunction
·CAREFUSION 207, INC·Product code CBK·October 26, 2009
WARMTOUCH COMPACT WARMING UNIT
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY TYCO HEALTHCARE·Product code DWJ·July 14, 2010
WARMTOUCH COMPACT WARMING UNIT
FDA Adverse Event
Malfunction
·COVIDIEN / FORMERLY TYCO HEALTHCARE·Product code DWJ·July 13, 2010
WARMTOUCH COMPACT WARMING UNIT
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY TYCO HEALTHCARE·Product code DWJ·July 14, 2010
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·March 26, 2013
ENCORE BALLOON CATHETER INFLATION DEVICE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - CORK·Product code MAV·March 16, 2011
ULTRATINE FOREHEAD
FDA Adverse Event
Injury
·COAPT SYSTEMS, INC.·Product code HWC·March 27, 2008
Synthes Inserter for Titanium Elastic Nails; The Inserter for Titanium Elastic Nails (TEN) is intended for fixation of diaphyseal fractures where the canal is narrow or flexibility of the implant is paramount. This includes: lower extremity fractures in pediatric and small-statured patients and upper extremity fractures in patients. This system is also intended to treat metaphyseal and episphyseal fractures, such as radial neck fractures, and is intended for fixation of small long bones, such as carpal and tarsal bones. In pediatric applications, the flexibility of the elastic nail allows it to be inserted at a point which avoids disruption of the bone growth plate.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·March 18, 2015
VIASYS
FDA Adverse Event
Other
·CAREFUSION 207, INC·Product code CBK·October 27, 2009