84 results
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21ms
·
Sources: EU EUDAMED, US FDA
INTELLIGENT DOSING SYSTEM FOR INSULIN-MY INSULIN DOSER
FDA 510(k)
FDA Class 2
·Anesthesiology
PMMA disc
FDA UDI
Dentsply International Inc.·D00180825120·
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776095505·Teardrop Suction Tube, Tapered
RONGEUR #12 LUER
FDA UDI
W.H. Holden, Inc.·D928100825120·
SETPOINT ENDOVASCULAR TEMPERATURE MANAGEMENT SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
TORAYSULFONE DIALYZER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
FDA Adverse Event
Injury
·SYNTHES USA·Product code NKB·March 25, 2015
ASAHI REXEED-LX SERIES DIALYZER
FDA Adverse Event
Injury
·ASAHI KASEI MEDICAL CO., LTD.·Product code KDI·May 4, 2012
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 10, 2011
COBAS 8000 E602 MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JLW·April 29, 2013
STERRAD NX STERILIZER
FDA Adverse Event
Malfunction
·ADVANCED STERILIZATION PRODUCTS·Product code MLR·July 24, 2008
LOCKING CAP
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code KTT·October 19, 2012
LOCKING CAP
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code KTT·October 19, 2012
LOCKING CAP
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code KTT·October 19, 2012
LOCKING CAP
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code KTT·October 19, 2012
STERITITE Containers: STERITITE Container Kit, 1/4 size, 3" high, product code: 13902; STERITITE Mini Mid Size, 3" high, product code: 13903; STERITITE Container Kit, 1/2 size, 4" high, product code: 13904; STERITITE Container Kit, 3/4 size, 4" high, product code: 13905; STERITITE Container Kit, Full size, 4" high, product code: 13906. The ASP STERITITE sealed container system provides an efficient and cost-effective way to package and protect surgical instruments for sterilization, transportation, storage, and aseptic presentation of contents.
FDA Enforcement
Class III
·Terminated·Advanced Sterilization Products·December 11, 2013
OT VITA METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·December 20, 2010
OT VITA METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·March 24, 2011
OT VITA ENHANCED METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·January 12, 2012
OT VITA METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·March 21, 2011