21 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FRIALIT-2 ESTHETICBASE ABUTMENT
FDA 510(k)
FDA Class 2
·Dental
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033491928·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033491959·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033491966·
Navagio
FDA UDI
Kalitec Direct LLC·B07330K0134080·Trial, TLIF, 27L OB STR 7Deg, 8mm
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033491935·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033491911·
Phonak
FDA UDI
Phonak AG·07613275085783·Phonak Naída Q70-SP (purple transparent)
SMART RAD
FDA 510(k)
FDA Class 2
·Radiology
MAXITEX DUPLEX POWDER FREE LATEX STERILE SURGEON GLOVES PROTEIN LABELING CLAIM (50 MICRGRAMS OR LESS)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·March 20, 2013
LIGAMAX-5MM ENDO CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·March 10, 2011
SPRINT FIDELIS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·March 10, 2008
TAXUS? ELEMENT?
FDA Adverse Event
Death
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·September 18, 2013
TAXUS? ELEMENT?
FDA Adverse Event
Death
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·September 18, 2013
TAXUS? ELEMENT?
FDA Adverse Event
Death
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·September 18, 2013
TAXUS? ELEMENT?
FDA Adverse Event
Death
·Product code NIQ·September 18, 2013
TAXUS? ELEMENT?
FDA Adverse Event
Death
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·September 18, 2013
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·June 29, 2022