21 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BioQuick®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR70612511·BioQuick-Brackets FACE Evolution II System .022...
SPROTTE®
FDA UDI
Pajunk GmbH Medizintechnologie·04048223104590·Needle
SPROTTE®
FDA UDI
Pajunk GmbH Medizintechnologie·04048223115312·Needle
3M™ Unitek™ Victory Series™
FDA UDI
3M UNITEK CORPORATION·00652221020369·Victory Series(TM) BuccalTube Double Convert We...
SPROTTE® 2.G
FDA UDI
Pajunk GmbH Medizintechnologie·14048223024277·SPROTTE® 2.G
Standa...
SNIPER, MODEL OR-3872XX SERIES
FDA 510(k)
FDA Class 2
·Cardiovascular
SPARC SLING SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SMARTMONITOR 2 PS
FDA Adverse Event
Malfunction
·PHILLIPS RESPIRONICS - CHMV·Product code FLS·February 21, 2014
RX ACCUNET CAROTID EMBOLIC PROTECTION SYSTEM
FDA Adverse Event
Injury
·GUIDANT VASCULAR SOLUTIONS·Product code NFA·July 27, 2006
SMART MONITOR 2 PS
FDA Adverse Event
Malfunction
·PHILIPS RESPIRONICS -CHMV·Product code NPF·August 26, 2014
RX ACCUNET EMBOLIC PROTECTION SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code NTE·August 19, 2009
PCA PLS II
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·April 10, 2013
TI CLICK'X LOCKING CAP FOR TI 3-D HEAD
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code KWP·April 11, 2011
FREESTYLE FREEDOM
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·June 19, 2008
SMARTMONITOR 2 PROFESSIONAL SERIES
FDA Adverse Event
Malfunction
·PHILIPS RESPIRONICS - CHMV·Product code FLS·August 23, 2013
SMART MONITOR 2 PS
FDA Adverse Event
Malfunction
·PHILIPS RESPIRONICS - CHMV·Product code NPF·May 30, 2013
SMART MONITOR 2 PS
FDA Adverse Event
Malfunction
·PHILIPS RESPIRONICS - CHMV·Product code NPF·September 4, 2013
SMART MONITOR 2 PS
FDA Adverse Event
Malfunction
·PHILIPS RESPIRONICS - CHMV·Product code NPF·October 11, 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