11 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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LACTOSORB CRANIOFACIAL ANCHOR-PUSH SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
DISTRACTION SYSTEM
FDA UDI
BIOMET MICROFIXATION, INC·00841036010874·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033510735·
INSET II
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·January 9, 2026
JAX GRANULES BONE VOID FILLER
FDA 510(k)
FDA Class 2
·Orthopedic
ACON THC ONE STEP MARIJUANA TEST STRIP(URINE);ACON THC ONE STEP MARIJUANA TEST DEVICE (URINE)
FDA 510(k)
FDA Class 2
·Clinical Toxicology
SMARTSETMV ENDURANCE 20 G
FDA Adverse Event
Injury
·DEPUY CMW·Product code LOD·March 20, 2013
IVENT 201
FDA Adverse Event
Malfunction
·VERSAMED MEDICAL SYSTEMS LTD.·Product code CBK·February 3, 2011
SIGMA 300 DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code DXY·March 10, 2008
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
Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.
FDA Enforcement
Class II
·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014