9 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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RIVULET VENTRICULAR AND SNAP SHUNT AND CONVERTIBLE VENTRICULAR CATHETERS, MODELS 41701 AND 41704-41715
FDA 510(k)
FDA Class 2
·Neurology
PERFORMATRAK
FDA UDI
Respironics, Inc.·00606959011601·PerformaTrak Full Mask with Standard Elbow, wit...
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code PQF·June 26, 2020
THE SUAD DEVICE
FDA 510(k)
FDA Class 2
·Dental
SYNTHES SYNEX SPACER SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
LTV
FDA Adverse Event
Malfunction
·CAREFUSION 203, INC·Product code CBK·April 3, 2013
BRAVO
FDA Adverse Event
Malfunction
·GIVEN IMAGING LTD.·Product code FFT·April 7, 2011
HOMECHOICE AUTOMATED PD SET W/CASSETTE - 4 PRONG
FDA Adverse Event
Malfunction
·Product code FKX·June 19, 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