9 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PROFILE -ER
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033334·Baltic Denture System BDLoad BDLoad Mn7 PLSEbi...
ENDOFLIP
FDA 510(k)
FDA Class 2
·Orthopedic
STICK NET
FDA 510(k)
FDA Class 2
·Dental
ACCU-CHEK ® AVIVA
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code NBW·April 3, 2013
ZY PACING LEAD
FDA Adverse Event
Malfunction
·OSCOR INC.·Product code DTB·March 21, 2011
6.0MM TI CURVED SOFT ROD 70MM
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code KWP·April 23, 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
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024