9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SYNTAC (DENTIN BONDING AGENT)
FDA 510(k)
FDA Class 2
·Dental
Stern EX Acid Etched Implant RP 3.75x13.0mm, Machined Collar, Ti
FDA UDI
STERNGOLD DENTAL LLC·00841549109430·The Sterngold Acid Etch Dental Implant System c...
HALO MOLAR BAND
FDA UDI
Ortho Arch Company Inc·D9099019131·L6R HALO MOLAR BAND .022 DBL CV AUX -25T BT
HI TECH IMPLANT, HT PHYSIO IMPLANT
FDA 510(k)
FDA Class 1
·Dental
CLEARFIL ST OPAQUER
FDA 510(k)
FDA Class 2
·Dental
LEAD MODEL 302
FDA Adverse Event
Malfunction
·CYBERONICS·Product code LYJ·June 30, 2014
COBAS INTEGRA 800
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·November 18, 2010
VERSACARE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·November 21, 2012
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