9 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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IMEX DOP-TONE II
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Printed Lower Crown Pack for Herbst LR7 8mm
FDA UDI
SPECIALTY APPLIANCES, LLC·D8199015930·
Map-iT
FDA UDI
ACCESS POINT TECHNOLOGIES, INC.·00818083014926·Fixed, 10 electrode, MPB, 4-4-4-29-5-5-5-5-5mm ...
MODIFICATION TO STATSIGN SALINE ELECTROLYTE GEL, GRAHAM-FIELD SALINE ELECTROLYTE GEL
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ANGIO JET ULTRA DVX AND XPEEDIOR THROMBECTOMY SETS
FDA 510(k)
FDA Class 2
·Cardiovascular
PALMAZ GENESIS AMIIA
FDA Adverse Event
Malfunction
·CORDIS DE MEXICO·Product code FGE·June 30, 2014
EXXCEL SOFT THIN WALL STR EXT S 8/70/70
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code GEI·January 4, 2013
INTEGRITY RX CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR GALWAY·Product code MAF·November 12, 2010
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