11 results
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24ms
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Sources: EU EUDAMED, US FDA
CHIROFLEX LENS MICROSERT
FDA 510(k)
FDA Class 1
·Ophthalmic
Brigade
FDA UDI
Nuvasive, Inc.·00887517963857·Brigade Lateral Trial, 9x38x32mm 12°
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·July 5, 2024
PREGNANCY ONE STEP RAPID TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2
FDA 510(k)
FDA Class 2
·Neurology
PRESSUREGUARD EASY AIR
FDA Adverse Event
Malfunction
·SPAN-AMERICA MEDICAL SYSTEM, INC.·Product code FNM·November 12, 2010
LARYNGOSCOPE
FDA Adverse Event
Malfunction
·KARL STORZ·Product code CCW·December 31, 2012
530G INSULIN PUMP
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·June 30, 2014
STEALTHSTATION¿ S8 SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·May 8, 2025
RESONANCE STENT SET
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FAD·April 25, 2014
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