12 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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SYNTHES (USA) CHRONOS
FDA 510(k)
FDA Class 2
·Orthopedic
APOLLO Ankle Fracture Plating System
FDA UDI
Glw, Inc.·18435711004174·APOLLO Ankle Fracture Plates / 4.3mm / Non-Lock...
MICRORUPTER V
FDA 510(k)
FDA Class 2
·Ophthalmic
HA-TI (HAND TITANIUM SCREW) IMPLANT
FDA 510(k)
FDA Class 2
·Dental
NUVASIVE
FDA Adverse Event
Injury
·NUVASIVE·Product code NKB·January 10, 2011
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·February 21, 2025
GRAFTON PLUS¿ DBM
FDA Adverse Event
Malfunction
·Product code NUN·August 28, 2020
GRAFTON PLUS¿ DBM
FDA Adverse Event
Malfunction
·Product code NUN·August 28, 2020
STEALTHSTATION S7 SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·April 9, 2013
OXIMAX N-595 PULSE OXIMETER
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY TYCO HEALTHCARE·Product code DQA·February 23, 2011
VITALITY 2 DR
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 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