8 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BIORETEC ACTIVASCREW, ACTIVASCREW CANNULATED AND ACTIVASCREW CANNULATED WITH ACTIVAPIN
FDA 510(k)
FDA Class 2
·Orthopedic
MICRA LENS INJECTOR, MICRA CARTRIDGE LENS, MICRA LENS LOADER
FDA 510(k)
FDA Class 1
·Ophthalmic
GLYCOSAL HBA1C TEST
FDA 510(k)
FDA Class 2
·Hematology
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 8, 2024
RESTORE SENSOR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·April 26, 2013
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·July 9, 2014
SETROX S 45
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG,·Product code NVZ·April 29, 2011
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