16 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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X-MIND prime (under trade mark Acteon), I-MAX (under trade mark Owandy Radiology)
FDA 510(k)
FDA Class 2
·Dental
Oph. Cystotomes
FDA UDI
KATENA PRODUCTS, INC.·00841668113738·CCC CYSTOTOME FORMED 25GA
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668114049·J-SHAPED CANNULA 25GA STRAIGHT (PK/10)
GROSHONG NXT DUAL LUMEN PICC CATHETERS
FDA 510(k)
FDA Class 2
·General Hospital
FERMIT PLUS
FDA 510(k)
FDA Class 2
·Dental
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 30, 2025
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 9.75CM ACCESS PORT I
FDA Adverse Event
Malfunction
·COSTA RICA·Product code LTI·October 14, 2008
ENRHYTHM DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code DXY·August 11, 2011
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·July 2, 2013
CHECK-IT
FDA Adverse Event
Malfunction
·LUCIRA HEALTH, INC.·Product code QJR·September 2, 2022
CHECK-IT
FDA Adverse Event
Malfunction
·LUCIRA HEALTH, INC.·Product code QJR·September 2, 2022
CHECK-IT
FDA Adverse Event
Malfunction
·LUCIRA HEALTH, INC.·Product code QJR·September 25, 2022
CHECK-IT
FDA Adverse Event
Malfunction
·LUCIRA HEALTH, INC.·Product code QJR·August 5, 2022
CHECK-IT
FDA Adverse Event
Malfunction
·LUCIRA HEALTH, INC.·Product code QJR·September 1, 2022
OMNIPOD 5 CONTROLLER
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code QFG·August 17, 2022
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