16 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Oph. Cystotomes
FDA UDI
KATENA PRODUCTS, INC.·00841668113738·CCC CYSTOTOME FORMED 25GA
Disposable Latex Examination Gloves (Non-Sterile), Disposable Nitrile Examination Gloves (Non-Sterile)
FDA 510(k)
FDA Class 1
·General Hospital
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112595·BARRON CORNEAL PUNCH 7.0MM
Needle aspiration and injection
FDA UDI
KATENA PRODUCTS, INC.·00841668113608·PERIBULBAR NEEDLE 25GA 22MM
IMBIBE BONE MARROW ASPIRATION SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
O-arm O2 Imaging System
FDA 510(k)
FDA Class 2
·Radiology
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 17, 2014
CARELINK PROGRAM W/TELEMETRY C
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code DXY·August 11, 2011
RESOLUTION CLIP CLIPPING DEVICE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code MND·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