14 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Cartesion Prime (PCD-1000A/3) V10.8
FDA 510(k)
FDA Class 2
·Radiology
Medicom Safemask
FDA UDI
AMD Medicom Inc·10686864056918·Medicom Safemask ArchitectPro - Surgical/N95 Re...
Needle aspiration and injection
FDA UDI
KATENA PRODUCTS, INC.·00841668113608·PERIBULBAR NEEDLE 25GA 22MM
CLOTRAC HEPARINASE TEST CARTIDGE (HTC) COAGULATION CONTROL
FDA 510(k)
FDA Class 2
·Hematology
MICROFIX
FDA 510(k)
FDA Class 2
·Orthopedic
ACTIVA
FDA Adverse Event
Injury
·NEURO - VILLALBA·Product code MHY·April 7, 2014
ACTIVA
FDA Adverse Event
Injury
·NEURO - VILLALBA·Product code MHY·April 7, 2014
EON
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·October 23, 2014
ENRHYTHM DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code DXY·August 11, 2011
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 2, 2013
MultiDiagnost Eleva; x-ray system. Product Codes: 708032, 708036
FDA Enforcement
Class II
·Terminated·Philips Electronics North America Corporation·August 10, 2016
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
paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024
smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024