11 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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NUVASIVE MASH
FDA 510(k)
FDA Class 2
·Orthopedic
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496023319·PANTY, SIZE XXL, NOISETTE, MICRO-MASSAGING PANT...
Class A 21 CHG&E - 18 Metal
FDA UDI
Certified Safety Manufacturing, Inc.·00766588233192·Class A 21 CHG&E - 18 Metal
BIS Module (Package/ accessory/FDA)
FDA UDI
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904085968·
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMPICILLIN/SULBACTAM (0.5/0.25-64/34 UG/ML)
FDA 510(k)
FDA Class 2
·Microbiology
NONIN MODEL 2120 PULSE OXIMETER AND NONINVASIVE BLOOD PRESSURE (NIBP) MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
THORATEC® HEARTMATE 3® LVAS IMPLANT KIT
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·May 18, 2026
HEARTSTART MRX- EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·February 28, 2013
PENUMBRA SYSTEM 041
FDA Adverse Event
Injury
·PENUMBRA, INC.·Product code NRY·March 15, 2011
ECHELON 60 ENDOPATH STAPLER
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, INC.·Product code GDW·April 1, 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