12 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CRC(CYANMETHEMOGLOBIN REAGENT CONCENT
FDA 510(k)
FDA Class 2
·Hematology
BRANAN MEDICAL CORPORATION MONITECT MORPHINE 2000 DRUG SCREEN TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
CAPNOSTREAM20 WITH INTEGRATED PULMONARY INDEX
FDA 510(k)
FDA Class 2
·Cardiovascular
BD PLASTIPAK¿ LUER-LOCK SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·June 25, 2018
PROFEMUR(R) COCR NECK
FDA Adverse Event
Injury
·MICROPORT ORTHOPEDICS INC.·Product code KWA·May 9, 2014
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·October 5, 2007
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
SHUNLONG PHYSICAL THERAPY EQUIPMENT·Product code ITJ·October 23, 2012
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·October 23, 2018
SYRINGE 30ML LL BNS
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND COMPANY·Product code FMF·September 20, 2019
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