12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TOXOPLASMA GONDII SEROLOGICAL REAGENTS
FDA 510(k)
FDA Class 2
·Microbiology
FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
FUKUDA DENSHI
FDA 510(k)
FDA Class 2
·Cardiovascular
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 9, 2014
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·October 24, 2012
FREESTYLE
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code NBW·August 31, 2007
ALINITY M RESP-4-PLEX AMPLIFICATION REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT MOLECULAR, INC.·Product code QJR·December 8, 2022
ALINITY M RESP-4-PLEX AMPLIFICATION REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT MOLECULAR, INC.·Product code QJR·December 8, 2022
ALINITY M RESP-4-PLEX AMPLIFICATION REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT MOLECULAR, INC.·Product code QJR·December 8, 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
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