11 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EEG NEUROAMP, MODEL CS10137
FDA 510(k)
FDA Class 2
·Neurology
LACTOSORB CRANIOFACIAL ANCHOR-PUSH SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
ACON THC ONE STEP MARIJUANA TEST STRIP(URINE);ACON THC ONE STEP MARIJUANA TEST DEVICE (URINE)
FDA 510(k)
FDA Class 2
·Clinical Toxicology
AMNISURE ROM TEST
FDA Adverse Event
Malfunction
·QIAGEN SCIENCES, INC.·Product code NQM·March 24, 2025
VERCISE GENUS?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code NHL·May 30, 2025
PEN NDL 32G 6MM 3B TW 100CT US
FDA Adverse Event
Malfunction
·BECTON DICKNSON AND CO. - DUN LAOGHAIRE CO, IRELAND·Product code FMI·February 14, 2024
PEN NDL 32G 6MM 3B TW 100CT US
FDA Adverse Event
Malfunction
·EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND·Product code FMI·February 24, 2025
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 23, 2013
UNKNOWN DEPUY MBT TRAY
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JWH·April 26, 2011
TENDRIL ST
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·July 11, 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