11 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
KINETIC ANTERIOR CERVICAL PLATE
FDA 510(k)
FDA Class 2
·Orthopedic
BLASTOMERE BIOPSY PIPETTE, MODELS H-55530 AND H-55540
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
APEX MEDICAL LCD TENS-VII
FDA 510(k)
FDA Class 2
·Neurology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 17, 2025
ADVANTA BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·March 19, 2013
ACCU-CHEK SPIRIT
FDA Adverse Event
Injury
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·April 11, 2011
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Malfunction
·COCHLEAR LTD.·Product code MCM·June 11, 2008
EDWARDS LOCKING SYRINGE
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code MAV·June 16, 2023
EDWARDS LOCKING SYRINGE
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES LLC·Product code MAV·March 29, 2022
THERAPY COOL PATH ABLATION CATHETER
FDA Adverse Event
Malfunction
·IRVINE BIOMEDICAL, INC.·Product code LPB·October 31, 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