9 results
·
23ms
·
Sources: EU EUDAMED, US FDA
DUCKWORTH & KENT, LTD., IMPLANTATION SYSTEM, MODEL DK7786
FDA 510(k)
FDA Class 1
·Ophthalmic
AARON 2100 HIGH FREQUENCY ELECTROSURGICAL GENERATOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
XTRAC EXCIMER LASER SYSTEM, MODEL AL 7000
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 7, 2025
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·April 26, 2013
*
FDA Adverse Event
Malfunction
·B. BRAUN MEDICAL, INC.·Product code FPA·July 6, 2008
OMNIPOD INSULIN PUMP
FDA Adverse Event
Injury
·INSULET CORPORATION·Product code LZG·April 29, 2011
MEDISLIM
FDA Adverse Event
Injury
·MEDICREATIONS, LLC·Product code GEX·April 27, 2020
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