7 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
MODIFICATION TO KAVO QUATTROCARE
FDA 510(k)
FDA Class 2
·Dental
TC-PLUS POROUS TIBIAL COMPONENTS
FDA 510(k)
FDA Class 2
·Orthopedic
DR180-II
FDA 510(k)
FDA Class 2
·Cardiovascular
HEARTSTART MRX - EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·April 9, 2013
GIA 60-3.8 SINGLE US RELOADABLE STAPLER
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY USSC PUERTO RICO, INC.·Product code GDW·September 5, 2014
RESTORE RECHARGABLE NEUROSTIMULATOR
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·July 8, 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