11 results
·
27ms
·
Sources: EU EUDAMED, US FDA
CAREO RETRACTABLE SAFETY SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
Graves Vu-Max Large
FDA UDI
MEDGYN PRODUCTS, INC.·M8030030976·Graves Vu-Max Large 5" (127mm)
BAUMER MULLER HIP PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
DIAMOND (MAMMOGRAPHIC X-RAY SYSTEM)
FDA 510(k)
FDA Class 2
·Radiology
MICROBLATER 30 WITH INTEGRATED CABLE
FDA Adverse Event
Malfunction
·ARTHROCARE CORPORATION·Product code GEI·March 28, 2013
LIVEWIRE EP CATHETER 5F, DECA, MED SWP, 2MM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, AF DIVISION·Product code DRA·March 22, 2011
HEARTSTART MRX -EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·July 16, 2014
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
Spirit Plus Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
Spirit Select Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018