10 results
·
26ms
·
Sources: EU EUDAMED, US FDA
MONOSPHERICAL SHOULDER PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
CAMERON-MILLER
FDA UDI
CAMERON-MILLER INC·B3708021230·
ACUMED
FDA UDI
Acumed LLC·10806378090455·Total Wrist Fusion Plating System Lid
DEXTEX II STERILIZATION WRAP
FDA 510(k)
FDA Class 2
·General Hospital
VIZION DR
FDA 510(k)
FDA Class 2
·Radiology
CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·October 23, 2012
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·December 30, 2013
CIDEX PLUS 28 DAY SOLUTION
FDA Adverse Event
Injury
·ADVANCED STERILIZATION PRODUCTS·Product code LRJ·August 17, 2010
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021
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