9 results
·
22ms
·
Sources: EU EUDAMED, US FDA
FLOTATION PAD FOR OPERATING TABLE
FDA 510(k)
FDA Class 1
·General Hospital
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209133383·
GUIDANT RETRIEVER DEVICE
FDA 510(k)
FDA Class 2
·Cardiovascular
DENJECTOR
FDA 510(k)
FDA Class 2
·Dental
BRILLIANCE 64
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.·Product code JAK·April 25, 2014
OBTAPE TRANSOBTURATOR SLING
FDA Adverse Event
Injury
·MENTOR WORLDWIDE LLC·Product code FTL·October 12, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC.·Product code LFR·September 27, 2007
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022
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