8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
SEMI-OVAL MODULAR SUNTANNING BOOTH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
EASE-A-CULT
FDA 510(k)
FDA Class 2
·Hematology
RAVEN PROTEST - STEAM BIOLOGICAL INDICATOR
FDA 510(k)
FDA Class 2
·General Hospital
PLUMSET CLAVE PORT CLAVE SITE 103IN NDHP
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·February 21, 2014
ENDOPATH** XCEL* BLADELESS TROCAR
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·October 24, 2012
CAPSURE SP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 17, 2010
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