11 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
UNISIGHT SYSTEM WITH UNIGATE
FDA 510(k)
FDA Class 2
·Radiology
LIFTLOC SAFETY INFUSION SET
FDA 510(k)
FDA Class 2
·General Hospital
APPALEAD GW+03XXXXXXR SERIES
FDA 510(k)
FDA Class 2
·Cardiovascular
TITAN
FDA Adverse Event
Injury
·COLOPLAST A/S·Product code FHW·June 3, 2022
OASYS BLOCKER
FDA Adverse Event
Injury
·STRYKER SPINE-FRANCE·Product code KWP·November 30, 2015
APC PLUS, CLARITY, MINI UNI-TWIN, VICTORY SERIES
FDA Adverse Event
Injury
·3M UNITEK·Product code DYH·May 9, 2012
PROPAQ LT
FDA Adverse Event
Malfunction
·WELCH ALLYN PROTOCOL, INC.·Product code DRT·March 1, 2013
ASR ACETABULAR IMPLANT
FDA Adverse Event
Malfunction
·DEPUY INTERNATIONAL, LTD.·Product code KWA·March 2, 2011
EXPRESS2 MONORAIL CORONARY STENT DELIVERY SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code MAF·April 2, 2008
Titan Pump - Product Usage: indicated for male patients suffering from erectile dysfunction (impotence) who are considered to be candidates for implantation of a penile prosthesis.
FDA Enforcement
Class II
·Terminated·Coloplast Manufacturing US, LLC·December 2, 2020
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