11 results · 20ms · Sources: EU EUDAMED, US FDA

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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