14 results · 30ms · Sources: EU EUDAMED, US FDA

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HYDROCOIL EMBOLIC SYSTEM (HYDROSOFT) AND MICROPLEX COIL SYSTEM (HYPERSOFT)

FDA 510(k)
FDA Class 2 ·Neurology

XTD THROMBECTOMY CATHETER, XX CM

FDA 510(k)
FDA Class 2 ·Cardiovascular

TAMPONS

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

FDA Adverse Event
Injury ·ABBOTT VASCULAR·Product code MGB·December 27, 2022

XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM

FDA Adverse Event
Malfunction ·ABBOTT VASCULAR·Product code NIQ·May 5, 2020

PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

FDA Adverse Event
Injury ·ABBOTT VASCULAR·Product code MGB·December 27, 2022

PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

FDA Adverse Event
Injury ·ABBOTT VASCULAR·Product code MGB·December 27, 2022

DPM CENTRAL STATION

FDA Adverse Event
Malfunction ·MINDRAY DS USA, INC.·Product code MHX·April 30, 2013

GRANUFLO

FDA Adverse Event
Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·August 22, 2014

M2A MAGNUM MODULAR HEAD

FDA Adverse Event
Injury ·BIOMET UK LTD.·Product code KWA·April 28, 2011

Z NAIL CMF 10.5 X 95LAG SCR

FDA Adverse Event
Injury ·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·July 14, 2022

Z NAIL CMF 11.5MMX17.5CM 125R

FDA Adverse Event
Injury ·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·July 14, 2022

XIENCE SIERRA

FDA Adverse Event
Injury ·ABBOTT VASCULAR·Product code NIQ·December 18, 2019

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