21 results · 21ms · Sources: EU EUDAMED, US FDA

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NBD CEMENT RESTRICTOR DEVICE

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Timesco Healthcare Ltd

FDA registration
Timesco Healthcare Ltd·15 products·🇬🇧 United Kingdom

EVERSTICK

FDA 510(k)
FDA Class 2 ·Dental

ESTATION ELECTRONIC STETHOSCOPE, MODEL DR200

FDA 510(k)
FDA Class 2 ·Cardiovascular

ZILVER 635 BILIARY SELF EXPANDING METAL STENT

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FGE·December 17, 2018

ZILVER BILIARY SELF-EXPANDING STENT

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code FGE·March 5, 2020

ZILVER 635 BILIARY SELF EXPANDING METAL STENT

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FGE·September 26, 2018

ZILVER 635 BILIARY SELF EXPANDING METAL STENT

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FGE·August 24, 2018

ZILVER 635 BILIARY SELF EXPANDING METAL STENT

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FGE·August 24, 2018

LUMAX 540 DR-T

FDA Adverse Event
Death ·BIOTRONIK SE & CO. KG·Product code MRM·March 26, 2013

MAXIMO VR

FDA Adverse Event
Death ·MEDTRONIC MED REL, INC.·Product code LWS·March 17, 2011

ELLIPSE DR, DF-4 CONNECTOR

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·August 19, 2014

ZILVER 635 BILIARY SELF EXPANDING METAL STENT

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code FGE·October 11, 2017

ZILVER 635 BILIARY SELF EXPANDING METAL STENT

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code FGE·October 11, 2017

ZILVER 635 BILIARY SELF EXPANDING METAL STENT

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code FGE·October 11, 2017

ZILVER 635 BILIARY SELF EXPANDING METAL STENT

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FGE·August 2, 2018

ZILVER 635 BILIARY SELF EXPANDING METAL STENT

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FGE·March 5, 2020

FGE CATHETER, BILIARY, DIAGNOSTIC

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FGE·March 13, 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

The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.

FDA Enforcement
Class II ·Terminated·Welch Allyn Protocol, Inc·January 15, 2014