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

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AVAULTA SUPPORT SYSTEM/AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM

FDA 510(k)
FDA Class 3 ·Obstetrics/Gynecology

MODIFICATION TO MALE TO MALE LUER ADAPTER

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

ENTERYX INJECTOR

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

RESONANCE STENT SET

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code FAD·December 13, 2018

RESONANCE STENT SET

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code FAD·October 31, 2018

V12 COVERED STENT

FDA Adverse Event
Malfunction ·ATRIUM MEDICAL CORP.·Product code JCT·April 12, 2013

FOUNDATION SHOULDER SYSTEM

FDA Adverse Event
Other ·ENCORE MEDICAL, L.P.·Product code HSD·June 20, 2008

ARCTIC FRONT CARDIAC CRYOABLATION CATHETER

FDA Adverse Event
Injury ·MEDTRONIC CRYOCATH LP·Product code OAE·April 13, 2011

RESONANCE STENT SET

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code FAD·October 6, 2023

RESONANCE STENT SET

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FAD·July 25, 2018

RESONANCE STENT SET

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code FAD·May 29, 2015

RESONANCE STENT SET

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code FAD·October 11, 2018

RESONANCE STENT SET

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code FAD·November 22, 2018

RESONANCE STENT SET

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code FAD·September 27, 2023

RESONANCE STENT SET

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code FAD·August 13, 2018

RESONANCE STENT SET

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FAD·September 12, 2018

RESONANCE STENT SET

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code FAD·August 16, 2018

RESONANCE STENT SET

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code FAD·January 22, 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

CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

FDA Enforcement
Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015