21 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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