19 results
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24ms
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Sources: EU EUDAMED, US FDA
IQMARK EZ STRESS
FDA 510(k)
FDA Class 2
·Cardiovascular
CURON CONTROL MODULE ELECTROSURGICAL GENERATOR AND ACCESSORIES, MODEL S500-ST
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MODIFICATION TO: CSC14 BLOOD CARDIOPLEGIA SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
ST. JOSEPH HSP BALTIMORE MD1
FDA Adverse Event
Other
·SORIN GROUP USA, INC.·Product code DWF·October 1, 2010
UNSPECIFIED SAFESET TRANSPAC SETS
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code DRS·January 2, 2025
QUATTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·April 2, 2013
COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL
FDA Adverse Event
Malfunction
·STAAR SURGICAL CO.·Product code HQL·May 22, 2008
COGNIS
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·April 13, 2011
MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·June 11, 2021
CSC14 BLOOD CARDIOPLEGIA SYSTEM
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTR·December 23, 2020
CHILDRENS MERCY KS CITY MO1
FDA Adverse Event
Other
·SORIN GROUP USA, INC.·Product code DTZ·August 10, 2010
SIMULUS FULLY FLEXIBLE ANNULOPLASTY BAND
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·September 30, 2020
SMART, PERFUSION PACKS, CONNECTORS, TUBING
FDA Adverse Event
Malfunction
·LIVANOVA USA·Product code DWE·August 1, 2023
CSC14 CARDIOLOGIA HEAT EXCHANGER
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTR·April 20, 2023
CSC14 BLOOD CARDIOPLEGIA SYSTEM
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTR·March 10, 2016
CSC14 BLOOD CARDIOPLEGIA SYSTEM
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTR·November 20, 2015
CSC14 BLOOD CARDIOPLEGIA SYSTEM
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTR·October 18, 2019
CHILDRENS MERCY KS CITY MO1
FDA Adverse Event
Other
·SORIN GROUP USA, INC.·Product code DTZ·August 10, 2010
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