58 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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KARL STORZ INSULATED BIOPSY FORCEPS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PHOENIX 5 URODYNAMICS SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
INSET PATELLAR COMPONENT
FDA 510(k)
FDA Class 2
·Orthopedic
WIRELESS BATTERY MODULE G
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP.·Product code FRN·January 11, 2013
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·December 6, 2010
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·July 18, 2014
BD ALARIS PUMP MODULE INFUSION SET
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·May 30, 2023
BD AS LVP 20D 2SS CV
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FPA·August 18, 2022
BD ALARIS PUMP MODULE SMARTSITE INFUSION SET
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·November 2, 2022
BD ALARIS PUMP MODULE SMARTSITE INFUSION SET
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·November 2, 2022
PKG, METZENBAUM SCISSORS, CURVED LONG, P/N 0250080265. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014
AS LVP 20D 2SS CV
FDA Adverse Event
Malfunction
·Product code FPA·May 26, 2021
AS LVP 20D 2SS CV
FDA Adverse Event
Malfunction
·Product code FPA·June 18, 2021
UNSPECIFIED BD INTRAVASCULAR ADMINISTRATION SET
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FPA·May 26, 2021
UNSPECIFIED BD ALARIS INFUSION SET
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FPA·May 28, 2021
UNSPECIFIED BD PUMP SET
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FPA·April 16, 2021
AS LVP 20D DEHP 3SS CV
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·April 27, 2021
UNSPECIFIED BD TUBING SET
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FPA·May 19, 2021
BD ALARIS PUMP MODULE SMARTSITE INFUSION SET
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FPA·December 14, 2021
AS LVP 20D 2SS CV
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·April 8, 2021