58 results · 30ms · Sources: EU EUDAMED, 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