15 results · 22ms · Sources: EU EUDAMED, US FDA

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COMFIT

FDA 510(k)
FDA Class 1 ·General Hospital

SINGLE LUMEN CATHETERS, MODIFICATION

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

STOCKERT-SHILEY ATRIAL LEFT VENTRICULAR VENT CATH

FDA 510(k)
FDA Class 2 ·Cardiovascular

CHAMBER COMPLETE AUTOFEED 900

FDA Adverse Event
Malfunction ·Product code BTT·May 5, 2021

CHAMBER COMPLETE AUTOFEED 900

FDA Adverse Event
Malfunction ·Product code BTT·January 21, 2020

LIGASURE ADVANCE PISTOL GRIP

FDA Adverse Event
Malfunction ·COVIDIEN LP·Product code GEI·January 30, 2013

GREENLIGHT ADDSTAT

FDA Adverse Event
Malfunction ·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·December 29, 2010

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

FDA Adverse Event
Injury ·BAXTER HEALTHCARE CORPORATION·Product code KDJ·July 18, 2014

VENTED HUMIDIFICATION CHAMBER

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·July 17, 2023

VENTED AUTOFEED HUMIDIFICATION CHAMBER

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·February 20, 2023

VENTED AUTOFEED HUMIDIFICATION CHAMBER

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·January 23, 2024

CHAMBER COMPLETE AUTOFEED 900

FDA Adverse Event
Malfunction ·Product code BTT·June 3, 2021

FISHER & PAYKEL HEALTHCARE

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·May 15, 2024

CHAMBER COMPLETE AUTOFEED 900

FDA Adverse Event
Malfunction ·Product code BTT·February 4, 2021

PKG, 3MM INSERT, MARYLAND, FORCEPS CURVED, 20CM, P/N 0250282011 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