15 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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