20 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Dual-Safety Pen Needle
FDA 510(k)
FDA Class 2
·General Hospital
WRIGHT RESPIROMETER, MARK 8, AND 14 RESPIROMETER, MODEL 700-021, 700-008, 700-014
FDA 510(k)
FDA Class 2
·Anesthesiology
PLAC TEST REAGENT KIT, MODELS 90107, 90112, 90115, 90116, 10-0112, 10-0113, 10-0115
FDA 510(k)
FDA Class 2
·Immunology
AESCULAP SURGICAL INSTRUMENTS
FDA Adverse Event
Injury
·CHRISTOPH MIETHKE GMBH & CO. KG·Product code JXG·November 27, 2019
AESCULAP SURGICAL INSTRUMENTS
FDA Adverse Event
Injury
·CHRISTOPH MIETHKE GMBH & CO. KG·Product code JXG·November 27, 2019
VICTORY XL DR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, CRMD·Product code LWP·January 13, 2014
DAILY ACTIVITY ASSIST DEVICES
FDA Adverse Event
PINGHU WEIFENG MATERIAL TECHNOLOGY·Product code IKX·June 26, 2013
LEAD MODEL 302
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·July 22, 2011
PROGAV SYS PED.W/SA 15 A.PRECHAMBER
FDA Adverse Event
Injury
·CHRISTOPH MIETHKE GMBH & CO. KG·Product code JXG·April 4, 2019
HEARTMATE 3 LVAS IMPLANT KIT
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·December 21, 2022
LIVER ACCESS AND BIOPSY SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·July 15, 2024
PROGAV 2.0 SYS PED.W/SA15 A.PRECHAMBER
FDA Adverse Event
Injury
·CHRISTOPH MIETHKE GMBH & CO. KG·Product code JXG·August 6, 2020
LIVER ACCESS AND BIOPSY SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·June 29, 2020
LIVER ACCESS AND BIOPSY SET
FDA Adverse Event
Injury
·COOK INC·Product code DYB·June 14, 2024
LIVER ACCESS AND BIOPSY SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·August 19, 2021
LIVER ACCESS AND BIOPSY SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·May 15, 2023
LIVER ACCESS AND BIOPSY SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·February 14, 2023
LIVER ACCESS AND BIOPSY SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·December 7, 2023
LIVER ACCESS AND BIOPSY SET
FDA Adverse Event
Injury
·COOK INC·Product code DYB·January 27, 2022
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024