10 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Nihon Kohden NKV-440 Ventilator System
FDA 510(k)
FDA Class 2
·Anesthesiology
ARTIS ZEE/ZEEGO WITH CSX-10 DETECTOR SW VC21
FDA 510(k)
FDA Class 2
·Radiology
RETRO REPAIR KIT, MODEL PRRK5
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TITAN
FDA Adverse Event
Malfunction
·COLOPLAST A/S·Product code FHW·December 17, 2020
CAPTURE-R READY ID
FDA Adverse Event
Malfunction
·IMMUCOR, INC.·Product code KSZ·November 10, 2008
EXTENSION SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·August 25, 2011
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·July 12, 2013
MEDTRONIC IPG
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code NVZ·October 21, 2025
MEDTRONIC LEAD
FDA Adverse Event
Death
·MEDTRONIC, INC.·Product code DXY·October 21, 2025
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024