14 results
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32ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Macroduct Advanced Model 3710
FDA 510(k)
FDA Class 2
·Physical Medicine
SignaLoc Screw
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215116736·
PROMEDICAL SURGICAL GOWNS, MODELS: 1002494A, 100770A
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NEXSITE 9FR DUAL LUMEN CRITICAL CARE CENTRAL VENOUS CATHETER
FDA 510(k)
FDA Class 2
·General Hospital
COVIDIEN
FDA Adverse Event
Malfunction
·CARDINAL HEALTH, INC.·Product code KNT·July 24, 2024
COVIDIEN
FDA Adverse Event
Malfunction
·CARDINAL HEALTH, INC.·Product code KNT·July 24, 2024
KANGAROO
FDA Adverse Event
Malfunction
·CARDINAL HEALTH 200, LLC·Product code KNT·January 28, 2026
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·June 20, 2013
COLLEAGUE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 27, 2011
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS INC.·Product code CBK·October 15, 2014
STEALTHSTATION S7 NAVIGATION
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·December 7, 2020
Natural-Knee System Patella Bushings Orthopedic surgical instrument. Part Number 6290-00-704. Per the Natural-Knee II Primary System Surgical Technique, the patellar bushing is placed on the cut surface of the patella and used as a guide for the matching size patella cutter
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·September 10, 2014
ROSA Brain 3.0 Application-Brain
FDA Enforcement
Class II
·Terminated·MEDTECH SAS·February 19, 2020
Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.
FDA Enforcement
Class II
·Ongoing·Draegar Medical Systems, Inc.·May 4, 2022