9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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I.V. SETS WALRUS BRAND VARIOUS CONFIGUR-
FDA 510(k)
FDA Class 2
·General Hospital
HICUT HIGHSPEED INSTRUMENT
FDA 510(k)
FDA Class 2
·Neurology
NuEra Tight RF Model OptiStream
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ABBOCATH-T 20G 1-1/4
FDA Adverse Event
Malfunction
·AMSINO MEDICAL CO., LTD·Product code FOZ·April 27, 2009
ABX MINOTROL 16
FDA Adverse Event
Other
·HORIBA MEDICAL·Product code GKZ·June 6, 2013
MINICAP TRANSFER SET
FDA Adverse Event
Injury
·BAXTER HEALTHCARE-MOUNTAIN HOME·Product code KDJ·May 23, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·November 13, 2012
CURRENT RF VR
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·September 10, 2010
Pinnacle Cups, Part numbers 121701048 121701050 121701052 121701054 121701056 121701058 121701060 121701062 121711048 121711052 121712050 121712052 121712056 121722048 121722050 121722052 121722054 121722056 121722058 121722060 121722062 121731048 121731050 121731052 121731054 121731056 121731058 121731060 121731062 121732048 121732050 121732052 121732054 121732056 121732058 121732060 121732062 121732064 - Product Usage: The PINNACLE CUP devices are part of the Pinnacle Hip Solution for the anatomic reconstruction of the hip joint, which promotes prosthetic joint load and function.
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·January 13, 2021