9 results
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36ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ABC IN-LINE BLOOD SAMPLING KIT
FDA 510(k)
FDA Class 1
·Anesthesiology
CD 3700 SL
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS DIVISION/CELLDYN·Product code GKZ·May 23, 2007
TENS PRO 900
FDA 510(k)
FDA Class 2
·Neurology
PEDIATRIC INTRA-AORTIC BALLOON CATHETERS
FDA 510(k)
FDA Class 2
·Cardiovascular
HALO XP ELECTROPHYSIOLOGY CATHETER WITH AUTO ID
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code DRF·June 13, 2012
UNKNOWN PATELLA
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·February 11, 2013
TENDRIL SDX
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·January 10, 2011
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 24, 2014
Acumatch L-Series BIPOLAR LINER, 22mm (BIPOLAR ENDOPROSTHESIS-Hip), Item Numbers: a) 100-22-19, SZ. L; b) 100-22-20, SZ. M; c) 100-22-21, SZ. N; d) 100-22-22, SZ. P; e) 100-22-23, SZ. R; f) 100-22-24, SZ. S; g) 100-22-25, SZ. T
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·July 10, 2024