7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MONOJECT CORVAC STAT VAC TUBE W/THROM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (MEDICAL AND POSTEROLATERAL DISTAL HUMERUS PLATES)
FDA 510(k)
FDA Class 2
·Orthopedic
EBV V VCA IGM ELISA KIT MODEL# EBM-200
FDA 510(k)
FDA Class 1
·Microbiology
TRACER HYBRID WIRE GUIDE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC.·Product code KOG·April 11, 2014
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·November 6, 2012
2PC VSYS W/9FR INTRO KIT/2.8OD
FDA Adverse Event
Injury
·UNITED STATES SURGICAL·Product code LJT·August 27, 2010
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022