8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ODC B2 BIPOLAR CUP
FDA 510(k)
FDA Class 2
·Orthopedic
KISS OF MINT(TM) NON-LUBRICATED CONDOM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Sysmex XN-L Automated Hematology Analyzer
FDA 510(k)
FDA Class 2
·Hematology
CADD-LEGACY® PCA AMBULATORY INFUSION PUMP
FDA Adverse Event
Injury
·SMITHS MEDICAL ASD INC.,·Product code MEA·March 29, 2016
6.0MMTI PANGEA (TM) POLYAXIAL
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code NKB·February 26, 2013
CARDIOVASCULAR PROCEDURE KIT
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORPORATION·Product code OEZ·January 14, 2011
TOTAL ASR ACET IMP SIZE 58
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·August 6, 2014
Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024