11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IntraClude Intra-Aortic Occlusion Device
FDA 510(k)
FDA Class 2
·Cardiovascular
BIOMET HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304256712·
Biomet® Hip System
FDA UDI
Biomet Orthopedics, LLC·00887868310737·
GUTTA PERCHA POINTS
FDA UDI
DiaDent Group International·08806383562010·Gutta Percha Points is used to root canal filin...
FORSURE ONE STEP FECAL OCCULT BLOOD (FOB) SCREEN CARD TEST
FDA 510(k)
FDA Class 2
·Hematology
VANTAGE ABI
FDA 510(k)
FDA Class 2
·Cardiovascular
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 11, 2013
RSP SHOULDER
FDA Adverse Event
Other
·ENCORE MEDICAL, L.P.·Product code KWS·June 15, 2011
CONTOUR TEST STRIPS (50)
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE, LLC.·Product code NBW·September 9, 2008
BD PHOENIX¿ NMIC-306
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·December 10, 2024
Natural-Knee System Patella Bushings. Orthopedic surgical instrument. Part Number 6290-00-690. 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