9 results
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25ms
·
Sources: EU EUDAMED, US FDA
ALBUMIN (BCP)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Natural-Knee System Patella Bushings Orthopedic surgical instrument. Part Number 6290-00-704. 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
EPIC Extremely Small Staple
FDA 510(k)
FDA Class 2
·Orthopedic
EVOKED RESPONSE STIMULATORS
FDA 510(k)
FDA Class 2
·Neurology
BONE ANCHOR SYSTEM FOR SOFT TISSUE SUPPORT
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - SPENCER·Product code MBI·April 27, 2012
React Health PHOENIX 5L Oxygen Concentrator
FDA Recall
Open, Classified
·3B Medical, Inc.
5475 Rings Rd Ste 550
Dublin OH 43017-7537·Product code CAW·February 4, 2026
ATTAIN ABILITY
FDA Adverse Event
Injury
·MPRI·Product code OJX·June 10, 2014
CAPSUREFIX
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 9, 2010
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·December 10, 2012