2 results
·
17ms
·
Sources: EU EUDAMED, US FDA
Filters
FDA Enforcement
×
Trabecular Metal (TM) Reverse Glenosphere 36mm Part 00-4349-036-11 The reverse shoulder system is used in the treatment of the following: severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint; un-united humeral head fractures of long duration; irreducible 3 and 4-part proximal humeral fractures; avascular necrosis of the humeral head, or other difficult clinical management problems (such as a failed total shoulder arthropolastey or grossly rotator cuff deficient joint) where arthrodesis or resectional arthroplasty is not acceptable. 510(k) K130661
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·January 8, 2014
BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest.
FDA Enforcement
Class II
·Ongoing·Biointellisense Inc.·August 21, 2024