5 results
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11ms
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Sources: EU EUDAMED, US FDA
Contra-Angles CA1:1L EVO 15 Catalog numbers: 1600939-001 and 1600938-001 Used for generally dentistry procedures
FDA Enforcement
Class II
·Terminated·Bien Air Dental SA·September 30, 2015
JK Bariatric Beds, True Air Technologies, Inc.
FDA Enforcement
Class II
·Terminated·SCM True Air Technologies LLC·May 28, 2014
MaXair True Low Air Loss Mattress Replacement System, True Air Technologies, Inc.
FDA Enforcement
Class II
·Terminated·SCM True Air Technologies LLC·May 28, 2014
ECATS E 850 Bariatric Bed, True Air Technologies, Inc.
FDA Enforcement
Class II
·Terminated·SCM True Air Technologies LLC·May 28, 2014
Ki Mobility, Little Wave Tyke (Weight Limit: 95 lbs), Specifically the IFU The Little Wave Tyke is a manually operated device that can be used for medical purposes and is used to assist a disabled person to move from one place to another while sitting. Intended to be used by persons up to 95 pounds for transport.
FDA Enforcement
Class III
·Terminated·Ki Mobility Llc·January 19, 2022