7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
DISPOSABLE RADIOLUCENT RUBBER DAM CLAMP
FDA 510(k)
FDA Class 1
·Dental
MICRO-AIRE SOFT-ICE, COLD THERAPY COMPRESS
FDA 510(k)
FDA Class 1
·Physical Medicine
OXICOMPLUS
FDA 510(k)
FDA Class 2
·Cardiovascular
PLUM A+ TRIPLE NEW 8
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·May 16, 2014
GEMSTAR DOCK STA
FDA Adverse Event
Malfunction
·HOSPIRA, INC.·Product code FRN·November 2, 2010
HEARTSINE SAMARITAN 300P AND PAD PAK
FDA Adverse Event
Malfunction
·HEARTSINE TECHNOLOGIES LTD·Product code MKJ·December 19, 2012
Arthrex IBalance TKA Tibial Tray Size 2 - Catalog # AR-503-TTTC, Size 3 - Catalog # AR-503-TTTD, Size 4 -Catalog # AR-503-TTTE, Size 5 - Catalog # AR-503-TTTF, Size 6 - Catalog # AR-503-TTTG , Size 7 -Catalog # AR-503-TTTH, and Size 8 - Catalog # AR-503-TTTJ. Intended for implantation with bone cement, with the exception of the porous coated femoral components which can be used cemented or uncemented (biological fixation).
FDA Enforcement
Class II
·Terminated·Arthrex, Inc.·March 30, 2016