9 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FLIPSCREEN (TM) TOTAL E IMMUNOASSAY
FDA 510(k)
FDA Class 2
·Immunology
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011885307180·dentaform® Band, tooth 36, size 7/Roth 18
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011885307220·dentaform® Band, tooth 36, size 7/Roth 22
OLV 1100; OLV 1200 PULSE OXIMETERS
FDA 510(k)
FDA Class 2
·Cardiovascular
ALKALINE PHOSPHATASE REAGENT SET
FDA 510(k)
FDA Class 2
·Clinical Chemistry
LIGAMAX
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·June 19, 2014
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 25, 2010
PROLIFT PELVIC FLOOR REPAIR
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·December 26, 2012
CORAIL AMT COXA VARA NECK SEGMENT (KLA) Pro. Code L20432 Product Usage: The affected CORAIL Neck Trials are surgical instruments used in CORAIL total and partial hip arthroplasty.
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·April 17, 2019