10 results
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19ms
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Sources: EU EUDAMED, US FDA
SPIN-A-PULL
FDA 510(k)
FDA Class 1
·Physical Medicine
Ceramill Sintron®
FDA UDI
Amann Girrbach AG·E4947611201·
Needle Holder
FDA UDI
KATENA PRODUCTS, INC.·00841668108093·JAFFE NEEDLE HOLDER CURVED WITH LOCK
Straumann Sintron
FDA UDI
Amann Girrbach AG·E494761120STM1·
SYNERGEYES (PAFLUFOCON D HEM-IBERFILCON A) HYBRID CONTACT LENSES
FDA 510(k)
FDA Class 2
·Ophthalmic
SMR TT Metal Back Glenoid, Bone Graft instruments
FDA 510(k)
FDA Class 2
·Orthopedic
COAGUCHEK S SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JPA·July 19, 2007
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·September 26, 2012
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·December 31, 2013
Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·July 22, 2015