15 results
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18ms
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Sources: EU EUDAMED, US FDA
SURGIN EYE SHIELD
FDA 510(k)
FDA Class 1
·Ophthalmic
LinkSymphoKnee - Instruments
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575308705·Knee tibia prosthesis trial - LinkSymphoKnee Sy...
LinkSymphoKnee - Instruments
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575308330·Knee tibia prosthesis trial - LinkSymphoKnee Sy...
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011881232180·dentaform® Snap Band, Tooth 36, Size 32/Roth 18
LinkSymphoKnee - Instruments
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575308576·Knee tibia prosthesis trial - LinkSymphoKnee Sy...
LinkSymphoKnee - Instruments
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575308453·Knee tibia prosthesis trial - LinkSymphoKnee Sy...
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011881232220·dentaform® Snap Band, Tooth 36, Size 32/Roth 22
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011881232000·dentaform® Snap Band, Tooth 36, Size 32
TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH PRAXITELES
FDA 510(k)
FDA Class 2
·Neurology
Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism, Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia
FDA 510(k)
FDA Class 2
·Ophthalmic
DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D·Product code NVY·January 13, 2014
WARMTOUCH COMPACT WARMING UNIT
FDA Adverse Event
Malfunction
·COVIDIEN/FORMERLY TYCO HEALTHCARE·Product code DWJ·October 6, 2010
PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE
FDA Adverse Event
Malfunction
·SMITHS MEDICAL INTERNATIONAL LTD.·Product code BTO·November 14, 2012
MR Coils The MR Coil is intended to be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the anatomy of interest that can be interpreted by a trained physician.
FDA Enforcement
Class III
·Terminated·Invivo Corporation·October 28, 2020
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