16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Arthrex Plates, Screws, and Staples
FDA 510(k)
FDA Class 2
·Orthopedic
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526768505·GENUMEDI PSS GREEN VI
OSS™ Orthopedic Salvage System
FDA UDI
Biomet Orthopedics, LLC·00880304239777·
AGXO
FDA UDI
Oticon A/S·05707131289018·H110V2 TI, RITE 312 WL STG AGXO
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613084875·K-Wire, Double Ended, Trocar Point, Diameter 0....
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100134·KRATZ-BARRAQUER SPECULUM LEFT EYE
Femoral Cutting Block Size 1
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215074364·
CVUE ADVANCED DEFINITIVE
FDA 510(k)
FDA Class 2
·Ophthalmic
MEDRAD AVANTA FLUID MANAGEMENT INJECTION SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC·Product code MKJ·August 8, 2016
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 6, 2013
SYNCHRON LX20 PRO SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·June 8, 2011
GE OEC 9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 9, 2008
CUSA EXCEL 23KHZ STANDARDTIP
FDA Adverse Event
Malfunction
·INTEGRA LIFESCIENCES(IRELAND)·Product code LFL·March 15, 2016
CUSA EXCEL 23KHZ STANDARDTIP
FDA Adverse Event
Malfunction
·INTEGRA LIFESCIENCES(IRELAND)·Product code LFL·March 15, 2016
Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black; MT20649-PNK, Receiver (mg/dL), Pink; MT20649-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.
FDA Enforcement
Class I
·Terminated·Dexcom Inc·April 20, 2016