9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GRASPING FORCEPS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Young Specialties
FDA UDI
Young Innovations, Inc.·00843471188293·.022 U/R STD. WELD SIZE #6
DIAGNOSTIC HYBRIDS D3 DFA VARICELLA-ZOSTER VIRUS IDENTIFICATION KIT, 01-020000
FDA 510(k)
FDA Class 2
·Microbiology
Arthrex FiberTape Cerclage
FDA 510(k)
FDA Class 2
·Orthopedic
PROFEMUR(R) MODULAR FEMORAL NECK
FDA Adverse Event
Injury
·MICROPORT ORTHOPEDICS INC.·Product code LWJ·April 24, 2014
THOR STANDARD SCREW 6.0X31MM
FDA Adverse Event
Malfunction
·STRYKER SPINE BORDEAUX·Product code KWQ·October 1, 2012
GUNTHER TULIP FEMORAL VENA CAVA FILTER
FDA Adverse Event
Injury
·COOK, INC.·Product code DTK·July 21, 2010
InnoWave Sonic Irrigator, There are currently six models (PCF, Pro, Ultra, Ultra+, Unity, and ECO) - Product Usage: STERIS InnoWave Sonic Irrigators are intended to thoroughly clean (remove tissue, blood, and other contaminants from) a variety of reusable surgical instruments. The equipment provides sonic irrigation (ultrasonic cavitation) to both interior and exterior of lumened instruments.
FDA Enforcement
Class II
·Terminated·Steris Corporation·August 5, 2020
Alcon Custom Pak
FDA Enforcement
Class II
·Ongoing·Alcon Research, LTD.·August 23, 2023