10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Oocyte Flushing & Retrieval Medium; Gamete Buffer
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Insignia
FDA UDI
ALPHATEC SPINE, INC.·00190376264455·4.0mm Fixed Angle, Self Tapping Screw, Dual Lea...
JDEVOLUTION PLUS
FDA Adverse Event
Injury
·J DENTAL CARE SRL·Product code DZE·August 6, 2025
2300 SERIES MGO PORTABLE OXYGEN
FDA 510(k)
FDA Class 2
·Anesthesiology
MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DE1-1
FDA 510(k)
FDA Class 2
·General Hospital
TERUMO ADVANCED PERFUSION SYSTEM 1
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·October 9, 2012
GX770 INTRAORAL X-RAY SYSTEM
FDA Adverse Event
Malfunction
·GENDEX DENTAL SYSTEMS·Product code EHD·November 19, 2008
TRIATHLON CR FEM COMP #3 L-CEM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS LIMERICK·Product code JWH·August 29, 2011
SERVO-S
FDA Adverse Event
Malfunction
·MAQUET CRITICAL CARE AB·Product code CBK·July 11, 2013
Product Name: Alcon Custom Pak Model/Catalog Number: Many Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure. Component: N/A
FDA Enforcement
Class II
·Ongoing·Alcon Research LLC·August 28, 2024