11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Urea Nitrogen, Medicon Hellas Glucose, Medicon Hellas Total Bilirubin, Medicon Hellas Direct Bilirubin
FDA 510(k)
FDA Class 2
·Clinical Chemistry
OsteoMed
FDA UDI
OSTEOMED LLC·00845694053303·1.6mm ICON Rainbow Drill, Long Cannula, J-Latch
EEG WITH VIDEO, MODEL EX-NW
FDA 510(k)
FDA Class 2
·Neurology
D.SIGN 15 (DW286 B)
FDA 510(k)
FDA Class 2
·Dental
Hill-Rom® Heart and Respiration Rate Monitoring System powered by EarlySense®
FDA UDI
EARLYSENSE LTD·07290016169232·
SROM STM STD 36+12L 13X18
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·March 5, 2020
MICRO DRILL MEDIUM STRAIGHT ATTACHMENT
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code ERL·July 1, 2011
NATURALYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·October 22, 2014
OT ULTRA EASY METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 2, 2013
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 2024
CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquisition and computer aided chromosome analysis system which assists the operator in viewing chromosomes and looking for cellular anomalies. CytoVision enables a qualified Cytogeneticist to rapidly and accurately analyze the chromosome banding pattern.
FDA Enforcement
Class III
·Terminated·Leica Biosystems Richmond Inc.·June 29, 2016