9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Stone Extraction Baskets
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
INSPIRACHAMBER ANTI-STATIC VALVED HOLDING CHAMBER
FDA 510(k)
FDA Class 2
·Anesthesiology
MEDISISS REPROCESSED ULTRASONIC SURGICAL INSTRUMENTS
FDA 510(k)
FDA Unclassified
·Unknown
NATURALYTE
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·October 22, 2014
EON MINI RECHARGEABLE IPG
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·August 12, 2011
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·July 16, 2013
9200C and 9200D Laryngeal Strobe Product Usage: The 9310HD is used to electronically record, display, transfer, and store digital video data of laryngeal or pharyngeal structures, and audio data, for medical and pedagogical applications.
FDA Enforcement
Class II
·Terminated·Pentax of America Inc·July 26, 2017
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021
CODMAN Disposable Perforator, 14mm. Cranial perforator.
FDA Enforcement
Class I
·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·May 14, 2025