14 results
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40ms
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Sources: EU EUDAMED, US FDA
Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source
FDA 510(k)
FDA Class 2
·Radiology
PROVU (TM) DENTAL X-RAY SYSTEM
FDA 510(k)
FDA Class 2
·Dental
EZSLEEP SLEEP QUALITY RECORDER
FDA 510(k)
FDA Class 2
·Cardiovascular
AIRVO TUBE AND CHAMBER KIT WITH NEBULIZER ADAPTER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·November 23, 2021
AIRVO TUBE AND CHAMBER KIT WITH NEBULIZER ADAPTER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·April 18, 2022
AIRVO2 TUBE AND CHAMBER KIT WITH NEBULIZER ADAPTER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·January 18, 2022
GYNECARE TVT RETROPUBIC SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·June 11, 2013
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·July 14, 2011
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE INC.·Product code LZG·July 16, 2014
HEATED BREATHING TUBE AND CHAMBER KIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·April 5, 2022
AIRVO TUBE AND CHAMBER KIT WITH NEBULIZER ADAPTER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·November 18, 2021
AIRVO TUBE AND CHAMBER KIT WITH NEBULIZER
FDA Adverse Event
Malfunction
·Product code BTT·October 7, 2021
FISHER & PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code CAF·November 7, 2023
RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014