9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Palm-Pro Chemo-Guard Nitrile Powder Free Examination Glove
FDA 510(k)
FDA Class 1
·General Hospital
MEDISLIM
FDA Adverse Event
Injury
·MEDICREATIONS, LLC·Product code GEX·April 27, 2020
PSYCHEMEDICS CANNABINOIDS EIA
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ZEPHYR 'X-SERIES PATIENT TRANSFER SLED
FDA 510(k)
FDA Class 2
·General Hospital
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 9, 2024
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 10, 2014
ATTAIN ABILITY
FDA Adverse Event
Death
·MPRI·Product code OJX·June 11, 2013
VASOVIEW HEMOPRO EVH SYSTEM
FDA Adverse Event
Injury
·MAQUET CARDIOVASCULAR, LLC·Product code GEI·July 11, 2011
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