9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Disposable Biopsy Refill Needle
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SEMPERMED DERMA PLUS, SIZES 5.5,6,6.5,7,7.5,8,8.5,9
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
RECONSTRUCTION LOCKING PLATE AND 3.5MM LOCKING SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
OVERJET CARIES ASSIST
FDA Adverse Event
Malfunction
·OVERJET·Product code MYN·February 18, 2025
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 23, 2024
INTELLIVUE MULTI MEASUREMENT SERVER X2
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MHX·July 12, 2011
PENTA
FDA Adverse Event
Injury
·ST JUDE MED - NEUROMODULATION·Product code GZB·October 24, 2014
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 9, 2013
BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 15, 2021