12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EARP Interbody System
FDA 510(k)
FDA Class 2
·Orthopedic
Oticon
FDA UDI
Oticon A/S·05707131376145·OPN S 1, MINIRITE 312 2.4G NFM PB C090
Deltec
FDA UDI
ICU MEDICAL, INC.·10610586040214·
PALINDROME H, SI, HSI CHRONIC CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LIFESTYLES LUXE PREMIUM PERSONAL LUBRICANT
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 23, 2024
PLASMABLADE 3.0 WIDE SPATULA
FDA Adverse Event
Malfunction
·MEDTRONIC ADVANCED ENERGY·Product code DWG·October 30, 2014
CLINICATH PERIPHERALLY INSERTED CATHETER
FDA Adverse Event
Malfunction
·SMITHS MEDICAL MD (FORMERLY DELTEC, INC)·Product code LJS·March 12, 2007
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·July 9, 2013
PRIMEADVANCED
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 28, 2014
DRX Revolution Mobile X-Ray System
FDA Enforcement
Class II
·Ongoing·Carestream Health, Inc.·December 13, 2023
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