12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LENSAR LASER SYSTEM
FDA 510(k)
FDA Class 2
·Ophthalmic
Amara View
FDA UDI
Respironics, Inc.·00606959009233·Amara View Mask without Headgear, USA, Medium
Phonak
FDA UDI
Phonak AG·07612847818484·Phonak Ambra microP (light pink)
RTE SNAPCONE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FHW·July 11, 2023
RIGIDFIX SOFT TISSUE ACL CROSSPIN SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SYNTHETIC GLASS BONE GRAFT MATERIAL
FDA 510(k)
FDA Class 2
·Dental
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 17, 2024
REAR TIP EXTENDER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code N/A·December 30, 2025
RTE SNAPCONE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code FHW·February 17, 2021
MINICAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·May 2, 2013
5MM PEEK MULTIFUNCTION HANDLE
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY-SAN JOSE·Product code KOG·September 15, 2014
R SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·April 19, 2011