12 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GME ExSys 308
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Oticon
FDA UDI
Oticon A/S·05707131281999·H15V2, MINIBTE 312 WL 85 STG
HNM MEDICAL
FDA UDI
HNM STAINLESS, LLC.·00842962162095·BABY TISCHLER PUNCH, 10", 2MMX4MM, TIP UP, TITA...
LINEAR ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·December 29, 2024
AESCULAP ORTHOPILOT 2 THA V 2.0
FDA 510(k)
FDA Class 2
·Neurology
PEAK UNIVERSAL BOND (LIGHT CURE RESIN ADHESIVE AND CHLORHEXIDINE)
FDA 510(k)
FDA Class 2
·Dental
ACCESSORIES
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR INC.·Product code DQX·March 20, 2025
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 6, 2011
RESTORE
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·June 6, 2013
GE OEC 9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 9, 2008
GUIDE WIRE, BALL-TIPPED, STERILE T2 FEMUR Ø3X1000 MM
FDA Adverse Event
Malfunction
·STRYKER TRAUMA KIEL (MDR)·Product code LXH·May 29, 2015
Phaco Standalone Tips
FDA Enforcement
Class II
·Ongoing·Alcon Research, LTD.·August 23, 2023