16 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EXETER HIP STEM
FDA 510(k)
FDA Class 2
·Orthopedic
NeoPAP Cannula - XXS
FDA UDI
CIRCADIANCE, LLC·B0361110290·NeoPAP Cannula - XXS
TRUELOK SYSTEM
FDA UDI
ORTHOFIX SRL·18056099649490·TL PLUS THREADED HINGE ROD L30MM
NIDO Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07315K1102000·Tray, 2 inch base
LipiVage®
FDA UDI
GENESIS BIOSYSTEMS, INC.·00818257020012·LipiVage Harvester
LipiVage®
FDA UDI
GENESIS BIOSYSTEMS, INC.·00818257020029·LipiVage Harvester with cannula
ONE TOUCH ULTRA
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·July 30, 2002
AFX INTRODUCER SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
ESTEMP NE
FDA 510(k)
FDA Class 2
·Dental
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 7, 2025
EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope EG-3870UTK Ultrasound Video Gastroscope FG-36UX Ultrasound Fiber Gastroscope Used to provide optical and sonographic visualization of and therapeutic access to the Upper Gastrointestinal Tract.
FDA Enforcement
Class II
·Terminated·Pentax Medical Company·July 30, 2014
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·September 29, 2015
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 13, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 23, 2014
Video Duodenoscope
FDA Enforcement
Class II
·Terminated·Pentax Medical Company·June 8, 2016
Spectral CT. Computed tomography X-ray system.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·July 2, 2025