14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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V-PRIMER
FDA 510(k)
FDA Class 2
·Dental
Medtronic Reusable Instruments
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994866707·HOLDER 2942017 XPAK DILATOR HOLDER
Instrument Case
FDA UDI
KATENA PRODUCTS, INC.·00841668110928·STERILIZING CASE SINGLE VR
Ophthalmic Scissors
FDA UDI
KATENA PRODUCTS, INC.·00841668105184·TERRY MICRO CORNEAL SCISSORS LEFT
X-PORTE ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
BAHA DIVINO
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code PQF·January 15, 2018
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·January 15, 2018
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code OYC·August 3, 2017
OTOLOGY VENT TUBE
FDA Adverse Event
Injury
·MEDTRONIC XOMED INC.·Product code ETD·August 9, 2017
LEAD MODEL 302
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·February 4, 2013
GEMSTR 1.2 MICRN ASV
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·November 9, 2010
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 5, 2014
BD SEDI-40
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code JKA·August 24, 2022