48 results
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21ms
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Sources: EU EUDAMED, US FDA
STRYKER SWITCHPOINT INFINITY 3 CONTROL SYSTEM, MODEL: 067-8001-000
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Bur PM2-70 80K steelØ1.8x80 St
FDA UDI
Bien-Air Surgery SA·17630055512915·
MICRO ANEURYSM CLIP
FDA UDI
SONTEC INSTRUMENTS, INC.·B09921008520·MICRO ANEURYSM CLIP STRAIGHT JAW
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100152111·IN-OVATION® C Base Rx 022 U5-5 CS-BC HK
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100152611·IN-OVATION® C Roncone 022 U5-5 CS-BC HK
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100152101·IN-OVATION® C Base Rx 022 U5-5 CS HK
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100152001·IN-OVATION® C Base Rx 022-U5-5
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100152801·IN-OVATION® C EURO 022 U5-5 CS HK
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100152811·IN-OVATION® C EURO 022 U5-5 CS-BC HK
RENEW NEUROSTIMULATION SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
OSMED TISSUE EXPANDER
FDA 510(k)
FDA Class 2
·Ophthalmic
Widex
FDA UDI
Widex A/S·05706069723496·Widex D-XP ITE (Dark brown S-330 ) Telecoil, RC...
Widex
FDA UDI
Widex A/S·05706069725742·Widex EVOKE E-CIC (Dark brown S-330 ) Right, RC...
Widex
FDA UDI
Widex A/S·05706069724424·Widex UNIQUE U-CIC (Dark brown S-330 ) Right, R...
Widex
FDA UDI
Widex A/S·05706069725148·Widex EVOKE E-XP (Dark brown S-330 ) Telecoil, ...
Widex
FDA UDI
Widex A/S·05706069724783·Widex D-CIC (Dark brown S-330 ) Right, RC coil
Widex
FDA UDI
Widex A/S·05706069723014·Widex UNIQUE U-XP ITE (Dark brown S-330 ) Telec...
Widex
FDA UDI
Widex A/S·05706069722598·Widex mind330 M3-X ITE (Dark brown S-330 ) Tele...
COULTER AC*T DIFF 2 ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·May 8, 2013
SUR-FIT NATURA STOMAHESIVE FLEXIBLE SKIN BARRIER W/FLANGE W/WHITE TAPE CAOLLAR A
FDA Adverse Event
Injury
·CONVATEC, INC.·Product code EXE·September 12, 2014