38 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
AVA NAVIGATOR PEEK SPACERS, MODEL 48392XXX, 48393XXX
FDA 510(k)
FDA Class 2
·Orthopedic
Bur PM2-70 80K Diam Ø3.1x80 St
FDA UDI
Bien-Air Surgery SA·17630055514841·
TISSUE FORCEPS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896049901·TISSUE FORCEPS TUNGSTEN CARBIDE SERRATED TIP
BIO-KINETIX® THERMAL NITANIUM®ARCHWIRES
FDA UDI
Ortho Organizers, Inc.·00190707058517·.017 X .025 Lower Bio-Kinetix® Thermal Nitanium...
Monoblock Tibial Trial UC Insert
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215043537·
Zavation
FDA UDI
Zavation LLC·00197157002237·6.5mm Cannulated Tap
UA Temporization Sleeve
FDA UDI
BICON, LLC·00813110027085·UA6 SP-TP Temporization Sleeves (3)
AMSCO CENTURY MEDIUM STERILIZER, MODEL CENTURY
FDA 510(k)
FDA Class 2
·General Hospital
QUIK-CAP
FDA 510(k)
FDA Class 2
·Neurology
Widex
FDA UDI
Widex A/S·05706069727913·Widex EVOKE E-FA (Titanium grey S-440 ) Telecoi...
Widex
FDA UDI
Widex A/S·05706069729917·Widex EVOKE E-FP (Titanium grey S-440 ) Telecoi...
Widex
FDA UDI
Widex A/S·05706069727517·Widex EVOKE E-FM (Titanium grey S-440 ) RC coil
LEAD MODEL 302
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·May 8, 2013
SUR-FIT NATURA DURAHESIVE SKIN BARRIER W/CONVEX-IT W/45MM(1 3/4")FLANGE W/WHITE
FDA Adverse Event
Injury
·CONVATEC, INC.·Product code EXE·September 12, 2014
D.A.S.H. DOMETIP DOUBLE LUMEN SPHINCTEROTOME
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL, INC.·Product code KNS·May 13, 2011
DIVA
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·July 7, 2020
DIVA
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·July 7, 2020
SENRI
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code DQY·December 25, 2016
METACROSS RX PTA BALLOON DILATATION CATHETER
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·October 15, 2019
TherMax Blood Warmer Unit
FDA Enforcement
Class II
·Terminated·Baxter Healthcare Corporation·November 6, 2019