47 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Nanova Universal Composite
FDA 510(k)
FDA Class 2
·Dental
APEX Revision Knee
FDA UDI
Omni Life Science, Inc.·00841690124016·Modular Offset Stem 19mm x 100mm x 4mm
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690128038·Revision Offset Stem 19mm x 100mm x 4mm
LEONE SPA
FDA UDI
LEONE SPA·08033707013846·CALIBRA 1ST MOL BANDS W/G8325-02 n.UR 4
Geneva
FDA UDI
Nucletron B.V.·08717213055971·Ovoid Tube 2 - Interstitial Ovoid 13mm
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613053604·ID Instrument Sheet Tape, Solid, Red, 8-1/2" x ...
Engage Partial Knee System
FDA UDI
Engage UNI LLC·B6951520040000·Left Tray
VASCON NEUROPATH GUIDING CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
ENDEAVOUR MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
TERRA NOVA MI Access System
FDA UDI
VB Spine LLC·10888857185548·Blade Handle
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·June 10, 2020
Herbert/Whipple®
FDA UDI
Zimmer, Inc.·00889024033764·
BD BBL Sensi Disc Ertapenem- 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 232174 and 232175¿
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·February 14, 2024
VISIAN ICL (IMPLANTABLE COLLAMER LENS)
FDA Adverse Event
Injury
·STAAR SURGICAL COMPANY·Product code HQL·July 7, 2011
SOLYX SIS SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 7, 2013
BAXTER
FDA Adverse Event
Malfunction
·BAXTER CORPORATION·Product code LKN·August 20, 2008
CD HORIZON® FENESTRATED SCREW SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·September 3, 2024
LINEAR ST
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 25, 2023
WIENER LAB. CA-COLOR ARSENAZO III AA, MODEL 4X50 ML CAT.NR. 1152004, WIENER LAB.CA-COLOR ARSENAZO III AA, MODEL 8 X 20 5
FDA 510(k)
FDA Class 2
·Clinical Chemistry
FLEXOR RADIAL ACCESS SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·December 12, 2017