10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SIMPLEX/SARAL
FDA UDI
PARAMOUNT SURGICALS, INC.·00852647007917·3 LEVEL CERVICAL PLATE 67 MM
TriVerse Modular Tray Trial
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215097660·
PROGRESS GUIDE WIRE FAMILY, PILOT GUIDE WIRE FAMILY
FDA 510(k)
FDA Class 2
·Cardiovascular
IMTEC SENDAX MDI ORTHO6 AND ORTHO8
FDA 510(k)
FDA Class 2
·Dental
CURRENT RF DR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·November 10, 2008
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 10, 2011
HI-TORQUE INTERMEDIATE GUIDE WIRE
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code DQX·July 12, 2013
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 2024
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018