11 results
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17ms
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Sources: EU EUDAMED, US FDA
CLINITRON AIR FLUIDIZED SUPPORT SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
Bioplate®
FDA UDI
Bioplate, Inc.·M3848135840·Self-Drilling Screw - Ø1.9 mm x 4 mm (2) [10 PK]
EXCITE SELF ETCH
FDA 510(k)
FDA Class 2
·Dental
PRESSUREWIRE CERTUS, CERTUS 300, AERIS, AERIS 300, AND RECEIVER
FDA 510(k)
FDA Class 2
·Cardiovascular
KAPPA 700 DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code DXY·October 31, 2012
TRILOGY 100
FDA Adverse Event
Malfunction
·RESEPIRONICS, INC.·Product code CBK·March 26, 2014
SCREW-IN
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 25, 2010
Ingenia Elition X- For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 1) 782151; 2) 782119; 3) 781358; 4) 782107; 5) 782136
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·October 2, 2024
Ingenia Elition X- For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 1) 782151; 2) 782119; 3) 781358; 4) 782107; 5) 782136
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·September 3, 2024
Terumo Dual-stage Venous Return Cannulae 28/38, 29/37, 32/40, 34/46, 36/46 & 36/51 Fr with 1/2" flare or connector Product Usage: Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior vena cava
FDA Enforcement
Class II
·Terminated·Terumo Cardiovascular Systems Corporation·July 30, 2014
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015