13 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FLOCAP
FDA 510(k)
FDA Class 2
·Anesthesiology
PIVOX™ Oblique Lateral Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169606173·SPACER 2133540 OLIF25 27MM 18 DEG 16X40
OsteoMed
FDA UDI
OSTEOMED LLC·00845694035477·3.5mm x 40mm Locking Screw
Freedom Pedicle Screw System
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215027667·
TRANSXCHANGE SUPPORT CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
PSORIA-LIGHT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Gibralt
FDA UDI
Choice Spine, LP·10885862303073·
Gibralt®
FDA UDI
INNO Holdings, Inc.·M711050021335400·Posterior Cervical, Rod, Prebent, CoCr, 3.5mm x...
ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER
FDA Adverse Event
Malfunction
·MEDTRONIC CRYOCATH LP·Product code OAE·April 20, 2016
NC TREK CORONARY DILATATION CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LOX·October 1, 2014
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 29, 2013
ENTERRA
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LNQ·June 15, 2011
Compress, Mini Compress; Item Nos. 178350 178351 178352 178353 178354 178355 178356 178357 178358 178359 178360 178361 178362 178363 178364 178365 178366 178367 178368 178369 178370 178371 178372 178373 178464 178472 178480 178488 178496 178504 178575 178576 178577 178578 178579 178580 178730 178731 178732 178733 178734 178735 178354S 178754 178755 178756 178757 178758 178759 Product Usage: 1) Correction of revision of unsuccessful osteotomy, arthrodesis or previous joint replacement 2) Tumor resections 3) Revision of previously failed total joint arthroplasty 4) Trauma The ComPreSs Distal Femoral Replacement System is intended for uncemented use.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·December 4, 2019