9 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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WallFlex Biliary PLUS RX Stent System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
devemed
FDA UDI
devemed GmbH·04061644032853·dev-aspir 1 | Suction cannula tip Ø6.0mm
Insert...
Reicodent
FDA UDI
devemed GmbH·04061644061631·REIC-aspir 1 | Suction cannula tip Ø6.0mm
Inser...
VAG O SPECULUM, MODELS VS1, VM1, VL1
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Acrobat Calibrated Tip Wire Guide
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·November 21, 2008
FORTIFY VR, DF-4 CONNECTOR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·September 11, 2011
ZIMMER M/L TAPER FEMORAL STEM
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code LPH·July 19, 2013
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