11 results
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17ms
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Sources: EU EUDAMED, US FDA
CERVICAL PILLOW
FDA 510(k)
FDA Class 1
·Physical Medicine
NA
FDA UDI
Richard Wolf GmbH·04055207039830·CANNULA FOR DRAINAGE Ø 4.5MM WL 71.5MM with tw...
MONDEAL
FDA UDI
MONDEAL Medical Systems GmbH·04050435062322·MCD Screw 3.0 x 50 mm cannulated M2
partia...
iNSitu Hip System
FDA UDI
NEXTSTEP ARTHROPEDIX, LLC·00816127025877·Acetabular Reamer, Full Hemisphere, Crossbar, 50mm
PROCELLERA
FDA 510(k)
FDA Unclassified
·Unknown
EXPRESS MINI GLAUCOMA SHUNT
FDA 510(k)
FDA Class 2
·Ophthalmic
STRATA II VALVE, SMALL, BIOGLIDE
FDA Adverse Event
Injury
·MEDTRONIC NEUROSURGERY·Product code JXG·May 23, 2014
POWER PRO AMBULANCE COT
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code INK·October 10, 2012
PER-Q-CATH PLUS DUAL-LUMEN MIDLINE WITH STYLET
FDA Adverse Event
BARD ACCESS SYSTEMS INC.·Product code LJS·August 19, 2010
BIOMET StageOne Knee Tibial Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 433170.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
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