10 results
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17ms
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Sources: EU EUDAMED, US FDA
FITKIT I CHECKUP KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MONDEAL
FDA UDI
MONDEAL Medical Systems GmbH·04050435062278·MCD Screw 3.0 x 40 mm cannulated M2
partia...
iNSitu Hip System
FDA UDI
NEXTSTEP ARTHROPEDIX, LLC·00816127025778·Acetabular Reamer, Full Hemisphere, Crossbar, 40mm
AUTOLOGEL PROCESS CENTRIFUGE, MODEL B4360 (100-103, 100-129)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
LOCKING BONE PLATES AND SCREWS
FDA 510(k)
FDA Class 2
·Orthopedic
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 23, 2014
MEDTRONIC INSULIN PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code FPA·November 7, 2012
AUTOMATED PD SET W/CASSETTE4 PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 10, 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