9 results
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21ms
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Sources: EU EUDAMED, US FDA
CARDIOLIPIN IGG,M,A EIA TEST KIT
FDA 510(k)
FDA Class 2
·Immunology
Ophthalmic Forceps
FDA UDI
KATENA PRODUCTS, INC.·00841668106310·CASTROVIEJO FORCEPS 0.5MM
Cooley Vascular Clamp
FDA UDI
KOROS U.S.A., INC.·10840199540096·Cooley Vascular Clamp Large 60 Degree 16.5cm 6-...
RAPID FORSURE ONE STEP MULTIPLE DRUG (UP TO 6) SCREEN TEST DEVICE FOR AMPHETAMINE, METHAMPHETAMINE, BENZOYLECGONINE, THC
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Magicore System
FDA 510(k)
FDA Class 2
·Dental
VIRTUOSO DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·February 9, 2013
VITALITY 2
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·January 7, 2011
3.5MM CORTEX SCREW SELF-TAPPING 20MM
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·July 23, 2014
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