11 results
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26ms
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Sources: EU EUDAMED, US FDA
MAGNESIUM ASSAY KIT, CAT.# 100-12
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Edge™ Diamond ND008-3F Composite Needle
FDA UDI
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172002660·Diamond dental bur, reusable
REVELATION DIAMOND
FDA UDI
Ss White Burs, Inc.·D6909128252·REVELATION DIAMOND 856-012SC - 5 PACK
Gen. Acces/ Instr. Tip Guard
FDA UDI
KATENA PRODUCTS, INC.·00841668110867·TIP GUARDS VENTED BLUE PACK OF 100
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450309070·
AVITA ARM TYPE BLOOD PRESSURE MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
HEARTTRENDS
FDA 510(k)
FDA Class 2
·Cardiovascular
ACRYSOF
FDA Adverse Event
Other
·ALCON RESEARCH, LTD. / HUNTINGTON·Product code HQL·November 5, 2010
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·November 30, 2012
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 3, 2014
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021