10 results
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29ms
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Sources: EU EUDAMED, US FDA
TRIGLYCERIDE (GPO) REAGENT, UNIVERSAL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
External Hex Tool
FDA UDI
STERNGOLD DENTAL LLC·00841549117947·.048", Short
3M™ Victory Series™
FDA UDI
3M UNITEK CORPORATION·00652221113337·3M™ Victory Series™ Second Molar Bands, 905-226...
CHEM 1 CLINICAL ANALYZER (METHOD URINE CALCIUM)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DEXTROLYTE II, PERITONEAL DIALYSIS NO. 48-1001-6
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ZIMMER AIR DERMATOME II HANDPIECE
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL·Product code GFD·May 28, 2014
VM1
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MHX·July 10, 2015
ACCENT DR RF
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·January 9, 2013
CIRCUIT PED 5FT DUAL-HTD 20/CS
FDA Adverse Event
Malfunction
·CAREFUSION·Product code BZE·June 1, 2012
OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts, Product Line 02-012-44-XXXX; c. OPTETRAK Logic CR Tibial Inserts, Product Line 02-012-47-XXXX; d. OPTETRAK Logic CR Slope + Tibial Inserts, Product Line 02-012-48-XXXX; e. OPTETRAK Logic CR Slope ++ Tibial Inserts, Product Line 02-012-49-XXXX; f. OPTETRAK Logic CRC Tibial Inserts, Product Line 02-012-51-XXXX; g. OPTETRAK Logic CC Tibial Inserts, Product Line 02-012-65-XXXX; Affected 510(k) numbers include: K033883, K132161, K093360, K110547, K111400, K121307, K123342, K150890. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021