13 results
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18ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ANTISERA TO HUMAN FAB FRAGMENT
FDA 510(k)
FDA Class 2
·Immunology
NA
FDA UDI
KEY SURGICAL, INC.·10849771049460·K-Wires, Single diamond, round end, .045-inch (...
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704293142·
K-Wire w. lanzet/round end 1.14mm/229mm, 6 pcs./unit
FDA UDI
mahe medical gmbh·EMAHKM712420·K-Wire w. lanzet/round end
1.14mm...
mahe medical GmbH
FDA UDI
mahe medical gmbh·04050659484610·K-Wire w. lanzet/round end _x000D_...
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515201750·Chandler MIS Retractor, 3/4" wide, 8 5/8"
Symmetry Aufranc
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482125755·Symmetry® Retractor, Aufranc Cobra, 10 mm Serra...
DBEST ONE STEP OCCULT BLOOD TEST KITS
FDA 510(k)
FDA Class 2
·Hematology
Alma LipoFlow System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MAXISKY 600
FDA Adverse Event
Malfunction
·ARJOHUNTLEIGH MAGOG INC·Product code FSA·January 14, 2014
COAGUCHEK XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·February 15, 2008
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 14, 2015
Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021