12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Wedge XL Delivery Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Sklar®
FDA UDI
SKLAR CORPORATION·10649111356643·SKLARLITE ROCH-PEAN CVD 7.25"
Ophthalmic Spatula
FDA UDI
KATENA PRODUCTS, INC.·00841668103234·SMILE SPATULA, DOUBLE ENDED
ImmunoCAP Total IgE Conjugate 400
FDA UDI
Phadia AB·07333066019864·ImmunoCAP Total IgE Conjugate 400
TRANSGATE GUIDE CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
MODIFICATION TO CONTOUR SE MICROSPHERES
FDA 510(k)
FDA Class 2
·Neurology
AMPLATZER TORQVUE DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL·Product code DQY·June 28, 2024
INFANT BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·November 13, 2008
DEXTRUS 4135
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVZ·August 19, 2011
LCS COMPLETE FEM POR R STD
FDA Adverse Event
Injury
·9616671 DEPUY (IRELAND)·Product code NJL·July 18, 2013
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 4MM(H) Reference Number: IEHA564
FDA Enforcement
Class II
·Terminated·Biomet 3i, LLC·March 4, 2020
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 4MM(H) Reference Number: IEHA564
FDA Enforcement
Class II
·Terminated·Biomet 3i, LLC·March 4, 2020