11 results
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27ms
·
Sources: EU EUDAMED, US FDA
BIODEX SYSTEM 2,MODEL S2-S
FDA 510(k)
FDA Class 2
·Physical Medicine
PathFinder NXT Minimally Invasive Pedicle Screw System
FDA UDI
Highridge Medical, LLC·03662663161237·Bevel Tip Targeting Needle with Luer Lock
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·04546540355324·INSTRUMENT TRAY F. MAND. FRACTURE INSTR
MATIRA ANTERIOR CERVICAL SYSTEM
FDA UDI
Kalitec Direct LLC·B07307K0130201·PLATE CALIPER
VenaPro Vascular Therapy System
FDA 510(k)
FDA Class 2
·Cardiovascular
IMMULISA ENHANCED (TM) CARDIOLIPIN IGA, IGG, IGM AND IGA/IGG/IGM ANTIBODY (ACA) ELISAS
FDA 510(k)
FDA Class 2
·Immunology
ULTRASAFE X225L PR WHITE SSL
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code MEG·October 28, 2020
PRECISION XTRA/OPTIUM
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE LIMITED UK·Product code NBW·November 15, 2007
AMPLATZER TORQVUE FX DELIVERY SYSTEM
FDA Adverse Event
Injury
·AGA MEDICAL CORPORATION·Product code DQY·January 14, 2013
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 14, 2014
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024