14 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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REAL INTELLIGENCE CORI
FDA 510(k)
FDA Class 2
·Neurology
NA
FDA UDI
DEPUY MITEK, LLC·10886705007172·Cancellous Screw 6.5mm x 55mm
TISSUE FORCEPS MICRO SURGICAL 7" ROUND STRAIGHT SMOOTH
FDA UDI
W.H. Holden, Inc.·D9282202550·
Symmetry Ribbon
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482045725·Symmetry® Retractor, Ribbon, Malleable, 2 in Wi...
SacroFuse
FDA UDI
SPINEFRONTIER, INC.·00190361035893·FENESTRATED SCREW, CANNULATED, Ø12MM x 55MM, SA...
LINK Instruments - Saw and drill guides
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575341399·Orthopaedic implant aiming/guiding block, reusa...
RIWO NET OPERATING OPERATING CONTROL SYSTEM, MODEL #5590
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PHILIPS MICRODOSE
FDA 510(k)
FDA Class 2
·Radiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 9, 2025
PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES
FDA Adverse Event
EMG TECHNOLOGY CO. LTD·Product code BTI·November 3, 2014
OCTRODE PERCUTANEOUS LEAD
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·August 16, 2011
DURATA STS OPTIM ACTIVE FIXATION
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·July 11, 2013
dS Breast 7ch 3.0T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 4, 2024
Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected system. Affected PCs: XRay PC, Suite PC, and FlexViewing PC Azurion Model Name - Model Number: Azurion 3 M12 722063 722221; Azurion 3 M15 722064 722222; Azurion 5 M20 722228; Azurion 7 B12 722067 722225; Azurion 7 B20 722068 722226; Azurion 7 M12 722078 722223; Azurion 7 M20 722079 722224;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024