11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System, TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
Packed iTero Computing Unit RMA 5D Plus
FDA UDI
Align Technology, Inc.·00816063021049·PPC RMAs
NA
FDA UDI
SYNTHES (U.S.A.) LP·10886982152497·5.0MM LCKNG SCREW SLF-DRLG W/T25 STARDRIVE RECE...
PILLING
FDA UDI
TELEFLEX INCORPORATED·24026704514292·
VIALOK SINGLE VIAL ACCESS DEVICE VENTED
FDA 510(k)
FDA Class 2
·General Hospital
METAL HALIDE LIGHT SOURCE, MODELS MV-9088-T, MV-9088
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code LWR·October 17, 2008
CAPSURE SP NOVUS
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 15, 2011
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 9, 2013
Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10F (722002), Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 722013), Allura Xper FD20 OR Table (722015, 722023, 722035), Allura Xper FD20 Biplane OR Table (722025), Allura Xper FD20/10 (722029), Allura Xper FD20/15 (722058), Allura Xper FD20/15 OR Table (722059), Allura Xper FD20/20 (722038), Allura Xper FD20/20 OR Table (722039), Cardio Vascular-Allura (722400);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 27, 2026
DRX Revolution Mobile X-Ray System
FDA Enforcement
Class II
·Ongoing·Carestream Health, Inc.·December 13, 2023