16 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BriefCase-Quantification
FDA 510(k)
FDA Class 2
·Radiology
LEONE SPA
FDA UDI
LEONE SPA·08033707061489·BRACKETS 22 T+5 A+10 LAT U/L
Portex
FDA UDI
ICU MEDICAL, INC.·15019517072624·
MORELAND
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295123026·MORELAND REV INST EXTRACTION HOOK
Atricure Cryo Module System; cryoICE cryoablation probe
FDA 510(k)
FDA Class 2
·Neurology
LEONARDO SYNGO CARDIOLOGY WORKSTATION
FDA 510(k)
FDA Class 2
·Radiology
PURE PECTUS
FDA UDI
KLS-Martin L.P.·00888118142337·PULLOUT TRAY, INSTRUMENTS 1
PURE PECTUS
FDA UDI
KLS-Martin L.P.·00888118142320·LID, CASE, INSTRUMENTS
PURE PECTUS
FDA UDI
KLS-Martin L.P.·00888118142313·CASE, FOR INSTRUMENTS
PURE PECTUS
FDA UDI
KLS-Martin L.P.·00888118142344·PULLOUT TRAY, INSTRUMENTS 2
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·November 2, 2023
BIO-COMP INTERFSCRW W/DISP SHTH
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code MAI·October 3, 2025
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH·Product code MCM·November 24, 2008
INTERMATE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code FRN·September 9, 2011
ACCU-CHEK ® MULTICLIX
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·July 23, 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