8 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Disposable Medical Mask
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NA
FDA UDI
Synthes GmbH·10886982152909·2.4MM LOCKING SCREW SLF-TPNG WITH STARDRIVE REC...
BIOPORTA G, MODEL 2052
FDA 510(k)
FDA Class 2
·Dental
NOORVMS-OXY TISSUE OXYGEN AND TEMPERTURE MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
10-LEAD ECG TRUNK CABLE, 12-PIN, 1.3M
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE - ANDOVER·Product code MKJ·July 12, 2011
PENTA
FDA Adverse Event
Injury
·ST JUDE MED - NEUROMODULATION·Product code GZB·October 24, 2014
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·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