11 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Palomar Icon Aesthetic System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DreamWear
FDA UDI
Respironics, Inc.·00606959056800·DreamWear Nasal Mask Kit, Small Medium with Hea...
NIHON KOHDEN CNS-6200 SERIES CENTRAL NURSE STATION, MODEL CNS-6201
FDA 510(k)
FDA Class 2
·Cardiovascular
ACUMEN SHEATH, MODEL TTW7807
FDA 510(k)
FDA Class 2
·Cardiovascular
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·October 5, 2014
PELVICOL ACELLULAR COLLAGEN MATRIX
FDA Adverse Event
Injury
·TISSUE SCIENCE LABORATORIES·Product code FTL·May 15, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code MDS·June 21, 2011
BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·November 6, 2023
Philips Upgrade to MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782130.
FDA Enforcement
Class II
·Ongoing·Philips North America·May 6, 2026
Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026