12 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SENSITITRE SUSCEPTIBILITY PLATES
FDA 510(k)
FDA Class 2
·Microbiology
UHF70 Transducer
FDA UDI
FUJIFILM SONOSITE, INC.·00841517105464·
OsteoMed
FDA UDI
OSTEOMED LLC·00842528114322·1.6MM DRIVER STEM W/POST, AO SHNK, MED
STRYKER LEIBINGER SKELETAL ANCHORING SYSTEM
FDA 510(k)
FDA Class 2
·Dental
ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE, ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
Matrixx System
FDA UDI
NEXXT SPINE, LLC·00889929065624·Corpectomy, 14Dx16Wx51H 6°
Matrixx System
FDA UDI
NEXXT SPINE, LLC·00889929065310·Corpectomy, 14Dx16Wx51H 0°
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 27, 2011
RESERVOIR 3ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·October 4, 2014
Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025
Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025