10 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VITEK ANAEROBE IDENTIFICATION CARD, MODIFICATION
FDA 510(k)
FDA Class 1
·Microbiology
XPS 3000 SYSTEM WITH RECIPROCATING ADAPTER AND SUCTION CANNULAE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CYGNUS Anterior Cervical Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code MEH·October 15, 2025
SWARTZ 8.5F BRAIDED TRANS INTRODUCER, SL0, 63CM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, AF DIVISION·Product code DYB·November 22, 2010
FINELINE II
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVN·January 11, 2013
ACCU-CHEK ® INFORM II TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·July 2, 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; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 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