13 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DISPOSABLE CHIBA-TYPE NEEDLE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
FDA 510(k)
FDA Class 2
·Microbiology
VANCE PERCUTANEOUS MALECOT NEPHROSTOMY
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
REUSABLE NEONATAL SINGLE HEATED BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·February 9, 2017
JAMSHIDI BONE MARROW TRAY 11G X4 15G ASP
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code KNW·March 12, 2026
PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER
FDA Adverse Event
Death
·PENUMBRA, INC.·Product code NRY·May 15, 2014
SPRINT
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 31, 2012
RENAL - DISPOSABLE
FDA Adverse Event
Death
·Product code FKX·August 24, 2010
FISHER & PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·October 15, 2025
REUSABLE NEONATAL SINGLE HEATED BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·May 23, 2023
JAMSHIDI BONE MARROW TRAY 11G X4 15G ASP
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code LWE·October 8, 2025
Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; 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 FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025