18 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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D²RS and D²RS 9090
FDA 510(k)
FDA Class 2
·Radiology
NA
FDA UDI
Synthes GmbH·10886982156365·1.3MM Y-PLATE 3 HOLES HEAD/ 8 HOLES SHAFT
G-DERM POWDER-FREE SYNTHETIC SURGICAL GLOVE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
MONARCH SPINE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
FISHER & PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code QAV·August 12, 2025
INTERSTIM II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code EZW·February 16, 2012
MECHANICAL CHAIR/TRANSPORT CHAIR
FDA Adverse Event
KENSTONE METAL·Product code INM·November 3, 2014
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 24, 2011
POSEY BED
FDA Adverse Event
Malfunction
·J. T. POSEY CO.·Product code OYS·July 1, 2013
FISHER & PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code QAV·April 17, 2026
FISHER & PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code QAV·January 29, 2026
FISHER & PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code QAV·April 10, 2026
FISHER & PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code QAV·January 22, 2026
FISHER & PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code QAV·April 17, 2026
FISHER & PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code QAV·December 27, 2025
FISHER & PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code QAV·September 16, 2025
THORATEC® HEARTMATE 3¿ SYSTEM CONTROLLER
FDA Adverse Event
Malfunction
·THORATEC CORPORATION·Product code DSQ·January 14, 2026
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 2024