11 results
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35ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HEALTH-PLUS, SANITEX, RELIANCE POWEDER-FREE STERILE LATEX SURGICAL GLOVES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
artegral life
FDA UDI
Merz Dental GmbH·D7091993201·anteriors; shade B2; mould BXL
BTL-785F
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BONE PLATE
FDA 510(k)
FDA Class 2
·Orthopedic
CONSULT HCG TEST
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code JHI·March 4, 2025
SCORPIO PS FEMUR WAFFLE W/LFIT
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code JWH·July 21, 2010
METRX SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code HRX·June 10, 2024
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FPA·March 7, 2013
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 7, 2011
CAPSUREFIX
FDA Adverse Event
Injury
·MPRI·Product code DTB·August 8, 2014
Sterile Custom Packs to be used in surgical procedures.
FDA Enforcement
Class II
·Terminated·American Contract Systems·June 10, 2020