13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ORTHOFIX ACP (ANTERIOR CERVICAL PLATE SYSTEM)
FDA 510(k)
FDA Class 2
·Orthopedic
LARGE CANNULATED SCREWS
FDA UDI
Smith & Nephew, Inc.·03596010064042·CANNULATED HIP PIN 50MM
AFFINITY CP CENTRIFUGAL BLLOD PUMP WITH CARMEDA BIOACTIVE SURFACE
FDA 510(k)
FDA Class 2
·Cardiovascular
WATERLASE MD TURBO PLUS MODEL 7200XXX
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BD SYR 10ML SURESCRUB POSIFLUSH SALINE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·June 19, 2019
SYR 10ML SURESCRUB POSIFLUSH SALINE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·May 3, 2019
SYR 10ML SURESCRUB POSIFLUSH SALINE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·June 4, 2019
QUICKFLEX MICRO LV LEAD
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, CRMD·Product code NIK·January 13, 2014
PLATINUM PLUS?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code DQX·May 21, 2013
SIGMA PS CEM FEM SZ3 L
FDA Adverse Event
Injury
·DEPUY (IRELAND)·Product code JWH·June 2, 2011
SYR 10ML SURESCRUB POSIFLUSH SALINE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·April 24, 2019
SYR 10ML SURESCRUB POSIFLUSH SALINE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·August 14, 2020
ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).
FDA Enforcement
Class II
·Ongoing·FUJIFILM Healthcare Americas Corporation·August 6, 2025