9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SORIBIE RESURFACING TOTAL ELBOW SYSTEM (PROPOSED NAME)
FDA 510(k)
FDA Class 2
·Orthopedic
SIGMA
FDA UDI
DEPUY (IRELAND)·10603295232544·SIGMA FEMORAL TC3 CEMENTED 2 RIGHT
SIGMA PS CEM FEM SZ2.5 R
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JWH·April 9, 2020
Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright
FDA 510(k)
FDA Class 2
·Radiology
ACCUVIX V7 DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
REVOLUTION 45 MHZ ROTATIONAL IMAGING CATHETER
FDA Adverse Event
Malfunction
·VOLCANO CORPORATION·Product code OBJ·May 29, 2014
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
DANYANG MAXTHAI MEDICAL EQUIPMENT·Product code ITJ·February 13, 2013
TOTALCARE
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·December 17, 2010
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024