11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IMMILITE TOTAL IGE
FDA 510(k)
FDA Class 2
·Immunology
N/A
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994550811·CADDY 7960067 SCREW
Titan Reverse Shoulder System
FDA UDI
Smith & Nephew, Inc.·00885556863886·RSS GLENOSPHERE REMOVAL HANDLE
MASKMEDIC CONCEPT NASAL MASK
FDA 510(k)
FDA Class 2
·Anesthesiology
RenovoCath
FDA 510(k)
FDA Class 2
·Cardiovascular
Titan™
FDA UDI
Ascension Orthopedics, Inc.·10381780245476·Titan™ Reverse Shoulder System
The handle is us...
¿GLENOSPHERE REMOVAL HANDLE MOD¿
FDA Adverse Event
Malfunction
·ASCENSION ORTHOPEDICS·Product code LXH·December 12, 2017
INTERLOCK¿
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - CORK·Product code KRD·August 3, 2015
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·January 13, 2011
NATURALYTE
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·July 17, 2014
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