9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LOC GUIDE WIRE EXTENSION
FDA 510(k)
FDA Class 2
·Cardiovascular
DENTOMAT 3 AMALGAMATORS
FDA 510(k)
FDA Class 1
·Dental
BOUNDARY REINFORCED SINGLE-USE GOWNS
FDA 510(k)V18 CONTROL WIRE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORP·Product code DQX·March 16, 2007
V18 CONTROL WIRE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code DQX·May 23, 2007
SYSTEM 7 SAG SAW
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code HWE·January 30, 2013
ACCU-CHEK SPIRIT
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS, INC.·Product code LZG·December 3, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·February 4, 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