8 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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WHISPERFLOW OXYGEN FLOW GENERATOR - ADJUSTABLE MODEL WF 8500 WHISPERFLOW OXYGEN FLOW GENERATOR - FIXED MODEL WF 8530 WH
FDA 510(k)
FDA Class 2
·Anesthesiology
FUSE Pedicle Screw System
FDA 510(k)
FDA Class 2
·Orthopedic
BOUFFANT CAP
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code HWC·January 4, 2017
MINI-CAP, DISCONNET WIPVP-1 SOLUTION
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code KDI·June 4, 2007
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO. MED-REL·Product code MDS·February 1, 2011
LEAD MODEL 304
FDA Adverse Event
Injury
·CYBERONICS INC·Product code LYJ·August 5, 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