12 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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XN CAL
FDA 510(k)
FDA Class 2
·Hematology
MINI MAXLOCK EXTREME PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
XPAND BALLOON-EXPANDABLE TRANSHEPATIC BILIARY STENT SYSTEM, MODELS 20587, 20588, 20589, 20603, 20604, 20605
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PLEURX LOCKABLE DRAINAGE LINE SET
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code DWM·April 2, 2026
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 4, 2014
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 28, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 28, 2011
PLEURX
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code DWM·September 26, 2025
PLEURX
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code DWM·June 2, 2025
PEN NEEDLE AUTOSHIELD DUO 30GX5MM
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·November 24, 2020
CVS Pharmacy Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 050428102909 item # 409170 Used to secure, close and support small cuts and wounds.
FDA Enforcement
Class II
·Terminated·ASO, LLC·August 14, 2013
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024