12 results · 28ms · Sources: EU EUDAMED, 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