10 results · 21ms · Sources: EU EUDAMED, US FDA

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ANATOMIC PROPORTIONAL SHOULDER APS (HEMI-SHOULDER) SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

TRANSDUCER PROTECTOR

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

SLEEPAP

FDA 510(k)
FDA Class 2 ·Anesthesiology

COBAS C 503 ANALYTICAL UNIT

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·April 2, 2026

S-ROM TOTAL HIP SYSTEM ZTT OVERSIZE PROXIMAL SLEEVE

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JDI·January 25, 2013

SPECTRUM INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORP·Product code FRN·February 3, 2014

SPRINT QUATTRO SECURE

FDA Adverse Event
Death ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·December 22, 2010

POWERPICC SOLO CATHETER W/ SHERLOCK 3CG (TPS) STYLET 4F FULL TRAY

FDA Adverse Event
Malfunction ·C.R. BARD, INC. (BASD) -3006260740·Product code LJS·September 11, 2023

COBAS C 303 ANALYTICAL UNIT

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·May 22, 2026

ASSISTO Arm System Table-mounted self retaining instrument holder system consisting of stainless steel tubular, articulated arms. Product Usage: ASSISTO Arm Systems with a holding power of up to 50N are designed as universal support systems for ventilator tubing and breathing tubes. When equipped with the appropriate accessories these arm systems may also be used to hold endoscopes. They are usually proved with non-insulated clamp sockets. All ASSISTO Arm Systems with a holding power of up to 100N are designed as universal support and holding systems for endoscope holders and detractors or other accessories. These systems are attached to the operating table with an electrically insulated clamp socket and are designed to hold the accessory in the desired position for a short period of time (which may exceed 60 minutes.

FDA Recall
Terminated ·Geomed Medizin-Technik Gmbh & Co. Ludwigstaler Strasse 27, Postfach 4047 Tuttlingen Germany·Product code GWG·December 16, 2011