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

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CoRoent® Ti-C System

FDA 510(k)
FDA Class 2 ·Orthopedic

MEDICON MOGEN CLAMP

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

ATLAS SPINAL CAGE, MODELS SC-150-007, 009, 011, 013, 015, 017.

FDA 510(k)
FDA Class 2 ·Orthopedic

MOZEC¿ NC RX PTCA BALLOON DILATATION CATHETER

FDA Adverse Event
Malfunction ·MERIL LIFE SCIENCES PRIVATE LIMITED·Product code LOX·December 13, 2022

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013

SYNCHROMED II

FDA Adverse Event
Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·June 16, 2011

FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE (SG)·Product code FRN·September 17, 2008

AIRVO2 HUMIDIFIER

FDA Adverse Event
Injury ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·June 8, 2017

Artis zeego, Material no. 10280959 , for angiography and whole body radiographic/fluoroscopic procedures.

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 4, 2018

Artis zeego, Model Number 10280959

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022

Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to , pediatric and obese patients. Procedures that can be performed with the AXIOM Artis-zee/zeego and Q/Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis zee/zeego and Q/Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·September 6, 2017

Artis zee Biplane, Model No. 10094141; Artis zee Ceiling, Model No. 10094137; Artis zee Floor, Model No. 10094135; Artis zeego, Model No. 10280959 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·March 25, 2020