17 results · 20ms · Sources: EU EUDAMED, US FDA

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Sterilization Tray

FDA 510(k)
FDA Class 2 ·General Hospital

N/A

FDA UDI
GEORGE TIEMANN & CO.·B5821609120·

Lip Retractors Large

FDA UDI
PRACTICON, INC.·00723896021750·Plastic lip retractor large

Lip Retractors Small

FDA UDI
PRACTICON, INC.·00723896021675·plastic lip retractor small

TALOS® IBF

FDA UDI
MEDITECH SPINE, LLC·B167311609120·

TALOS® HA PEEK IBF

FDA UDI
MEDITECH SPINE, LLC·B167321609120·

Scorpio

FDA UDI
Howmedica Osteonics Corp.·07613154020652·Cruciate Retaining Tibial Insert

VIDAS® LYME IGM II

FDA Adverse Event
Malfunction ·BIOMERIEUX SA·Product code LSR·March 3, 2016

DISPOSABLE NERVE STIMULATING PROBE, BIPOLAR CONCENTRIC, DISPOSABLE NERVE STIMULATOR PROBE, BIPOLAR SIDE BY SIDE

FDA 510(k)
FDA Class 2 ·Neurology

MODIFICATION TO: HI-ART SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

OT VERIO IQ METER

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

POLYFLUX R CAPILLARY DIALYZER

FDA Adverse Event
Other ·GAMBRO DIALYSATOREN GMBH·Product code KDI·July 11, 2008

SYNCHROMED II

FDA Adverse Event
Malfunction ·MEDTRONIC NEUROMODULATION·Product code LKK·June 16, 2011

SMART RELIEF TENS THERAPY

FDA Adverse Event
Injury ·CHATTEM·Product code NUH·October 11, 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