25 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TEXTURED, BLUE, LATEX, POWDER FREE EXAMINATION GLVOES, WITH PROTEIN LABELING CLAIM (50UG/DM OR LESS OF WATER SOLUBLE PRO
FDA 510(k)
FDA Class 1
·General Hospital
RUSCH
FDA UDI
TELEFLEX INCORPORATED·04026704300747·Nasopharyngeal Airway (Amber)
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587A123026120·12mm H x 30mm W x 26mm L x 12 degrees ALIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587A123026150·12mm H x 30mm W x 26mm L x 15 degrees ALIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587A12302680·12mm H x 30mm W x 26mm L x 8 degrees ALIF
ELECTRO SENSOR -BODY COMPOSITION
FDA 510(k)
FDA Class 2
·Cardiovascular
PERFORMER HT/ HANG&GO HT BASIC
FDA 510(k)
FDA Class 2
·General Hospital
CODMAN CRANIOTOMY KIT, MODELS 26-1229, 26-1230, 26-1231
FDA 510(k)
FDA Class 2
·Neurology
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·March 31, 2014
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 21, 2013
530G INSULIN PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OZO·September 26, 2014
FLEXCATH STEERABLE SHEATH
FDA Adverse Event
Malfunction
·MEDTRONIC CRYOCATH LP·Product code DRA·June 14, 2011
HANG&GO HT BASIC
FDA Adverse Event
Malfunction
·RAND S.R.L.·Product code LGZ·May 15, 2017
Artis systems with large display from Siemens Medical Solutions USA, Inc. Interventional Fluoroscopic X-ray for angiographic procedures.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·December 30, 2015
Artis Q.zen Biplane, Model No. 10848355 Artis Q.zen Ceiling, Model No. 10848354 Artis Q.zen Floor, Model No. 10848353 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
Artis Q.zen biplane, Model Number 10848355
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 Q/ Q zen systems; Artis Q/ Q zen systems are 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 include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·April 22, 2015
Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO)
FDA Enforcement
Class II
·Ongoing·Isopure Corp·July 20, 2022
Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE
FDA Enforcement
Class II
·Ongoing·Electro Medical Systems SA·May 1, 2024