11 results
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FRYE ELECTRONICS, INC.
FDA registration
FRYE ELECTRONICS, INC.·1 product·🇺🇸 United States
Fonix
FDA UDI
FRYE ELECTRONICS, INC.·B191FONIXCOLT0·
HearLab
FDA UDI
FRYE ELECTRONICS, INC.·B191HEARLABACA0·
Fonix
FDA UDI
FRYE ELECTRONICS, INC.·FONIXFP35·The FONIX FP35 provides quick, accurate informa...
Fonix
FDA UDI
FRYE ELECTRONICS, INC.·FONIX8000·The 8000 Hearing Aid Test System performs a bro...
Varian brand Varian Eclipse Treatment Planning System for radiotherapy; Model Number: H48; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye.
FDA Recall
Terminated
·Varian Medical Systems, Inc. Oncology Systems·Product code MUJ·June 18, 2012
Aeroneb Go Micropump Nebulizer Featuring OnQ electronic micropump, RX, Manufactured by Medical Industries America Inc., Adel, IA. The product is sold individually or in master packs of 8 under the following model numbers (all using the same box label): Model 7000 - Consisting of the Aeroneb Go, battery controller, battery controller cable, 3 AA alkaline batteries, mask elbow, mouthpiece, carry bag, and user manual; Model 7030 - Consisting of the Aeroneb Go, AC wall adapter, mask elbow, mouthpiece, carry bag, and user manual; Model 7070 - Consisting of the Aeroneb Go, battery controller, battery controller cable, 3 AA alkaline batteries, AC wall adapter, mask elbow, mouthpiece, carry bag, and user manual; Model 7000-1 - Consisting of the Aeroneb Go, battery controller, battery controller cable, 3 AA alkaline batteries, European mask elbow, mouthpiece, carry bag, and user manual; Model 7030-1 - Consisting of the Aeroneb Go, AC wall adapter, European mask elbow, mouthpiece, carry bag, and user manual; Model 7070-1 - Consisting of the Aeroneb Go, battery controller, battery controller cable, 3 AA alkaline batteries, AC wall adapter, European mask elbow, mouthpiece, carry bag, and user manual. 7000LINCARE - Consisting of the Aeroneb Go, battery controller with a Lincare private label cover plate, battery controller cable, 3 AA alkaline batteries, mask elbow, mouthpiece, carry bag, and user manual; 7070LINCARE - Consisting of the Aeroneb Go, battery controller with the Lincare private label cover plate, battery controller cable, 3 AA alkaline batteries, AC wall adapter, mask elbow, mouthpiece, carry bag, and user manual.
FDA Recall
Terminated
·Medical Industries America Inc·Product code CAF·September 7, 2004
Eclipse Treatment Planning System, Client software versions 8.0 through 8.6; Model Number: H48; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye.
FDA Recall
Terminated
·Varian Medical Systems, Inc. Oncology Systems·Product code MUJ·April 4, 2011
Artis icono floor in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic imaging and interventional procedures. Model: 11327700
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code OWB·February 25, 2022
Artis icono biplane- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic imaging and interventional procedures. Model: 11327600
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code OWB·February 25, 2022
Artis pheno- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use-single and biplane diagnostic imaging and interventional procedures. Model: 10849000
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code OWB·February 25, 2022