Emphasys Medical Fda

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510(k) Premarket Notification - Food and Drug …

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K211657

Device Classification Name. prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented. 22. 510 (k) Number. K211657. Device Name. …

Emphasys Medical Submits PMA for Bronchial Valve Therapy

https://www.fdanews.com/articles/99215-emphasys-medical-submits-pma-for-bronchial-valve-therapy

Emphasys Medical has submitted a premarket approval (PMA) application to the FDA requesting regulatory approval to market its Emphasys endobronchial valve, the …

Emphasys Medical: Navigating Complex Clinical and …

https://www.gsb.stanford.edu/faculty-research/case-studies/emphasys-medical-navigating-complex-clinical-regulatory-challenges

Emphasys Medical: Navigating Complex Clinical and Regulatory Challenges on the Path to Market. For roughly a decade, the team at Emphasys Medical had been working to …

Pulmonx, Inc. Acquires Assets of Emphasys Medical | BioSpace

https://www.biospace.com/article/releases/pulmonx-inc-acquires-assets-of-emphasys-medical-/

Treatment of emphysema by ELVR using the Emphasys EBV has been shown in the Endobronchial Valve for Emphysema PalliatioN Trial, known as VENT, to …

EMPHASYS 474112200 Medical Device Identification - fda.report

https://fda.report/GUDID/10603295505518

emphasys femoral broach size 4: 10603295513711: emphasys femoral broach size 3: 10603295513704: emphasys femoral broach size 2: 10603295513698: emphasys …

Device development | Emphasys Innovatec

https://www.emphasys-industrial.com/

Emphasys Innovatec design and engineering expertise allows development of novel products on the field of medical devices and dispensing systems for pharmaceuticals and …

EMPHASYS ACETABULAR X-RAY TEMPLATE Medical Device …

https://fda.report/GUDID/10603295537304

EMPHASYS FEMORAL BROACH SIZE 1. 10603295507024. EMPHASYS FEMORAL STEM COLLARLESS HIGH OFFSET HA COATED CEMENTLESS 12 HO. …

EMPHASYS ACETABULAR SHELL NO-HOLE 58MM Medical …

https://fda.report/GUDID/10603295503095

emphasys femoral broach size 4: 10603295513711: emphasys femoral broach size 3: 10603295513704: emphasys femoral broach size 2: 10603295513698: emphasys femoral …

EMPHASYS INCLINATION GUIDE ADAPTOR Medical Device …

https://fda.report/GUDID/10603295545460

EMPHASYS: Version Model Number: 4813-00-550: Catalog Number: 481300550: Company DUNS: 989365556: Company Name: DEPUY (IRELAND) Device Count: 1: DM Exempt: …

Emphasys Medical Granted Expedited Review From FDA for

https://www.biospace.com/article/releases/emphasys-medical-granted-expedited-review-from-fda-for-zephyr-r-endobronchial-valve-/

REDWOOD CITY, Calif., Oct. 30 /PRNewswire/ -- Emphasys Medical, Inc. today announced that its pre-market approval (PMA) application for the Zephyr (R) …

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