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https://www.fda.gov/media/184399/download
Application of Adaptive Perfusion as In Vitro Release Testing Method...Application of Adaptive Perfusion as In Vitro Release Testing Method to ...
https://www.fda.gov/science-research/licensing-and-collaboration-opportunities/adaptive-perfusion-novel-in-vitro-drug-release-testing-method-complex-drug-products
Adaptive Perfusion: A Novel In Vitro Drug Release Testing Method for Complex...Adaptive Perfusion: A Novel In Vitro Drug Release Testing Method for ...
https://www.fda.gov/media/169146/download
Adaptive Perfusion: A Novel In Vitro Release Testing Method for Complex Ophthalmic...Ophthalmic Drug Products Adaptive Perfusion: A Novel In Vitro ...
https://www.fda.gov/media/105167/download
.................35 4.6.4. Start of Perfusate Circulation .......................6.5. Injecting Additives Into the Perfusate and Preparing for Use ...
https://www.fda.gov/medical-devices/hde-approvals/listing-cdrh-humanitarian-device-exemptions
...2014-M-1265 XVIVO Perfusion System (XPS™) with STEEN Solution™ Perfusate XVIVO Perfusion...XPS™ System with STEEN Solution™ Perfusate. The device is ...
https://www.fda.gov/media/159534/download
Methods Under Development • Ex vivo perfusion measurements • Glomerular Filtration...resistance • Machine perfusion characteristics • Perfusate ...
https://www.fda.gov/radiation-emitting-products/initiative-reduce-unnecessary-radiation-exposure-medical-imaging/letter-medical-imaging-technology-alliance-regarding-ct-recommendations
...2009 in connection with CT brain perfusion studies, we think that it would be...CT manufacturers in MITA. 1. Brain-perfusion CT—Provide particular ...
https://www.fda.gov/media/176268/download
JL. DTPA aerosol in ventilation/ perfusion scintigraphy for diagnosing pulmonary...full examination (ventilation scan, perfusion scan and chest ...
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/spectrum-medical-ltd-666543-09292023
...device manufacturer of the Quantum Perfusion Systems family of devices, which...tubing sets and cannulas, Quantum Perfusion Roller Pumps, Quantum Pump ...
https://www.fda.gov/media/176269/download
...pulmonary embolism when paired with perfusion imaging Adult and pediatric Reference...pulmonary embolism when paired with perfusion imaging in adults ...
https://www.fda.gov/media/150709/download
Generic Name: Ex Vivo Portable Organ Perfusion System for Donor Livers Device Trade...is a portable extracorporeal liver perfusion and monitoring ...
https://www.fda.gov/media/176285/download
...controlled laboratory studies -Test low perfusion as a mediator explaining differences...-Interfering pigments -Anemia -Low perfusion -Motion “Occult ...
https://www.fda.gov/radiation-emitting-products/initiative-reduce-unnecessary-radiation-exposure-medical-imaging/radiation-dose-quality-assurance-questions-and-answers
CTDI100 values. In typical brain-perfusion scanning the patient table is stationary...of the average CTDIvol for brain-perfusion scans ...
https://www.fda.gov/media/176283/download
...situations including states of low perfusion as is common in critical illness...situations including states of low perfusion as is common in critical ...
https://www.fda.gov/media/72470/download
...(including use under motion and low perfusion conditions, if applicable, and any...accuracy under low perfusion for oximeters making low perfusion ...
https://www.fda.gov/media/168887/download
...glucose) and EXCELL® Advanced CHO HD Perfusion Medium. Samples were taken either...2 4 6 8 10 12 14 16 18 LCD Perfusion HCD Perfusion Fed-Batch w/out ...
https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/extracorporeal-blood-circuit-defoamer-510k-submissions-final-guidance-industry-and-fda
...probe) are sized properly. __Assemble perfusion circuit in a sterile manner. __Allow...__Gravity-prime and debubble pump and perfusion circuit ...
https://www.fda.gov/drugs/science-and-research-drugs/physiologically-based-pharmacokinetic-modeling-sertraline-dosing-pregnancy
...gut, plasma, richly perfused tissues, and slowly perfused tissues. Drug distribution...compartment can either be limited by perfusion (blood flow) or ...
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/pulse-oximeters-premarket-notification-submissions-510ks-guidance-industry-and-food-and-drug
...(including use under motion and low perfusion conditions, if applicable, and any...accuracy under low perfusion for oximeters making low perfusion ...
https://www.fda.gov/media/176282/download
...--------·-·-·-·-~--- .. . :·· :· Simulate Hypo-perfusion Conditions • SpO2-SaO2 correlations...Major Recommendations Simulate Hypo-perfusion ...
