fda
3 records
FDA Device Recall: VerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code: 1071123415007
2025-11-19
Class III — Due to an device without a premarket clearance being incorrectly package and distributed.
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FDA Device Recall: VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064
2025-01-22
Class II — Platelet Reactivity Test distributed without appropriate US-FDA market clearance; if used healthcare personnel could use the baseline PRUTest measurement prior to initiating drug therapy, a...
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FDA Device Recall: AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-o
2024-11-06
Class II — Values used to calibrate whole blood oximeter instruments were observed to be higher than normal, which may result in incorrect patient results where oxygen levels are higher than actual re...
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ny_corps
1 records
NY Corp: ACCRIVA DIAGNOSTICS, INC.
2001-04-04
FOREIGN BUSINESS CORPORATION | County: New York | Jurisdiction: Delaware
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