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Binax, Inc.: NOW RSV Test Item Number 430-430, Kit Number 430-00R

Pouch integrity compromised

FDAFeb 18, 2004KS• Binax, Inc.

Cryolife Inc: CryoValve, Aortic Valve and Conduit

CryoLife received additional information after release of tissue indicating the donor had repeatedly reactive test results for antibody to HCV (EIA) in 1995.

FDAFeb 18, 2004TX, DC• Cryolife Inc

Cryolife Inc: CryoValve, Pulmonary Valve and Conduit

CryoLife received additional information after release of tissue indicating the donor had repeatedly reactive test results for antibody to HCV (EIA) in 1995.

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Binax, Inc.: NOW RSV Test Item Number 430-430, Kit Number 430-00R

Cryolife Inc: CryoValve, Aortic Valve and Conduit

Cryolife Inc: CryoValve, Pulmonary Valve and Conduit

Arrow International Inc: Two Lumen 14F Hemodialysis Catheter Kits/Sets with Blue F...

ATS Medical, Inc.: ATS Open Pivot Mechanical Heart Valve

Binax, Inc.: NOW Filariasis Rapid test for W. bancrofti antigen. (Expo...

Medex Inc: Medex 3000 Series Syringe Infusion Pumps

Abbott Laboratories HPD/ADD/GPRD: TDx/TDxFLx Cortisol Reagent Pack, list 9116-65; Abbott L...

Beckman Coulter Inc: DL 2000 Data Manager, Software Version 6.2

Boston Scientific Scimed: Impulse 5F 145 (degree) Multipack Angiographic Catheters,...

Beckman Coulter Inc: Cytomics MXP Software, Version 1.0, Part No. 623688.

Beckman Coulter Inc: Cytomics RXP Software, Version 1.0, Part Numbers: 175488...

Del Medical Systems Group: DCTM Digital Ceiling Tube Mount, model DCTM; a fully coun...

Beckman Coulter Inc: CXP software, Part No. 623560, version 1.0

Boston Scientific Corporation: Vaxcel Port with PASV Valve, 8 Fr polyurethane catheter, ...

Stryker Howmedica Osteonics: Restoration Hip system Cylindrical Distal Extension. Cat...

C.R. Bard, Inc., Urological Division: BardiaComplete Foley Kit, Single use only, Do not resteri...

Plus Orthopedics: Biolox Ceramic Head XL

Staar Surgical Co Inc: Collamer UV One-Piece IntraOcular Lens. Models 4205BF...

General Electric Med Systems: Seneographe 700T Mammography X-Ray Systems