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HemoSense Inc: HemoSense brand INRatio Prothombin Time Monitoring System...

A software problem that may cause the INRatio meter to incorrectly display 'INR>7.5' test message under a particular use condition.

FDASep 7, 2005IN, OR• HemoSense Inc

Datascope Corp: Spectrum Patient Monitor, Physiological, Patient with arr...

Software anomalies which include shut down while printing, invalid diastolic blood pressure display, and incomplete and inaccurate interpretation reports of 12-Lead ECG data.

FDASep 7, 2005CA, IL, NY +1 more• Datascope Corp

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HemoSense Inc: HemoSense brand INRatio Prothombin Time Monitoring System...

Datascope Corp: Spectrum Patient Monitor, Physiological, Patient with arr...

Datascope Corp: Passport 2 with View 12 ECG Analysis Module. It is a tra...

Beckman Coulter Inc: Synchron LX Systems Version 4.5 Operating Software

AGA Medical Corporation: AMPLATZER Duct Occluder, Order No. 9-PDA-003, Device Siz...

Alcon Research, Ltd: Lasik Custom Pak containing 1 dual tip irrigator, 8 ports...

Medtronic Emergency Response Systems, Inc.: QUIK-COMBO pacing/defibrillation/ECG (therapy) cables use...

Merit Medical Systems, Inc: Merit Custom Procedure Kit

Medtronic Emergency Response Systems, Inc.: standard (hard) paddles used with the LIFEPAK 12 defibril...

Smiths Medical PM, Inc.: Advisor Vital Signs Monitor (model 9200), catalog number ...

B. Braun Medical, Inc.: 7F Locking Tearaway Introducers non-sterile. Part number ...

Terumo Cardiovascular Systems Corp: Terumo Advanced Perfusion System 4 inch diameter Roller P...

Power Surgical Solutions: Medtronic Midas Rex Classic, GS and Legend dissecting too...

Medtronic Cardiac Surgery Technologies: Medtronic SPYDER Anastomotic Device. Sterilized using ir...

AGA Medical Corporation: AMPLATZER Vascular Plug, Manufactured by AGA Medical Corp...

Enpath Medical, Inc.: Enpath Steerable Sheath, model 10775-003, Sterile EO. Si...

Nichols Institute Diagnostics: Hyperglycosylated Human Chorionic Gonadotropin (H-hCG) As...

Remington Medical Inc.: Model 6149 Pacing Vector Selector Cable Switch for use wi...

Nichols Institute Diagnostics: Nichols Advantage Invasive Trophoblast Antigen (ITA)Assay...

Ethicon, Inc US: J-VAC Reservoir is a component of the J-VAC Closed Wound ...