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Showing 63321–63340 of 68218 results

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Advanced Bionics Corporation 12740 San Fernando Rd Bldgs. 1 & 3 Sylmar CA 91342: HiRes 90K devices with Helix Electrodes Model CI 1400-02H...

Advanced Bionics is recalling the the HiRes 90K cochlear implant with HiFocus Helix Electrode because of loose-fitting insertion tool assemblies.

FDASep 14, 2007Nationwide• Advanced Bionics Corporation 12740 San Fernando Rd Bldgs. 1 & 3 Sylmar CA 91342

Advanced Bionics Corporation: HiRes 90K devices with Helix Electrodes Model CI 1400-02H...

Advanced Bionics is recalling the the HiRes 90K cochlear implant with HiFocus Helix Electrode because of loose-fitting insertion tool assemblies.

Class IIModerate

FDASep 14, 2007Nationwide

• Advanced Bionics Corporation

Precept Medical Products, Inc.: Precept Medical Products, Foam Fog Shield Surgical Mask G...

Small slits under the folds of the masks; thus they may not provide the protection necessary between the patient and surgical staff

FDASep 14, 2007Nationwide• Precept Medical Products, Inc.

Fertility Technology Resources, Inc.: Tucker Embryo Catheter with URM Tip, Embryo Transfer Cath...

Expiration Date for sterility; The 5 year dating could not be validated/supported for sterility assurance.

FDASep 13, 2007CA, CO, FL +13 more• Fertility Technology Resources, Inc.

Fertility Technology Resources, Inc.: Tucker Embryo Catheter, Stylet, For use with Embryo Trans...

Expiration Date for Sterility; The 5 year dating could not be validated/supported for sterility assurance.

FDASep 13, 2007CA, CO, FL +13 more• Fertility Technology Resources, Inc.

Medtronic Sofamor Danek USA Inc: Satellite Spinal System Primary User Group Reference Guid...

Surgical manual lacks information required as a condition of the 510(k) approval.

FDASep 13, 2007Nationwide• Medtronic Sofamor Danek USA Inc

Medtronic Sofamor Danek USA Inc: Medtronic Sofamor Danek, 9 mm Satellite Sphere CoCr, Size...

Labeling, including indications for use, lack 510 (K) approval

FDASep 13, 2007Nationwide• Medtronic Sofamor Danek USA Inc

Medtronic Sofamor Danek USA Inc: Medtronic Sofamor Danek, 10 mm Satellite Sphere CoCr, Siz...

Labeling, including indications for use, lack 510 (K) approval

FDASep 13, 2007Nationwide• Medtronic Sofamor Danek USA Inc

Fertility Technology Resources, Inc.: Tucker Embryo Catheter for Trial Transfer, 20 cm, Order #...

Expiration Date for sterility; The 5 year dating could not be validated/supported for sterility assurance.

FDASep 13, 2007CA, CO, FL +13 more• Fertility Technology Resources, Inc.

Medtronic Sofamor Danek USA Inc: Medtronic Sofamor Danek, 11 mm Satellite Sphere CoCr, Siz...

Labeling, including indications for use, lack 510 (K) approval

FDASep 13, 2007Nationwide• Medtronic Sofamor Danek USA Inc

Medtronic Sofamor Danek USA Inc: Medtronic Sofamor Danek, 12 mm Satellite Sphere CoCr, Siz...

Labeling, including indications for use, lack 510 (K) approval

FDASep 13, 2007Nationwide• Medtronic Sofamor Danek USA Inc

Medtronic Sofamor Danek USA Inc: Medtronic Sofamor Danek, Satellite System Sphere PEEK, Si...

Labeling, including indications for use, lack 510 (K) approval

FDASep 13, 2007Nationwide• Medtronic Sofamor Danek USA Inc

Fertility Technology Resources, Inc.: Morton IUI Catheter, Sterile, Single Use Only, Order #: f...

Expiration Date for sterility; The 5 year dating could not be validated/supported for sterility assurance.

FDASep 13, 2007CA, CO, FL +13 more• Fertility Technology Resources, Inc.

Medtronic Sofamor Danek USA Inc: Medtronic Sofamor Danek, 15 mm Satellite Sphere CoCr, Siz...

Labeling, including indications for use, lack 510 (K) approval

FDASep 13, 2007Nationwide• Medtronic Sofamor Danek USA Inc

Medtronic Sofamor Danek USA Inc: Medtronic Sofamor Danek, 8 mm Curette, size 8 mm, Materia...

Marketed without approval: The surgical technique includes reference to an 8mm Trial and 8mm Curette, while the cleared -510 (k)- device only includes spheres between 9.5 and 19 mm.

FDASep 13, 2007Nationwide• Medtronic Sofamor Danek USA Inc

Medtronic Sofamor Danek USA Inc: Medtronic Sofamor Danek, 13 mm Satellite Sphere CoCr, Siz...

Labeling, including indications for use, lack 510 (K) approval

FDASep 13, 2007Nationwide• Medtronic Sofamor Danek USA Inc

Medtronic Sofamor Danek USA Inc: Medtronic Sofamor Danek, 8 mm Trial, size 8 mm, Material ...

Marketed without approval: The surgical technique includes reference to an 8mm Trial and 8mm Curette, while the cleared -510 (k)- device only includes spheres between 9.5 and 19 mm.

FDASep 13, 2007Nationwide• Medtronic Sofamor Danek USA Inc

Medtronic Sofamor Danek USA Inc: Medtronic Sofamor Danek, 16 mm Satellite Sphere CoCr, Siz...

Labeling, including indications for use, lack 510 (K) approval

FDASep 13, 2007Nationwide• Medtronic Sofamor Danek USA Inc

Medtronic Sofamor Danek USA Inc: Satellite Spinal System Surgical Technique, LITSATFUSST7-...

Surgical manual/technique lack information required as a condition of the 510(k) approval.

FDASep 13, 2007Nationwide• Medtronic Sofamor Danek USA Inc

Medtronic Sofamor Danek USA Inc: Medtronic Sofamor Danek, 14 mm Satellite Sphere CoCr, Siz...

Labeling, including indications for use, lack 510 (K) approval

FDASep 13, 2007Nationwide• Medtronic Sofamor Danek USA Inc

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