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Showing 17661–17680 of 22534 results

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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

Conmed Corporation: FRAZIER Olive Tip Suction Instrument, 10 French with Cont...

Sterility (package integrity) compromised -- Frazier and Poole suction instruments may have an inadequate seal. The product pouch seal made during assembly of this product, may be incomplete or not present.

FDASep 12, 2007Nationwide• Conmed Corporation

Steris Corporation Hopkins Facility: Steris QFC1728 and QFC1729 Quick Connects;(used to connec...

Loose or missing adaptor: The center insert of the adaptor #6 restrictor could become loose and/or come out of the adaptor's housing. The absence of adaptor #6's center insert may affect the sterilization process of the attached endoscope.

FDASep 12, 2007Nationwide• Steris Corporation Hopkins Facility

Conmed Corporation: FRAZIER Atraumatic Soft Tip Surgical Suction Instrument w...

Sterility (package integrity) compromised -- Frazier and Poole suction instruments may have an inadequate seal. The product pouch seal made during assembly of this product, may be incomplete or not present.

FDASep 12, 2007Nationwide• Conmed Corporation

Conmed Corporation: FRAZIER Surgical Suction Instrument, 3 French with Contro...

Sterility (package integrity) compromised -- Frazier and Poole suction instruments may have an inadequate seal. The product pouch seal made during assembly of this product, may be incomplete or not present.

FDASep 12, 2007Nationwide• Conmed Corporation

Philips Medical Systems: Philips PageWriter Touch Cardiograph, Model: 860284, Phil...

Incorrect display: When using the 16 lead Patient Interface Module (PIM), lead tracings of V3R and V4R are reversed in the extended lead modes of Pediatric and Balanced.

FDASep 12, 2007Nationwide• Philips Medical Systems

Conmed Corporation: POOLE Suction Instrument, Product Code: 0035040, 50/C. ...

Sterility (package integrity) compromised -- Frazier and Poole suction instruments may have an inadequate seal. The product pouch seal made during assembly of this product, may be incomplete or not present.

FDASep 12, 2007Nationwide• Conmed Corporation

Boston Scientific: Boston Scientific mach 1 Guide Catheter, 8F, FCL 3.5 SH F...

Missing holes: Catheters are missing the catheter's side holes.

FDASep 11, 2007NY, PA• Boston Scientific

Global Protection Corp.: Lubricated Latex Condom. Labeled in part: "COMING TOGETH...

Condoms fail the water leak test and package integrity

FDASep 11, 2007DC• Global Protection Corp.

Stryker Howmedica Osteonics Corp.: Stryker Orthopaedics PAL Pelvic Alignment Level, Ref: PAL...

The bubble in a vial of the Pelvic Alignment Level (PAL) was wider than the level marking. Upon opening the PAL and removing the vial, it was discovered that the vial was leaking

FDASep 11, 2007Nationwide• Stryker Howmedica Osteonics Corp.

Nicolet Biomedical Div of Viasys Healthcare: Viasys Healthcare NicoletOne ICU Monitor, Modular Neurod...

Display lock-up: VIASYS Healthcare NicoletOne ICU Monitor freezes up during operation when using the digital video option.

FDASep 11, 2007Nationwide• Nicolet Biomedical Div of Viasys Healthcare

Terumo Cardiovascular Systems Corp: Terumo Advanced Perfusion System, 1 Roller Pump, 4 inch d...

Failure to operate; The pump may fail to operate, and be difficult to hand crank, due to an internal electrical short condition.

FDASep 10, 2007AL, AZ, FL +7 more• Terumo Cardiovascular Systems Corp

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