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Showing 67681–67700 of 68218 results

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DentSply Professional Division: Midwest Tradition PB High Speed Handpiece with Push Butto...

Small cracks in the dental handpiece's chuck could allow the dental burs to drift out of the chuck over time.

FDAOct 14, 2003Nationwide• DentSply Professional Division

DentSply Professional Division: Midwest XGT High Speed Handpiece with Fiber Optics and Pu...

Small cracks in the dental handpiece's chuck could allow the dental burs to drift out of the chuck over time.

FDAOct 14, 2003Nationwide• DentSply Professional Division

DentSply Professional Division: Midwest Tradition PB Non-Fiber Optic High Speed Handpiece...

Small cracks in the dental handpiece's chuck could allow the dental burs to drift out of the chuck over time.

FDAOct 14, 2003Nationwide• DentSply Professional Division

Kyphon Inc: KyphX Xpander brand Inflation Syringe; Merit Medical Par...

Devices for which sterility may be compromised as evidenced by a loss of package integrity.

FDAOct 13, 2003Nationwide• Kyphon Inc

Kyphon Inc: KyphXR brand KyphoPak Tray, a Introducer Tool kit for Inf...

Devices for which sterility may be compromised as evidenced by a loss of package integrity.

FDAOct 13, 2003Nationwide• Kyphon Inc

Beckman Coulter Inc: Synchron LX Clinical Systems, Operating Software, All ver...

Numeric results are erroneously accepted by the in-house information system without qualifying symbols "<" or ">". In addition, the in-house system may interpret the results incorrectly.

FDAOct 10, 2003Nationwide• Beckman Coulter Inc

Philips Medical Systems Sales & Service Region No. America: Clea Stand Ceiling used with the Integris X-Ray System H5...

The cable carrier and cables may fall after repeat collisions with OR lamps, radiation shields or other supported accessories.

FDAOct 10, 2003Nationwide• Philips Medical Systems Sales & Service Region No. America

Beckman Coulter Inc: Coulter DNA Prep Reagents Kit Part 6607055

Labeling Error-Omission of 'Research Use Only'

FDAOct 10, 2003Nationwide• Beckman Coulter Inc

Philips Medical Systems Sales & Service Region No. America: Monitor Ceiling Suspension for Fluoroscopic and Angiograp...

The thumbscrew hinge pin on the monitor support arm could become loose allowing the monitor to fall.

FDAOct 10, 2003Nationwide• Philips Medical Systems Sales & Service Region No. America

Portex Inc: Portex Spinal Tray with 25G Whitacre Needle. Kit contains...

Spinal trays labeled as containing a Whitacre 25g x 3.5' needle actually contain a Quincke 25g x 3.5' needle.

FDAOct 10, 2003Nationwide• Portex Inc

Becton Dickinson & Co: Chocolate II Agar (GC II Agar with Hemoglobin and Iso Vit...

Microbiological media may exhibit reduced colony size of bacteria, Haemophilus species.

FDAOct 10, 2003Nationwide• Becton Dickinson & Co

Smith And Nephew, Inc. Endoscopy Division: Smith & Nephew Endocoupler C-Mount 30mm Focal Length Ref...

Hardware of the camera coupler may rust and result in an ineffective sterilization/cleaning process.

FDAOct 10, 2003Nationwide• Smith And Nephew, Inc. Endoscopy Division

Vascular Solutions, Inc: Vari-Lase Endovenous Laser Procedural Kit, Model 7000

An internal gasket of the Fiber Lock component of the Vari-Lase Kit contains natural rubber latex, but the product labeling does not recognize the presence of latex and include the required cautionary statement.

FDAOct 9, 2003Nationwide• Vascular Solutions, Inc

Konica Medical Imaging, Inc.: Konica Minolta Duplicating Film Emulsions. Konica Medica...

Loss of detail at density of 1.00 to 2.00, on certain bony structures found in original clinical films.

FDAOct 9, 2003Nationwide• Konica Medical Imaging, Inc.

Richard Wolf Medical Instrument Corp: Sonotrode Probe, a straight nephroscopy probe with a 3.5 ...

The sonotrode tube could become blocked by the stone fragments, causing overheating and damage to the device.

FDAOct 9, 2003IL, MN, NE +1 more• Richard Wolf Medical Instrument Corp

Anika Therapeutics: Staarvisc II Sodium Hyaluronate 0.8 mL 12mg/mL Syringe. S...

Stability failure at the 20 month for viscosity specification

FDAOct 8, 2003CA, MO, NC +1 more• Anika Therapeutics

Anika Therapeutics: ShellGell Sodium Hyaluronate 0.8mL Syringe, 12 mg/mL. St...

Stability failure at the 20 month for viscosity specification

FDAOct 8, 2003CA, MO, NC +1 more• Anika Therapeutics

Anika Therapeutics: Amvisc Intraocular Injection Sodium hyaluronate 12 mg/ml ...

Stability failure at the 20 month for viscosity specification

FDAOct 8, 2003CA, MO, NC +1 more• Anika Therapeutics

Anika Therapeutics: Amvisc Sodium Hyaluronate 0.8 mL 12 mg/mL Syringe. Steril...

Stability failure at the 20 month for viscosity specification

FDAOct 8, 2003CA, MO, NC +1 more• Anika Therapeutics

Anika Therapeutics: Hialuronato Sodico Sodium Hyaluronate 12 mg/mL 1X0.8 mL S...

Stability failure at the 20 month for viscosity specification

FDAOct 8, 2003CA, MO, NC +1 more• Anika Therapeutics

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