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Showing 7321–7340 of 8389 results

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W L Gore & Associates, Inc.: REF/Catalogue Number GSX0025A, GORE CARDIOFORM SEPTAL OCC...

Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.

FDASep 2, 2021AL, AZ, AR +44 more• W L Gore & Associates, Inc.

W L Gore & Associates, Inc.: REF/Catalogue Number GSXE0030B, GORE CARDIOFORM SEPTAL OC...

Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.

FDASep 2, 2021AL, AZ, AR +44 more• W L Gore & Associates, Inc.

Medtronic Xomed, Inc.: Medtronic sterile single-use blades that are components o...

There was an increase in complaints related to tip breaks and wobble/vibration.

FDAAug 31, 2021Nationwide• Medtronic Xomed, Inc.

Exactech, Inc.: Vantage Total Ankle System including a. Vantage Fixed-B...

Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

FDAAug 30, 2021Nationwide• Exactech, Inc.

Exactech, Inc.: OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as th...

Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

FDAAug 30, 2021Nationwide• Exactech, Inc.

Exactech, Inc.: ARTHROFOCUS Polyethylene Tibial Inserts (Product Line: 25...

Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

FDAAug 30, 2021Nationwide• Exactech, Inc.

Exactech, Inc.: TRULIANT Knee System including TRULIANT Tibial Inserts, a...

Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

FDAAug 30, 2021Nationwide• Exactech, Inc.

Exactech, Inc.: OPTETRAK Comprehensive Knee System, labeled as the follow...

Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

FDAAug 30, 2021Nationwide• Exactech, Inc.

North Coast Medical Inc: Norco Ultrasound Gel, Item/Description: NC70479/Norco Ult...

Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a Letter to Health Care Providers to further address this issue: https://www.fda.gov/medical-devices/letters-health-care-providers/stop-using-all-eco-med-ultrasound-gels-and-lotions-due-risk-bacterial-contamination-letter-health

FDAAug 27, 2021Nationwide• North Coast Medical Inc

North Coast Medical Inc: EcoLotion Transmission Lotion, used in ultrasound procedu...

Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a Letter to Health Care Providers to further address this issue: https://www.fda.gov/medical-devices/letters-health-care-providers/stop-using-all-eco-med-ultrasound-gels-and-lotions-due-risk-bacterial-contamination-letter-health

FDAAug 27, 2021Nationwide• North Coast Medical Inc

GE Healthcare, LLC: SIGNA Creator, SIGNA Explorer nuclear magnetic resonance...

Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.

FDAAug 26, 2021Nationwide• GE Healthcare, LLC

GE Healthcare, LLC: SIGNA Pioneer nuclear magnetic resonance imaging system

Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.

FDAAug 26, 2021Nationwide• GE Healthcare, LLC

GE Healthcare, LLC: SIGNA Voyager nuclear magnetic resonance imaging system

Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.

FDAAug 26, 2021Nationwide• GE Healthcare, LLC

GE Healthcare, LLC: Discovery MR750w 3.0T nuclear magnetic resonance imaging...

Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.

FDAAug 26, 2021Nationwide• GE Healthcare, LLC

GE Healthcare, LLC: 1.5T SIGNA HDxt MR System nuclear magnetic resonance ima...

Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.

FDAAug 26, 2021Nationwide• GE Healthcare, LLC

GE Healthcare, LLC: SIGNA Artist nuclear magnetic resonance imaging system

Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.

FDAAug 26, 2021Nationwide• GE Healthcare, LLC

GE Healthcare, LLC: Discovery MR750 3.0T nuclear magnetic resonance imaging ...

Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.

FDAAug 26, 2021Nationwide• GE Healthcare, LLC

GE Healthcare, LLC: Optima MR450w 1.5T nuclear magnetic resonance imaging sy...

Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.

FDAAug 26, 2021Nationwide• GE Healthcare, LLC

GE Healthcare, LLC: SIGNA Premier nuclear magnetic resonance imaging system

Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.

FDAAug 26, 2021Nationwide• GE Healthcare, LLC

GE Healthcare, LLC: SIGNA Architect nuclear magnetic resonance imaging system

Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.

FDAAug 26, 2021Nationwide• GE Healthcare, LLC

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