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Showing 7841–7860 of 8389 results

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Tenderneeds Fertility LLC: Professional Artificial Intrauterine Insemination Kit (SK...

Device was distributed without a proper marketing authorization.

FDADec 23, 2020Nationwide• Tenderneeds Fertility LLC

Tenderneeds Fertility LLC: 2 X Sterile Human Home Artificial Insemination Semen Kit ...

Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.

FDADec 23, 2020Nationwide• Tenderneeds Fertility LLC

Tenderneeds Fertility LLC: At Home Semi-Flex/Rigid Insemination Device (SKU 64404278...

Device was distributed without a proper marketing authorization.

FDADec 23, 2020Nationwide• Tenderneeds Fertility LLC

Tenderneeds Fertility LLC: At Home Artificial Intrauterine Insemination Kit (SKU 636...

Device was distributed without a proper marketing authorization.

FDADec 23, 2020Nationwide• Tenderneeds Fertility LLC

Tenderneeds Fertility LLC: Ultimate Fertility At Home Insemination Kit with Sperm Wa...

Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.

FDADec 23, 2020Nationwide• Tenderneeds Fertility LLC

Tenderneeds Fertility LLC: Deluxe IntraCervical Insemination (ICI) Kit (3), SKU 3829...

Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.

FDADec 23, 2020Nationwide• Tenderneeds Fertility LLC

Tenderneeds Fertility LLC: Deluxe At-Home Human Artificial Intracervical (ICI) Insem...

Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.

FDADec 23, 2020Nationwide• Tenderneeds Fertility LLC

Tenderneeds Fertility LLC: TenderNeeds Fertility PRO IUI Human Artificial Home Insem...

Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.

FDADec 23, 2020Nationwide• Tenderneeds Fertility LLC

Tenderneeds Fertility LLC: Professional Clinical Artificial Intrauterine Inseminatio...

Device was distributed without a proper marketing authorization.

FDADec 23, 2020Nationwide• Tenderneeds Fertility LLC

Tenderneeds Fertility LLC: Deluxe At Home Artificial Insemination Kit (SKU 636391205...

Device was distributed without a proper marketing authorization.

FDADec 23, 2020Nationwide• Tenderneeds Fertility LLC

Draegar Medical Systems, Inc.: Infinity Acute Care System (IACS) Monitoring Solution: Th...

The Infinity M540 patient monitor may randomly reboot due to an error to correctly transmit and read the header data of files in the memory of the device. Under this situation, the device will try to reboot to mitigate the error. The device will be available again for use within 30 seconds. If this error continues and the M540 reboots three times in a time span of 10 minutes, it will enter a fail-state. A fail-state will annunciate itself with a continuous sound to alert the user. The M540 will reset to factory default and the user can manually configure and readmit the patient to continue patient monitoring.

FDADec 23, 2020Nationwide• Draegar Medical Systems, Inc.

Nihon Kohden America Inc: PSG-1100 Sleep Diagnostic System. Sample product label: ...

Medical device non-conformance to electrical safety standard (IEC 60601-1).

FDADec 21, 2020Nationwide• Nihon Kohden America Inc

Medtronic Neurosurgery: REF 27219-5 X1, Medtronic, Delta Valve, Neonatal, Perfor...

Neonatal Valves were manufactured with a ventricular catheter connection site shorter than the design specification. The defect can lead to difficulty in securing the valve to the proximal catheter which could result in disconnection of the ventricular catheter from the valve and shunt malfunction

FDADec 16, 2020Nationwide• Medtronic Neurosurgery

Medtronic Neurosurgery: REF 27219-1 X1, Medtronic, Delta Valve, Neonatal, Perfor...

Neonatal Valves were manufactured with a ventricular catheter connection site shorter than the design specification. The defect can lead to difficulty in securing the valve to the proximal catheter which could result in disconnection of the ventricular catheter from the valve and shunt malfunction

FDADec 16, 2020Nationwide• Medtronic Neurosurgery

Medtronic Neurosurgery: REF 27219-2 X1, Medtronic, Delta Valve, Neonatal, Perfor...

Neonatal Valves were manufactured with a ventricular catheter connection site shorter than the design specification. The defect can lead to difficulty in securing the valve to the proximal catheter which could result in disconnection of the ventricular catheter from the valve and shunt malfunction

FDADec 16, 2020Nationwide• Medtronic Neurosurgery

Bard Peripheral Vascular Inc: VENOVO Venous Stent System 10F Product Description(REF)/...

Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system.

FDADec 14, 2020Nationwide• Bard Peripheral Vascular Inc

Bard Peripheral Vascular Inc: VENOVO Venous Stent System 8F Product Description(REF)/d...

Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system.

FDADec 14, 2020Nationwide• Bard Peripheral Vascular Inc

Bard Peripheral Vascular Inc: VENOVO Venous Stent System 9F Product Description(REF)/d...

Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system.

FDADec 14, 2020Nationwide• Bard Peripheral Vascular Inc

Ortho Clinical Diagnostics Inc: VITROS Chemistry Products CKMB Slides: (1)VITROS CKMB Sl...

VITROS Chemistry Products CKMB Slides Potential for Falsely Elevated Results Due to CK-MM Interference

FDADec 11, 2020Nationwide• Ortho Clinical Diagnostics Inc

GE Healthcare, LLC: GE NM/CT 870 CZT system Model Number H3906CW - Product Us...

GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector.

FDADec 10, 2020Nationwide• GE Healthcare, LLC

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