Calendar

Week of Sep 22, 2025

Sep 25, 2025device 510k328d agoYung Sheng Optical Co., Ltd. — Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear (Daily Wear); Pure Plus UV Aspheric (Otufilcon A) 1-Day Silicone Soft (hydrophilic) Contact Lens (Daily Disposable) (510k cleared)

Product code: LPL. Advisory committee: Ophthalmic. Type: Traditional

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Sep 25, 2025device 510k328d agoAuxano Medical, LLC — Auxano® Wedge Fixation System (510k cleared)

Product code: PLF. Advisory committee: Orthopedic. Type: Traditional

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Sep 25, 2025device 510k328d agoStryker Instruments — RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip Cartridge; RPS Console Cart Attachment; Ball Tip Pointer (510k cleared)

Product code: OLO. Advisory committee: Neurology. Type: Traditional

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Sep 25, 2025device 510k328d agoUnited Orthopedic Corporation — Stem Extension Line (U2 Total Knee SystemPSA Type) (510k cleared)

Product code: JWH. Advisory committee: Orthopedic. Type: Special

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Sep 25, 2025device 510k328d agoQuantib B.V. — Brain WMH (510k cleared)

Product code: QIH. Advisory committee: Radiology. Type: Traditional

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Sep 25, 2025device 510k328d agoEssilor Of America, Inc. — Essilor® Stellest® (510k cleared)

Product code: QUR. Advisory committee: Ophthalmic. Type: Direct

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Sep 25, 2025device pma328d agoEdwards Lifesciences, LLC — Edwards EVOQUE Tricuspid Valve Replacement System (PMA supplement)Edwards Lifesciences Corp

Supplement type: 30-Day Notice. Product code: NPW. Advisory committee: CV. Decision: OK30

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Sep 25, 2025device pma328d agoABBOTT MEDICAL — DBS Neurostimulation System (PMA supplement)

Supplement type: 30-Day Notice. Product code: MHY. Advisory committee: NE. Decision: OK30

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Sep 25, 2025device pma328d agoABBOTT MEDICAL — SCS Neurostimulation System (PMA supplement)

Supplement type: 30-Day Notice. Product code: LGW. Advisory committee: NE. Decision: OK30

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Sep 25, 2025device pma328d agoABBOTT MEDICAL — DRG Neurostimulation System (PMA supplement)

Supplement type: 30-Day Notice. Product code: PMP. Advisory committee: NE. Decision: OK30

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Sep 25, 2025device pma328d agoGuardant Health, Inc. — Guardant360 CDx (PMA supplement)Guardant Health, Inc.

Supplement type: Panel Track. Product code: PQP. Advisory committee: PA. Decision: APPR

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Sep 25, 2025device recall328d agoPHILIPS MEDICAL SYSTEMS device recall (Cls II)

Model: Incisive CT for Brazil SKD; Product Code (REF): 728146; Software Versions: 5.1.0.X & 5.1.1.X; — Reason: Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is used requiring use of manual stop. Issue 2. When performing a helical/Axial scan with ORI (Dose Right index)/ DOM (Dose Modulation), the WED (Water Equivalent Diameter) value might set itself to zero, and this may lead to an insufficient dose setting after the surview. If operator misses the insufficient dose and the WED value in User Interface and continues with the subsequent helical/Axial scans, then the obtained images will be noisy due to low dose setting. Issue 3: Due to a software failure, the ECG wave file is not saved. As a result, the cardiac offline image reconstruction fails due to the missing ECG wave file, and the user might rescan the patient. Issue 4: This issue is software fault in which the patient orientation will be changed to NULL under specific random scenarios resulting in radiation being delivered from the wrong orientation (surview scan) or in the wrong position (clinical scan) and will generate incorrect and undiagnosable surview/clinical images. Patients may be rescanned for surview and/or clinical images. Issue 5: During scanning, the preview image display is not consistent, the images are not arriving at a fixed rate, skipping images from time to time during scanning. The obtained images might not support making the clinical diagnosis and the user might decide to re-scan the patient. Issue 6: If a user presses the left and middle/right mouse buttons together or afterwards in a short time, both commands are executed and an incorrect auto ROI is created. This ROI coordinates won t be assigned as the object is empty. As a result, the threshold of contrast level will not be reached in the UI and this will prevent the system from automatically triggering the subsequent clinical scan. There is potential safety risk identified for additionally tracker shots and/or rescan of a patient when the clinical scan is not triggered. This issue only affects the manual ROI process. — Status: Ongoing

Sep 25, 2025device recall328d agoCovidien, LP device recall (Cls II)

Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); BOX LOBECTOMIA VATS 3D; CFN: BOX06170V4; — Reason: A manufacturing issue could lead to a malformed cover tube press which can lead to internal components' movement during firing - leading to the potential for uncontrolled motion. — Status: Ongoing

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Sep 25, 2025device recall328d agoPHILIPS MEDICAL SYSTEMS device recall (Cls II)

Model: CT 5300; Product Code (REF): 728285; Software Versions: 5.1.0.X & 5.1.1.X; — Reason: Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is used requiring use of manual stop. Issue 2. When performing a helical/Axial scan with ORI (Dose Right index)/ DOM (Dose Modulation), the WED (Water Equivalent Diameter) value might set itself to zero, and this may lead to an insufficient dose setting after the surview. If operator misses the insufficient dose and the WED value in User Interface and continues with the subsequent helical/Axial scans, then the obtained images will be noisy due to low dose setting. Issue 3: Due to a software failure, the ECG wave file is not saved. As a result, the cardiac offline image reconstruction fails due to the missing ECG wave file, and the user might rescan the patient. Issue 4: This issue is software fault in which the patient orientation will be changed to NULL under specific random scenarios resulting in radiation being delivered from the wrong orientation (surview scan) or in the wrong position (clinical scan) and will generate incorrect and undiagnosable surview/clinical images. Patients may be rescanned for surview and/or clinical images. Issue 5: During scanning, the preview image display is not consistent, the images are not arriving at a fixed rate, skipping images from time to time during scanning. The obtained images might not support making the clinical diagnosis and the user might decide to re-scan the patient. Issue 6: If a user presses the left and middle/right mouse buttons together or afterwards in a short time, both commands are executed and an incorrect auto ROI is created. This ROI coordinates won t be assigned as the object is empty. As a result, the threshold of contrast level will not be reached in the UI and this will prevent the system from automatically triggering the subsequent clinical scan. There is potential safety risk identified for additionally tracker shots and/or rescan of a patient when the clinical scan is not triggered. This issue only affects the manual ROI process. — Status: Ongoing

Sep 25, 2025device recall328d agoBALT USA, LLC device recall (Cls I)Bayer USA LLC

Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model/Catalog Number: MEGABT09180, MEGABT09190, MEGABT091100, MEGABT091110 Software Version: N/A Product Description: The Mega Ballast 091 is designed with a semi-rigid proximal shaft and a highly flexible distal shaft. The design facilitates the advancement of the Mega Ballast to access the tortuous vasculature over a guidewire and a respective dilator. The outer surface of the Mega Ballast is coated with a hydrophilic coating to facilitate lubricity from tip to 40 cm proximal. The proximal end of the Mega Ballast incorporates a Luer fitting hub for the attachment of accessories. The Mega Ballast is provided sterile, non-pyrogenic, and is intended for single use only. Component: Not a component — Reason: Due to an identified manufacturing defect involving coating material lifting within the catheter's distal inner diameter/lumen. — Status: Ongoing

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Sep 25, 2025device recall328d agoPHILIPS MEDICAL SYSTEMS device recall (Cls II)

Model: Incisive CT; Product Code (REF): (1) 728143, (2) 728144; Software Versions: 5.1.0.X & 5.1.1.X; — Reason: Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is used requiring use of manual stop. Issue 2. When performing a helical/Axial scan with ORI (Dose Right index)/ DOM (Dose Modulation), the WED (Water Equivalent Diameter) value might set itself to zero, and this may lead to an insufficient dose setting after the surview. If operator misses the insufficient dose and the WED value in User Interface and continues with the subsequent helical/Axial scans, then the obtained images will be noisy due to low dose setting. Issue 3: Due to a software failure, the ECG wave file is not saved. As a result, the cardiac offline image reconstruction fails due to the missing ECG wave file, and the user might rescan the patient. Issue 4: This issue is software fault in which the patient orientation will be changed to NULL under specific random scenarios resulting in radiation being delivered from the wrong orientation (surview scan) or in the wrong position (clinical scan) and will generate incorrect and undiagnosable surview/clinical images. Patients may be rescanned for surview and/or clinical images. Issue 5: During scanning, the preview image display is not consistent, the images are not arriving at a fixed rate, skipping images from time to time during scanning. The obtained images might not support making the clinical diagnosis and the user might decide to re-scan the patient. Issue 6: If a user presses the left and middle/right mouse buttons together or afterwards in a short time, both commands are executed and an incorrect auto ROI is created. This ROI coordinates won t be assigned as the object is empty. As a result, the threshold of contrast level will not be reached in the UI and this will prevent the system from automatically triggering the subsequent clinical scan. There is potential safety risk identified for additionally tracker shots and/or rescan of a patient when the clinical scan is not triggered. This issue only affects the manual ROI process. — Status: Ongoing

Sep 25, 2025device recall328d agoCovidien, LP device recall (Cls II)

Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); CFN: SIGSDL45CTVT; — Reason: A manufacturing issue could lead to a malformed cover tube press which can lead to internal components' movement during firing - leading to the potential for uncontrolled motion. — Status: Ongoing

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Sep 25, 2025device recall328d agoDJO, LLC device recall (Cls II)

Cold Form Wrap: Back, REF: DP163CT03-BLK-L,XL, and Shoulder, REF: DP163CT02 — Reason: The IFU (Information for Use) on the wrap instructs the user to heat the hot and cold compression wrap in the microwave for 3 minutes, which may cause the wrap to leak or break at the seams and/or reach temperatures capable of causing a second degree burn. — Status: Ongoing

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Sep 25, 2025device recall328d agoLeMaitre Vascular, Inc. device recall (Cls II)LEMAITRE VASCULAR INC

Artegraft¿ Collagen Vascular Graft; REF: AG1015; — Reason: The device was incorrectly packed in the wrong size labeled outer packaging. — Status: Ongoing

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Sep 25, 2025grant328d agoUNIVERSITY OF ALABAMA AT BIRMINGHAM — iHEAL : Improving HEalth Across the Lifespan

NR grant. $268,612. PI: Marie Anne Bakitas

Week of Sep 22, 2025