Calendar

Week of Feb 2, 2026

Feb 2, 2026device 510k193d agoNano-X Imaging , Ltd. — TAP2D (510k cleared)Nano-X Imaging Ltd.

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

Feb 2, 2026device 510k193d agoChengdu Besmile Medical Technology Co., Ltd. — BIORES Dental Implant System (510k cleared)

Product code: DZE. Advisory committee: Dental. Type: Abbreviated

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Feb 2, 2026device 510k193d agoOxehealth Limited — Vital Signs (510k cleared)

Product code: QME. Advisory committee: Cardiovascular. Type: Traditional

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Feb 2, 2026device 510k193d agoBeijing Kreate Medical Co., Ltd. — Redermax Antibacterial Wound Matrix (510k cleared)

Product code: FRO. Advisory committee: Unknown. Type: Traditional

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Feb 2, 2026device 510k193d agoAsahi Intecc Co., Ltd. — CHIKAI Nexus petit (510k cleared)

Product code: MOF. Advisory committee: Cardiovascular. Type: Traditional

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Feb 2, 2026device pma193d agoPhilips Medical Systems, Inc. — HeartStart OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (Model M5068A) (PMA supplement)MERIT MEDICAL SYSTEMS INC

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

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Feb 2, 2026device pma193d agoCooperVision, Inc. — Biofmity XR Torie (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (PMA supplement)

Supplement type: 30-Day Notice. Product code: LPM. Advisory committee: OP. Decision: OK30

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Feb 2, 2026device pma193d 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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Feb 2, 2026device pma193d agoPhilips Medical Systems — HeartStart FRx Defibrillator (PMA supplement)

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

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Feb 2, 2026device recall193d agoB Braun Medical Inc device recall (Cls II)B. Braun Medical Inc

Brand Name: B. Braun Product Name: 21GA WINGED INF SET Model/Catalog Number: 7M2802 Software Version: N/A Product Description: A device designed for subcutaneous implantation and intended to be used temporarily to expand an implanted tissue expander by percutaneous injection of air or fluids. Component: N/A — Reason: The potential for the needle tip to be dull/blunt, difficult to advance, and/or break. — Status: Ongoing

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Feb 2, 2026device recall193d agoHowmedica Osteonics Corp. device recall (Cls II)

MICS3 Angled Sagittal Saw Attachment; Part Number: 210490 — Reason: A potential issue was identified with the torque strength on the external screws of the MICS3 Angled Sagittal Saw Attachment. These screws, which secure the cover to the Angled Saw Housing, may loosen during use and detach from the attachment. — Status: Ongoing

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Feb 2, 2026device recall193d agoB Braun Medical Inc device recall (Cls II)B. Braun Medical Inc

Brand Name: B. Braun Product Name: 21GA WINGED INFUSION, SINGLE PK Model/Catalog Number: 7A3842 Software Version: N/A Product Description: A device designed for subcutaneous implantation and intended to be used temporarily to expand an implanted tissue expander by percutaneous injection of air or fluids. Component: N/A — Reason: The potential for the needle tip to be dull/blunt, difficult to advance, and/or break. — Status: Ongoing

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Feb 2, 2026device recall193d agoB Braun Medical Inc device recall (Cls II)B. Braun Medical Inc

Brand Name: B. Braun Product Name: BBraun Medical 21G X4.4CM Winged INF Model/Catalog Number: 7B3050 Software Version: N/A Product Description: A device designed for subcutaneous implantation and intended to be used temporarily to expand an implanted tissue expander by percutaneous injection of air or fluids. Component: N/A — Reason: The potential for the needle tip to be dull/blunt, difficult to advance, and/or break. — Status: Ongoing

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Feb 2, 2026grant193d agoUNIVERSITY OF GEORGIA — Establishing a cystic fibrosis ferret model of chronic Mycobacterium abscessu...

AI grant. $224,857. PI: Tuhina Gupta

Week of Feb 2, 2026