Calendar

Week of Sep 15, 2025

Sep 19, 2025device 510k334d agoNakanishi, Inc. — VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11) (510k cleared)

Product code: ELC. Advisory committee: Dental. Type: Traditional

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Sep 19, 2025device 510k334d agoZeus Scientific — Alegria Flash ENA Screen (510k cleared)Dawn Sea Therapeutics

Product code: LLL. Advisory committee: Immunology. Type: Traditional

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Sep 19, 2025device 510k334d agoCytocell Limited — KMT2A Breakapart FISH Probe Kit PDx (CDA-LPH013) (510k cleared)

Product code: SFS. Advisory committee: Hematology. Type: Direct

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Sep 19, 2025device pma334d agoBoston Scientific Corp — Vercise Deep Brain Stimulation (DBS) Systems (PMA supplement)BOSTON SCIENTIFIC CORP

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

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Sep 19, 2025device pma334d agoAbiomed, Inc. — Impella RP, Impella RP with SmartAssist, Impella RP Flex with SmartAssist (PMA supplement)Abion Inc

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

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Sep 19, 2025device pma334d agoContego Medical, Inc. — Neuroguard IEP® 3-in-1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard I (PMA supplement)

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

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Sep 19, 2025device pma334d agoRoche Molecular Systems, Inc. — cobas HPV (PMA supplement)

Supplement type: Special (Immediate Track). Product code: MAQ. Advisory committee: MI. Decision: APPR

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Sep 19, 2025device pma334d agoBoston Scientific Corp — Carotid Wallstent Monorail Endoprosthesis (PMA supplement)BOSTON SCIENTIFIC CORP

Supplement type: Special (Immediate Track). Product code: NIM. Advisory committee: CV. Decision: APPR

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Sep 19, 2025device pma334d agoIllumina, Inc. — TruSight Oncology Comprehensive (PMA supplement)ILLUMINA, INC.

Supplement type: 30-Day Notice. Product code: PQP. Advisory committee: PA. Decision: OK30

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Sep 19, 2025device pma334d agoOrganox Limited — OrganOx metra® System (PMA supplement)

Supplement type: 30-Day Notice. Product code: QQK. Advisory committee: GU. Decision: OK30

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Sep 19, 2025device pma334d agoRoche Molecular Systems, Inc. — cobas HBV (PMA supplement)

Supplement type: Special (Immediate Track). Product code: MKT. Advisory committee: MI. Decision: APPR

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Sep 19, 2025device pma334d agoMedtronic, Inc. — Sphere-9 Catheter and Affera Ablation System (PMA supplement)Medtronic plc

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

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Sep 19, 2025device pma334d agoBoston Scientific Corp — Precision Spinal Cord Stimulator (SCS) Systems (PMA supplement)BOSTON SCIENTIFIC CORP

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

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Sep 19, 2025device pma334d agoAbiomed, Inc. — Impella 2.5; Impella CP; Impella CP with SmartAssist; Impella 5.0; Impella 5.5 with SmartAssist; Impella LD (PMA supplement)Abion Inc

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

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Sep 19, 2025device recall334d agoKico Knee Innovation Company device recall (Cls II)

Brand Name: ARVIS Product Name: ARVIS" Shoulder Model/Catalog Number: IN-27300, Arvis Surgical Planning Software Software Version: V2025.1.2 Product Description: Intended Use: The ARVIS" system is a computer-controlled navigation system intended to provide intra-operative measurements to the surgeon to aid in selection and positioning of orthopedic implant components. Description: ARVIS Shoulder is a computer-controlled surgical navigation system for shoulder arthroplasty. It aids the surgeon in making intra-operative measurements and locating anatomical structures of the shoulder joint based on the patient s preoperative imaging to assist with selection and positioning of orthopedic implant components. The system consists of software, electronic hardware and surgical instruments. The device s workflow involves CT based preoperative planning followed by intraoperative navigation and execution. The preoperative planning software enables 3D virtual implant positioning based on the patient s CT reconstructed digital bone model and bony landmarks. The shoulder navigation application software then matches the patient s digital bone model and landmarks to the intraoperative landmarks registered by the surgeon, allowing an image-based navigation to follow. The surgeon uses the plan data as guidance to navigate and help position shoulder instruments and implants. — Reason: Complaint identified issue with AI surgical planning software that may result in implant malalignment and/or decrease range of motion. — Status: Ongoing

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Sep 19, 2025device recall334d agoBeckman Coulter, Inc. device recall (Cls II)

DxI 9000 Access Immunoassay Analyzer, Part Number C11137 — Reason: Beckman Coulter has confirmed a software anomaly on DxI 9000 Access Immunoassay Analyzer and the DxC 500i Clinical Analyzer that may prevent correct application of user-specified manual dilution factors when ordering additional tests for samples already "In Progress" using the same "Sample ID number". This can lead to false low or high patient results and potential delays in reporting, risking erroneous diagnoses if undetected. — Status: Ongoing

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Sep 19, 2025device recall334d agoOrthofix U.S. LLC device recall (Cls II)

Virata Preassembled Polyaxial Screw, utilized in the Virata Spinal Fixation System. The following sizes are affected: 1. POLYAXIAL SCREW, CC, 5.5mm X 30mm; Item Number: TL1-10755030. 2. POLYAXIAL SCREW, CC, 5.5mm X 35mm; Item Number: TL1-10755035. 3. POLYAXIAL SCREW, CC, 5.5mm X 40mm; Item Number: TL1-10755040. 4. POLYAXIAL SCREW, CC, 5.5mm X 45mm; Item Number: TL1-10755045. 5. POLYAXIAL SCREW, CC, 5.5mm X 50mm; Item Number: TL1-10755050. 6. POLYAXIAL SCREW, CC, 6.5mm X 30mm; Item Number: TL1-10765030. 7. POLYAXIAL SCREW, CC, 6.5mm X 35mm; Item Number: TL1-10765035. 8. POLYAXIAL SCREW, CC, 6.5mm X 40mm; Item Number: TL1-10765040. 9. POLYAXIAL SCREW, CC, 6.5mm X 45mm; Item Number: TL1-10765045. 10. POLYAXIAL SCREW, CC, 6.5mm X 50mm; Item Number: TL1-10765050. 11. POLYAXIAL SCREW, CC, 6.5mm X 55mm; Item Number: TL1-10765055. 12. POLYAXIAL SCREW, CC, 6.5mm X 60mm; Item Number: TL1-10765060. 13. POLYAXIAL SCREW, CC, 7.5mm X 30mm; Item Number: TL1-10775030. 14. POLYAXIAL SCREW, CC, 7.5mm X 35mm; Item Number: TL1-10775035. 15. POLYAXIAL SCREW, CC, 7.5mm X 40mm; Item Number: TL1-10775040. 16. POLYAXIAL SCREW, CC, 7.5mm X 45mm; Item Number: TL1-10775045. 17. POLYAXIAL SCREW, CC, 7.5mm X 50mm; Item Number: TL1-10775050. 18. POLYAXIAL SCREW, CC, 7.5mm X 55mm; Item Number: TL1-10775055. 19. POLYAXIAL SCREW, CC, 7.5mm X 60mm; Item Number: TL1-10775060. 20. POLYAXIAL SCREW, CC, 8.5mm X 35mm; Item Number: TL1-10785035. 21. POLYAXIAL SCREW, CC, 8.5mm X 40mm; Item Number: TL1-10785040. 22. POLYAXIAL SCREW, CC, 8.5mm X 45mm; Item Number: TL1-10785045. 23. POLYAXIAL SCREW, CC, 8.5mm X 50mm; Item Number: TL1-10785050. 24. POLYAXIAL SCREW, CC, 8.5mm X 55mm; Item Number: TL1-10785055. 25. POLYAXIAL SCREW, CC, 8.5mm X 60mm; Item Number: TL1-10785060. — Reason: Polyaxial screws do not meet performance standards. — Status: Ongoing

Sep 19, 2025device recall334d agoBeckman Coulter, Inc. device recall (Cls II)

DxC 500i Clinical Analyzer Modules, DxC 500 AU Module w/ISE, DxC 500i (Part Number C63522), DxC 500 AU Module, DxC 500i (Part Number C63521), and Access 2 Module, DxC 500i (Part Number C13252) — Reason: Beckman Coulter has confirmed a software anomaly on DxI 9000 Access Immunoassay Analyzer and the DxC 500i Clinical Analyzer that may prevent correct application of user-specified manual dilution factors when ordering additional tests for samples already "In Progress" using the same "Sample ID number". This can lead to false low or high patient results and potential delays in reporting, risking erroneous diagnoses if undetected. — Status: Ongoing

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Sep 19, 2025grant334d agoEMORY UNIVERSITY — SMILE (Sickle Cell Disease Microbiologic and Immunologic Links to Health)Emory University

HL grant. $794,661. PI: Matthew Z Anderson

Week of Sep 15, 2025