Calendar

Week of Sep 1, 2025

Sep 5, 2025device pma341d agoMedtronic Neuromodulation — Master Restore, Itrel®, Synergy IntellisTM, VantaTM and InceptivTM Spinal Cord Stimulation Systems and PiscesTM, Specify (PMA supplement)

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

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Sep 5, 2025device pma341d agoThe Straumann Company — Straumann Emdogain (PMA supplement)

Supplement type: 30-Day Notice. Product code: NQA. Advisory committee: DE. Decision: OK30

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Sep 5, 2025device pma341d agoMedtronic, Inc. — Astra S DR MRI IPG (X3DR01); Astra S SR MRI IPG (X3SR01); Astra XT DR MRI IPG (X1DR01); Astra XT SR MRI IPG (X1SR01); Az (PMA supplement)Medtronic plc

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

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Sep 5, 2025device pma341d agoMedtronic, Inc. — SynchroMed® Infusion System, Ascenda® Intrathecal Catheters (PMA supplement)Medtronic plc

Supplement type: 30-Day Notice. Product code: LKK. Advisory committee: HO. Decision: OK30

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Sep 5, 2025device pma341d agoKeri Medical SA — TOUCH® CMC 1 Prosthesis (PMA supplement)

Supplement type: Normal 180 Day Track No User Fee. Product code: SFA. Advisory committee: OR. Decision: APPR

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Sep 5, 2025device pma341d agoLivaNova USA, Inc. — VNS Therapy System (PMA supplement)

Supplement type: Special (Immediate Track). Product code: LYJ. Advisory committee: NE. Decision: APPR

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Sep 5, 2025device pma341d agoMedtronic, Inc. — Aurora EV-ICD System (DVEA3E4) (PMA supplement)Medtronic plc

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

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Sep 5, 2025device pma341d agoMedtronic Neuromodulation — InterStim® Therapy System; Verify® Evaluation System (PMA supplement)

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

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Sep 5, 2025device pma341d agoMedtronic Cardiac Rhythm Disease Management — Percepta Bipolar CRT-P W1TR1; Percepta Quadripolar CRT-P W4TR01; Serena Bipolar CRT-P W1TR02; Serena Quadripolar CRT-P W (PMA supplement)

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

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Sep 5, 2025device pma341d agoMedtronic, Inc. — Miera AV TPS (MC1AVR1); Miera A V2 TPS (MC2AVR1); Miera TPS (MC1VR01); Miera VR2 TPS (MC2VR01) (PMA supplement)Medtronic plc

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

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Sep 5, 2025device pma341d agoPhilips Medical Systems — HeartStart FRx Defibrillator and HeartStart SMART Pads II (PMA supplement)

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

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Sep 5, 2025device recall341d agoPhilips Ultrasound, Inc device recall (Cls III)

Philips S5-2 Ultrasound Transducer — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

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Sep 5, 2025device recall341d agoGE Medical Systems, SCS device recall (Cls II)

AW Server 2.0, AW Server 3.0, AW Server 3.1, AW Server 3.2 — Reason: Firm has identified a security vulnerability in AW Server products. If exploited, a malicious actor could compromise the confidentiality, integrity, and availability of patient data. — Status: Ongoing

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Sep 5, 2025device recall341d agoWipro GE Healthcare Private Ltd. device recall (Cls II)

GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5, Part Number 5867474-03; Medical Display, cathode ray tube — Reason: GE HealthCare has identified an issue affecting Carescape" Central Station (CSCS) with software version V3.0.5, which can cause the system to enter a continuous reboot cycle. If this occurs, a loss of central monitoring of connected patients could result. This issue occurs only when the number of central stations connected to the network is 118, 119 or 120. — Status: Ongoing

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Sep 5, 2025device recall341d agoPhilips Ultrasound, Inc device recall (Cls III)

Philips S4-1 Ultrasound Transducer — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

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Sep 5, 2025device recall341d agoExactech, Inc. device recall (Cls II)

Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 46mm Model/Catalog Number: 321-59-46 Software Version: N/A Product Description: rTSA Reamer, 46mm Component: Not a component — Reason: Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria. — Status: Ongoing

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Sep 5, 2025device recall341d agoPhilips Ultrasound, Inc device recall (Cls III)

Philips X3-1 Ultrasound Transducer — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

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Sep 5, 2025device recall341d agoPhilips Ultrasound, Inc device recall (Cls III)

Philips OMNI II TEE Ultrasound Transducer — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

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Sep 5, 2025device recall341d agoSpacelabs Healthcare, Inc. device recall (Cls II)HCA Healthcare, Inc.

Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0893-01 Software Version: N/A Product Description: 16 inch DVI-I to DVI-I male/male display cable. Component: Yes, the cable is an external display cable used with the 91390 and 91393 — Reason: Due to display cables used for monitors were not in compliance with electromagnetic interference from inadequately shielded cables which may pose serious risk to patient's safety by interfering with the operation of another electronically sensitive medical device are in use. — Status: Ongoing

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Sep 5, 2025device recall341d agoPhilips Ultrasound, Inc device recall (Cls III)

Philips L17-5 Ultrasound Transducer — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

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Sep 5, 2025device recall341d agoWipro GE Healthcare Private Ltd. device recall (Cls II)

GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5; Part Number 5867474-04; Medical Display, cathode ray tube — Reason: GE HealthCare has identified an issue affecting Carescape" Central Station (CSCS) with software version V3.0.5, which can cause the system to enter a continuous reboot cycle. If this occurs, a loss of central monitoring of connected patients could result. This issue occurs only when the number of central stations connected to the network is 118, 119 or 120. — Status: Ongoing

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Sep 5, 2025device recall341d agoSpacelabs Healthcare, Inc. device recall (Cls II)HCA Healthcare, Inc.

Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0895-12 Software Version: N/A Product Description: 12 foot DVI-I to DVI-I male/male display cable. Component: Yes, the cable is an external display cable used with the 91390 and 91393 — Reason: Due to display cables used for monitors were not in compliance with electromagnetic interference from inadequately shielded cables which may pose serious risk to patient's safety by interfering with the operation of another electronically sensitive medical device are in use. — Status: Ongoing

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Sep 5, 2025device recall341d agoPhilips Ultrasound, Inc device recall (Cls III)

Philips Mini Multi TEE Ultrasound Transducer — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

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Sep 5, 2025device recall341d agoPhilips Ultrasound, Inc device recall (Cls III)

Philips OMNI III TEE Ultrasound Transducer — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

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Sep 5, 2025device recall341d agoSpacelabs Healthcare, Inc. device recall (Cls II)HCA Healthcare, Inc.

Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0895-01 Software Version: N/A Product Description: 6 foot DVI-I to DVI-I male/male display cable. Component: Yes, the cable is an external display cable used with the 91390 and 91393 — Reason: Due to display cables used for monitors were not in compliance with electromagnetic interference from inadequately shielded cables which may pose serious risk to patient's safety by interfering with the operation of another electronically sensitive medical device are in use. — Status: Ongoing

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Sep 5, 2025device recall341d agoExactech, Inc. device recall (Cls II)

Brand Name: Equinoxe Ergo Product Name: Ergo Augments Pilot Tip Converter Model/Catalog Number: 301-11-11 Software Version: N/A Product Description: Pilot Tip Converter Piece Component: Not a component — Reason: Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria. — Status: Ongoing

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Sep 5, 2025device recall341d agoPhilips Ultrasound, Inc device recall (Cls III)

Philips 3D6-2 Ultrasound Transducer — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

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Sep 5, 2025device recall341d agoPhilips Ultrasound, Inc device recall (Cls III)

Philips X7-2 Ultrasound Transducer — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

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Sep 5, 2025device recall341d agoPhilips Ultrasound, Inc device recall (Cls III)

Philips C9-4 Ultrasound Transducer — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

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Sep 5, 2025device recall341d agoPhilips Ultrasound, Inc device recall (Cls III)

Philips L12-5 Ultrasound Transducer — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

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Sep 5, 2025device recall341d agoExactech, Inc. device recall (Cls II)

Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 42mm Model/Catalog Number: 321-59-42 Software Version: N/A Product Description: rTSA Reamer, 42mm Component: Not a component — Reason: Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria. — Status: Ongoing

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Sep 5, 2025device recall341d agoMICROVENTION INC. device recall (Cls II)MICROVISION, INC.

Flow Re-Direction Endoluminal Devices: FRED 27, REF: FRED5019, FRED5029, FRED4528, FRED4026, FRED5526, FRED4508, FRED5514, FRED3536, FRED3511, FRED5014, FRED3516, MV-F451827; FRED X 27, REF: XFRED4017-MVE, XFRED4528-MVE, MV-F501427X, XFRED4518-MVE, XFRED5526-MVE, XFRED4539-MVE, FREDX5522-PMA, FREDX3522-PMA, FREDX4525-PMA, FREDX5015-PMA, FREDX5532-PMA, FREDX4013-PMA, FREDX3513-PMA, FREDX4515-PMA, FREDX3517-PMA, MV-F352427X — Reason: Flow diverter may have a manufacturing issue related to the tantalum length and/or tantalum attachment pattern, which may lead the device to be incompletely open or not properly apposed to the vessel wall, which may necessitate device recapture and withdrawal of the delivery system and microcatheter together. Insufficient apposition could lead to long-term health consequences. — Status: Ongoing

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Sep 5, 2025grant341d agoEVOQUANT LLC — Leveraging Large Scale Bioinformatics and AI for Natural Product Drug Discove...

AT grant. $306,872. PI: Chase Madison Clark

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Sep 5, 2025grant341d agoPERFUSION SOLUTIONS, INC. — A Fail Safe, High Output Failing Fontan Pump

HL grant. $320,838. PI: WILLIAM A SMITH

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Sep 5, 2025grant341d agoUNIVERSITY OF CALIFORNIA LOS ANGELES — Understanding Mechanisms Driving Poor Outcomes in Women with DermatomyositisUniversity of California Los Angeles

AR grant. $366,639. PI: Christina Charles-Schoeman

full page →nih reporter ↗

Sep 5, 2025grant341d agoUNIVERSITY OF PENNSYLVANIA — Development of Dual-Action Nanoparticle-Loaded Microparticles for Osteoarthri...University of Pennsylvania

AR grant. $646,506. PI: Zhiliang Cheng

full page →nih reporter ↗

Sep 5, 2025grant341d agoBOSTON CHILDREN'S HOSPITAL — Mental and Behavioral Health Among Vulnerable Adolescents and Young Adults in...Boston Children's Hospital

HD grant. $787,154. PI: Sabra L. Katz-Wise

full page →nih reporter ↗

Sep 5, 2025grant341d agoUNIVERSITY OF ALABAMA AT BIRMINGHAM — Resource Core

HD grant. $236,547. PI: Hui-Ju Young

full page →nih reporter ↗

Sep 5, 2025grant341d agoSCRIPPS RESEARCH INSTITUTE, THE — in vivo modeling of IgH-reprogrammed B cells in mice

HL grant. $647,573. PI: James Even Voss

full page →nih reporter ↗

Sep 5, 2025grant341d agoUT SOUTHWESTERN MEDICAL CENTER — Project 2: Hepatocyte-targeted HCC chemoprevention with Anillin knockdown

CA grant. $425,304. PI: Hao Zhu

full page →nih reporter ↗

Sep 5, 2025grant341d agoUNIVERSITY OF PENNSYLVANIA — A mixed methods approach to understanding dementia caregiver stress when cari...University of Pennsylvania

NR grant. $52,538. PI: Lauren Anne Fisher

full page →nih reporter ↗

Sep 5, 2025grant341d agoUNIVERSITY OF CALIFORNIA, SAN FRANCISCO — Bridging the Gap Between Prediction and Reality in Structural BiologyUniversity of California San Francisco

GM grant. $501,000. PI: James M Holton

full page →nih reporter ↗

Sep 5, 2025grant341d agoUTAH STATE HIGHER EDUCATION SYSTEM--UNIVERSITY OF UTAH — Integrating multi-omics data to understand the heterogeneity of preeclampsia ...University of Utah

HL grant. $524,179. PI: Nathan Richard Blue

full page →nih reporter ↗

Sep 5, 2025grant341d agoDUKE UNIVERSITY — Evaluating two novel, population-tailored health insurance designs: impact on...Duke University

DK grant. $843,485. PI: James Franklin Wharam

full page →nih reporter ↗

Sep 5, 2025grant341d agoWEILL MEDICAL COLL OF CORNELL UNIV — Graft Stiffness as a Substrate for Adverse Cardiovascular Remodeling and Clin...

HL grant. $174,389. PI: Nupoor Narula

full page →nih reporter ↗

Sep 5, 2025grant341d agoTUFTS UNIVERSITY MEDFORD — Pulse-oximetry method for un-biased assessment of arterial saturation

HL grant. $134,537. PI: Giles Blaney

full page →nih reporter ↗

Sep 5, 2025grant341d agoMEDICAL COLLEGE OF WISCONSIN — Evaluation of the influence of angiotensin type 1 receptor expression under d...

DK grant. $49,538. PI: Gabriella Robilotto

full page →nih reporter ↗

Sep 5, 2025grant341d agoLSU HEALTH SCIENCES CENTER — Kappa Opioid Receptor modulation of BLA inputs to the BNST and stress-escalat...

AA grant. $337,500. PI: Rajani Maiya

full page →nih reporter ↗

Sep 5, 2025grant341d agoJOHNS HOPKINS UNIVERSITY — Investigating a novel vascular pathway that regulates neuronal survivalJohns Hopkins University

AG grant. $480,710. PI: SHANTHINI SOCKANATHAN

full page →nih reporter ↗

Sep 5, 2025grant341d agoNORTHWESTERN UNIVERSITY AT CHICAGO — Bile Resistance in Pseudomonas aeruginosaNorthwestern University

AI grant. $240,000. PI: Kelly Erin Riordan Bachta

full page →nih reporter ↗

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Week of Sep 1, 2025