Calendar

Week of Feb 9, 2026

Feb 12, 2026device pma181d agoMedtronic Neuromodulation — SNS Bowel Neurostimulator Models 97800, 97810; SNS Bowel Screening Trialing System Model 3531 (PMA supplement)

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

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Feb 12, 2026device pma181d agoMedtronic, Inc. — DBS Implantable Neurostimulator Models B35200, B35300; DBS Implantable Neurostimulators Activa Family Models 37601, 3760 (PMA supplement)Medtronic plc

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

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Feb 12, 2026device pma181d agoMedtronic Neuromodulation — Altaviva Model P7850N (PMA supplement)

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

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Feb 12, 2026device pma181d agoMedtronic, Inc. — Consulta CRT-P C4TR01 Syncra CRT-P C2TR01 (PMA supplement)Medtronic plc

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

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Feb 12, 2026device pma181d agoMedtronic Cardiac Rhythm Disease Management — Amplia MRI CRT-D DTMB1D1, DTMB1D4 Amplia MRI Quad CRT-D DTMB1Q1, DTMB1QQ Brava CRT-D DTBC1D1, DTBC1D4 Brava Quad CRT-D D (PMA supplement)

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

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Feb 12, 2026device pma181d agoInstylla, Inc. — Embrace Hydrogel Embolic System (HES) (PMA supplement)

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

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Feb 12, 2026device pma181d agoPhilips Image Guided Therapy Corporation — Duo Venous Stent System (PMA supplement)

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

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Feb 12, 2026device pma181d agoEdwards Lifesciences, LLC — Edwards Commander Delivery System (9600LDS20, 9600LDS23, 9600LDS26, 9600LDS29, 9750CM20, 9750CM23, 9750CM26) (PMA supplement)Edwards Lifesciences Corp

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

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Feb 12, 2026device pma181d agoEdwards Lifesciences, LLC — Edwards EVOQUE Tricuspid Valve Replacement System (9850TDS) (PMA supplement)Edwards Lifesciences Corp

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

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Feb 12, 2026device pma181d agoMedtronic Neuromodulation — External Neurostimulator (ENS) Model 97725; Intellis Model 97716; Intellis Model 97715; SCS Implantable Neurostimulator (PMA supplement)

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

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Feb 12, 2026device pma181d agoMedtronic Cardiac Rhythm Disease Management — Evera MRI DF-1 ICD DDMB1D1, DDMC3D1, DVMB1D1, DVMC3D1 Evera MRI ICD DDMB1D4, DDMC3D4, DVMB1D4, DVMC3D4 Evera S DR ICD DD (PMA supplement)

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

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Feb 12, 2026device pma181d agoABBOTT MEDICAL — Amplatzer Piccolo Occluder (PMA supplement)

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

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Feb 12, 2026device pma181d agoMedtronic, Inc. — Drug Delivery Infusion Pump Model 8667 (PMA supplement)Medtronic plc

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

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Feb 12, 2026device pma181d agoMedtronic, Inc. — Evolut PRO, PRO+, FX, FX+ (PMA supplement)Medtronic plc

Supplement type: 135 Review Track For 30-Day Notice. Product code: NPT. Advisory committee: CV. Decision: APPR

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Feb 12, 2026device pma181d agoBiosense Webster, Inc. — VARIPULSE Platform (VARIPULSE Catheter; TRUPULSE Generator; Sterile Interface Cable; nGEN Pump) (PMA supplement)

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

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Feb 12, 2026device pma181d agoMedtronic, Inc. — Freestyle Bioprosthesis (PMA supplement)Medtronic plc

Supplement type: 135 Review Track For 30-Day Notice. Product code: LWR. Advisory committee: CV. Decision: APPR

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Feb 12, 2026device pma181d agoAbbott Laboratories — ARCHITECT Free PSA; Alinity i Free PSA (LN 6C07/07P93) (PMA supplement)ABBOTT LABORATORIES

Supplement type: 30-Day Notice. Product code: MTG. Advisory committee: IM. Decision: OK30

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Feb 12, 2026device pma181d agoMedtronic, Inc. — Harmony Transcatheter Pulmonary Valve (PMA supplement)Medtronic plc

Supplement type: 135 Review Track For 30-Day Notice. Product code: NPV. Advisory committee: CV. Decision: APPR

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Feb 12, 2026device pma181d agoBecton, Dickinson and Company — BD FOX PCR Extraction Tubes; BD Onclarity HPV Assay (PMA supplement)BECTON DICKINSON & CO

Supplement type: 30-Day Notice. Product code: MAQ. Advisory committee: MI. Decision: OK30

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Feb 12, 2026device pma181d agoEmpirical Spine, Inc. — LimiFlex Dynamic Sagittal Tether (PMA)

Product code: SGK. Advisory committee: OR. Decision: APPR

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Feb 12, 2026device pma181d agoDepuy, Inc. — LCS® Total Knee System (PMA supplement)

Supplement type: Special (Immediate Track). Product code: NJL. Advisory committee: OR. Decision: APPR

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Feb 12, 2026device pma181d agoMedtronic, Inc. — Advisa DR IPG A4DR01 Advisa DR MRI IPG A2DR01 Advisa SR MRI IPG A3SR01 (PMA supplement)Medtronic plc

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

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Feb 12, 2026device pma181d agoMedtronic, Inc. — Mosaic Bioprosthesis (PMA supplement)Medtronic plc

Supplement type: 135 Review Track For 30-Day Notice. Product code: DYE. Advisory committee: CV. Decision: APPR

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Feb 12, 2026device recall181d agoErbe USA Inc device recall (Cls I)

Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401 STERILEEO. For surgical use — Reason: Probes may rupture/burst during activation — Status: Ongoing

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Feb 12, 2026device recall181d agoErbe USA Inc device recall (Cls I)

Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use — Reason: Probes may rupture/burst during activation — Status: Ongoing

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Feb 12, 2026device recall181d agoOlympus Corporation of the Americas device recall (Cls II)

Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443. — Reason: The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors. — Status: Ongoing

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Feb 12, 2026device recall181d agoOlympus Corporation of the Americas device recall (Cls II)

Olympus Endoscope Reprocessor OER-Pro. Model Number: N3058140. — Reason: The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors. — Status: Ongoing

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Feb 12, 2026device recall181d agoOlympus Corporation of the Americas device recall (Cls II)

Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340. — Reason: The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors. — Status: Ongoing

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Feb 12, 2026device recall181d agoOlympus Corporation of the Americas device recall (Cls II)

Olympus Endoscope Air/Water Valve - MAJ-1444. Model Number: MAJ-1444. — Reason: The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors. — Status: Ongoing

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Feb 12, 2026device recall181d agoErbe USA Inc device recall (Cls I)

Flexible Cryoprobe (OD 1.7mm, L1.15mm) REF: 20402-410. For surgical use — Reason: Probes may rupture/burst during activation — Status: Ongoing

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Feb 12, 2026grant181d agoNORTHWESTERN UNIVERSITY AT CHICAGO — Capacity Building for the Diagnosis and Treatment of Neuromyelitis Optica usi...Northwestern University

TW grant. $372,306. PI: Farrah Jasmine Mateen

full page →nih reporter ↗

Feb 12, 2026grant181d agoUNIVERSITY OF NEW MEXICO HEALTH SCIS CTR — Investigating the Role of CircRNAs in Pain and Nocieptive Sensitization

GM grant. $191,972. PI: June Bryan de la Pena

full page →nih reporter ↗

Feb 12, 2026grant181d agoUNIVERSITY OF MINNESOTA — Differentiation and characteristics of Helios+ CD8+ T cellsUniversity of Minnesota

AI grant. $407,326. PI: STEPHEN C JAMESON

full page →nih reporter ↗

Feb 12, 2026grant181d agoRUTGERS THE STATE UNIV OF NJ CAMDEN — In vivo platforms for exploring co-evolution of ligands, receptors, and their...

GM grant. $423,734. PI: Nir Yakoby

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Feb 13, 2026approval180d agoMETRONIDAZOLE — FDA approvalMETRONIDAZOLE

Sponsor: ZYDUS LIFESCIENCES. Form: GEL. Route: TOPICAL

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Feb 13, 2026approval180d agoAVOPEF (ETOPOSIDE) — FDA approvaletoposide

Sponsor: AVYXA HOLDINGS. Form: SOLUTION. Route: INTRAVENOUS

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Feb 13, 2026approval180d agoCEFAZOLIN SODIUM — FDA approvalSamson Medical Technologies LLC

Sponsor: HQ SPCLT PHARMA. Form: POWDER. Route: INTRAVENOUS

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Feb 13, 2026approval180d agoWAKIX (PITOLISANT HYDROCHLORIDE) — FDA approvalpitolisant hydrochloride

Sponsor: HARMONY. Form: TABLET. Route: ORAL

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Feb 13, 2026approval180d agoTRAMADOL HYDROCHLORIDE — FDA approvalTrigen Laboratories Inc

Sponsor: UNICHEM. Form: TABLET. Route: ORAL

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Feb 13, 2026approval180d agoTRAMADOL HYDROCHLORIDE — FDA approvalTrigen Laboratories Inc

Sponsor: UNICHEM. Form: TABLET. Route: ORAL

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Feb 13, 2026approval180d agoAMMONIA N 13 (AMMONIA N-13) — FDA approval

Sponsor: WA UNIV SCH MED. Form: INJECTABLE. Route: INTRAVENOUS

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Feb 13, 2026approval180d agoRYBREVANT FASPRO (AMIVANTAMAB AND HYALURONIDASE-LPUJ) — FDA approval(amivantamab + hyaluronidase (human recombinant))

Sponsor: JANSSEN BIOTECH. Form: VIAL. Route: SINGLE-USE

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Feb 13, 2026approval180d agoGADAVIST (GADOBUTROL) — FDA approval

Sponsor: BAYER HLTHCARE. Form: SOLUTION. Route: INTRAVENOUS

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Feb 13, 2026approval180d agoRAPIBLYK (LANDIOLOL HYDROCHLORIDE) — FDA approvalAOP Health

Sponsor: AOP HLTH US. Form: POWDER. Route: INTRAVENOUS

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Feb 13, 2026approval180d agoEOVIST (GADOXETATE DISODIUM) — FDA approval

Sponsor: BAYER HLTHCARE. Form: SOLUTION. Route: INTRAVENOUS

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Feb 13, 2026approval180d agoCOLCHICINE — FDA approvalCOLCHICINE

Sponsor: MACLEODS PHARMS LTD. Form: TABLET. Route: ORAL

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Feb 13, 2026device 510k180d agoShenzhen Best Electronics Co., Ltd. — NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122, BCS-222, BCS-322, BCS-422, BCS-522, BCS-622, BCS-722, BCD-112, BCD-212, BCD-312, BCD-412, BCD-512, BCD-612, BCD-712, BCD-122, BCD-222, BCD-322, BCD-422, BCD-522, BCD-622, BCD-722) (510k cleared)

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

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Feb 13, 2026device 510k180d agoClouds of Care — PreOp v3 (510k cleared)

Product code: OLX. Advisory committee: Neurology. Type: Special

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Feb 13, 2026device 510k180d agoShenzhen TPH Technology Co., Ltd. — Wearable Breast Pump (Model W2) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

Product code: HGX. Advisory committee: Obstetrics/Gynecology. Type: Traditional

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Feb 13, 2026device 510k180d agoABBOTT MEDICAL — Armada 14 NC PTA Catheter (510k cleared)

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

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Week of Feb 9, 2026