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calendar

1,359 catalysts · 4,728 grant · 3,603 8k filing · 2,594 approval · 1,952 device 510k · 1,578 device recall · 1,359 device pma

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type: device pma×from 2025-09-02×clear all
type
  • grant4,728
  • 8k filing3,603
  • approval2,594
  • device 510k1,952
  • device recall1,578
  • device pma1,359
device adverse event
1,000
  • earnings585
  • recall544
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Sep 1, 2025

    44
    ›Sep 2, 2025device pma362d agoBoston Scientific Corp — Opal HDx Ablation Connection Box (Maestro); Opal HDx Ablation Connection Box - IntellaNav StablePoint; Opal HDx Ablation (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Sep 2, 2025device pma362d agoJohnson & Johnson Surgical Vision, Inc. — TECNIS™ Toric II 1-Piece IOLs, ZCU TECNIS Symfony Toric II Extended Range of Vision IOLs, ZXU TECNIS Eyhance Toric II IO (PMA supplement)JOHNSON & JOHNSON

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

    full page →fda device pma ↗
    ›Sep 2, 2025device pma362d agoCochlear Americas — Cochlear™ Nucleus® System (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 2, 2025device pma362d agoJohnson & Johnson Surgical Vision, Inc. — TECNIS 3-Piece Acrylic Monofocal, Model ZA9003 (PMA supplement)JOHNSON & JOHNSON

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

    full page →fda device pma ↗
    ›Sep 2, 2025device pma362d agoCentinel Spine, LLC — PRODISC L (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 2, 2025device pma362d agoRxsight, Inc. — LIGHT ADJUSTABLE LENS (LAL) AND LIGHT DELIVERY DEVICE (LDD) (PMA supplement)RxSight, Inc.

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

    full page →fda device pma ↗
    ›Sep 2, 2025device pma362d agoJohnson & Johnson Surgical Vision, Inc. — TECNIS 3-Piece Multifocal, Model ZMA00 (PMA supplement)JOHNSON & JOHNSON

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

    full page →fda device pma ↗
    ›Sep 2, 2025device pma362d agoHeartsine Technologies, Ltd. — HeartSine’s samaritan® Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P) and Accessories (PMA supplement)TAT TECHNOLOGIES LTD

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

    full page →fda device pma ↗
    ›Sep 3, 2025device pma361d agoSymatese — EVOLYSSE® FORM and EVOLYSSE® SMOOTH (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 3, 2025device pma361d agoBolton Medical, Inc. — RelayPro (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 3, 2025device pma361d agoMicroTransponder, Inc. — Vivistim® System (PMA supplement)

    Supplement type: 30-Day Notice. Product code: QPY. Advisory committee: PM. Decision: OK30

    full page →fda device pma ↗
    ›Sep 3, 2025device pma361d agoSirtex Medical, Inc. — Lava Liquid Embolic System (Lava LES) and Lava Mixing Kit (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 3, 2025device pma361d agoBoston Scientific Corp — ACUITY X4 Straight, Models 4671 and 4672; ACUITY X4 Spiral S, Models 4674 and 4675; ACUITY X4 Spiral L, Models 4677 and (PMA supplement)BOSTON SCIENTIFIC CORP

    Supplement type: Real-Time Process. Product code: NIK. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Sep 3, 2025device pma361d agoEBR Systems, Inc. — WiSE® (Wireless Stimulation of the Endocardium Technology) CRT System (PMA supplement)EBR Systems, Inc.

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

    full page →fda device pma ↗
    ›Sep 3, 2025device pma361d agoBolton Medical, Inc. — RelayPlus (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 3, 2025device pma361d agoBolton Medical, Inc. — TREO® Abdominal Stent-Graft System (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 4, 2025device pma360d agoETHICON, Inc. — SURGICEL® Absorbable Hemostats (PMA supplement)

    Supplement type: 30-Day Notice. Product code: LMG. Advisory committee: SU. Decision: OK30

    full page →fda device pma ↗
    ›Sep 4, 2025device pma360d agoMedtronic, Inc. — Sphere-9™ Mapping and Ablation Catheter (PMA supplement)Medtronic plc

    Supplement type: Real-Time Process. Product code: QZI. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Sep 4, 2025device pma360d agoLutonix — Lutonix 018 (Model 9014) (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 4, 2025device pma360d agoETHICON, Inc. — GYNECARE INTERCEED™ Absorbable Adhesion Barrier (PMA supplement)

    Supplement type: 30-Day Notice. Product code: MCN. Advisory committee: OB. Decision: OK30

    full page →fda device pma ↗
    ›Sep 4, 2025device pma360d agoVentana Medical Systems, Inc. — CINtec PLUS Cytology (PMA supplement)MERIT MEDICAL SYSTEMS INC

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

    full page →fda device pma ↗
    ›Sep 4, 2025device pma360d agoBoston Scientific Corp — WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY (PMA supplement)BOSTON SCIENTIFIC CORP

    Supplement type: Real-Time Process. Product code: NGV. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Sep 4, 2025device pma360d agoLutonix — Lutonix 035 (Model 9004 and Model 9010) (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 5, 2025device pma359d agoMedtronic, Inc. — Percepta Bipolar CRT-P (W1TR01); Percepta Quadripolar CRT-P (W4TR01); Serena Bipolar CRTP (W1TR02); Serena Quadripolar C (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Sep 5, 2025device pma359d agoIllumina, Inc. — TruSight Oncology Comprehensive (PMA supplement)ILLUMINA, INC.

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

    full page →fda device pma ↗
    ›Sep 5, 2025device pma359d agoABBOTT MEDICAL — AVEIR Leadless Pacemaker (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 5, 2025device pma359d 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

    full page →fda device pma ↗
    ›Sep 5, 2025device pma359d agoMedtronic Cardiac Rhythm Disease Management — Amplia MRI CRT-D (DTMB1D1, DTMB1D4); Amplia MRI Quad CRT-D (DTMB1Q1, DTMB1QQ); Brava CRT-D (DTBC1D1, DTBC1D4); Brava Qua (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 5, 2025device pma359d agoMedtronic, Inc. — Harmony™ TPV System (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Sep 5, 2025device pma359d agoMedtronic, Inc. — Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Sep 5, 2025device pma359d agoMedtronic Neuromodulation — InterStim® Therapy System; Verify® Evaluation System (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 5, 2025device pma359d 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

    full page →fda device pma ↗
    ›Sep 5, 2025device pma359d agoThe Straumann Company — Straumann Emdogain (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 5, 2025device pma359d 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

    full page →fda device pma ↗
    ›Sep 5, 2025device pma359d 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

    full page →fda device pma ↗
    ›Sep 5, 2025device pma359d 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

    full page →fda device pma ↗
    ›Sep 5, 2025device pma359d agoLivaNova USA, Inc. — VNS Therapy System (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 5, 2025device pma359d agoMedtronic, Inc. — Aurora EV-ICD System (DVEA3E4) (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Sep 5, 2025device pma359d agoMedtronic Neuromodulation — InterStim® Therapy System; Verify® Evaluation System (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 5, 2025device pma359d 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

    full page →fda device pma ↗
    ›Sep 5, 2025device pma359d 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

    full page →fda device pma ↗
    ›Sep 5, 2025device pma359d 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

    full page →fda device pma ↗
    ›Sep 7, 2025device pma357d agoABBOTT MEDICAL — Liberta RC™ DBS IPG (PMA supplement)

    Supplement type: Normal 180 Day Track. Product code: MHY. Advisory committee: NE. Decision: APPR

    full page →fda device pma ↗
    ›Sep 7, 2025device pma357d agoABBOTT MEDICAL — Eterna™ SCS IPG (PMA supplement)

    Supplement type: Normal 180 Day Track. Product code: LGW. Advisory committee: NE. Decision: APPR

    full page →fda device pma ↗

    Week of Sep 8, 2025

    6
    ›Sep 8, 2025device pma356d agoFerrosan Meidcal Devices A/S — SURGIFOAM® Absorbable Gelatin Sponge (PMA supplement)

    Supplement type: 30-Day Notice. Product code: LMF. Advisory committee: SU. Decision: OK30

    full page →fda device pma ↗
    ›Sep 8, 2025device pma
    ← prev
    page 1 of 28
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    356d ago
    Croma-Pharma GmbH — saypha® MagIQ™ (PMA)

    Product code: LMH. Advisory committee: SU. Decision: APPR

    full page →fda device pma ↗
    ›Sep 8, 2025device pma356d agoOrganox Limited — OrganOx metra® System (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 9, 2025device pma355d agoDepuy, Inc. — LCS® Total Knee System (PMA supplement)

    Supplement type: 30-Day Notice. Product code: NJL. Advisory committee: OR. Decision: OK30

    full page →fda device pma ↗
    ›Sep 9, 2025device pma355d agoW. L. Gore & Associates, Inc. — GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 9, 2025device pma355d agoIntegra Lifesciences Corp. — INTEGRA® Dermal Regeneration Template, Integra® Meshed Dermal Regeneration Template, and Integra® Omnigraft Dermal Regen (PMA supplement)INTEGRA LIFESCIENCES HOLDINGS CORP

    Supplement type: 30-Day Notice. Product code: MGR. Advisory committee: SU. Decision: OK30

    full page →fda device pma ↗
    $BSX46.84+0.36%
    $MMSI90.49+1.06%
    $JNJ268.04+0.85%
    $MDT91.23+1.40%
    $EBRCZ0.2780+48.56%
    $JNJ268.04+0.85%
    $TATT
    $JNJ268.04+0.85%
    $RXST
    $BSX46.84+0.36%
    $BSX46.84+0.36%
    $MDT91.23+1.40%
    $MDT91.23+1.40%
    $ILMN227.69+1.27%
    $MDT91.23+1.40%
    $MDT91.23+1.40%
    $IART16.85-0.18%
    $MDT91.23+1.40%
    $MDT91.23+1.40%
    $MDT91.23+1.40%