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calendar

2,000 catalysts · 18,987 approval · 5,000 device 510k · 4,779 phase readout · 4,728 grant · 2,387 8k filing · 2,000 device pma

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type: device pma×clear all
type
  • approval18,987
  • device 510k5,000
  • phase readout4,779
  • grant4,728
  • 8k filing2,387
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • earnings295
  • therapy area

    no tagged catalysts yet

    Week of Oct 6, 2025

    17
    ›Oct 9, 2025device pma288d agoMedtronic Minimed — Guardian Connect System (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 9, 2025device pma288d agoW. L. Gore & Associates, Inc. — GORE® EXCLUDER® AAA Endoprosthesis and Iliac Branch Endoprosthesis (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 10, 2025device pma287d agoDiaSorin, Inc. — LIAISON® XL MUREX HBeAg and LIAISON® XL MUREX Control HBeAg (PMA supplement)

    Supplement type: Real-Time Process. Product code: LOM. Advisory committee: MI. Decision: APPR

    full page →fda device pma ↗
    ›Oct 10, 2025device pma287d agoDiaSorin, Inc. — LIAISON® XL MUREX Anti-HBe and LIAISON® XL MUREX Control Anti-HBe (PMA supplement)

    Supplement type: Real-Time Process. Product code: LOM. Advisory committee: MI. Decision: APPR

    full page →fda device pma ↗
    ›Oct 10, 2025device pma287d agoMedtronic, Inc. — DiamondTemp Ablation System (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Oct 10, 2025device pma287d agoDiaSorin, Inc. — LIAISON® XL MUREX HBc IgM and LIAISON® XL MUREX Control HBc IgM (PMA supplement)

    Supplement type: Real-Time Process. Product code: LOM. Advisory committee: MI. Decision: APPR

    full page →fda device pma ↗
    ›Oct 10, 2025device pma287d agoMerz North America, Inc. — Belotero Balance (+) Lidocaine Dermal Filler (PMA supplement)Sustained Therapeutics Inc

    Supplement type: Normal 180 Day Track. Product code: LMH. Advisory committee: SU. Decision: APPR

    full page →fda device pma ↗
    ›Oct 10, 2025device pma287d agoEdwards Lifesciences, LLC — SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES (PMA supplement)Edwards Lifesciences Corp

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

    full page →fda device pma ↗
    ›Oct 10, 2025device pma287d agoBolton Medical, Inc. — RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 10, 2025device pma287d agoDiaSorin, Inc. — LIAISON® Biotrin Parvovirus B19 IgG Plus, LIAISON® Biotrin Control Parvovirus B19 IgG Plus (PMA supplement)

    Supplement type: Real-Time Process. Product code: MYL. Advisory committee: MI. Decision: APPR

    full page →fda device pma ↗
    ›Oct 10, 2025device pma287d agoCentinel Spine, LLC — prodisc C SK and prodisc C Vivo (PMA supplement)

    Supplement type: Panel Track. Product code: MJO. Advisory committee: OR. Decision: APPR

    full page →fda device pma ↗
    ›Oct 10, 2025device pma287d agoDiaSorin, Inc. — LIAISON® XL Murex Anti-HBc and LIAISON® XL MUREX Control anti-HBc (PMA supplement)

    Supplement type: Real-Time Process. Product code: LOM. Advisory committee: MI. Decision: APPR

    full page →fda device pma ↗
    ›Oct 10, 2025device pma287d agoPramand, LLC — CraniSeal Dural Sealant (PMA supplement)

    Supplement type: Real-Time Process. Product code: NQR. Advisory committee: NE. Decision: APPR

    full page →fda device pma ↗
    ›Oct 10, 2025device pma287d agoDiaSorin, Inc. — LIAISON® XL MUREX HBsAg Qual and LIAISON® XL MUREX Control HBsAg Qual (PMA supplement)

    Supplement type: Real-Time Process. Product code: LOM. Advisory committee: MI. Decision: APPR

    full page →fda device pma ↗
    ›Oct 10, 2025device pma287d agoBiotronik, Inc. — Orsiro Mission Sirolimus Eluting Coronary Stent System (PMA supplement)OrphAI Therapeutics Inc

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

    full page →fda device pma ↗
    ›Oct 10, 2025device pma287d agoDiaSorin, Inc. — LIAISON® QuantiFERON® - TB Gold Plus and LIAISON® XL Control QuantiFERON-TB Gold Plus (PMA supplement)

    Supplement type: Real-Time Process. Product code: NCD. Advisory committee: MI. Decision: APPR

    full page →fda device pma ↗
    ›Oct 10, 2025device pma287d agoDiaSorin, Inc. — LIAISON® XL Murex Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL Murex Anti-HBs Verifier (PMA supplement)

    Supplement type: Real-Time Process. Product code: LOM. Advisory committee: MI. Decision: APPR

    full page →fda device pma ↗

    Week of Oct 13, 2025

    33
    ›Oct 14, 2025device pma283d agoShockwave Medical, Inc. — Shockwave™ lntravascular Lithotripsy {IVL) System with Shockwave C2/ C2+/ C2 Aero Coronary IVL Catheter (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 14, 2025device pma
    ← prev
    page 19 of 40
    next →
    283d ago
    Physio-Control, Inc. — LIFEPAK 1000 defibrillator (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 14, 2025device pma283d agoAdvanced Bionics — HiResolution™ Bionic Ear System (PMA supplement)

    Supplement type: 30-Day Notice. Product code: MCM. Advisory committee: EN. Decision: OK30

    full page →fda device pma ↗
    ›Oct 15, 2025device pma282d agoABBOTT MEDICAL — FlexNav Delivery System; Navitor Transcatheter Aortic Valves (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 15, 2025device pma282d agoABBOTT MEDICAL — Masters Series Mechanical Heart Valve (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 15, 2025device pma282d agoAnika Therapeutics, Inc. — Ophthalin; Nuvisc; Anikavisc (PMA supplement)Anika Therapeutics, Inc.

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

    full page →fda device pma ↗
    ›Oct 15, 2025device pma282d agoLife Technologies Corporation — Oncomine Dx Express Test (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 15, 2025device pma282d agoW. L. Gore & Associates, Inc. — GORE® TAG® Conformable Thoracic Endoprosthesis (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 16, 2025device pma281d agoVascutek, Ltd. — Thoraflex™ Hybrid (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 16, 2025device pma281d agoCochlear Americas — Nucleus® 24 Cochlear Implant System (PMA supplement)

    Supplement type: Real-Time Process. Product code: MCM. Advisory committee: EN. Decision: APPR

    full page →fda device pma ↗
    ›Oct 16, 2025device pma281d 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 ↗
    ›Oct 16, 2025device pma281d agoMedtronic Minimed — Guardian Connect System Simplera System (PMA supplement)

    Supplement type: 30-Day Notice. Product code: MDS. Advisory committee: CH. Decision: OK30

    full page →fda device pma ↗
    ›Oct 16, 2025device pma281d agoEdwards Lifesciences, LLC — INSPIRIS RESILIA Aortic Valve; MITRIS RESILIA Mitral Valve (PMA supplement)Edwards Lifesciences Corp

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

    full page →fda device pma ↗
    ›Oct 16, 2025device pma281d agoCochlear Americas — Nucleus® Hybrid™ L24 Cochlear Implant System (PMA supplement)

    Supplement type: Real-Time Process. Product code: PGQ. Advisory committee: EN. Decision: APPR

    full page →fda device pma ↗
    ›Oct 16, 2025device pma281d agoEdwards Lifesciences, LLC — Carpentier-Edwards PERIMOUNT RSR Pericardial Aortic Bioprosthesis; Carpentier-Edwards PERIMOUNT Plus Mitral Bioprosthesi (PMA supplement)Edwards Lifesciences Corp

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

    full page →fda device pma ↗
    ›Oct 16, 2025device pma281d agoBiotronik, Inc. — Edora 8 DR-T 407145, Evity 8 DR-T 407146, Enitra 8 DR-T 407147, Enticos 8 DR-T 407148, Evity 6 DR-T 407149, Enitra 6 DR- (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 16, 2025device pma281d agoMedtronic Minimed — Medtronic MiniMed 630G System (PMA supplement)

    Supplement type: 30-Day Notice. Product code: OZO. Advisory committee: CH. Decision: OK30

    full page →fda device pma ↗
    ›Oct 16, 2025device pma281d agoBiotronik, Inc. — Ilivia 7 VR-T DX 404624; Intica 7 VR-T DX 404633; Intica 5 VR-T DX 404688; Ilivia 7 VR-T 404625; Intica 7 VR-T 404634; I (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 16, 2025device pma281d agoEdwards Lifesciences, LLC — EDWARDS INTUITY Elite Valve (PMA supplement)Edwards Lifesciences Corp

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

    full page →fda device pma ↗
    ›Oct 16, 2025device pma281d agoMedtronic Minimed, Inc. — Simplera Sync Sensor, Guardian 4 Sensor (PMA supplement)Medtronic USA Inc

    Supplement type: 30-Day Notice. Product code: SFI. Advisory committee: CH. Decision: OK30

    full page →fda device pma ↗
    ›Oct 16, 2025device pma281d agoBiotronik, Inc. — Ilivia Neo 7 VR-T DX 429530; Intica Neo 7 VR-T DX 429559; Intica Neo 5 VR-T DX 429569 (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 16, 2025device pma281d agoFerring Pharmaceuticals, Inc. — EUFLEXXA® (1% SODIUM HYALURONATE) (PMA supplement)Ferring Pharmaceuticals Inc

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

    full page →fda device pma ↗
    ›Oct 16, 2025device pma281d agoABBOTT MEDICAL — FlexAbility™ Ablation Catheter, Sensor Enabled™ (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 16, 2025device pma281d agoMedtronic Minimed, Inc. — MiniMed 670G System; MiniMed 770G System; MiniMed 780G System (PMA supplement)Medtronic USA Inc

    Supplement type: 30-Day Notice. Product code: OZP. Advisory committee: CH. Decision: OK30

    full page →fda device pma ↗
    ›Oct 16, 2025device pma281d agoBiotronik, Inc. — Ilivia Neo 7 DR-T 429529; Intica Neo 7 DR-T 429558; Intica Neo 5 DR-T 429568 (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 16, 2025device pma281d agoEdwards Lifesciences, LLC — Edwards SAPIEN 3 Transcatheter Heart Valve (PMA supplement)Edwards Lifesciences Corp

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

    full page →fda device pma ↗
    ›Oct 16, 2025device pma281d agoEdwards Lifesciences, LLC — Edwards SAPIEN 3 Transcatheter Heart Valve; Edwards SAPIEN 3 Ultra Transcatheter Heart Valve; Edwards SAPIEN 3 Ultra RES (PMA supplement)Edwards Lifesciences Corp

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

    full page →fda device pma ↗
    ›Oct 16, 2025device pma281d 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 ↗
    ›Oct 16, 2025device pma281d agoCarl Zeiss Meditec, Inc. — VISUMAX 800 Femtosecond Laser (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 16, 2025device pma281d 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 ↗
    ›Oct 16, 2025device pma281d 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 ↗
    ›Oct 16, 2025device pma281d agoBiotronik, Inc. — Edora 8 HF-T QP 407137 Edora 8 HF-T 407138 Evity 8 HF-T QP 407139 Evity 8 HF-T 407140 Enitra 8 HF-T QP 407141 Enitra 8 H (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 16, 2025device pma281d agoMedtronic Neuromodulation — Restore, Itrel®, Synergy IntellisTM, VantaTM and InceptivTM Spinal Cord Stimulation Systems and PiscesTM, Specify®, and (PMA supplement)

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

    full page →fda device pma ↗
    $EW91.33-2.47%
    $MDT82.01+0.15%
    $ANIK
    $EW91.33-2.47%
    $EW91.33-2.47%
    $MDT82.01+0.15%
    $EW91.33-2.47%
    $EW91.33-2.47%
    $EW91.33-2.47%
    $MDT82.01+0.15%