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calendar

19,683 catalysts · 4,728 grant · 3,153 8k filing · 2,768 device 510k · 2,721 approval · 2,000 device recall · 1,955 device pma

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2026-08-10: 0 catalysts2026-08-11: 0 catalysts2026-08-12: 46 catalysts2026-08-13: 19 catalysts2026-08-14: 4 catalysts2026-08-15: 0 catalysts2026-08-16: 0 catalysts2026-08-17: 1 catalyst2026-08-18: 2 catalysts2026-08-19: 3 catalysts2026-08-20: 0 catalysts2026-08-21: 0 catalysts2026-08-22: 0 catalysts2026-08-23: 0 catalysts2026-08-24: 0 catalysts2026-08-25: 0 catalysts2026-08-26: 1 catalyst2026-08-27: 1 catalyst2026-08-28: 0 catalysts2026-08-29: 0 catalysts2026-08-30: 0 catalysts2026-08-31: 0 catalysts2026-09-01: 1 catalyst2026-09-02: 0 catalysts2026-09-03: 1 catalyst2026-09-04: 0 catalysts2026-09-05: 0 catalysts2026-09-06: 0 catalysts2026-09-07: 0 catalysts2026-09-08: 0 catalysts2026-09-09: 0 catalysts2026-09-10: 0 catalysts2026-09-11: 0 catalysts2026-09-12: 0 catalysts2026-09-13: 0 catalysts2026-09-14: 0 catalysts2026-09-15: 0 catalysts2026-09-16: 0 catalysts2026-09-17: 0 catalysts2026-09-18: 0 catalysts2026-09-19: 0 catalysts2026-09-20: 0 catalysts2026-09-21: 0 catalysts2026-09-22: 0 catalysts2026-09-23: 2 catalysts2026-09-24: 0 catalysts2026-09-25: 0 catalysts2026-09-26: 0 catalysts2026-09-27: 0 catalysts2026-09-28: 0 catalysts2026-09-29: 0 catalysts2026-09-30: 0 catalysts2026-10-01: 0 catalysts2026-10-02: 0 catalysts2026-10-03: 0 catalysts2026-10-04: 0 catalysts2026-10-05: 0 catalysts2026-10-06: 0 catalysts2026-10-07: 0 catalysts2026-10-08: 2 catalysts2026-10-09: 0 catalysts2026-10-10: 0 catalysts2026-10-11: 0 catalysts2026-10-12: 0 catalysts2026-10-13: 1 catalyst2026-10-14: 1 catalyst2026-10-15: 0 catalysts2026-10-16: 0 catalysts2026-10-17: 0 catalysts2026-10-18: 0 catalysts2026-10-19: 1 catalyst2026-10-20: 2 catalysts2026-10-21: 2 catalysts2026-10-22: 2 catalysts2026-10-23: 1 catalyst2026-10-24: 0 catalysts2026-10-25: 0 catalysts2026-10-26: 1 catalyst2026-10-27: 8 catalysts2026-10-28: 12 catalysts2026-10-29: 21 catalysts2026-10-30: 4 catalysts2026-10-31: 0 catalysts2026-11-01: 0 catalysts2026-11-02: 9 catalysts2026-11-03: 18 catalysts2026-11-04: 22 catalysts2026-11-05: 37 catalysts2026-11-06: 2 catalysts2026-11-07: 0 catalysts2026-11-08: 0 catalysts
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  • grant4,728
  • 8k filing3,153
  • device 510k2,768
  • approval2,721
  • device recall2,000
  • device pma1,955
device adverse event
1,000
  • recall693
  • earnings584
  • phase 2 completion172
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of Jun 16, 2025

    50
    ›Jun 18, 2025device pma421d agoAlcon Laboratories, LLC — Clareon Aspheric Hydrophobic Acrylic Intraocular Lenses (PMA supplement)Alcon Laboratories Inc

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

    full page →fda device pma ↗
    ›Jun 18, 2025device pma421d agoABBOTT MEDICAL — Allure™ PM3120; Allure Quadra™ RF PM3242; Allure Quadra™ PM3140; Allure RF PM3222; Anthem PM3210; Quadra Allure PM3542; (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 18, 2025device pma421d agoABBOTT MEDICAL — IsoFlex Optim Lead 1944, 1948 (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 18, 2025device pma421d agoMedtronic Neuromodulation — Restore, Itrel®, Synergy Intellis™, Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems and Pisces™, Specify®, and Vect (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 18, 2025device pma421d agoNeomend, Inc. — TRIDYNE™ Vascular Sealant (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 18, 2025device pma421d agoMentor Corp. — MENTOR™ MemoryGel™ Enhance Breast Implants (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 18, 2025device pma421d agoEdwards Lifesciences, LLC — Edwards EVOQUE Tricuspid Valve Replacement System (PMA supplement)Edwards Lifesciences Corp

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

    full page →fda device pma ↗
    ›Jun 18, 2025device pma421d agoInfusyn Therapeutics, LLC — PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM (PMA supplement)LIB Therapeutics LLC

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

    full page →fda device pma ↗
    ›Jun 18, 2025device pma421d agoMedtronic Cardiac Rhythm Disease Management — Cobalt MRI ICD DDPB3D1, DDPB3D4; Cobalt MRI ICD DVPB3D1, DVPB3D4; Cobalt XT MRI ICD DDPA2D1, DVPA2D1, DVPA2D4; Cobalt XT (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 18, 2025device pma421d agoABBOTT MEDICAL — Durata 7120, 7121, 7122, 7130, 7131, 7170, 7171, 7120, 7120Q, 7121Q, 7122, 7122Q, 7170Q, 7171Q, 7172Q; Optisure LDA210, (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 18, 2025device pma421d agoCerapedics, Inc. — PearlMatrix™ Bone Graft (PMA)

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

    full page →fda device pma ↗
    ›Jun 18, 2025device pma421d agoMedtronic Cardiac Rhythm Disease Management — Amplia MRI CRT-D DTMB1D1, DTMB1D4; Amplia MRI Quad CRT-D DTMB1Q1, DTMB1QQ; Brava CRT-D DTBC1D4; Brava CRT-D DTBC1D1; Bra (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 18, 2025device pma421d agoMedtronic, Inc. — Micra AV TPS MC1AVR1, Micra AV2 TPS MC2AVR1, Micra TPS MC1VR01, Micra 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 ↗
    ›Jun 18, 2025device pma421d agoABBOTT MEDICAL — OptiSense 1999; Tendril SDX Lead 1688T/TC DTB; Tendril ST Lead 1888TC, 1882TC; Tendril STS Lead 2088TC; Tendril STS Lead (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 18, 2025device pma421d agoABBOTT MEDICAL — Avant HF CDHFA700B, CDHFA700D, CDHFA700Q, CDHFA700T; Entrant HF CDHFA300B, CDHFA300D, CDHFA300Q, CDHFA300T; Gallant HF C (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 18, 2025device pma421d agoInspire Medical Systems — Inspire® Upper Airway Stimulation (UAS) (PMA supplement)Inspire Medical Systems, Inc.

    Supplement type: 30-Day Notice. Product code: MNQ. Advisory committee: AN. Decision: OK30

    full page →fda device pma ↗
    ›Jun 18, 2025device pma421d 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, Enitr (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 18, 2025device pma421d agoMedtronic, Inc. — SYNERGYST II PULSE GENERATOR MODELS 7070 & 7071 (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Jun 18, 2025device pma421d agoABBOTT MEDICAL — Gallant DR CDDRA500Q; Gallant VR CDVRA500Q; Neutrino NxT DR CDDRA800Q; Neutrino NxT DR CDDRA600Q; Neutrino NxT VR CDVRA8 (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 18, 2025device pma421d agoMedtronic, Inc. — Consulta CRT-P C4TR01; Percepta Bipolar CRT-P W1TR01; Percepta Quadripolar CRTP W4TR01; Serena Bipolar CRT-P W1TR02; Ser (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Jun 18, 2025device pma421d agoIntersect Ent. — PROPEL, PROPEL MINI and PROPEL CONTOUR (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 18, 2025device pma421d agoBausch & Lomb, Inc. — enVista® Hydrophobic Acrylic Intraocular Lens (IOL) (PMA supplement)Bausch & Lomb Corp

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

    full page →fda device pma ↗
    ›Jun 18, 2025device pma421d agoCaris Life Sciences — MI Cancer Seek (PMA supplement)Caris Life Sciences, Inc.

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

    full page →fda device pma ↗
    ›Jun 18, 2025device pma421d agoBiotronik, Inc. — Acticor 7 VR-T 429526, Rivacor 7 VR-T 429536, Rivacor 5 VR-T 429565, Rivacor 3 VR-T 429574, Acticor 7 VR-T DX 429525, Ri (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 18, 2025device pma421d agoAlcon Laboratories, Inc. — AcrySof Posterior Chamber Intraocular Lenses and Delivery Systems (PMA supplement)Alcon Laboratories Inc

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

    full page →fda device pma ↗
    ›Jun 18, 2025device pma421d 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 ↗
    ›Jun 18, 2025device pma421d agoNeomend, Inc. — PROGEL™ Pleural Air Leak Sealant (PMA supplement)

    Supplement type: 30-Day Notice. Product code: NBE. Advisory committee: AN. Decision: OK30

    full page →fda device pma ↗
    ›Jun 18, 2025device 510k421d agoShenzhen Wikkon Precision Technologies Co., Ltd. — Extracorporeal Shock Wave Lithotripter (U200) (510k cleared)

    Product code: LNS. Advisory committee: Gastroenterology, Urology. Type: Traditional

    full page →fda device 510k ↗
    ›Jun 18, 2025device 510k421d agoAlton (Shanghai) Medical Instruments Co., Ltd. — Ureteral Stents (AF-D series) (510k cleared)

    Product code: FAD. Advisory committee: Gastroenterology, Urology. Type: Traditional

    full page →fda device 510k ↗
    ›Jun 18, 2025device 510k421d agoSeaSpine Orthopedics Corporation — Virata Spinal Fixation System (510k cleared)

    Product code: NKB. Advisory committee: Orthopedic. Type: Traditional

    full page →fda device 510k ↗
    ›Jun 18, 2025device 510k421d agoAcumed, LLC — The Acumed Wrist Fixation System (510k cleared)

    Product code: HRS. Advisory committee: Orthopedic. Type: Traditional

    full page →fda device 510k ↗
    ›Jun 18, 2025device 510k421d agoHappy Health, Inc. — Happy Health Home Sleep Test (510k cleared)

    Product code: MNR. Advisory committee: Anesthesiology. Type: Traditional

    full page →fda device 510k ↗
    ›Jun 18, 2025device 510k421d agoCenterPoint Systems, LLC — FlexiGo 3D Delivery Catheter (510k cleared)

    Product code: DQY. Advisory committee: Cardiovascular. Type: Special

    full page →fda device 510k ↗
    ›Jun 18, 2025device 510k421d agoFisher & Paykel Healthcare Limited — F&P Nova Nasal Mask (510k cleared)

    Product code: BZD. Advisory committee: Anesthesiology. Type: Traditional

    full page →fda device 510k ↗
    ›Jun 18, 2025device 510k421d agoCuriteva, Inc. — Curiteva Porous PEEK Standalone ALIF System (510k cleared)

    Product code: OVD. Advisory committee: Orthopedic. Type: Traditional

    full page →fda device 510k ↗
    ›Jun 18, 2025device 510k421d agoBard Access Systems, Inc. — PowerPort™ isp Implantable Port; PowerPort™ Slim Implantable Port; PowerPort™ M.R.I. ™ Implantable Port; PowerPort™ M.R.I.™ isp Implantable Port (510k cleared)

    Product code: LJT. Advisory committee: General Hospital. Type: Special

    full page →fda device 510k ↗
    ›Jun 18, 2025device 510k421d agoSpineart SA — SPINEART Navigation Instrument System (510k cleared)

    Product code: OLO. Advisory committee: Neurology. Type: Traditional

    full page →fda device 510k ↗
    ›Jun 18, 2025device 510k421d agoConmed Corporation — CONMED Argo Knotless® Anchor (510k cleared)CONMED Corp

    Product code: MBI. Advisory committee: Orthopedic. Type: Special

    full page →fda device 510k ↗
    ›Jun 18, 2025device 510k421d agoHMC Premedical S.p.A. — Enteral Drainage System, Enteral Medicine straw (510k cleared)

    Product code: PIF. Advisory committee: Gastroenterology, Urology. Type: Traditional

    full page →fda device 510k ↗
    ›Jun 18, 2025device 510k421d agoBioline Dental Implant Systems, Ltd. — Bioline Dental Implant System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 18, 2025device 510k421d agoJiangxi Jiangte Electric Vehicle Co., Ltd. — Mobility Scooter (JT10) (510k cleared)

    Product code: INI. Advisory committee: Physical Medicine. Type: Traditional

    full page →fda device 510k ↗
    ›Jun 18, 2025device 510k421d agoEyeq, Inc. — EyeQ nanoECP (510k cleared)

    Product code: HQF. Advisory committee: Ophthalmic. Type: Traditional

    full page →fda device 510k ↗
    ›Jun 18, 2025device 510k421d agoO&M Halyard, Inc. — Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs; Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Singles (510k cleared)

    Product code: LZA. Advisory committee: General Hospital. Type: Abbreviated

    full page →fda device 510k ↗
    ›Jun 18, 2025device 510k421d agoExcite Medical of Tampa Bay, LLC — DRX9000C-SL Cervical Spinal Decompression System (510k cleared)

    Product code: ITH. Advisory committee: Physical Medicine. Type: Traditional

    full page →fda device 510k ↗
    ›Jun 18, 2025device 510k421d agoEsaote, S.p.A. — 6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70) (510k cleared)

    Product code: IYN. Advisory committee: Radiology. Type: Traditional

    full page →fda device 510k ↗
    ›Jun 18, 2025device 510k421d agoShanghai Saints Sages Surgical Co., Ltd. — SanAgile™ Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD14); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD23); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD36); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD45) (510k cleared)

    Product code: LFL. Advisory committee: Unknown. Type: Traditional

    full page →fda device 510k ↗
    ›Jun 18, 2025device 510k421d agoWinner Medical Co., Ltd. — Procedure mask/Surgical mask/Face mask (510k cleared)

    Product code: FXX. Advisory committee: General, Plastic Surgery. Type: Traditional

    full page →fda device 510k ↗
    ›Jun 18, 2025device 510k421d agoGE Medical Systems SCS — CardIQ Suite (510k cleared)

    Product code: JAK. Advisory committee: Radiology. Type: Traditional

    full page →fda device 510k ↗
    ›Jun 18, 2025device 510k421d agoLin-Zhi International, Inc. — LZI Fentanyl III Enzyme Immunoassay (510k cleared)LIQTECH INTERNATIONAL INC

    Product code: DJG. Advisory committee: Clinical Toxicology. Type: Special

    full page →fda device 510k ↗
    ›Jun 18, 2025device 510k421d agoPhilips Ultrasound, LLC — EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems (510k cleared)

    Product code: IYN. Advisory committee: Radiology. Type: Special

    full page →fda device 510k ↗
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    $MDT90.02-0.73%
    $CAI
    $MDT90.02-0.73%
    $BLCO16.35-3.08%
    $INSP42.44+0.38%
    $EW91.33-2.47%
    $CNMD32.58+1.46%
    $MDT90.02-0.73%
    $MDT90.02-0.73%
    $LIQT