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calendar

2,000 catalysts · 18,987 approval · 5,000 device 510k · 4,876 phase readout · 4,728 grant · 2,415 8k filing · 2,000 device pma

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type: device pma×clear all
type
  • approval18,987
  • device 510k5,000
  • phase readout4,876
  • grant4,728
  • 8k filing2,415
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • earnings295
  • therapy area

    no tagged catalysts yet

    Week of Dec 15, 2025

    29
    ›Dec 18, 2025device pma220d agoOcclutech Holding AG — Occlutech ASD Occluder; Occlutech Pistol Pusher (OPP); Occlutech ASD Occluder Procedure Pack (PMA supplement)

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

    full page →fda device pma ↗
    ›Dec 18, 2025device pma220d agoSpectranetics (Philips) — GlideLight Laser Sheath (PMA supplement)

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

    full page →fda device pma ↗
    ›Dec 18, 2025device pma220d agoDepuy, Inc. — ATTUNE™ Revision Rotating Platform (RP) Knee System (PMA supplement)

    Supplement type: Normal 180 Day Track. Product code: NJL. Advisory committee: OR. Decision: APPR

    full page →fda device pma ↗
    ›Dec 18, 2025device pma220d agoVasorum, Ltd. — CELT ACD Vascular Closure Device (PMA supplement)

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

    full page →fda device pma ↗
    ›Dec 19, 2025device pma219d agoMedtronic Vascular — Resolute Onyx Zotarolimus-Eluting Coronary Stent System - RX and OTW; Onyx Frontier Zotarolimus-Eluting Coronary Stent S (PMA supplement)

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

    full page →fda device pma ↗
    ›Dec 19, 2025device pma219d agoAbiomed, Inc. — Impella CP with SmartAssist; Impella 5.5 with SmartAssist (PMA supplement)Abion Inc

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

    full page →fda device pma ↗
    ›Dec 19, 2025device pma219d agoSeikagaku Corp. — SUPARTZ FX; VISCO-3 (PMA supplement)Seikagaku Corp

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

    full page →fda device pma ↗
    ›Dec 19, 2025device pma219d agoIrvine Biomedical, Inc. — Cool Point™ Tubing Set (PMA supplement)RNR BioMedical Inc

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

    full page →fda device pma ↗
    ›Dec 19, 2025device pma219d agoBerlin Heart, Inc. — EXCOR Pediatric Ventricular Assist Device (PMA supplement)

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

    full page →fda device pma ↗
    ›Dec 19, 2025device pma219d agoSymatese — Evolysse Injectable Hyaluronic Acid (PMA supplement)

    Supplement type: Real-Time Process. Product code: LMH. Advisory committee: SU. Decision: APPR

    full page →fda device pma ↗
    ›Dec 19, 2025device pma219d agoEndotronix, Inc. — CorPASS System (PMA supplement)

    Supplement type: Normal 180 Day Track. Product code: MOM. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Dec 19, 2025device pma219d agoMedtronic Neuromodulation — Medtronic Altaviva System (PMA supplement)

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

    full page →fda device pma ↗
    ›Dec 19, 2025device pma219d agoGraphic Controls D.B.A. Vermed — HeartSync Multifunction Disposable Single-Use Defibrillator Pads (PMA supplement)

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

    full page →fda device pma ↗
    ›Dec 19, 2025device pma219d agoABBOTT MEDICAL — Volt™ PFA System (PMA)

    Product code: QZI. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Dec 19, 2025device pma219d agoGuidant Corp. — VALITUDE™ (Model U125) VALITUDE™ X4 (Model U128) VISIONIST™ (Models U225, U226) VISIONIST™ X4 (Model U228) Firmware Vers (PMA supplement)Guident Corp.

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

    full page →fda device pma ↗
    ›Dec 19, 2025device pma219d agoW. L. Gore & Associates, Inc. — GORE® VIABAHN® FORTEGRA Venous Stent (PMA)

    Product code: QTL. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Dec 19, 2025device pma219d agoBoston Scientific Corp — ALTRUA™ 2 (Models S701, S702, S722) ESSENTIO™ (Models L100, L101, L121) PROPONENT™ (Models L200, L201, L221) ACCOLADE™ ( (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Dec 19, 2025device pma219d agoDiaSorin, Inc. — LIAISON® Biotrin Parvovirus B19 IgG Plus, LIAISON® Biotrin Control Parvovirus B19 IgG Plus (PMA supplement)

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

    full page →fda device pma ↗
    ›Dec 19, 2025device pma219d agoW. L. Gore & Associates, Inc. — GORE® CARDIOFORM Septal Occluder; GORE® CARDIOFORM ASD Occluder (PMA supplement)

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

    full page →fda device pma ↗
    ›Dec 19, 2025device pma219d agoMedtronic Cardiac Rhythm Disease Management — Cobalt MRI CRT-D DTPB2D1, DTPB2D4 NIK Cobalt XT MRI CRT-D DTPA2D1, DTPA2D4 NIK Crome MRI CRT-D DTPC2D1, DTPC2D4 (PMA supplement)

    Supplement type: Normal 180 Day Track. Product code: NIK. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Dec 19, 2025device pma219d agoBoston Scientific — ESSENTIO™ MRI (Models L110, L111, L131) PROPONENT™ MRI (Models L210, L211, L231) ACCOLADE™ MRI (Models L310, L311, L331) (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Dec 19, 2025device pma219d agoDiaSorin, Inc. — LIAISON® QuantiFERON-TB Gold Plus and LIAISON® Control QuantiFERON-TB Gold Plus (PMA supplement)

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

    full page →fda device pma ↗
    ›Dec 19, 2025device pma219d agoBoston Scientific Corporation — Axonics Sacral Neuromodulation System (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Dec 19, 2025device pma219d agoAbiomed, Inc. — Impella CP with SmartAssist; Impella 5.5 with SmartAssist (PMA supplement)Abion Inc

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

    full page →fda device pma ↗
    ›Dec 19, 2025device pma219d agoCochlear Americas — NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (PMA supplement)

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

    full page →fda device pma ↗
    ›Dec 19, 2025device pma219d agoMedtronic, Inc. — SynchroMed™ Infusion Systems (PMA supplement)Medtronic plc

    Supplement type: Normal 180 Day Track. Product code: LKK. Advisory committee: HO. Decision: APPR

    full page →fda device pma ↗
    ›Dec 19, 2025device pma219d agoMedtronic, Inc. — Percepta Bipolar CRT-P W1TR01 NKE Percepta Quadripolar CRT-P W4TR01 NKE Serena Bipolar CRT-P W1TR02 NKE Serena Quadripol (PMA supplement)Medtronic plc

    Supplement type: Normal 180 Day Track. Product code: LWP. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Dec 19, 2025device pma219d agoSequana Medical NV — alfapump System (PMA supplement)

    Supplement type: Real-Time Process. Product code: SDQ. Advisory committee: GU. Decision: APPR

    full page →fda device pma ↗
    ›Dec 19, 2025device pma219d agoBoston Scientific Corporation — Axonics Sacral Neuromodulation System (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗

    Week of Dec 22, 2025

    21
    ›Dec 22, 2025device pma216d 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 ↗
    ›Dec 22, 2025device pma
    ← prev
    page 27 of 40
    next →
    216d ago
    Medtronic 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 ↗
    ›Dec 22, 2025device pma216d agoCorcym S.r.l. — Perceval Sutureless Heart Valve (PMA supplement)

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

    full page →fda device pma ↗
    ›Dec 22, 2025device pma216d agoEdwards Lifesciences, LLC — SAPIEN M3 Transcatheter Mitral Valve Replacement System (PMA)Edwards Lifesciences Corp

    Product code: NPU. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Dec 22, 2025device pma216d 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 ↗
    ›Dec 22, 2025device pma216d agoProllenium Medical Technologies, Inc. — Revanesse Versa; Revanesse Versa+ (with lidocaine); Revanesse Lips+ (with lidocaine) (PMA supplement)Medical Care Technologies Inc.

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

    full page →fda device pma ↗
    ›Dec 22, 2025device pma216d agoMedtronic Neuromodulation — Master Restore; Itrel; Synergy; Intellis; Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces; Specify; and Ve (PMA supplement)

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

    full page →fda device pma ↗
    ›Dec 22, 2025device pma216d agoAtrium Medical Corp. — iCast Covered Stent System (PMA supplement)Apyx Medical Corp

    Supplement type: Normal 180 Day Track. Product code: PRL. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Dec 22, 2025device pma216d agoBausch & Lomb — ADATO SIL-OL 5000 Silicone Oils (PMA supplement)Bausch & Lomb Corp

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

    full page →fda device pma ↗
    ›Dec 22, 2025device pma216d agoHeartsine Technologies, Ltd. — samaritan® Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P) and Accessories (PMA supplement)TAT TECHNOLOGIES LTD

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

    full page →fda device pma ↗
    ›Dec 22, 2025device pma216d 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 ↗
    ›Dec 22, 2025device pma216d agoGuardant Health, Inc. — Shield (PMA supplement)Guardant Health, Inc.

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

    full page →fda device pma ↗
    ›Dec 23, 2025device pma215d agoABBOTT MEDICAL — Infinity™ Deep Brain Stimulation (DBS) System (PMA supplement)

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

    full page →fda device pma ↗
    ›Dec 23, 2025device pma215d agoMesoblast — SYNOJOYNT™ (PMA supplement)MESOBLAST LTD

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

    full page →fda device pma ↗
    ›Dec 23, 2025device pma215d agoABBOTT MEDICAL — Proclaim™ Spinal Cord Stimulation (SCS) System (PMA supplement)

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

    full page →fda device pma ↗
    ›Dec 23, 2025device pma215d 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 ↗
    ›Dec 23, 2025device pma215d agoQ-Med AB — Restylane® Lyft with Lidocaine (PMA supplement)Sustained Therapeutics Inc

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

    full page →fda device pma ↗
    ›Dec 23, 2025device pma215d agoRayner Intraocular Lenses , Ltd. — C-FLEX MODEL 570C INTRAOCULAR LENS (IOL) (PMA supplement)

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

    full page →fda device pma ↗
    ›Dec 23, 2025device pma215d agoBioventus, LLC — DUROLANE (PMA supplement)Bioventus Inc.

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

    full page →fda device pma ↗
    ›Dec 23, 2025device pma215d agoCooperVision, Inc. — MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear (PMA supplement)

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

    full page →fda device pma ↗
    ›Dec 23, 2025device pma215d agoSt Jude Medical — TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (PMA supplement)

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

    full page →fda device pma ↗
    $MDT83.21+1.46%
    $GDNT
    $BSX44.25+1.54%
    $MDT83.21+1.46%
    $BSX44.25+1.54%
    $BSX44.25+1.54%
    $BSX44.25+1.54%
    $EW91.33-2.47%
    $MDT83.21+1.46%
    $MDCE0.00020.00%
    $APYX
    $TATT
    $BLCO16.17+1.19%
    $MDT83.21+1.46%
    $GH131.78+2.07%
    $MESO
    $BVS8.6700+1.40%