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14,072 catalysts · 3,316 8k filing · 2,402 grant · 2,299 approval · 1,631 device 510k · 1,179 device recall · 1,115 device pma

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  • 8k filing3,316
  • grant2,402
  • approval2,299
  • device 510k1,631
  • device recall1,179
  • device pma1,115
device adverse event
1,000
  • earnings584
  • recall465
  • phase 2 completion172
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of Oct 13, 2025

    50
    ›Oct 16, 2025approval303d agoAMJEVITA (ADALIMUMAB-ATTO) — FDA approvalAMJEVITA

    Sponsor: AMGEN INC. Form: INJECTABLE. Route: INJECTION

    full page →AMJEVITA →fda approvals ↗
    ›Oct 16, 2025approval303d agoTRIMETHOBENZAMIDE HYDROCHLORIDE — FDA approvalGavis Pharmaceuticals LLC

    Sponsor: BPI LABS. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Oct 16, 2025approval303d agoCYLTEZO (ADALIMUMAB-ADBM) — FDA approvalCYLTEZO

    Sponsor: BOEHRINGER INGELHEIM. Form: INJECTABLE. Route: INJECTION

    full page →CYLTEZO →fda approvals ↗
    ›Oct 16, 2025approval303d agoHYRIMOZ (ADALIMUMAB-ADAZ) — FDA approvalHYRIMOZ

    Sponsor: SANDOZ INC. Form: INJECTABLE. Route: INJECTION

    full page →HYRIMOZ →fda approvals ↗
    ›Oct 16, 2025approval303d agoZTALMY (GANAXOLONE) — FDA approvalganaxolone

    Sponsor: IMMEDICA PHARMA. Form: SUSPENSION. Route: ORAL

    full page →ganaxolone →fda approvals ↗
    ›Oct 16, 2025approval303d agoZTALMY (GANAXOLONE) — FDA approvalganaxolone

    Sponsor: IMMEDICA PHARMA. Form: SUSPENSION. Route: ORAL

    full page →ganaxolone →fda approvals ↗
    ›Oct 16, 2025approval303d agoFERABRIGHT (FERUMOXYTOL) — FDA approvalCovis Pharma BV

    Sponsor: COVIS. Form: SOLUTION. Route: INTRAVENOUS

    full page →fda approvals ↗
    ›Oct 16, 2025approval303d agoSOJOURN (SEVOFLURANE) — FDA approvalSEVOFLURANE

    Sponsor: PIRAMAL CRITICAL. Form: LIQUID. Route: INHALATION

    full page →SEVOFLURANE →fda approvals ↗
    ›Oct 16, 2025approval303d agoYUFLYMA (ADALIMUMAB-AATY) — FDA approvalYUFLYMA

    Sponsor: CELLTRION. Form: INJECTABLE. Route: INJECTION

    full page →YUFLYMA →fda approvals ↗
    ›Oct 16, 2025device 510k303d agoCryosurgery, Inc. — CryoFreeze Wart and Skin Tag Remover (510k cleared)

    Product code: GEH. Advisory committee: General, Plastic Surgery. Type: Special

    full page →fda device 510k ↗
    ›Oct 16, 2025device 510k303d agoGcmedica Enterprise Ltd.(Wuxi) — Uterine Aspiration Set (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 16, 2025device 510k303d agoMerchsource, LLC — Light Therapy Mask (1019055) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 16, 2025device 510k303d agoBrainlab AG — Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 16, 2025device 510k303d agoOlympus Medical Systems Corporation — Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use Injector (NM-400U); Injector Force Max Single Use Injector (NM-400Y); Injector Force Max Single Use Injector (NM-401L) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 16, 2025device 510k303d agoCMT Health PTE., Ltd. — Profoject™ Disposable Needle (510k cleared)

    Product code: FMI. Advisory committee: General Hospital. Type: Traditional

    full page →fda device 510k ↗
    ›Oct 16, 2025device 510k303d agoElos Medtech Pinol A/S — Elos Accurate Hybrid Base (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 16, 2025device 510k303d agoRecensmedical, Inc. — TargetCool™ (RM-DT02W) (510k cleared)

    Product code: GEH. Advisory committee: General, Plastic Surgery. Type: Special

    full page →fda device 510k ↗
    ›Oct 16, 2025device 510k303d agoNeuraxis — NeurAxis IB-Stim (01-1020) (510k cleared)Neuraxis, INC

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

    full page →fda device 510k ↗
    ›Oct 16, 2025device 510k303d agoMode Sensors AS — Re:Balans (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 16, 2025device 510k303d agoSHENZHEN SUPERLINE TECHNOLOGY CO., LTD. — Alpha Endo Handpiece (Alpha Endo) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

    full page →fda device 510k ↗
    ›Oct 16, 2025device 510k303d agoPenumbra, Inc. — INDIGO® Aspiration System – Lightning Flash Aspiration Tubing; INDIGO® Aspiration System – Lightning Bolt Aspiration Tubing (510k cleared)Penumbra Inc

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

    full page →fda device 510k ↗
    ›Oct 16, 2025device 510k303d agoArthrex, Inc. — Arthrex Synergy Vision Imaging System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 16, 2025device 510k303d agoRiverpoint Medical — ProZip Knotless Implant (510k cleared)

    Product code: GAT. Advisory committee: General, Plastic Surgery. Type: Special

    full page →fda device 510k ↗
    ›Oct 16, 2025device 510k303d agoSc Medica — FFX Facet Fixation System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 16, 2025device 510k303d agoMatelaser, Inc. — MateLaser Medical Diode Laser Systems (ML-DLS-30) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 16, 2025device 510k303d agoAsterasys Co., Ltd. — Coolfase (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 16, 2025device 510k303d agoMaxigen Biotech, Inc. — SurgiAid Collagen Wound Dressing (HA) (510k cleared)NKGen Biotech Inc

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

    full page →fda device 510k ↗
    ›Oct 16, 2025device pma303d 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 pma303d 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 pma303d 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 pma303d 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 pma303d 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 pma303d 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 pma303d 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 pma303d 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 pma303d 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 pma303d 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 pma303d 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 pma303d 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 pma303d 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 pma303d 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 pma303d 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 pma303d 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 pma303d 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 pma303d 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 pma303d 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 pma303d 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 pma303d 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 pma303d 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 pma303d 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 ↗
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