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5,000 catalysts · 18,987 approval · 5,627 phase readout · 5,000 device 510k · 4,728 grant · 2,757 8k filing · 2,000 device pma

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2026-08-03: 0 catalysts2026-08-04: 0 catalysts2026-08-05: 45 catalysts2026-08-06: 12 catalysts2026-08-07: 1 catalyst2026-08-08: 0 catalysts2026-08-09: 0 catalysts2026-08-10: 2 catalysts2026-08-11: 1 catalyst2026-08-12: 2 catalysts2026-08-13: 2 catalysts2026-08-14: 1 catalyst2026-08-15: 0 catalysts2026-08-16: 0 catalysts2026-08-17: 0 catalysts2026-08-18: 2 catalysts2026-08-19: 0 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: 0 catalysts2026-08-27: 0 catalysts2026-08-28: 0 catalysts2026-08-29: 0 catalysts2026-08-30: 0 catalysts2026-08-31: 0 catalysts2026-09-01: 1 catalyst2026-09-02: 0 catalysts2026-09-03: 0 catalysts2026-09-04: 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: 1 catalyst2026-09-24: 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: 0 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: 0 catalysts2026-10-20: 2 catalysts2026-10-21: 1 catalyst2026-10-22: 2 catalysts2026-10-23: 1 catalyst2026-10-24: 0 catalysts2026-10-25: 0 catalysts2026-10-26: 0 catalysts2026-10-27: 2 catalysts2026-10-28: 2 catalysts2026-10-29: 7 catalysts2026-10-30: 3 catalysts2026-10-31: 0 catalysts2026-11-01: 0 catalysts
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type: device 510k×clear all
type
  • approval18,987
  • phase readout5,627
  • device 510k5,000
  • grant4,728
  • 8k filing2,757
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • earnings340
  • therapy area

    no tagged catalysts yet

    Week of Jan 12, 2026

    50
    ›Jan 14, 2026device 510k204d agoSync Surgical — Cervical Interbody and VBR Fusion System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 14, 2026device 510k204d agoZiehm-Orthoscan, Inc. — Orthoscan TAU MVP Mini C-Arm System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 14, 2026device 510k204d agoMeticuly Co., Ltd. — METICULY Patient-specific titanium mesh implant (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 14, 2026device 510k204d agoPhilips Medical Systems Nederland B.V. — dS Base 1.5T; dS Base 3.0T; dS Head 1.5T; dS Head 3.0T; dS HeadNeck 1.5T; dS HeadNeck 3.0T (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 14, 2026device 510k204d agoCardinalhealth — Cardinal Health Nitrile Examination Gloves Extended Cuff (510k cleared)CARDINAL HEALTH INC

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

    full page →fda device 510k ↗
    ›Jan 14, 2026device 510k204d agoBrainlab SE — ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 14, 2026device 510k204d agoMedtronic Minimed, Inc. — SmartGuard technology; Predictive Low Glucose technology (510k cleared)Medtronic USA Inc

    Product code: QJI. Advisory committee: Clinical Chemistry. Type: Traditional

    full page →fda device 510k ↗
    ›Jan 14, 2026device 510k204d agoLaboratorios Biogalenic S.A. DE C.V. — Laboratorios Biogalenic Sterile Water for Inhalation, USP (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 14, 2026device 510k204d agoMedtronic, Inc. — Concerto Versa™ Detachable Coil (510k cleared)Medtronic plc

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

    full page →fda device 510k ↗
    ›Jan 14, 2026device 510k204d agoEntire Medical , Ltd. — ENTire IRE System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 15, 2026device 510k203d agoCuriteva, Inc. — Curiteva Porous PEEK Cervical Interbody Fusion System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 15, 2026device 510k203d agoBAAT Medical Products B.V. — SDS Growing Rod (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 15, 2026device 510k203d agoFoshan Dahao Medical Technology Co., Ltd. — Electric Wheelchair (DH01168) (510k cleared)NewBay Medical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Jan 15, 2026device 510k203d agoThera B Medical Products — SnugLit(TM) Wearable Phototherapy System (SNGL-01-US) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 15, 2026device 510k203d agoSiemens Healthineers AG — BIOGRAPH One (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 15, 2026device 510k203d agoDGNCT, LLC — Diagnocat (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 15, 2026device 510k203d agoMedtronic, Inc. — Bio-Medicus Life Support Catheter and Introducer (510k cleared)Medtronic plc

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

    full page →fda device 510k ↗
    ›Jan 15, 2026device 510k203d agoSleepnet Corporation — Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 15, 2026device 510k203d agoPhenox, Ltd. — Esperance pHLO Aspiration System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 15, 2026device 510k203d agoInMode , Ltd. — Ignite RF System (510k cleared)InMode Ltd.

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

    full page →fda device 510k ↗
    ›Jan 15, 2026device 510k203d agoElekta Solutions AB — EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekta Synergy) (510k cleared)Scilex Holding Co

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

    full page →fda device 510k ↗
    ›Jan 15, 2026device 510k203d agoMaxx Orthopedics, Inc. — Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 15, 2026device 510k203d agoBridge TO Life, Ltd. — VitaSmart Hypothermic Oxygenated Perfusion System (510k cleared)

    Product code: SGY. Advisory committee: Gastroenterology, Urology. Type: Direct

    full page →fda device 510k ↗
    ›Jan 15, 2026device 510k203d agoShoulder Innovations, Inc. — N22 EZ Glenosphere (510k cleared)SHOULDER INNOVATIONS, INC.

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

    full page →fda device 510k ↗
    ›Jan 15, 2026device 510k203d agoShanghai Bangbang Robotics Co., Ltd. — Electric Wheelchair (Robooter E80) (BBR-E80-01); Electric Wheelchair (Robooter E80) (BBR-E80-02) (510k cleared)

    Product code: ITI. Advisory committee: Physical Medicine. Type: Special

    full page →fda device 510k ↗
    ›Jan 15, 2026device 510k203d agoMedtronic Minimed, Inc. — MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894) (510k cleared)Medtronic USA Inc

    Product code: QFG. Advisory committee: Clinical Chemistry. Type: Traditional

    full page →fda device 510k ↗
    ›Jan 15, 2026device 510k203d agoEncore Medical L.P. — AltiVate Reverse® ADLC Glenosphere (510k cleared)Encore Medical, Inc.

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

    full page →fda device 510k ↗
    ›Jan 15, 2026device 510k203d agoTriMed, Inc. — TriMed Volar Bearing Plates (VBEAL-13-7S); TriMed Volar Bearing Plates (VBEAR-13-7S); TriMed Volar Bearing Plates (VBEAL-14-7S); TriMed Volar Bearing Plates (VBEAR-14-7S); TriMed Volar Bearing Plates (VBEAL-16-7S); TriMed Volar Bearing Plates (VBEAR-16-7S) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 15, 2026device 510k203d agoInquis Medical — Aventus Thrombectomy System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 15, 2026device 510k203d agoNano-Ditech Corporation — Nano-Check Influenza A+B Test (510k cleared)

    Product code: PSZ. Advisory committee: Microbiology. Type: Dual Track

    full page →fda device 510k ↗
    ›Jan 16, 2026device 510k202d agoSolius Labs, Inc. — SOLIUS PRO UVB Light Panel (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 16, 2026device 510k202d agoCepheid — Xpert GI Panel (510k cleared)

    Product code: PCH. Advisory committee: Microbiology. Type: Traditional

    full page →fda device 510k ↗
    ›Jan 16, 2026device 510k202d agoSana Health — Sana Device (510k cleared)

    Product code: QYN. Advisory committee: Physical Medicine. Type: Direct

    full page →fda device 510k ↗
    ›Jan 16, 2026device 510k202d agoQure.Ai Technologies — qXR-Detect (510k cleared)BMP AI Technologies, Inc.

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

    full page →fda device 510k ↗
    ›Jan 16, 2026device 510k202d agoToro Neurovascular, Inc. — Toro 88 Superbore Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 16, 2026device 510k202d agoMedtronic — Affinity Pixie™ Arterial Filter with Balance™ Biosurface; Affinity® Pediatric Arterial Blood Filter (510k cleared)Medtronic plc

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

    full page →fda device 510k ↗
    ›Jan 16, 2026device 510k202d agoMY01, Inc. — MY01 Continuous Compartmental Pressure Monitor (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 16, 2026device 510k202d agoPhelcom Technologies — Eyer 2 (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 16, 2026device 510k202d agoVital Healthcare Sdn. Bhd. — VITAL Tubing Sets for Hemodialysis (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 16, 2026device 510k202d agoIntuitive Surgical, Inc. — da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator (510k cleared)INTUITIVE SURGICAL INC

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

    full page →fda device 510k ↗
    ›Jan 16, 2026device 510k202d agoCuriteva, Inc. — Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody System; Curiteva Porous PEEK Laminoplasty System; Curiteva Porous PEEK Standalone ALIF System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 16, 2026device 510k202d agoFlexicare Medical Limited. — FL-10000U Respiratory Humidifier (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 16, 2026device 510k202d agoLin-Zhi International, Inc. — LZI Buprenorphine II Enzyme Immunoassay (510k cleared)LIQTECH INTERNATIONAL INC

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

    full page →fda device 510k ↗
    ›Jan 16, 2026device 510k202d agoSpirair, Inc. — SeptAlign (510k cleared)SPIRE INC

    Product code: NHB. Advisory committee: Ear, Nose, Throat. Type: Traditional

    full page →fda device 510k ↗
    ›Jan 16, 2026device 510k202d agoPhilips Medical Systems B.V. — Azurion R3.1 (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 16, 2026device 510k202d agoSoftlink International Private Limited — Imagine® Enterprise Suite (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 16, 2026device 510k202d agoHycor Biomedical — NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Arachis hypogaea); Capture Reagent F076, Bos d 4 a-lactalbumin, Milk; Capture Reagent F077, Bos d 5 ß-lactoglobulin, Milk; Capture Reagent F232, Gal d 2 Ovalbumin, Egg (510k cleared)Dawn Sea Therapeutics

    Product code: DHB. Advisory committee: Immunology. Type: Traditional

    full page →fda device 510k ↗
    ›Jan 16, 2026device 510k202d agoIntuitive Surgical, Inc. — da Vinci Surgical System (IS5000) (510k cleared)INTUITIVE SURGICAL INC

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

    full page →fda device 510k ↗
    ›Jan 16, 2026device 510k202d agoSurGenTec, LLC — Ion-C (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 16, 2026device 510k202d agoTruvian Sciences, Inc. — Tru Hematology Test (510k cleared)

    Product code: GKZ. Advisory committee: Hematology. Type: Traditional

    full page →fda device 510k ↗
    ← prev
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    $EMI
    $ISRG368.26-1.90%
    $MDT86.20-0.55%
    $BMPA
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    $INMD
    $MDT86.20-0.55%
    $SCLX8.8000+25.00%
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    $ISRG368.26-1.90%