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calendar

20,120 catalysts · 4,728 grant · 3,126 8k filing · 3,076 device 510k · 2,774 approval · 2,000 device pma · 2,000 device recall

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2026-08-10: 0 catalysts2026-08-11: 97 catalysts2026-08-12: 19 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: 2 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 filing3,126
  • device 510k3,076
  • approval2,774
  • device pma2,000
  • device recall2,000
device adverse event
1,000
  • recall751
  • earnings583
  • phase 2 completion172
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of May 12, 2025

    34
    ›May 15, 2025device 510k454d agoEdwards Lifesciences, LLC — Hypertension Prediction Index (HePI) Algorithm (510k cleared)Edwards Lifesciences Corp

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

    full page →fda device 510k ↗
    ›May 15, 2025device 510k454d agoGuard Medical, Inc. — NPseal (510k cleared)Picard Medical, Inc.

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

    full page →fda device 510k ↗
    ›May 15, 2025device 510k454d agoEywa Srl — Limfa Therapy System (Limfa Therapy) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 15, 2025device 510k454d agoOlympus Medical Systems Corporation — Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal Videoscope (GIF-EZ1500) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 15, 2025device 510k454d agoNIKKISO CO., LTD. — BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series (AL-ADC-E(U), AL-CDC-E(U), C18RDC-E(U), C18BDD-E(U), C18SFD-E(U) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 15, 2025device 510k454d agoNIKKISO CO., LTD. — BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series AL-ADC-PU, AL-CDC-PU, C18RDC-PU, C18BDD-PU, C18SFD-PU (510k cleared)

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

    full page →fda device 510k ↗
    ›May 15, 2025device 510k454d agoEmbolization, Inc. — Nitinol Enhanced Device (NED) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 15, 2025device 510k454d agoMekics Co., Ltd. — HFT750U (510k cleared)

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

    full page →fda device 510k ↗
    ›May 15, 2025device 510k454d agoHardy Diagnostics — HardyDisk Aztreonam/Avibactam 30/20µg (AZA50) (510k cleared)Bristol-Myers Squibb Co

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

    full page →fda device 510k ↗
    ›May 15, 2025device 510k454d agoPhilips Ultrasound — Lumify Diagnostic Ultrasound System (510k cleared)Ocuvex Therapeutics Inc

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

    full page →fda device 510k ↗
    ›May 15, 2025device 510k454d agoMicroport Orthopedics, Inc. — NEXUS® Hip Stem (510k cleared)

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

    full page →fda device 510k ↗
    ›May 16, 2025device 510k453d agoShenzhen Mindray Bio-Medical Electronics Co., Ltd. — Diagnostic Ultrasound System (MX6); Diagnostic Ultrasound System (MX6S); Diagnostic Ultrasound System (MX6T); Diagnostic Ultrasound System (MX6 Exp); Diagnostic Ultrasound System (MX6 Pro); Diagnostic Ultrasound System (MX6 Super); Diagnostic Ultrasound System (MXG); Diagnostic Ultrasound System (Emerus MX6); Diagnostic Ultrasound System (Emerus MX6 Exp); Diagnostic Ultrasound System (Anesus MX6); Diagnostic Ultrasound System (Anesus MX6 Exp); Diagnostic Ultrasound System (Crius MX6); (510k cleared)

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

    full page →fda device 510k ↗
    ›May 16, 2025device 510k453d agoBrainlab AG — Mixed Reality Spine Navigation (510k cleared)

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

    full page →fda device 510k ↗
    ›May 16, 2025device 510k453d agoCellah Medical Co., Ltd. — BLESSING System (510k cleared)

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

    full page →fda device 510k ↗
    ›May 16, 2025device 510k453d agoVenocare, Inc. — Ruby Intravascular Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›May 16, 2025device 510k453d agoIorbit Digital Technologies Private Limited — iBSM (510k cleared)

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

    full page →fda device 510k ↗
    ›May 16, 2025device 510k453d agoMedicatech USA, Inc. — MasteRad MiniX Mobile Digital Imaging System (Mini-X) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 16, 2025device 510k453d agoSENTINEL CH. SpA — Cystatin C (510k cleared)

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

    full page →fda device 510k ↗
    ›May 16, 2025device 510k453d agoShanghai United Imaging Healthcare Co., Ltd. — uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS with uWS-CT-Dual Energy Analysis (510k cleared)

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

    full page →fda device 510k ↗
    ›May 16, 2025device 510k453d agoFujirebio Diagnostics,Inc. — Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio (510k cleared)Co-Diagnostics, Inc.

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

    full page →fda device 510k ↗
    ›May 16, 2025device 510k453d agoPhilips Medical Systems Technologies , Ltd. — Spectral CT (510k cleared)

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

    full page →fda device 510k ↗
    ›May 16, 2025device 510k453d agoByonyks Pvt, Ltd. — Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1 (510k cleared)

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

    full page →fda device 510k ↗
    ›May 16, 2025device 510k453d agoWaldemar Link GmbH & Co. KG — MobileLink Acetabular Cup System - inhouse coatings (510k cleared)

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

    full page →fda device 510k ↗
    ›May 16, 2025device 510k453d agoVarian Medical Systems — Mobius3D (4.1) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 16, 2025device 510k453d agoBreas Medical AB — Clearo (510k cleared)

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

    full page →fda device 510k ↗
    ›May 16, 2025device 510k453d agoInfervision Medical Technology Co., Ltd. — InferRead Lung CT.AI (510k cleared)NewBay Medical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›May 16, 2025device 510k453d agoOrtoma AB — OTS Hip (510k cleared)

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

    full page →fda device 510k ↗
    ›May 16, 2025device 510k453d agoEncore Medical L.P. — AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA Humeral System; PRIMA Glenoid System (510k cleared)Encore Medical, Inc.

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

    full page →fda device 510k ↗
    ›May 16, 2025device 510k453d agoHaolang Medical USA Corporation — Hemodialysis Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›May 16, 2025device 510k453d agoEsaote, S.p.A. — 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 16, 2025device 510k453d agoShenzhen Desida Technology Co., Ltd. — Electric Nasal Aspirator (NASA601,NASA602,NASA603,NASA605,NASA606,NASA608,NASA610) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

    full page →fda device 510k ↗
    ›May 16, 2025device 510k453d agoBiosphere Medical, S.A. — Embosphere Microspheres (510k cleared)

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

    full page →fda device 510k ↗
    ›May 16, 2025device 510k453d agoArthrex, Inc. — Arthrex Spine Endoscope (510k cleared)

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

    full page →fda device 510k ↗
    ›May 16, 2025device 510k453d agoAustin Medical Ventures, Inc. — Synthecure Synthetic Calcium Sulfate (510k cleared)

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

    full page →fda device 510k ↗

    Week of May 19, 2025

    16
    ›May 19, 2025approval450d agoSUBOXONE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

    Sponsor: INDIVIOR. Form: FILM. Route: BUCCAL, SUBLINGUAL

    full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
    ›May 19, 2025approval
    ← prev
    page 4 of 403
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    450d ago
    ZUBSOLV (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalEdenbridge Pharmaceuticals LLC

    Sponsor: EDENBRIDGE PHARMS. Form: TABLET. Route: SUBLINGUAL

    full page →fda approvals ↗
    ›May 19, 2025device 510k450d agoRowpar Pharmaceuticals, Inc. — CloSYS® Dry Mouth Sensitive Mouth Rinse (510k cleared)RVL Pharmaceuticals Inc

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

    full page →fda device 510k ↗
    ›May 19, 2025device 510k450d agoSplintek, Inc. — SleepRight Snore Aid (510k cleared)

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

    full page →fda device 510k ↗
    ›May 19, 2025device 510k450d agoRoute 92 Medical, Inc. — Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set (510k cleared)

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

    full page →fda device 510k ↗
    ›May 19, 2025device 510k450d agoNanjing Perlove Medical Equipment Co., Ltd. — Diagnostic X-ray System (510k cleared)

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

    full page →fda device 510k ↗
    ›May 19, 2025device 510k450d agoGigaalaser Company , Ltd. — Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 19, 2025device 510k450d agoDoc Brands, Inc. — Dentemp Pro-Comfort Dental Guard (510k cleared)BT Brands, Inc.

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

    full page →fda device 510k ↗
    ›May 19, 2025device 510k450d agoBecton, Dickinson and Company — BD Phoenix™ Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL) (510k cleared)BECTON DICKINSON & CO

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

    full page →fda device 510k ↗
    ›May 19, 2025device 510k450d agoShenzhen Mindray Bio-Medical Electronics Co., Ltd. — Diagnostic Ultrasound System (Recho R9W); Diagnostic Ultrasound System (Recho R9); Diagnostic Ultrasound System (Recho R9 Pro); Diagnostic Ultrasound System (Recho R9 Exp); Diagnostic Ultrasound System (Recho R9S); Diagnostic Ultrasound System (Recho R9T); Diagnostic Ultrasound System (Crius R9 CV); Diagnostic Ultrasound System (Anesus R9 CV); Diagnostic Ultrasound System (Recho R9 Super); Diagnostic Ultrasound System (Recho R9 Lumi); Diagnostic Ultrasound System (Recho R CV); Diagnost (510k cleared)

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

    full page →fda device 510k ↗
    ›May 19, 2025device 510k450d agoVision Rt, Ltd. — MapRT (510k cleared)Rail Vision Ltd.

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

    full page →fda device 510k ↗
    ›May 19, 2025device 510k450d agoZhengzhou PZ Laser Slim Technology Co., Ltd. — Muscle Stimulator Device (PZ-100) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 19, 2025device 510k450d agoResmed Pty , Ltd. — AirFit F20 Mask System; AirFit F20 NM Mask System (510k cleared)

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

    full page →fda device 510k ↗
    ›May 19, 2025device 510k450d agoRestor3D — restor3d Reverse Total Shoulder Arthroplasty System (510k cleared)

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

    full page →fda device 510k ↗
    ›May 20, 2025approval449d agoAMJEVITA (ADALIMUMAB-ATTO) — FDA approvalAMJEVITA

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

    full page →AMJEVITA →fda approvals ↗
    ›May 20, 2025approval449d agoCYLTEZO (ADALIMUMAB-ADBM) — FDA approvalCYLTEZO

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

    full page →CYLTEZO →fda approvals ↗
    $EW91.33-2.47%
    $CODX1.51000.00%
    $PMI0.1821-4.66%
    $INDV39.20+1.90%
    $FRTRY
    $EMI
    $BTBD
    $RVSN4.4000-4.56%
    $BDX181.41+0.99%
    $AMGN414.03-0.76%