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calendar

20,144 catalysts · 4,728 grant · 3,102 device 510k · 3,085 8k filing · 2,791 approval · 2,000 device pma · 2,000 device recall

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2026-08-10: 0 catalysts2026-08-11: 56 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
  • device 510k3,102
  • 8k filing3,085
  • approval2,791
  • device pma2,000
  • device recall2,000
device adverse event
1,000
  • recall773
  • earnings583
  • phase 2 completion172
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of Apr 28, 2025

    34
    ›May 1, 2025approval468d agoDEPAKOTE (DIVALPROEX SODIUM) — FDA approvaldivalproex sodium DR

    Sponsor: ABBVIE. Form: TABLET, DELAYED RELEASE. Route: ORAL

    full page →divalproex sodium DR →fda approvals ↗
    ›May 1, 2025approval468d agoTEVIMBRA (TISLELIZUMAB-JSGR) — FDA approvalBeOne Medicines Ltd.

    Sponsor: BEIGENE. Form: INJECTION. Route: SOLUTION

    full page →fda approvals ↗
    ›May 1, 2025approval468d agoTICAGRELOR — FDA approvalTICAGRELOR

    Sponsor: APOTEX. Form: TABLET. Route: ORAL

    full page →TICAGRELOR →fda approvals ↗
    ›May 1, 2025device 510k468d agoOlympus Medical Systems Corp. — Disposable Distal Attachment D-201 Series (510k cleared)

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

    full page →fda device 510k ↗
    ›May 1, 2025device 510k468d agoCepheid® — Xpert Xpress CoV-2/Flu/RSV plus (510k cleared)

    Product code: QOF. Advisory committee: Microbiology. Type: Special

    full page →fda device 510k ↗
    ›May 1, 2025device 510k468d agoInnovative Sterilization Technologies — ONE TRAY® Sealed Sterilization Container System (510k cleared)

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

    full page →fda device 510k ↗
    ›May 1, 2025device 510k468d agoShenzhen Qianyu Technology Co., Ltd. — Wrinkle Treatment Device (JM1, JM2B) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

    full page →fda device 510k ↗
    ›May 1, 2025device 510k468d agoAlembic, LLC — APRO 45 Catheter (510k cleared)Alembic Pharmaceuticals Inc

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

    full page →fda device 510k ↗
    ›May 1, 2025device 510k468d agoParagon 28, Inc. — APEX 3D Total Ankle Replacement System (510k cleared)

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

    full page →fda device 510k ↗
    ›May 1, 2025device 510k468d agoCepheid® — Xpert Xpress CoV-2/Flu/RSV plus (510k cleared)

    Product code: QOF. Advisory committee: Microbiology. Type: Special

    full page →fda device 510k ↗
    ›May 1, 2025device 510k468d agoTraferox Technologies, Inc. — X°Port Lung Preservation System; X°Port Lung Preservation Solution (510k cleared)TETRA TECHNOLOGIES INC

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

    full page →fda device 510k ↗
    ›May 1, 2025device 510k468d agoBioHorizons Implant Systems, Inc. — Conical Ti Base abutments (510k cleared)

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

    full page →fda device 510k ↗
    ›May 1, 2025device 510k468d agoUnited Orthopedic Corporation — Resolve Modular Revision Hip Stem (510k cleared)

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

    full page →fda device 510k ↗
    ›May 1, 2025device 510k468d agoCirca Scientific, Inc. — CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F) (510k cleared)Clear Scientific Inc

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

    full page →fda device 510k ↗
    ›May 1, 2025device 510k468d agoGE Medical Systems Ultrasound and Primary Care Diagnostics — Vscan Air (510k cleared)

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

    full page →fda device 510k ↗
    ›May 2, 2025approval467d agoTICAGRELOR — FDA approvalTICAGRELOR

    Sponsor: ALEMBIC. Form: TABLET. Route: ORAL

    full page →TICAGRELOR →fda approvals ↗
    ›May 2, 2025device 510k467d agoPfm Medical, Inc. — JetCan® Pro Safety Huber Needle (510k cleared)Picard Medical, Inc.

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

    full page →fda device 510k ↗
    ›May 2, 2025device 510k467d agoShockwave Medical, Inc. — Shockwave CS Guide Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›May 2, 2025device 510k467d agoHathor Professional Skincare , Ltd. — Sutil Rich Personal Lubricant (510k cleared)

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

    full page →fda device 510k ↗
    ›May 2, 2025device 510k467d agoSignature Orthopaedics Pty, Ltd. — Origin™ Cemented Hip Stem (510k cleared)

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

    full page →fda device 510k ↗
    ›May 2, 2025device 510k467d agoBeijing Rongrui-Century Science & Technology Co., Ltd. — SpO2 Extension Cable (510k cleared)

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

    full page →fda device 510k ↗
    ›May 2, 2025device 510k467d agoAbbott Point of Care, Inc. — i-STAT CG4+ cartridge with the i-STAT 1 System (510k cleared)

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

    full page →fda device 510k ↗
    ›May 2, 2025device 510k467d agoSg Endoscopy Pte, Ltd. — F88 URE-SD/RD Flexible Ureteroscope (510k cleared)

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

    full page →fda device 510k ↗
    ›May 2, 2025device 510k467d agoSTERIS Corporation — Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118 (510k cleared)STERIS plc

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

    full page →fda device 510k ↗
    ›May 2, 2025device 510k467d agoSeriously Clean, Ltd. — Nixall Antimicrobial Solutions™ Skin & Wound Hydrogel (510k cleared)

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

    full page →fda device 510k ↗
    ›May 2, 2025device 510k467d agoAtsens Co., Ltd. — AT-Patch (ATP-C130/ATP-C70) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 2, 2025device 510k467d agoMedical Electronic Systems , Ltd. — SQA-iOw Sperm Quality Analyzer (510k cleared)

    Product code: POV. Advisory committee: Hematology. Type: Dual Track

    full page →fda device 510k ↗
    ›May 2, 2025device 510k467d agoCionic, Inc. — CIONIC NEURAL SLEEVE (NS-200) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 2, 2025device 510k467d agoSkydance Vascular, Inc. — OSPREY Midline Closed IV Catheter System (OspreyEDC-F20) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 2, 2025device 510k467d agoIntradys — LUMYS (V1) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 2, 2025device 510k467d agoShenzhen AOJ Medical Technology Co., Ltd. — Wrist Blood Pressure Monitor (AOJ-35A); Wrist Blood Pressure Monitor (AOJ-35B); Wrist Blood Pressure Monitor (WRS-35B); Wrist Blood Pressure Monitor (AOJ-35D); Wrist Blood Pressure Monitor (AOJ-35E); Wrist Blood Pressure Monitor (AOJ-35F); Wrist Blood Pressure Monitor (AOJ-35G); Wrist Blood Pressure Monitor (WRS-35G); Wrist Blood Pressure Monitor (WRS-35H); Wrist Blood Pressure Monitor (WRS-35K); Wrist Blood Pressure Monitor (WRS-35N); Wrist Blood Pressure Monitor (WRS-35P); Wrist Bloo (510k cleared)NewBay Medical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›May 2, 2025device 510k467d agoKarl Storz SE & CO. KG — KARL STORZ Cysto-Urethro-Fiberscope (11272CU1); KARL STORZ Cysto-Urethro-Fiberscope (11272C2) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 2, 2025device 510k467d agoBrightheart — Fetal EchoScan (v1.1) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 2, 2025device 510k467d agoMomentis Surgical , Ltd. — Anovo Instrument ARM Curved Scissors ; Anovo Instrument ARM Hook Electrode (510k cleared)

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

    full page →fda device 510k ↗

    Week of May 5, 2025

    16
    ›May 5, 2025approval464d agoTICAGRELOR — FDA approvalInvaGen Pharmaceuticals Inc

    Sponsor: INVAGEN PHARMS. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›May 5, 2025approval
    ← prev
    page 2 of 403
    next →
    464d ago
    FENSOLVI KIT (LEUPROLIDE ACETATE) — FDA approvalLEUPROLIDE ACETATE

    Sponsor: TOLMAR. Form: POWDER. Route: SUBCUTANEOUS

    full page →LEUPROLIDE ACETATE →fda approvals ↗
    ›May 5, 2025device 510k464d agoZamar Medical D.O.O. — ZT Clinic (MG675A); ZT Cube (ZC3) (MG465A); Z-ONE (MG455A) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 5, 2025device 510k464d agoAevice Health Pte. , Ltd. — AeviceMD (510k cleared)

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

    full page →fda device 510k ↗
    ›May 5, 2025device 510k464d agoGenoss Co., Ltd. — Bluemoon (510k cleared)

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

    full page →fda device 510k ↗
    ›May 5, 2025device 510k464d agoPhilips Medizin Systeme Böblingen GmbH — Telemetry Monitor 5500 Release 4.0 (867232) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 5, 2025device 510k464d agoThermasolutions, LLC — ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 5, 2025device 510k464d agoPearl, Inc. — Second Opinion® Pediatric (510k cleared)

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

    full page →fda device 510k ↗
    ›May 5, 2025device 510k464d agoAsiga Pty, Ltd. — DentaTOOTH (510k cleared)

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

    full page →fda device 510k ↗
    ›May 5, 2025device 510k464d agoArthrex, Inc. — Arthrex Synergy Vision Endoscopic Imaging System (510k cleared)

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

    full page →fda device 510k ↗
    ›May 5, 2025device 510k464d agoDae Myung Chemical Co., Ltd. (Vietnam) — Dream Medi Sterile Surgical Gown (SurgicalGownUL) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 6, 2025approval463d agoTRAMADOL HYDROCHLORIDE — FDA approvaltramadol hydrochloride ER

    Sponsor: MACLEODS PHARMS LTD. Form: TABLET. Route: ORAL

    full page →tramadol hydrochloride ER →fda approvals ↗
    ›May 6, 2025device 510k463d agoMentice Spain S.L. — ANKYRAS (510k cleared)

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

    full page →fda device 510k ↗
    ›May 6, 2025device 510k463d agoWontech Co., Ltd. — Alma Veil (510k cleared)

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

    full page →fda device 510k ↗
    ›May 6, 2025device 510k463d agoSolutions For Tomorrow AB — !M1 (510k cleared)

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

    full page →fda device 510k ↗
    ›May 6, 2025device 510k463d agoHunan Vathin Medical Instrument Co., Ltd. — Single-use Flexible Ureteroscope (510k cleared)

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

    full page →fda device 510k ↗
    $ABBV247.97+0.78%
    $STE238.91+0.61%
    $ONC359.00+3.08%
    $PMI0.1821-4.66%
    $TTI
    $FRTRY