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calendar

34 catalysts · 26 device 510k · 8 approval

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2026-08-10: 0 catalysts2026-08-11: 16 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: 20 catalysts2026-10-30: 4 catalysts2026-10-31: 0 catalysts2026-11-01: 0 catalysts2026-11-02: 8 catalysts2026-11-03: 17 catalysts2026-11-04: 22 catalysts2026-11-05: 36 catalysts2026-11-06: 2 catalysts2026-11-07: 0 catalysts2026-11-08: 0 catalysts
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  • device 510k26
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no tagged catalysts yet

Week of Apr 21, 2025

34
›Apr 25, 2025approval473d ago
LAMICTAL ODT (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

full page →LAMOTRIGINE →fda approvals ↗
›Apr 25, 2025approval473d agoLAMICTAL ODT (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

full page →LAMOTRIGINE →fda approvals ↗
›Apr 25, 2025approval473d agoLAMICTAL (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET. Route: ORAL

full page →LAMOTRIGINE →fda approvals ↗
›Apr 25, 2025approval473d agoLAMICTAL (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET. Route: ORAL

full page →LAMOTRIGINE →fda approvals ↗
›Apr 25, 2025approval473d agoLAMICTAL CD (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET, FOR SUSPENSION. Route: ORAL

full page →LAMOTRIGINE →fda approvals ↗
›Apr 25, 2025approval473d agoLAMICTAL CD (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET, FOR SUSPENSION. Route: ORAL

full page →LAMOTRIGINE →fda approvals ↗
›Apr 25, 2025approval473d agoLAMICTAL XR (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →LAMOTRIGINE →fda approvals ↗
›Apr 25, 2025approval473d agoLAMICTAL XR (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →LAMOTRIGINE →fda approvals ↗
›Apr 25, 2025device 510k473d agoMicroaire Surgical Instruments, LLC — PAL 7020 Console (510k cleared)

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

full page →fda device 510k ↗
›Apr 25, 2025device 510k473d agoMako Surgical Corp. — Mako Total Knee Application (3.0); Hybrid Tip Pointer (510k cleared)

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

full page →fda device 510k ↗
›Apr 25, 2025device 510k473d agoCardio Flow Inc., — FreedomFlow™ Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration) (510k cleared)

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

full page →fda device 510k ↗
›Apr 25, 2025device 510k473d agoVarian Medical Systems — Intracavitary/Interstitial System (510k cleared)

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

full page →fda device 510k ↗
›Apr 25, 2025device 510k473d agoPromethean Restorative, LLC — DYNAMIS™ Implant System (510k cleared)

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

full page →fda device 510k ↗
›Apr 25, 2025device 510k473d agoEchoNous, Inc. — Kosmos (510k cleared)

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

full page →fda device 510k ↗
›Apr 25, 2025device 510k473d agoWellmed Dental Medical Supply Co., Ltd. — Self Sealing Sterilization Pouches (510k cleared)

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

full page →fda device 510k ↗
›Apr 25, 2025device 510k473d agoSorin Group Italia S.R.L. — DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14) (510k cleared)

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

full page →fda device 510k ↗
›Apr 25, 2025device 510k473d agoA.M.I. Agency For Medical Innovations GmbH — i-Cut (510k cleared)

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

full page →fda device 510k ↗
›Apr 25, 2025device 510k473d agoRoche Molecular Systems, Inc. — cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test (510k cleared)

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

full page →fda device 510k ↗
›Apr 25, 2025device 510k473d agoBhm-Tech Produktionsgesellschaft Mbh — contact forte Alpha (510k cleared)

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

full page →fda device 510k ↗
›Apr 25, 2025device 510k473d ago4Web Medical — Cervical Spine Truss System (CSTS) (510k cleared)

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

full page →fda device 510k ↗
›Apr 25, 2025device 510k473d agoRoche Molecular Systems, Inc. — cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test (510k cleared)

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

full page →fda device 510k ↗
›Apr 25, 2025device 510k473d agoMerit Medical Systems, Inc. — Prelude Wave Hydrophilic Sheath Introducer (510k cleared)MERIT MEDICAL SYSTEMS INC

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

full page →fda device 510k ↗
›Apr 25, 2025device 510k473d agoAgnes Medical Co., Ltd. — RFMagik Lite (510k cleared)

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

full page →fda device 510k ↗
›Apr 25, 2025device 510k473d agoShenzhen Urion Technology Co., Ltd. — Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM617) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

full page →fda device 510k ↗
›Apr 25, 2025device 510k473d agoInstitut Geroges Lopez — DCX Disposable Cassette (DCX) (510k cleared)

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

full page →fda device 510k ↗
›Apr 25, 2025device 510k473d agoCompact Medical, Inc. — butterflyBVM (510k cleared)

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

full page →fda device 510k ↗
›Apr 25, 2025device 510k473d agoL&K BIOMED Co., Ltd. — CastleLoc Pectus Bar System (510k cleared)NeuCen BioMed Co Ltd

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

full page →fda device 510k ↗
›Apr 25, 2025device 510k473d agoNeuhealth Digital , Ltd. — Neu Platform (510k cleared)

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

full page →fda device 510k ↗
›Apr 25, 2025device 510k473d agoCarefusion 303, Inc. — BD Alaris Infusion System with Guardrails Suite MX (510k cleared)

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

full page →fda device 510k ↗
›Apr 25, 2025device 510k473d agoSTERIS Corporation — VERIFY STEAM Integrating Indicator (510k cleared)STERIS plc

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

full page →fda device 510k ↗
›Apr 25, 2025device 510k473d agoGuangzhou Daxin Health Technology Co., Ltd. — Infrared Thermometer (510k cleared)Guangzhou Dazhou Biomedical Technology Co Ltd

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

full page →fda device 510k ↗
›Apr 25, 2025device 510k473d agoCentinel Spine, LLC — prodisc® L Instruments (510k cleared)

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

full page →fda device 510k ↗
›Apr 25, 2025device 510k473d agoSiemens Healthcare Diagnostics — Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L) (510k cleared)

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

full page →fda device 510k ↗
›Apr 25, 2025device 510k473d agoABBOTT MEDICAL — Amulet™ Steerable Delivery Sheath (510k cleared)

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

full page →fda device 510k ↗
$FRTRY
$STE238.91+0.61%
$MMSI89.75+0.80%