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calendar

27 catalysts · 23 device 510k · 4 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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no tagged catalysts yet

Week of Apr 7, 2025

27
›Apr 11, 2025approval487d ago
OPDIVO (NIVOLUMAB) — FDA approvalnivolumab

Sponsor: BRISTOL MYERS SQUIBB. Form: INJECTABLE. Route: INJECTION

full page →nivolumab →fda approvals ↗
›Apr 11, 2025approval487d agoSUBLOCADE (BUPRENORPHINE) — FDA approvalbuprenorphine LA

Sponsor: INDIVIOR. Form: SOLUTION, EXTENDED RELEASE. Route: SUBCUTANEOUS

full page →buprenorphine LA →fda approvals ↗
›Apr 11, 2025approval487d agoMORPHINE SULFATE — FDA approvalKapanol

Sponsor: ACTAVIS ELIZABETH. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →Kapanol →fda approvals ↗
›Apr 11, 2025approval487d agoCABENUVA KIT (CABOTEGRAVIR) — FDA approvalViiV Healthcare Company

Sponsor: VIIV HLTHCARE. Form: SUSPENSION, EXTENDED RELEASE. Route: INTRAMUSCULAR

full page →fda approvals ↗
›Apr 11, 2025device 510k487d agoFoshan Coxo Medical Instrument Co., Ltd. — LED Curing Lights (DB686 HALO) (510k cleared)

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

full page →fda device 510k ↗
›Apr 11, 2025device 510k487d agoNelson Environmental Technologies, Inc. — Chlorine Sentinel II (510k cleared)BION ENVIRONMENTAL TECHNOLOGIES INC

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

full page →fda device 510k ↗
›Apr 11, 2025device 510k487d agoOncospace, Inc. — Oncospace (510k cleared)

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

full page →fda device 510k ↗
›Apr 11, 2025device 510k487d agoSmartsurgN, Inc. — AirSurgN Insufflator (10030/AirSurgN) (510k cleared)

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

full page →fda device 510k ↗
›Apr 11, 2025device 510k487d agoShenzhen Trious Medical Technology Co., Ltd. — Disposable ureteral access sheath (510k cleared)NewBay Medical Technology Co Ltd

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

full page →fda device 510k ↗
›Apr 11, 2025device 510k487d agoAlma Lasers, Inc. — Alma Harmony (510k cleared)

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

full page →fda device 510k ↗
›Apr 11, 2025device 510k487d agoFujifilm Corporation — FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R (510k cleared)Fujifilm Holdings Corp

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

full page →fda device 510k ↗
›Apr 11, 2025device 510k487d agoXelite Biomed , Ltd. — XeliteMed VertehighFix High Viscosity Spinal Bone Cement System (510k cleared)

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

full page →fda device 510k ↗
›Apr 11, 2025device 510k487d agoCognoa, Inc. — Canvas Dx (510k cleared)

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

full page →fda device 510k ↗
›Apr 11, 2025device 510k487d agoGuilin Aesthedent Medical Instruments Co., Ltd. — Dental Implant Unit (510k cleared)

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

full page →fda device 510k ↗
›Apr 11, 2025device 510k487d agoDentsply Sirona — Atlantis® Abutments in Titanium (510k cleared)DENTSPLY SIRONA Inc.

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

full page →fda device 510k ↗
›Apr 11, 2025device 510k487d agoShenzhen Vivolight Medical Device & Technology Co., Ltd. — Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System (Mobile-E); LumenCross Imaging Catheter (F2) (510k cleared)

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

full page →fda device 510k ↗
›Apr 11, 2025device 510k487d agoKlaxon-Mobility GmbH — KLAXON (TWIST); KLAXON (TWIST R) (510k cleared)

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

full page →fda device 510k ↗
›Apr 11, 2025device 510k487d agoCooperSurgical, Inc. — CooperSurgical Milex® Pessaries (510k cleared)

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

full page →fda device 510k ↗
›Apr 11, 2025device 510k487d agoAidite (Qinhuangdao) Technology Co., Ltd. — Dental Zirconia Ceramic (510k cleared)

Product code: EIH. Advisory committee: Dental. Type: Special

full page →fda device 510k ↗
›Apr 11, 2025device 510k487d agoAsiga Pty, Ltd. — Asiga DentaBASE (510k cleared)

Product code: EBI. Advisory committee: Dental. Type: Abbreviated

full page →fda device 510k ↗
›Apr 11, 2025device 510k487d agoShanghai AnQing Medical Instrument Co., Ltd. — Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US) (510k cleared)

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

full page →fda device 510k ↗
›Apr 11, 2025device 510k487d agoCascination AG — OTOPLAN (510k cleared)

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

full page →fda device 510k ↗
›Apr 11, 2025device 510k487d agoClick Therapeutics, Inc. — CT-132 (510k cleared)Click Holdings Ltd.

Product code: SEE. Advisory committee: Neurology. Type: Direct

full page →fda device 510k ↗
›Apr 11, 2025device 510k487d agoPearl, Inc. — Second Opinion Periapical Radiolucency Contours (510k cleared)

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

full page →fda device 510k ↗
›Apr 11, 2025device 510k487d agoRoche Molecular Systems, Inc. — cobas liat SARS-CoV-2 v2 nucleic acid test (510k cleared)

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

full page →fda device 510k ↗
›Apr 11, 2025device 510k487d agoMedline Industries, LP — Medline UNITE® REFLEX® Hybrid Nitinol Implant System (510k cleared)

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

full page →fda device 510k ↗
›Apr 11, 2025device 510k487d agoGalileo Cds, Inc. — GBrain MRI (510k cleared)

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

full page →fda device 510k ↗
$BMY64.84+0.19%
$XRAY11.66-3.80%
$INDV38.47-0.90%
$CLIK
$BNET