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calendar

24 catalysts · 21 device 510k · 3 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: 21 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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Week of Sep 30, 2024

24
›Oct 4, 2024approval676d ago
COSENTYX (SECUKINUMAB) — FDA approvalNOVARTIS AG

Sponsor: NOVARTIS PHARMS CORP. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗
›Oct 4, 2024approval676d agoCOSENTYX (SECUKINUMAB) — FDA approvalNOVARTIS AG

Sponsor: NOVARTIS PHARMS CORP. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗
›Oct 4, 2024approval676d agoPYRIDOSTIGMINE BROMIDE — FDA approvalBausch Health US LLC

Sponsor: US ARMY. Form: TABLET. Route: ORAL

full page →fda approvals ↗
›Oct 4, 2024device 510k676d agoFengh Medical Co., Ltd. — Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (30mm series); Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (45mm series); Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (60mm series) (510k cleared)

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

full page →fda device 510k ↗
›Oct 4, 2024device 510k676d agoHunan Vathin Medical Instrument Co., Ltd. — Video Ureteroscope System (510k cleared)

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

full page →fda device 510k ↗
›Oct 4, 2024device 510k676d agoCenterPoint Systems, LLC — AuST Steerable Sheath (510k cleared)

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

full page →fda device 510k ↗
›Oct 4, 2024device 510k676d agoAdvamedix, GmbH — Bladeless Trocar; Bladed Trocar; Hasson Trocar (510k cleared)

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

full page →fda device 510k ↗
›Oct 4, 2024device 510k676d agoZeta Surgical, Inc. — Zeta Cranial Navigation System (ZNS131-US) (510k cleared)

Product code: HAW. Advisory committee: Neurology. Type: Special

full page →fda device 510k ↗
›Oct 4, 2024device 510k676d agoAlphatec Spine, Inc. — IdentiTi™ II Interbody System (510k cleared)

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

full page →fda device 510k ↗
›Oct 4, 2024device 510k676d agoDia Imaging Analysis, Ltd. — LVivo Software Application (510k cleared)

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

full page →fda device 510k ↗
›Oct 4, 2024device 510k676d agoShenzhen Besdata Technology Co., Ltd. — Single use flexible ureteroscope (UR-D1); Single use flexible ureteroscope (UR-D2); Single use flexible ureteroscope (UR-F1); Single use flexible ureteroscope (UR-F2) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

full page →fda device 510k ↗
›Oct 4, 2024device 510k676d agoLunit, Inc. — Lunit INSIGHT DBT v1.1 (510k cleared)

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

full page →fda device 510k ↗
›Oct 4, 2024device 510k676d agoUnited Medical Resources, LLC — UMED REPROCESSED AIRCAST VENAFLOW FOOT CUFF; UMED REPROCESSED KENDALL SCD EXPRESS SLEEVE; UMED REPROCESSED AIRCAST ELITE CALF CUFF 3040 3050; UMED REPROCESSED CTC VP 501 CALF CUFF; UMED REPROCESSED CTC VP 520 FOOT CUFF (510k cleared)

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

full page →fda device 510k ↗
›Oct 4, 2024device 510k676d agoOrthonovis, Inc. — BPS Wrist Fracture System (510k cleared)

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

full page →fda device 510k ↗
›Oct 4, 2024device 510k676d agoAnhui Jbh Medical Apparatus Co., Ltd. — Power Wheelchair (510k cleared)

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

full page →fda device 510k ↗
›Oct 4, 2024device 510k676d agoEcho IQ, Ltd. — EchoSolv AS (510k cleared)

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

full page →fda device 510k ↗
›Oct 4, 2024device 510k676d agoSurgnova Healthcare Technologies (Zhejiang) Co., Ltd. — Electroporation System (N3000) (510k cleared)

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

full page →fda device 510k ↗
›Oct 4, 2024device 510k676d agoActuated Medical, Inc. — GripTract-GI Endoscopic Tissue Manipulator Lower GI Models (510k cleared)

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

full page →fda device 510k ↗
›Oct 4, 2024device 510k676d agoPromisemed Hangzhou Meditech Co., Ltd. — Endoscopic Injection Needles (510k cleared)

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

full page →fda device 510k ↗
›Oct 4, 2024device 510k676d agoTreace Medical Concepts, Inc. — Treace Medical Concepts (TMC) Screw Fixation System (510k cleared)TREACE MEDICAL CONCEPTS, INC.

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

full page →fda device 510k ↗
›Oct 4, 2024device 510k676d agoTroCare, LLC — TroCare TroKit Laparoscope Lens Wiper (CP000626) (510k cleared)

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

full page →fda device 510k ↗
›Oct 4, 2024device 510k676d agoVivachek Biotech (Hangzhou) Co., Ltd. — BioSieve™ Fentanyl FIA Home Test Kit; BioSieve™ Fentanyl FIA Pro Test Kit; BioSieve™ Toxismart Reader (510k cleared)Hangzhou DAC Biotech Co Ltd

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

full page →fda device 510k ↗
›Oct 4, 2024device 510k676d agoShenzhen Finicare Co., Ltd. — Upper Arm Electronic Blood Pressure Monitor (FC-BP103, FC-BP106, FC-BP113, FC-BP120, FC-BP121, FC-BP130, FC-BP131) (510k cleared)

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

full page →fda device 510k ↗
›Oct 4, 2024device 510k676d agoEventum Orthopaedics, Ltd. — QUADSENSE (510k cleared)

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

full page →fda device 510k ↗
$NVS156.79+0.29%
$TMCI4.1900+4.49%
$FRTRY
$NVS156.79+0.29%