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calendar

14 catalysts · 12 device 510k · 2 approval

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no tagged catalysts yet

Week of Mar 17, 2025

14
›Mar 17, 2025approval532d ago
AMNESTEEM (ISOTRETINOIN) — FDA approvalMylan Pharmaceuticals Inc

Sponsor: MYLAN PHARMS INC. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗
›Mar 17, 2025approval532d agoIMULDOSA (USTEKINUMAB-SRLF) — FDA approvalustekinumab biosimilar

Sponsor: ACCORD BIOPHARMA INC.. Form: INJECTABLE. Route: INTRAVENOUS

full page →ustekinumab biosimilar →fda approvals ↗
›Mar 17, 2025device 510k532d agoCarlsmed, Inc. — aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar interbody fusion device with interfixation (510k cleared)CARLSMED, INC.

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

full page →fda device 510k ↗
›Mar 17, 2025device 510k532d agoCranial Technologies, Inc. — DOC Band 3D (510k cleared)Q/C TECHNOLOGIES, INC.

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

full page →fda device 510k ↗
›Mar 17, 2025device 510k532d agoLagis Enterprise Co., Ltd. — LAGIS Suction Irrigation System (510k cleared)Cre8 Enterprise Ltd

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

full page →fda device 510k ↗
›Mar 17, 2025device 510k532d agoServ Medical Pte., Ltd. — SERV MEDICAL CDSS (510k cleared)

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

full page →fda device 510k ↗
›Mar 17, 2025device 510k532d agoDia Imaging Analysis, Ltd. — LVivo Software Application (510k cleared)

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

full page →fda device 510k ↗
›Mar 17, 2025device 510k532d agoJiale Health Technology Shenzhen Co., Ltd. — Air Compression Leg Massager (K-705) (510k cleared)Aimei Health Technology Co., Ltd.

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

full page →fda device 510k ↗
›Mar 17, 2025device 510k532d agoThe Magstim Company Limited — Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0 TMS Therapy System (Horizon 3.0 with StimGuide Pro); Horizon® 3.0 TMS Therapy System (Horizon 3.0) (510k cleared)

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

full page →fda device 510k ↗
›Mar 17, 2025device 510k532d agoOrthonovis, Inc. — BPS Wrist Fracture System (510k cleared)

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

full page →fda device 510k ↗
›Mar 17, 2025device 510k532d agoGe Medical Systems, LLC — SIGNA Prime Elite (510k cleared)

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

full page →fda device 510k ↗
›Mar 17, 2025device 510k532d agoZiehm Imaging GmbH — Ziehm Solo FD (510k cleared)

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

full page →fda device 510k ↗
›Mar 17, 2025device 510k532d agoSpecialty Water Technologies, Inc. — UPT Series Medical RO Water Treatment System (510k cleared)WATTS WATER TECHNOLOGIES INC

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

full page →fda device 510k ↗
›Mar 17, 2025device 510k532d agoCentervue S.P.A. — MAIA (AHMACME001) (510k cleared)

Product code: MYC. Advisory committee: Ophthalmic. Type: Traditional

full page →fda device 510k ↗
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