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calendar

17 catalysts · 16 device 510k · 1 approval

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  • device 510k16
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no tagged catalysts yet

Week of Jan 13, 2025

17
›Jan 13, 2025approval595d ago
LURASIDONE HYDROCHLORIDE — FDA approvalLURASIDONE HYDROCHLORIDE

Sponsor: TORRENT. Form: TABLET. Route: ORAL

full page →LURASIDONE HYDROCHLORIDE →fda approvals ↗
›Jan 13, 2025device 510k595d agoXiamen Weiyou Intelligent Technology Co., Ltd. — Air Pressure Therapy System (510k cleared)

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

full page →fda device 510k ↗
›Jan 13, 2025device 510k595d agoBreas Medical AB — Vivo 45 LS (510k cleared)

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

full page →fda device 510k ↗
›Jan 13, 2025device 510k595d agoOsang, LLC — QuickFinder COVID-19/Flu Antigen Self Test / QuickFinder COVID-19/Flu Antigen Pro Test (510k cleared)

Product code: SCA. Advisory committee: Microbiology. Type: Traditional

full page →fda device 510k ↗
›Jan 13, 2025device 510k595d agoKico Knee Innovation Company Pty, Ltd. — ARVIS® Shoulder (510k cleared)

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

full page →fda device 510k ↗
›Jan 13, 2025device 510k595d agoHlb Co., Ltd. Healthcare — Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus (510k cleared)NVP Healthcare Co Ltd

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

full page →fda device 510k ↗
›Jan 13, 2025device 510k595d agoPrivapath Diagnostics Ltd (Dba Letsgetchecked) — LetsGetChecked Impress (510k cleared)

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

full page →fda device 510k ↗
›Jan 13, 2025device 510k595d agoArthrex, Inc. — Arthrex Intramedullary Nails (510k cleared)

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

full page →fda device 510k ↗
›Jan 13, 2025device 510k595d agoArineta , Ltd. — SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening Option (510k cleared)

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

full page →fda device 510k ↗
›Jan 13, 2025device 510k595d agoMegagen Implant Co., Ltd. — MegaGen Dental Implant Abutment (510k cleared)

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

full page →fda device 510k ↗
›Jan 13, 2025device 510k595d agoAlcon Laboratories, Inc. — Precision1; Precision1 for Astigmatism; Dailies Total1; Dailies Total1 for Astigmatism; Dailies Total1 Multifocal; Dailies Total1 Multifocal Toric (510k cleared)Alcon Laboratories Inc

Product code: LPL. Advisory committee: Ophthalmic. Type: Special

full page →fda device 510k ↗
›Jan 13, 2025device 510k595d agoOlympus Medical Systems Corporation — High Flow Insufflation Unit (UHI-4) (510k cleared)

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

full page →fda device 510k ↗
›Jan 13, 2025device 510k595d agoAdler Ortho S.P.A — Pantheon Proximal Femur Reconstruction (PFR) System (510k cleared)

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

full page →fda device 510k ↗
›Jan 13, 2025device 510k595d agoJoytech Healthcare Co. , Ltd. — Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62D0L, DBP-62D0B, DBP-61D0, DBP-61D0L, DBP-6293L, DBP-6293B, DBP-6193) (510k cleared)NVP Healthcare Co Ltd

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

full page →fda device 510k ↗
›Jan 13, 2025device 510k595d agoAzac Group — AAMI Level 4 Protective; Gown (510k cleared)

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

full page →fda device 510k ↗
›Jan 13, 2025device 510k595d agoKyocera Medical Technologies, Inc. — Initia Knee System (510k cleared)Medical Care Technologies Inc.

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

full page →fda device 510k ↗
›Jan 13, 2025device 510k595d agoMentor Worldwide, LLC — MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer (510k cleared)

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

full page →fda device 510k ↗
$MDCE0.00020.00%