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calendar

19 catalysts · 15 device 510k · 4 approval

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  • device 510k15
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no tagged catalysts yet

Week of Mar 24, 2025

19
›Mar 27, 2025approval522d ago
DOXYCYCLINE HYCLATE — FDA approvalDOXYCYCLINE HYCLATE

Sponsor: STRIDES PHARMA INTL. Form: TABLET. Route: ORAL

full page →DOXYCYCLINE HYCLATE →fda approvals ↗
›Mar 27, 2025approval522d agoDOXYCYCLINE HYCLATE — FDA approvalDOXYCYCLINE HYCLATE

Sponsor: STRIDES PHARMA INTL. Form: TABLET. Route: ORAL

full page →DOXYCYCLINE HYCLATE →fda approvals ↗
›Mar 27, 2025approval522d agoDOXYCYCLINE HYCLATE — FDA approvalDOXYCYCLINE HYCLATE

Sponsor: STRIDES PHARMA INTL. Form: TABLET. Route: ORAL

full page →DOXYCYCLINE HYCLATE →fda approvals ↗
›Mar 27, 2025approval522d agoMETHADONE HYDROCHLORIDE — FDA approvalMETHADONE HYDROCHLORIDE

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

full page →METHADONE HYDROCHLORIDE →fda approvals ↗
›Mar 27, 2025device 510k522d agoZmi Electronics , Ltd. — Levina Pelvic Floor Muscle Stimulator (RS-48) (510k cleared)

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

full page →fda device 510k ↗
›Mar 27, 2025device 510k522d agoBiocorp Production — MallyaD injection pen adapter (MallyaD) (510k cleared)

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

full page →fda device 510k ↗
›Mar 27, 2025device 510k522d agoArtrya Limited — Salix Central (510k cleared)

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

full page →fda device 510k ↗
›Mar 27, 2025device 510k522d agoEdwards Lifesciences — Edwards eSheath Optima introducer set (510k cleared)Edwards Lifesciences Corp

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

full page →fda device 510k ↗
›Mar 27, 2025device 510k522d agoAccess Vascular, Inc. — HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102); HydroMID 5F Dual Lumen Midline Catheter - Max Barrier Kit (70006104); HydroMID 5F Dual Lumen Midline Catheter - Mobile Max Barrier Kit (90006104) (510k cleared)

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

full page →fda device 510k ↗
›Mar 27, 2025device 510k522d agoAsahi Intecc Co., Ltd. — Crossloop (510k cleared)

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

full page →fda device 510k ↗
›Mar 27, 2025device 510k522d agoThreadstone, LLC — HyperSuture White/Green Extension Line (510k cleared)

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

full page →fda device 510k ↗
›Mar 27, 2025device 510k522d agoRestor3D, Inc. — iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement System (510k cleared)

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

full page →fda device 510k ↗
›Mar 27, 2025device 510k522d agoScivita Medical Technology Co., Ltd. — Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-2A-P, SUV-2B-B, SUB-2B-P, SUV-2C-B, SUV-2C-P;Single-use Flexible Cystoscope: SUV-1D-B, SUV-1D-P; Endoscopic Image Processor: HDVS-S100A, HDVS-S100D.) (510k cleared)NewBay Medical Technology Co Ltd

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

full page →fda device 510k ↗
›Mar 27, 2025device 510k522d agoFotona D.O.O. — StarFormer (M008-3T) (510k cleared)

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

full page →fda device 510k ↗
›Mar 27, 2025device 510k522d agoMedtronic, Inc. — SelectSite C304 Deflectable Catheter System (C304); C315 Delivery System (C315) (510k cleared)Medtronic plc

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

full page →fda device 510k ↗
›Mar 27, 2025device 510k522d agoHC Biologics, LLC — HC Biologics Osteopoint Spinal Fixation System (510k cleared)Hema Biologics LLC

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

full page →fda device 510k ↗
›Mar 27, 2025device 510k522d agoSiemens Healthcare GmbH — AI-Rad Companion Organs RT (510k cleared)

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

full page →fda device 510k ↗
›Mar 27, 2025device 510k522d agoV5med, Inc. — V5med Lung AI (510k cleared)

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

full page →fda device 510k ↗
›Mar 27, 2025device 510k522d agoHeadsafe Mfg Pty, Ltd. — Nurochek-Pro System (510k cleared)

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

full page →fda device 510k ↗
$MDT91.23+1.40%
$EW91.33-2.47%