Calendar

pharmadog

Week of Mar 24, 2025

Mar 26, 2025device 510k505d agoAZmed — Rayvolve LN (510k cleared)

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

full page →fda device 510k ↗

Mar 26, 2025device 510k505d agoKent Imaging, Inc. — SnapshotGLO (KB100) (510k cleared)

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

full page →fda device 510k ↗

Mar 26, 2025device 510k505d agoShenzhen Ulike Smart Electronics Co., Ltd. — Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH) (510k cleared)

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

full page →fda device 510k ↗

Mar 27, 2025approval504d agoDOXYCYCLINE HYCLATE — FDA approvalDOXYCYCLINE HYCLATE

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

full page →DOXYCYCLINE HYCLATE →fda approvals ↗

Mar 27, 2025approval504d agoDOXYCYCLINE HYCLATE — FDA approvalDOXYCYCLINE HYCLATE

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

full page →DOXYCYCLINE HYCLATE →fda approvals ↗

Mar 27, 2025approval504d agoDOXYCYCLINE HYCLATE — FDA approvalDOXYCYCLINE HYCLATE

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

full page →DOXYCYCLINE HYCLATE →fda approvals ↗

Mar 27, 2025approval504d agoMETHADONE HYDROCHLORIDE — FDA approvalMETHADONE HYDROCHLORIDE

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

full page →METHADONE HYDROCHLORIDE →fda approvals ↗

Mar 27, 2025device 510k504d 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 510k504d 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 510k504d agoArtrya Limited — Salix Central (510k cleared)

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

full page →fda device 510k ↗

Mar 27, 2025device 510k504d 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 510k504d 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 510k504d agoAsahi Intecc Co., Ltd. — Crossloop (510k cleared)

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

full page →fda device 510k ↗

Mar 27, 2025device 510k504d 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 510k504d 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 510k504d 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 510k504d 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 510k504d 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 510k504d 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 510k504d 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 510k504d agoV5med, Inc. — V5med Lung AI (510k cleared)

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

full page →fda device 510k ↗

Mar 27, 2025device 510k504d agoHeadsafe Mfg Pty, Ltd. — Nurochek-Pro System (510k cleared)

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

full page →fda device 510k ↗

Mar 28, 2025approval503d agoPLUVICTO (LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN) — FDA approvallutetium Lu 177 vipivotide tetraxetan

Sponsor: NOVARTIS. Form: SOLUTION. Route: INTRAVENOUS

full page →lutetium Lu 177 vipivotide tetraxetan →fda approvals ↗

Mar 28, 2025approval503d agoPLUVICTO (LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN) — FDA approvallutetium Lu 177 vipivotide tetraxetan

Sponsor: NOVARTIS. Form: SOLUTION. Route: INTRAVENOUS

full page →lutetium Lu 177 vipivotide tetraxetan →fda approvals ↗

Mar 28, 2025approval503d agoABILIFY MAINTENA KIT (ARIPIPRAZOLE) — FDA approvalaripiprazole LA

Sponsor: OTSUKA PHARM CO LTD. Form: FOR SUSPENSION, EXTENDED RELEASE. Route: INTRAMUSCULAR

full page →aripiprazole LA →fda approvals ↗

Mar 28, 2025approval503d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗

Mar 28, 2025approval503d agoBRIXADI (BUPRENORPHINE) — FDA approvalbuprenorphine LA

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

full page →buprenorphine LA →fda approvals ↗

Mar 28, 2025approval503d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗

Mar 28, 2025approval503d agoIMFINZI (DURVALUMAB) — FDA approvalASTRAZENECA PLC

Sponsor: ASTRAZENECA UK LTD. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Mar 28, 2025approval503d agoADZENYS XR-ODT (AMPHETAMINE) — FDA approvalTraws Pharma, Inc.

Sponsor: NEOS THERAPS. Form: TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Mar 28, 2025device 510k503d agoMedphoton GmbH — ImagingRing m (Version 2.0); Loop-X (Version 2.0); Loop-X Mobile Imaging Robot (Version 2.0) (510k cleared)

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

full page →fda device 510k ↗

Mar 28, 2025device 510k503d agoSiemens Healthcare Diagnostic Products GmbH — INNOVANCE Antithrombin (510k cleared)

Product code: JBQ. Advisory committee: Hematology. Type: Traditional

full page →fda device 510k ↗

Mar 28, 2025device 510k503d agoWuxi Jiajian Medical Instrument Co., Ltd. — Needle Stimulator (CMNS6-1 PLUS, CMNS6-3) (510k cleared)

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

full page →fda device 510k ↗

Mar 28, 2025device 510k503d agoBeckman Coulter, Inc. — Access Toxo IgG (510k cleared)

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

full page →fda device 510k ↗

Mar 28, 2025device 510k503d agoConvatec — Flexi-Seal AIR (with ENFit Connector) (510k cleared)

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

full page →fda device 510k ↗

Mar 28, 2025device 510k503d agoArthrex, Inc. — Arthrex FiberTak Suture Anchor (510k cleared)

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

full page →fda device 510k ↗

Mar 28, 2025device 510k503d agoMakani Science, Inc. — Makani Science Respiration Monitoring System (510k cleared)

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

full page →fda device 510k ↗

Mar 28, 2025device 510k503d agoTuring Medical Technologies, Inc. — Bullsai Confirm (510k cleared)Medical Care Technologies Inc.

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

full page →fda device 510k ↗

Mar 28, 2025device 510k503d agoSmith & Nephew, Inc. — CATALYSTEM Femoral Stems (510k cleared)SMITH & NEPHEW PLC

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

full page →fda device 510k ↗

Mar 28, 2025device 510k503d agoSynthes GmbH — Synthes Graphic Case & Tray System (510k cleared)

Product code: KCT. Advisory committee: General Hospital. Type: Traditional

full page →fda device 510k ↗

Mar 28, 2025device 510k503d agoSelux Diagnostics, Inc. — PBC Separator with Selux AST System (510k cleared)Co-Diagnostics, Inc.

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

full page →fda device 510k ↗

Mar 28, 2025device 510k503d agoVisby Medical, Inc. — Visby Medical Women's Sexual Health Test (510k cleared)Vivani Medical, Inc.

Product code: SEA. Advisory committee: Microbiology. Type: Direct

full page →fda device 510k ↗

Mar 30, 2025device 510k501d agoAlpha Omega Engineering , Ltd. — Neuro Omega System; NeuroSmart System (510k cleared)

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

full page →fda device 510k ↗

Mar 30, 2025device 510k501d agoPrecision Neuroscience, Corp. — Layer 7-T (510k cleared)

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

full page →fda device 510k ↗

Week of Mar 31, 2025

Mar 31, 2025approval500d agoDOXYCYCLINE HYCLATE — FDA approvalDOXYCYCLINE HYCLATE

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

full page →DOXYCYCLINE HYCLATE →fda approvals ↗

Mar 31, 2025approval

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