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Week of Mar 17, 2025

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Mar 19, 2025recall516d agoCareFusion 213, LLC recall (Cls I)Coorg Instituite of Dental Sciences

BD ChloraPrep Clear 1mL Applicators, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Sterile Solution, 0.03 fl. oz (1 mL) each, 60 Applicators per Carton, CareFusion 213, LLC, El Paso, TX 79912, Subsidiary of Becton, Dickinson and Co., REF 930480, NDC 54365-400-31. — Reason: Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding. — Status: Ongoing

full page →fda recalls ↗

Mar 19, 2025recall516d agoAspen Biopharma Labs Pvt., Ltd. recall (Cls II)Greenstone LLC

Voriconazole Container Description: voriconazole The product packed in white poly bag containing black poly bag and tied each individual finally packed in HDPE container for shipping. — Reason: CGMP Deviations — Status: Ongoing

full page →fda recalls ↗

Mar 19, 2025device 510k516d agoNanosonics Limited — CORIS System (510k cleared)

Product code: SEW. Advisory committee: General Hospital. Type: Direct

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Mar 19, 2025device 510k516d agoGigaalaser Company , Ltd. — Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D, VELAS II-6H, VELAS II-15D) (510k cleared)

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

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Mar 19, 2025device 510k516d agoCoreline Soft Co., Ltd. — AVIEW (510k cleared)

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

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Mar 19, 2025device 510k516d agoCampomats S.R.L. — 1NEED Pro (510k cleared)

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

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Mar 19, 2025device 510k516d agoTyber Medical, LLC — Tyber Medical Anatomical Plating System (510k cleared)

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

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Mar 19, 2025device 510k516d agoShenzhen Yang WO Electronic Co., Ltd. — IPL Hair Removal Device (BE965A, BE965B, BE965C) (510k cleared)

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

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Mar 19, 2025device 510k516d agoPeek Health, S.A. — PeekMed web (510k cleared)

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

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Mar 19, 2025device 510k516d agoDRTECH Corporation — EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343NP; EXPD 3643N1; EXPD 3643N; EXPD 3643U1; EXPD 3643NU; EXPD 3643NP (510k cleared)

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

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Mar 19, 2025device 510k516d agoMacromedics BV — DSPS-Prominent® baseplate, MR (113820); DSPS-Prominent® baseplate (113120); DSPS-Prominent® Cradle-I (113140); DSPS-Prominent® Cradle-II (113150); DSPS-Prominent® Cradle-III (113160); DSPS-Prominent® Cradle-IV (113170); DSPS-Prominent® Cradle-VI (113180); DSPS-Prominent® Cradle-VII (113260); Mask DSPS®-PROSCVRL set/5 (113760); Mask DSPS®-PROSC set/5 (113770); Mask DSPS®-PROSCVR set/5 (113780); Mask DSPS®-PROSCL set/5 (113790); Mask DSPS®-PROSHVRL set/5 (113890); Mask DSPS®-PROSH set (510k cleared)

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

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Mar 19, 2025device 510k516d agoOlympus Medical Systems Corporation — Luer-Split MAJ-2092 (510k cleared)

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

full page →fda device 510k ↗

Mar 19, 2025device 510k516d agoTriMed, Inc. — TriMed Ankle Fixation System (510k cleared)

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

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Mar 19, 2025device 510k516d agoTriMed, Inc. — TriMed Elbow and Forearm System (510k cleared)

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

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Mar 19, 2025device 510k516d agoMustech Electronics Co., Limited — IPL Hair Removal Device (M8011, M8012, M8013, M8015, M8021, M8022, M8023, M8025, M7011, M7012, M7021, M7023) (510k cleared)

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

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Mar 19, 2025device 510k516d agoShenB Co., Ltd. — Sunny (510k cleared)

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

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Mar 19, 2025device 510k516d agoScivita Medical Technology Co., Ltd. — Broncho Videoscope System (Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P); Full HD Visualization Endoscopic Image Processor (HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D); Endoscopic Image Processor (HDVS-S100A, HDVS-S100D)) (510k cleared)NewBay Medical Technology Co Ltd

Product code: EOQ. Advisory committee: Ear, Nose, Throat. Type: Special

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Mar 19, 2025device 510k516d agoAcurable Limited — AcuPebble Ox (200) (510k cleared)

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

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Mar 19, 2025device 510k516d agoSafesource Direct, LLC — SafeSource Direct Blue Powder-Free Nitrile Exam Gloves (AMERI-TUFF Series 4000, AMERI-TOUCH Series 5000) (510k cleared)

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

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Mar 20, 2025approval515d agoBYLVAY (ODEVIXIBAT) — FDA approvalodevixibat

Sponsor: IPSEN. Form: CAPSULE. Route: ORAL

full page →odevixibat →fda approvals ↗

Mar 20, 2025approval515d agoTREMFYA (GUSELKUMAB) — FDA approvalguselkumab

Sponsor: JANSSEN BIOTECH. Form: INJECTABLE. Route: INJECTION

full page →guselkumab →fda approvals ↗

Mar 20, 2025device 510k515d agoHangzhou AGS MedTech Co., Ltd. — Endoscopic Water Pump (510k cleared)

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

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Mar 20, 2025device 510k515d agoHunan Haipuming Technology Co., Ltd. — HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens (HPM38) (510k cleared)

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

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Mar 20, 2025device 510k515d agoBoston Scientific — iSLEEVE Introducer Set (510k cleared)BOSTON SCIENTIFIC CORP

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

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Mar 20, 2025device 510k515d agoCardiovia , Ltd. — ViaOne Epicardial Access System (510k cleared)

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

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Mar 20, 2025device 510k515d agoDRTECH Corporation — EXPD 114; EXPD 114G; EXPD 114P; EXPD 114PG (510k cleared)

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

full page →fda device 510k ↗

Mar 20, 2025device 510k515d agoSpectrawave, Inc. — Starlight Imaging Catheter (510k cleared)

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

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Mar 20, 2025device 510k515d agoPixee Medical — Knee+ (510k cleared)

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

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Mar 20, 2025device 510k515d agoAvatar Medical — brAIn Shoulder Positioning (510k cleared)

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

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Mar 20, 2025device 510k515d agoRiverpoint Medical, LLC — RootMend MRR (510k cleared)

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

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Mar 20, 2025device 510k515d agoShenzhen TPH Technology Co., Ltd. — Ameda GLO Wearable Breast Pump (Model W8S) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

Product code: HGX. Advisory committee: Obstetrics/Gynecology. Type: Special

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Mar 20, 2025device 510k515d agoJoylux, Inc. — Joylux Intimacy Gel (PG3100) (510k cleared)

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

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Mar 20, 2025device 510k515d agoMeridian Bioscience, Inc. — Revogene (510k cleared)Meridian Corp

Product code: OOI. Advisory committee: Clinical Chemistry. Type: Traditional

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Mar 20, 2025device 510k515d agoKyocera Medical Technologies, Inc. — Tesera-k PL System and Tesera-k XL System (510k cleared)Medical Care Technologies Inc.

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

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Mar 20, 2025device 510k515d agoVent Creativity — Vent Creativity Knee v1.0 (Hermes) (510k cleared)

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

full page →fda device 510k ↗

Mar 21, 2025approval514d agoNURTEC ODT (RIMEGEPANT SULFATE) — FDA approvalrimegepant sulfate ODT

Sponsor: PFIZER. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

full page →rimegepant sulfate ODT →fda approvals ↗

Mar 21, 2025approval514d agoPREZCOBIX (COBICISTAT) — FDA approvalGILEAD SCIENCES, INC.

Sponsor: JANSSEN PRODS. Form: TABLET. Route: ORAL

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Mar 21, 2025approval514d agoOTULFI (USTEKINUMAB-AAUZ) — FDA approvalOTULFI

Sponsor: FRESENIUS KABI USA. Form: INJECTABLE. Route: INJECTION

full page →OTULFI →fda approvals ↗

Mar 21, 2025approval514d agoXTANDI (ENZALUTAMIDE) — FDA approvalenzalutamide

Sponsor: ASTELLAS. Form: TABLET. Route: ORAL

full page →enzalutamide →fda approvals ↗

Mar 21, 2025approval514d agoXTANDI (ENZALUTAMIDE) — FDA approvalenzalutamide

Sponsor: ASTELLAS. Form: CAPSULE. Route: ORAL

full page →enzalutamide →fda approvals ↗

Mar 21, 2025approval514d agoVYEPTI (EPTINEZUMAB-JJMR) — FDA approvalH. Lundbeck AS

Sponsor: Lundbeck Seattle BioPharmaceuticals, Inc.. Form: INJECTABLE. Route: INJECTION

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Mar 21, 2025approval514d agoVYEPTI (EPTINEZUMAB-JJMR) — FDA approvalH. Lundbeck AS

Sponsor: Lundbeck Seattle BioPharmaceuticals, Inc.. Form: INJECTABLE. Route: INJECTION

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Mar 21, 2025approval514d agoQULIPTA (ATOGEPANT) — FDA approvalatogepant

Sponsor: ABBVIE. Form: TABLET. Route: ORAL

full page →atogepant →fda approvals ↗

Mar 21, 2025device 510k514d agoAZmed — Rayvolve PTX-PE (510k cleared)

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

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Mar 21, 2025device 510k514d agoFresenius Medical Care Renal Therapies Group, LLC — FX CorAL 40 (F00009214); FX CorAL 50 (F00009215) (510k cleared)Fresenius Medical Care AG

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

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Mar 21, 2025device 510k514d agoSolar LS Cjsc — Medical Laser System Incanto / Evoline Platinum /Evoline (510k cleared)

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

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Mar 21, 2025device 510k514d agoErbe Elektromedizin GmbH — FiAPC plus probes (510k cleared)

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

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Mar 21, 2025device 510k514d agoPrismatik Dentalcraft, Inc. — Autoclavable Cassette (Glidewell HT Implant Guided Surgical Kit, Glidewell HT Implant Surgical Kit, Glidewell Prosthetic Kit) (510k cleared)

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

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Mar 21, 2025device 510k514d agoKico Knee Innovation Company Pty Limited — ARVIS Surgical Navigation System (510k cleared)

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

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Mar 21, 2025device 510k514d agoCytovale, Inc. — IntelliSep Test (CV-ICG-048) (510k cleared)

Product code: QUT. Advisory committee: Microbiology. Type: Special

full page →fda device 510k ↗

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