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Week of Apr 21, 2025

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Apr 23, 2025recall483d agoThe Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recall (Cls II)Fosun Pharma USA Inc

ChlorproMAZINE Hydrochloride Tablets, USP, 10 mg, packaged in cartons of 100 TABLETS (10x10), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7129-61 — Reason: CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit — Status: Ongoing

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Apr 23, 2025device 510k483d agoHycor Biomedical — NOVEOS Specific IgE (sIgE) Assay; Capture Reagent G010, Johnson Grass (Sorghum halepense); Capture Reagent T007, Oak (Quercus alba) ; Capture Reagent G002, Bermuda Grass (Cynodon dactylon); Capture Reagent W001, Common Ragweed (Ambrosia artemisiifolia); Capture Reagent E005, Dog Dander (Canis familiaris); Capture Reagent T003, Common Silver Birch (Betula verrucosa); Capture Reagent F001, Egg White (Gallus gallus); Capture Reagent F002, Cow's Milk (Bos taurus); NOVEOS Immunoassay Analyz (510k cleared)Dawn Sea Therapeutics

Product code: DHB. Advisory committee: Immunology. Type: Traditional

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Apr 23, 2025device 510k483d agoShenzhen Kingboom Technology Co., Ltd. — Electric Nasal Aspirator (BC026, BC025, BC023) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

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Apr 23, 2025device 510k483d agoMedacta International S.A. — Mpact 3D Metal Augments II (510k cleared)Stemedica International S.A.

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

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Apr 23, 2025device 510k483d agoSofradim Production — Parietene Macroporous Mesh (PPM5050 ) (510k cleared)

Product code: FTL. Advisory committee: General, Plastic Surgery. Type: Special

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Apr 23, 2025device 510k483d agoNewclip Technics — Xpert Knee (510k cleared)

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

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Apr 23, 2025device 510k483d agoGmp Medicare Sdn. Bhd. — Nitrile Powder Free Examination Glove, Blue Tested for Use with 60 Chemotherapy Drugs, Gastric Acid, Xylazine and Fentanyl (510k cleared)NutriBand Inc.

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

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Apr 23, 2025device 510k483d agoLEM Surgical AG — Dynamis Robotic Surgical System (510k cleared)

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

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Apr 23, 2025device 510k483d agoEsonic Technology (Wuhan) Co., Ltd. — eHertz Functional Series Diagnostic Ultrasound System (eHertz C, eHertz E, eHertz R, eHertz S) (510k cleared)

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

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Apr 23, 2025device 510k483d agoAnnalise-Ai — Annalise Enterprise (510k cleared)

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

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Apr 23, 2025device 510k483d agoSonavex, Inc. — EchoGuide (Version 1) (510k cleared)

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

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Apr 23, 2025device 510k483d agoLaon Medi, Inc. — Laon Ortho (510k cleared)

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

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Apr 23, 2025device 510k483d agoMedacta International S.A. — MySpine WebPlanner (510k cleared)Stemedica International S.A.

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

full page →fda device 510k ↗

Apr 24, 2025approval482d agoALEVE (NAPROXEN SODIUM) — FDA approvalNAPROXEN SODIUM

Sponsor: BAYER. Form: TABLET. Route: ORAL

full page →NAPROXEN SODIUM →fda approvals ↗

Apr 24, 2025device 510k482d agoSurGenTec, LLC — ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) (510k cleared)

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

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Apr 24, 2025device 510k482d agoFreespira, Inc. — Freespira Breathing System (510k cleared)

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

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Apr 24, 2025device 510k482d agoShenzhen AOJ Medical Technology Co., Ltd. — Arm Blood Pressure Monitor (ARM-30H); Arm Blood Pressure Monitor (ARM-30J); Arm Blood Pressure Monitor (ARM-30K); Arm Blood Pressure Monitor (ARM-90B) (510k cleared)NewBay Medical Technology Co Ltd

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

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Apr 24, 2025device 510k482d agoShenzhen Rogin Medical Co., Ltd. — Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO) (510k cleared)

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

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Apr 24, 2025device 510k482d agoIvylaser (Beijing) Technology Co.,Ltd — Diode laser system (Night Universe; Predator) (510k cleared)

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

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Apr 24, 2025device 510k482d agoZhuozhou Summer Star Technologies Co., Ltd. — CO2 Laser System (CO2 Laser SST-L23) (510k cleared)

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

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Apr 24, 2025device 510k482d agoGo-Pen Aps — GO-PEN® (510k cleared)

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

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Apr 24, 2025device 510k482d agoMentor Worldwide, LLC — MENTOR PliaForm Breast Tissue Expander w/ Suture Tabs (510k cleared)

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

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Apr 24, 2025device 510k482d agoIntuitive Surgical, Inc. — da Vinci SP Surgical System (SP1098) (510k cleared)INTUITIVE SURGICAL INC

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

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Apr 24, 2025device 510k482d agoSound Health Systems, Inc. — Sonu (510k cleared)Tivic Health Systems, Inc.

Product code: QZC. Advisory committee: Ear, Nose, Throat. Type: Traditional

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Apr 24, 2025device 510k482d agoCirca Scientific, Inc. — PeriCross Epicardial Access Kit (510k cleared)Clear Scientific Inc

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

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Apr 24, 2025device 510k482d agoLife Spark Medical, LLC — Smart Check O2 (MA0236) (510k cleared)

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

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Apr 24, 2025device 510k482d agoCanwell Medical Co., Ltd. — CanMINI Hand and Foot System (510k cleared)

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

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Apr 24, 2025device 510k482d agoExo, Inc. — Lung AI (LAI001) (510k cleared)

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

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Apr 25, 2025approval481d agoLAMICTAL ODT (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

full page →LAMOTRIGINE →fda approvals ↗

Apr 25, 2025approval481d agoLAMICTAL ODT (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

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Apr 25, 2025approval481d agoLAMICTAL (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

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

full page →LAMOTRIGINE →fda approvals ↗

Apr 25, 2025approval481d agoLAMICTAL (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

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

full page →LAMOTRIGINE →fda approvals ↗

Apr 25, 2025approval481d agoLAMICTAL CD (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET, FOR SUSPENSION. Route: ORAL

full page →LAMOTRIGINE →fda approvals ↗

Apr 25, 2025approval481d agoLAMICTAL CD (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET, FOR SUSPENSION. Route: ORAL

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Apr 25, 2025approval481d agoLAMICTAL XR (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →LAMOTRIGINE →fda approvals ↗

Apr 25, 2025approval481d agoLAMICTAL XR (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →LAMOTRIGINE →fda approvals ↗

Apr 25, 2025device 510k481d agoMicroaire Surgical Instruments, LLC — PAL 7020 Console (510k cleared)

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

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Apr 25, 2025device 510k481d agoMako Surgical Corp. — Mako Total Knee Application (3.0); Hybrid Tip Pointer (510k cleared)

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

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Apr 25, 2025device 510k481d agoCardio Flow Inc., — FreedomFlow Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration) (510k cleared)

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

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Apr 25, 2025device 510k481d agoVarian Medical Systems — Intracavitary/Interstitial System (510k cleared)

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

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Apr 25, 2025device 510k481d agoPromethean Restorative, LLC — DYNAMIS Implant System (510k cleared)

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

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Apr 25, 2025device 510k481d agoEchoNous, Inc. — Kosmos (510k cleared)

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

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Apr 25, 2025device 510k481d agoWellmed Dental Medical Supply Co., Ltd. — Self Sealing Sterilization Pouches (510k cleared)

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

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Apr 25, 2025device 510k481d agoSorin Group Italia S.R.L. — DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14) (510k cleared)

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

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Apr 25, 2025device 510k481d agoA.M.I. Agency For Medical Innovations GmbH — i-Cut (510k cleared)

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

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Apr 25, 2025device 510k481d agoRoche Molecular Systems, Inc. — cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test (510k cleared)

Product code: QOF. Advisory committee: Microbiology. Type: Dual Track

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Apr 25, 2025device 510k481d agoBhm-Tech Produktionsgesellschaft Mbh — contact forte Alpha (510k cleared)

Product code: LXB. Advisory committee: Ear, Nose, Throat. Type: Traditional

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Apr 25, 2025device 510k481d ago4Web Medical — Cervical Spine Truss System (CSTS) (510k cleared)

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

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Apr 25, 2025device 510k481d agoRoche Molecular Systems, Inc. — cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test (510k cleared)

Product code: QOF. Advisory committee: Microbiology. Type: Dual Track

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Apr 25, 2025device 510k481d agoMerit Medical Systems, Inc. — Prelude Wave Hydrophilic Sheath Introducer (510k cleared)MERIT MEDICAL SYSTEMS INC

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

full page →fda device 510k ↗

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