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FDA Daily

FDA daily for Tuesday, September 15, 2026

187 FDA records across 3 sections. 5 touch MedGrid's categories and are listed first.

187FDA Records
3 of 7Sections With Data
5Touch MedGrid Categories

Sections in This Issue

Drug shortagesCovers FDA's Mon, Sep 14 (yesterday)
Nothing from FDA for this date
Drug approvalsCovers FDA's Tue, Sep 8 (a week ago)
3
  • BRIVARACETAM

    BRIVARACETAM — ZHEJIANG JUTAI PHARM

    ANDA220136 · Original approval

  • IBRUTINIB

    IBRUTINIB — HETERO LABS LTD V

    ANDA211182 · Original approval

  • TRIAMCINOLONE ACETONIDE

    TRIAMCINOLONE ACETONIDE — MICRO LABS

    ANDA040671 · Labeling

Drug recallsCovers FDA's Tue, Sep 8 (a week ago)
Nothing from FDA for this date
Food and supplement recallsCovers FDA's Tue, Sep 8 (a week ago)
Nothing from FDA for this date
Device recallsCovers FDA's Tue, Sep 8 (a week ago)
Nothing from FDA for this date
Device clearancesCovers FDA's Tue, Sep 1 (two weeks ago)
1 touch MedGrid10
  • CO2 Laser System (MBT- CO2 Laser)Touches MedGrid categories

    Beijing Mega Beauty Technology Co., Ltd.

    K262269 · Substantially Equivalent · General, Plastic Surgery

  • AMI™ Plasma Cartridge, AMI™

    Sequitur Health Corp.

    K260613 · Substantially Equivalent · Clinical Chemistry

  • Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSi…

    GE Healthcare Finland Oy

    K260656 · Substantially Equivalent · Cardiovascular

  • Arthrex DynaNite Staples

    Arthrex, Inc.

    K262451 · Substantially Equivalent · Orthopedic

  • MAGNETOM Free.Max; MAGNETOM Free.Star

    Siemens Shenzhen Magnetic Resonance , Ltd.

    K260758 · Substantially Equivalent · Radiology

  • UNIDRIVE Select System

    Karl Storz SE & CO. KG

    K260884 · Substantially Equivalent · Gastroenterology, Urology

  • PRIMED Chemotherapy Drug Tested Gowns (PM4-99450: PRIMED Chemotherapy Drug Tested Isolation Gown, Purple, AAMI Level 2;…

    PRIMED Medical Products, Inc.

    K261811 · Substantially Equivalent · General, Plastic Surgery

  • Wearable breast pump (Model: XN/MD-2249BS, ZFHF)

    Guangdong Horigen Mother & Baby Products Co., Ltd.

    K262774 · Substantially Equivalent · Obstetrics/Gynecology

  • RadiForce MX247W

    Eizo Corporation

    K262783 · Substantially Equivalent · Radiology

  • SK Knee System

    Just Medical Devices (Tianjin) Co., Ltd.

    K253961 · Substantially Equivalent · Orthopedic

Label changesCovers FDA's Tue, Sep 1 (two weeks ago)
4 touch MedGrid174
  • Sunski Hot Block Mineral Sunscreen Stick SPF 50Touches MedGrid categories

    Stewart Charley Ventures LLC dba Sunski

    Label version 4

  • Gaimoa Lidocaine Pain Relief Gel PatchesTouches MedGrid categories

    Henan Enokon Medical Instrument Co., Ltd.

    Label version 1

  • Lidocaine CreamTouches MedGrid categories

    InvaDerm Corporation

    Label version 1

  • Lidocaine PhenylephrineTouches MedGrid categories

    YYBA CORP

    Label version 1

  • MEMANTINE HYDROCHLORIDE

    NCS HealthCare of KY, LLC dba Vangard Labs

    Label version 1

  • Gas Relief

    United Natural Foods, Inc. dba UNFI

    Label version 3

  • Ibuprofen

    Gobrands, Inc. (Goodnow)

    Label version 3

  • Drug label

    Label version 8

  • PREDNISONE

    REMEDYREPACK INC.

    Label version 5

  • topiramate

    REMEDYREPACK INC.

    Label version 4

  • Terramed Just Think Comfort Hydrocortisone 1% Cream

    Rida LLC

    Label version 1

  • gentle lax

    Kroger Company

    Label version 13

Showing 12 of 174. Search the rest in openFDA.

How the FDA Daily Is WrittenSources, dates and what gets flagged

Every issue is written from FDA's public data (openFDA) and nothing else: the counts, names, firms and reasons are FDA's own. openFDA posts each kind of record on its own delay, so each section covers one FDA date and says which. Shortages cover yesterday; approvals, drug recalls, device recalls and food and supplement recalls cover a week ago; device clearances and label changes cover two weeks ago. Every FDA date appears in exactly one issue. Items that touch the categories MedGrid works in, such as GLP-1s, hormones, injectables, peptides, compounded products and aesthetic devices, are marked and listed first.

Subscribe with any feed reader, or point an email tool at theRSS feed. For the rules behind the headlines, see Regulations Research.

Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.