FDA daily for Monday, September 14, 2026
In this issue: 15 device decisions and 195 label changes. 2 items touch categories MedGrid carries, and they come first.
For MedGrid's categories
Items in this issue that name a product category sold on MedGrid. Each links to its full FDA record; the chip opens that category's federal and state rules.
Device clearances and approvals
FDA date:FDA decided 10 510(k)s and 5 PMA decisions on Mon, Aug 31.
- Lipipor NLF1A Infusion Filter, Lipipor NLF2A & NLF2NTA Infusion Filters, Lipipor TNA2A Infusion Filter
Global Life Sciences Solutions USA, LLC · General Hospital
- Nova HD+
Aura Wellness, LLC · Physical Medicine
- MULTIX Impact; MULTIX Impact C
Siemens Medical Solutions USA, Inc. · Radiology
- ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0
Abbott Diagnostics Scarborough, Inc. · Microbiology
- SYNERJET PRO (SP-1003); InPhiuse (SP-1003); WOWJET (SP-1003)
Hironic Co., Ltd. · Neurology
- Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty Device A-902; Facial Mask LED & EMS Beauty Device A-907)
Kam Yuen Plastic Products , Ltd. · General, Plastic Surgery
- Automatic Digital Blood Pressure monitor (LD-526)
Honsun (Nantong) Co., Ltd. · Cardiovascular
- Aerloom
Evolym, LLC · Cardiovascular
- Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)
Guilin Kevin Peter Technology Co., Ltd. · Dental
- EZFluence (RADEZ V2)
Radformation, Inc. · Radiology
Label updates
FDA date:195 drug labels took effect on Mon, Aug 31; 5 of the 25 read for this issue are for products in MedGrid's categories. Below: those, and labels carrying a boxed warning.
- Sildenafil
SILDENAFIL · Preferred Pharmaceuticals, Inc. · ORAL
- Procainamide Hydrochloride
PROCAINAMIDE HYDROCHLORIDE · REMEDYREPACK INC. · INTRAMUSCULAR, INTRAVENOUS
- Morphine Sulfate
MORPHINE SULFATE · Fresenius Kabi, USA LLC · INTRAMUSCULAR, INTRAVENOUS
FDA did not answer for Food and supplement recalls, Device recalls, Approvals, Drug recalls, Drug shortages while this issue was written; those sections will fill in on a later visit.
How the FDA daily is written
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 and 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. Complete response letters appear the day after FDA publishes a batch.
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