FDA daily for Monday, February 24, 2025
In this issue: 18 device decisions and 184 label changes. 4 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.
- Philips Lumea IPL
Philips Consumer Lifestyle B.V. · General, Plastic Surgery
- Myolight Microcurrent Handpiece
Raja Trading Company, Inc. · Neurology
Device clearances and approvals
FDA date:FDA decided 10 510(k)s and 8 PMA decisions on Mon, Feb 10.
- Philips Lumea IPL
Philips Consumer Lifestyle B.V. · General, Plastic Surgery
- Myolight Microcurrent Handpiece
Raja Trading Company, Inc. · Neurology
- Locking Plates and Screws Systems
Hebei Ruihe Medical Devices Co., Ltd. · Orthopedic
- Remi Custom Night Guard
Grindguard, Inc. · Unknown
- Ultrasound Workspace (UWS 6.0)
Philips Ultrasound, LLC · Radiology
- OTC TENS & EMS Unit
Changsha Anxiang Medical Technology Co., Ltd. · Physical Medicine
- Calcium2
Abbott Ireland · Clinical Chemistry
- BTL-398
BTL Industries, Inc. · Gastroenterology, Urology
Label updates
FDA date:184 drug labels took effect on Mon, Feb 10; 5 of the 25 read for this issue are for products in MedGrid's categories. Below: those, and labels carrying a boxed warning.
- Beeswax SPF 15 Broad Spectrum Lip Balm
BEESWAX SPF 15 BROAD SPECTRUM LIP BALM · Raining Rose, Inc · TOPICAL
- Sunitinib Malate
SUNITINIB MALATE · Novadoz Pharmaceuticals LLC · ORAL
- Quetiapine Fumarate
QUETIAPINE FUMARATE · Hikma Pharmaceuticals USA Inc. · ORAL
- Ibuprofen
IBUPROFEN · Brisk Pharmaceuticals · ORAL
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.
Subscribe with any feed reader, or point an email tool at the RSS feed to send each issue as a newsletter. Search any drug, device or company across every FDA dataset in the FDA data explorer.
