FDA daily for Tuesday, July 28, 2026
In this issue: 1 shortage update and 14 device decisions.
Drug shortages
FDA date:FDA updated 1 shortage entry on Mon, Jul 27: 1 new, 1 to be discontinued.
Device clearances and approvals
FDA date:FDA decided 8 510(k)s and 6 PMA decisions on Tue, Jul 14.
- VisuBreath
Affirm Medical Technologies II, LLC · Anesthesiology
- Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System
Alphatec Spine, Inc. · Orthopedic
- Symmetrix L Spinal System
Medtronic Sofamor Danek USA, Inc. · Orthopedic
- Universal Seal (5-12 mm)
Intuitive Surgical, Inc. · Gastroenterology, Urology
- Accoat Guide Wire
Sp Medical A/S · Cardiovascular
- LIXI (LXOSFM1)
Luwi, LLC · Obstetrics/Gynecology
- IERO Mobility Scooter (IERO-01)
Jochu Technology Co., Ltd. · Physical Medicine
FDA did not answer for Drug recalls, Labels, Approvals, Device recalls, Food and supplement recalls 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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