FDA daily for Thursday, February 27, 2025
In this issue: 3 approvals, 28 device recalls, 19 device decisions and 103 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.
- Azurion 7 B12; Catalog numbers: (1) 722067, (2) 722225, (3) 722235 (OUS ONLY).
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Possibility of the patient falling from the table related to the mattress used on the patient table.
- FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette
Assure Tech., LLC · Clinical Chemistry
- DreamBeam Sunscreen Sunlit
SUNSCREEN ZINC OXIDE · Kosas Cosmetics, LLC · TOPICAL
Drug and biologic approvals
FDA date:On Thu, Feb 20 FDA approved 2 new applications (0 brand or biologic, 2 generic) and 1 supplement to existing ones.
- SELENIOUS ACID
SUN PHARM · SELENIOUS ACID
- IBUPROFEN AND FAMOTIDINE
ZYDUS LIFESCIENCES · FAMOTIDINE, IBUPROFEN
Device recalls
FDA date:FDA posted 28 device recalls from 4 firms on Thu, Feb 20.
- Azurion 7 B12; Catalog numbers: (1) 722067, (2) 722225, (3) 722235 (OUS ONLY).
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Possibility of the patient falling from the table related to the mattress used on the patient table.
- Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Possibility of the patient falling from the table related to the mattress used on the patient table.
- Allura Xper FD10/10; Catalog numbers: (1) 722005, (2) 722011, (3) 722027.
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Possibility of the patient falling from the table related to the mattress used on the patient table.
- Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Possibility of the patient falling from the table related to the mattress used on the patient table.
- Allura Xper FD20 Biplane; Catalog numbers: (1) 722008, (2) 722013.
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Possibility of the patient falling from the table related to the mattress used on the patient table.
- Allura Xper FD20 Biplane OR Table; Catalog numbers: (1) 722020, (2) 722025.
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Possibility of the patient falling from the table related to the mattress used on the patient table.
- Allura Xper FD20 OR Table; Catalog numbers: (1) 722023, (2) 722035.
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Possibility of the patient falling from the table related to the mattress used on the patient table.
- Allura Xper FD20/10; Catalog numbers: 722029
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Possibility of the patient falling from the table related to the mattress used on the patient table.
- Allura Xper FD20/15; Catalog numbers: 722058
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Possibility of the patient falling from the table related to the mattress used on the patient table.
- Allura Xper FD20/20; Catalog numbers: 722038
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Possibility of the patient falling from the table related to the mattress used on the patient table.
- Allura CV20; Catalog numbers: 722031
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Possibility of the patient falling from the table related to the mattress used on the patient table.
- Allura Xper FD10C; Catalog number: 722001
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Possibility of the patient falling from the table related to the mattress used on the patient table.
Device clearances and approvals
FDA date:FDA decided 11 510(k)s and 8 PMA decisions on Thu, Feb 13, including 1 original PMA.
- EVOLYSSE SMOOTH and EVOLYSSE FORM
Symatese · Implant, dermal, for aesthetic use · General, Plastic Surgery
- FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette
Assure Tech., LLC · Clinical Chemistry
- Penumbra System (Reperfusion Catheter RED 72)
Penumbra, Inc. · Cardiovascular
- Body Temperature Software (BTS)
Fitbit, LLC · General Hospital
- Aptima SARS-CoV-2 Assay
Hologic, Inc. · Microbiology
- AH Plus Endodontic Sealer
Dentsply Sirona, Inc. · Dental
- Newclip Patient-matched instrumentation non sterile PSI
Newclip Technics · Orthopedic
- Freedom® Total Knee System - Porous Tibial Base Plate
Maxx Orthopedics, Inc. · Orthopedic
- Integrated Endo System (Meet Endo-II)
Denjoy Dental Co., Ltd. · Dental
- EDEN ControlCath
Jmt Co., Ltd. · Anesthesiology
- Ampa One System (AMPA-001)
Neuromodulatory Devices & Applications · Neurology
- Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System (Unicorn+ II); Unicorn+ RF System (Unicorn+ III)
Boston Aesthetics, Inc. · General, Plastic Surgery
Label updates
FDA date:103 drug labels took effect on Thu, Feb 13; 3 of the 25 read for this issue are for products in MedGrid's categories. Below: those, and labels carrying a boxed warning.
- DreamBeam Sunscreen Sunlit
SUNSCREEN ZINC OXIDE · Kosas Cosmetics, LLC · TOPICAL
- Revealer Skin-Improving Foundation
SUNSCREEN ZINC OXIDE · Kosas Cosmetics, LLC · TOPICAL
- Tramadol Hydrochloride
TRAMADOL HYDROCHLORIDE · Advanced Rx of Tennessee, LLC · 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.
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