FDA daily for Tuesday, March 11, 2025
In this issue: 7 approvals, 3 device recalls, 23 device decisions and 86 label changes. 3 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.
- METHYLENE BLUE
ZYDUS LIFESCIENCES · METHYLENE BLUE
Drug and biologic approvals
FDA date:On Tue, Mar 4 FDA approved 2 new applications (0 brand or biologic, 2 generic) and 5 supplements to existing ones.
- SOLIFENACIN SUCCINATE
TORRENT · SOLIFENACIN SUCCINATE
- ERIBULIN MESYLATE
CHIA TAI TIANQING · ERIBULIN MESYLATE
- METHYLENE BLUE
ZYDUS LIFESCIENCES · METHYLENE BLUE
Device recalls
FDA date:FDA posted 3 device recalls from 2 firms on Tue, Mar 4.
- MIM software; System, Image Processing, Radiological
MIM Software Inc · In situations where two images with differing Fields of View (FOV) complete an image fusion, an incorrect, elevated Maximum Standardized Uptake Value (SUV) wit…
- CircuitGuard ThermoFlo Filter -Combined Heat and Moisture Exchanger, Bacterial Viral Filter w O2 Port and Elbow (Model/Catalogue number: SK…
Kung Shin Plastics Co. Ltd. · The machine side connector of the filter HME may be occluded by plastic which prevents proper airflow. The issue may lead to ventilation bag malfunction in whi…
- CircuitGuard Bacterial/Viral Filter with Elbow (Model/Catalogue number: SK200FPE / 7056)
Kung Shin Plastics Co. Ltd. · The machine side connector of the filter HME may be occluded by plastic which prevents proper airflow. The issue may lead to ventilation bag malfunction in whi…
Device clearances and approvals
FDA date:FDA decided 9 510(k)s and 14 PMA decisions on Tue, Feb 25.
- BruxZir® Esthetic NOW
Prismatik Dentalcraft, Inc. · Dental
- Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)
Taiwan Aulisa Medical Devices Technologies, Inc. · Cardiovascular
- Loss of Pulse Detection
Fitbit · Cardiovascular
- ART-Plan+ (v.3.0.0)
Therapanacea Sas · Radiology
- EMS (FlexPulse, MagnaCore, Magnetika)
Cpmt Laser (Canadian Pioneer Medical Technology Corporation) · Physical Medicine
- WasherCap Fixation System
Abanza Tecnomed S.L · Orthopedic
- JLK-AILink
JLK, Inc. · Radiology
- 3DXR
GE Medical Systems SCS · Radiology
Label updates
FDA date:86 drug labels took effect on Tue, Feb 25; 3 of the 25 read for this issue are for products in MedGrid's categories. Below: those, and labels carrying a boxed warning.
- Sun Defense Minerals (Tan)
ZINC OXIDE, TITANIUM DIOXIDE · Eminence Organic Skin Care · TOPICAL
- NORETHINDRONE
NORETHINDRONE · Lupin Pharmaceuticals, Inc. · ORAL
- Duloxetine D/R
DULOXETINE D/R · Direct_Rx · 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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