FDA daily for Thursday, June 6, 2024
In this issue: 23 approvals, 12 device recalls, 34 device decisions and 85 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.
Drug and biologic approvals
FDA date:On Thu, May 30 FDA approved no new applications and 23 supplements to existing ones.
- TOPIRAMATE
AJANTA PHARMA LTD · TOPIRAMATE
- INDOMETHACIN SODIUM
HOSPIRA · INDOMETHACIN SODIUM
- POTASSIUM CITRATE
RISING · POTASSIUM CITRATE
- ALCAINE
ALCON LABS INC · PROPARACAINE HYDROCHLORIDE
- FINGOLIMOD HYDROCHLORIDE
ACCORD HLTHCARE · FINGOLIMOD HYDROCHLORIDE
- LISINOPRIL
HERITAGE PHARMA · LISINOPRIL
Device recalls
FDA date:FDA posted 12 device recalls from 4 firms on Thu, May 30.
- 20 Gauge V-Lance Knife Model/Catalog Number: 8065912001 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
Alcon Research LLC · Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Corneal/Scleral V-Lance Ophthalmic…
- ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065921541 Software Version: N/A Product Description: Ophthalmic Knif…
Alcon Research LLC · Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Corneal/Scleral V-Lance Ophthalmic…
- ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Model/Catalog Number: 8065771540 Software Version: N/A Product Description: Ophthalmic Kn…
Alcon Research LLC · Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Corneal/Scleral V-Lance Ophthalmic…
- ClearCut S Safety Sideport Knife 1.2mm Dual Bevel Model/Catalog Number: 8065771541 Software Version: N/A Product Description: Ophthalmic Kn…
Alcon Research LLC · Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Corneal/Scleral V-Lance Ophthalmic…
- Philips Interventional Hemodynamic Application R.1.2X, R.1.3.0, R1.2.1. Software that enables invasive investigation of cardiac and vascula…
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Potential for pressure wave data synchronization from two devices may not be correct.
- BD Pyxis MedStation ES, REF: 323, Medication Cabinet
CareFusion 303, Inc. · Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
- BD Pyxis MedStation 4000 System, REF: 303, Medication Cabinet
CareFusion 303, Inc. · Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
- BD Pyxis" MedStation ES 7-Drawer Auxiliary Tower, REF: 324
CareFusion 303, Inc. · Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
- BD Pyxis MedStation 4000 7-Drawer Auxiliary Tower, REF: 306
CareFusion 303, Inc. · Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
- BD Pyxis" Anesthesia Station ES, REF: 327
CareFusion 303, Inc. · Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
- BD Pyxis(TM) Anesthesia Station 4000, REF: 338
CareFusion 303, Inc. · Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
- RefleXion X1 Radiotherapy System Model RXM1000 Software version 2.1.19-3 Radiation therapy system is a device that combines the functionali…
Reflexion Medical, Inc. · A potential dose error exists for patients treated with an out of session SCINTIX partial fraction.
Device clearances and approvals
FDA date:FDA decided 11 510(k)s and 23 PMA decisions on Thu, May 23.
- 3M ActiV.A.C. Canister - 300ml with Gel (M8275058/5, M8275058/10)
Kci USA, Inc. · General, Plastic Surgery
- NOxBOXi Nitric Oxide Delivery System
Linde Gas & Equipment, Inc. · Anesthesiology
- Syngo Carbon Enterprise Access (VA40A)
Siemens Healthcare GmbH · Radiology
- dima Print Teeth & Temp
Kulzer, LLC · Dental
- VinDr-Mammo
Vinbigdata Joint Stock Company · Radiology
- 3DMatrix Surgical Mesh
Printbio, Inc. · General, Plastic Surgery
- CamAPS FX
Camdiab , Ltd. · Clinical Chemistry
- Drill Guide; Drill Bit; Spine & Trauma Navigation
Brainlab AG · Neurology
- uCerv Flux-C 3D Porous Titanium Cervical Interbody
Ulrich Medical USA, Inc. · Orthopedic
- AirKEE T900
Healkee Medical Pte, Ltd. · General Hospital
- CWM-930S, FIXER DV9
Chungwoo Co., Ltd. · General, Plastic Surgery
Label updates
FDA date:85 drug labels took effect on Thu, May 23; 2 of the 25 read for this issue are for products in MedGrid's categories. Below: those, and labels carrying a boxed warning.
- Lisinopril and Hydrochlorothiazide
LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS · Bryant Ranch Prepack · ORAL
- venlafaxine
VENLAFAXINE · Bryant Ranch Prepack · 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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