BRXClass I

Stool, Anesthesia

Anesthesiology · 21 CFR 868.6700

MDR events1All time

Recalls1All time

Registered firms2Currently listed

510(k) clearances1All time

Recent MDR events

1 adverse event reports on file

RELIANCE 546 STOOLJul 22, 2009
InjuryReliance Medical Products1523545-2009-00001

Event type breakdown

Injury1

Most-reported manufacturers

Reliance Medical Products1

Recalls

1 recall events for this product code

Gk Photonics Inc
Open, ClassifiedUnknown
Spectrum Laser Projection Series
The User Remote Interlock Dongle provided with the E-Stop Remote is not sufficient to fully comply with the FDA's Manual Reset Mechanism requirement for laser projectors and could unintentionally expose the user and/or observers to high power laser radiation. It needs to be replaced for safety reasons.
Z-2094-2019 · View FDA record ↗

Registered firms

2 firms currently registered for this product code

510(k) clearances

1 clearances for this product code

3M Health Care, Ltd.Dec 23, 1992
K924487 · RED DOT 2515 CARDIAC SENSOR SYSTEM