18 results · 26ms · Sources: EU EUDAMED, US FDA

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3M Attest Super Rapid Readout Biological Indicator, 3M Attest Auto-reader, 3M Attest Auto-reader

FDA 510(k)
FDA Class 2 ·General Hospital

ENVISEN NELLCOR, BCI, NONIN, CSI, HP/PHILIPS, DATEX-OHMEDA COMPATIBLE DISPOSABLE AND REUSABLE SPO2 SENSORS

FDA 510(k)
FDA Class 2 ·Cardiovascular

PRESSUREWIRE CERTUS, CERTUS 300, AERIS, AERIS 300, AND RECEIVER

FDA 510(k)
FDA Class 2 ·Cardiovascular

OPTICROSS HD

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·March 28, 2025

OPTICROSS? HD

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·July 7, 2025

OPTICROSS? HD

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·July 22, 2025

OPTICROSS? HD

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·February 11, 2025

OPTICROSS? HD

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·April 3, 2025

OPTICROSS? HD

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·December 11, 2025

OPTICROSS? HD

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·September 16, 2025

PATIENT INFORMATION CENTER IX

FDA Adverse Event
Death ·PHILIPS MEDICAL SYSTEMS·Product code MHX·October 6, 2023

OPTICROSS? HD

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·January 13, 2026

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·June 17, 2013

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 23, 2011

FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE·Product code FRN·September 25, 2008

BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code FOZ·November 2, 2022

OPTICROSS? HD

FDA Adverse Event
Death ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·May 22, 2025

OPTICROSS? HD

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·February 26, 2025