19 results · 32ms · Sources: EU EUDAMED, US FDA

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Aero Blue Performance Surgical Gowns

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)

FDA 510(k)
FDA Class 1 ·General Hospital

SLEEPWEAVER NASAL CPAP MASK

FDA 510(k)
FDA Class 2 ·Anesthesiology

INTELLAMAP ORION?

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·May 12, 2026

INTELLAMAP ORION

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·April 15, 2025

INTELLAMAP ORION

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·April 29, 2026

INTELLAMAP ORION?

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·April 17, 2026

TELESCOPE, 10 MM, 0°, QUICK LOCK, AUTOCLAVABLE

FDA Adverse Event
Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code HET·October 31, 2023

QUICKFLEX MICRO LV LEAD

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL, INC. CRMD·Product code NIK·January 11, 2014

OT ULTRAMINI METER

FDA Adverse Event
Injury ·LIFESCAN INC.·Product code NBW·August 4, 2011

POLARIS? ULTRA

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code FAD·June 27, 2013

TELESCOPE, 10 MM, 30°, HD, QUICK LOCK, AUTOCLAVABLE

FDA Adverse Event
Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code EWY·June 5, 2023

INTELLAMAP ORION?

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·January 30, 2026

INTELLAMAP ORION?

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·April 1, 2026

INTELLAMAP ORION

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·November 21, 2024

INTELLAMAP ORION?

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·February 26, 2026

INTELLAMAP ORION

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·December 12, 2024

ZOLL IVTM COOL LINE CATHETER

FDA Adverse Event
Malfunction ·ZOLL CIRCULATION INC·Product code NCX·April 22, 2024

cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

FDA Enforcement
Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014