19 results
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32ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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