19 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Digital Blood Pressure Monitor WBP Series
FDA 510(k)
FDA Class 2
·Cardiovascular
NEUTROPHASE(R) SKIN AND WOUND CLEANSER OTC
FDA 510(k)
FDA Unclassified
·Unknown
Arthrex Eclipse Shoulder Prosthesis System
FDA 510(k)
FDA Class 2
·Orthopedic
ADVANTAGE FIT ULTRA SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·November 7, 2025
ADVANTAGE FIT ULTRA SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·January 9, 2026
ADVANTAGE FIT ULTRA SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·January 9, 2026
ADVANTAGE FIT ULTRA SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·May 23, 2025
ADVANTAGE FIT ULTRA SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·March 25, 2026
ADVANTAGE FIT ULTRA SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·October 28, 2025
LYNX ULTRA SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·December 12, 2025
LYNX ULTRA SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·September 4, 2025
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 21, 2025
RESTORE ULTRA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·July 9, 2014
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FRN·November 18, 2008
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·July 22, 2011
CHARGING SYSTEM
FDA Adverse Event
Injury
·ST JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 12, 2013
ADVANTAGE FIT ULTRA SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·April 15, 2026
Revogene, Catalog no. 610210. IVD test instrument
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·August 3, 2022
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022