15 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C)
FDA 510(k)
FDA Class 2
·Neurology
Wet-Field® Eraser®
FDA UDI
Beaver-Visitec International, Inc.·30886158010488·18 GA Blunt Tip
Medetz Surgical Instruments
FDA UDI
Medetz Surgical Instruments LLC·G22312212510·Lieberman Microfinger & Spatula DBL-Ended Liebe...
ICEROD CX CRYOABLATION NEEDLE ICEROD CX CRYOABLATION NEEDLE MULTIPACK
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ST/AR ST AND ARRHYTHMIA SOFTWARE, RELEASE E.I.
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 13, 2025
MURANAKA SURGICAL MARKING PEN W;/RULER AND 6-UP LABELS, STERILE
FDA Adverse Event
Malfunction
·ASPEN SURGICAL PRODUCTS, CALEDONIA·Product code FZZ·June 28, 2021
CODMAN EXTERNAL DRAINAGE SYSTEM III
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF, INC./ MEDOS S.A.·Product code JXG·November 5, 2008
GORE EXCLUDER AAA ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MIH·August 17, 2011
ACCU-CHEK ® SPIRIT COMBO
FDA Adverse Event
Malfunction
·ROCHE HEALTH SOLUTIONS, INC.·Product code LZG·July 11, 2013
CD HORIZON® SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code LXH·March 5, 2026
CD HORIZON® SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code LXH·February 25, 2026
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FDA Adverse Event
Malfunction
·SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.·Product code FPA·June 1, 2007
BVI Wet -Field Eraser, 18GA Blunt Tip, 45Deg.-Intended to remove tissue and control bleeding by the use of high frequency electrical current Part Number: 221251
FDA Enforcement
Class II
·Ongoing·Beaver Visitec International, Inc.·June 29, 2022
BVI Wet -Field Eraser, 18GA Blunt Tip, 45Deg.-Intended to remove tissue and control bleeding by the use of high frequency electrical current Part Number: 221251
FDA Recall
Open, Classified
·Beaver Visitec International, Inc.·Product code GEI·April 26, 2022