11 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BTL-899MS
FDA 510(k)
FDA Class 2
·Physical Medicine
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772777518·LUMBAMED PLUS FLEX PAD M SILVER IV
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772777662·LUMBAMED BASIC DORSAL STAYS M SILVER IV
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·00636257125854·30-40 MV FOR MEN CLSC CALF STD GREY IV
ASPIRON ACP SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
LASERPRO CO2 CARBON DIOXIDE LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 10, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 9, 2011
BIOPSY FORCEPS
FDA Adverse Event
Other
·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code KNW·July 16, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013