8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MiniGuard Arterial Safety Valve
FDA 510(k)
FDA Class 2
·Cardiovascular
OsteoMed
FDA UDI
OSTEOMED LLC·00842528127933·2.4 X 42mm Cannulated Headed Screw, T7
E.S.O. (ELECTRO SENSOR OXI)
FDA 510(k)
FDA Class 2
·Cardiovascular
MODIFICATION TO MICROFUSE BONE VOID FILLER
FDA 510(k)
FDA Class 2
·Orthopedic
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 17, 2014
HEARTSTART MRX - EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 11, 2013
SERIES 7000 STANDARD TIBIA
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code JWH·July 19, 2011
CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000.
FDA Enforcement
Class II
·Terminated·Cardiovascular Systems Inc·May 31, 2017