9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CardiMax Electrocardiograph
FDA 510(k)
FDA Class 2
·Cardiovascular
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814299·GENUMEDI PT SILVER R VI
Novo Surgical Inc.
FDA UDI
NOVO SURGICAL, INC.·00842331128981·adson thumb forceps, standard pattern, tissue f...
CINCH KNOTLESS FIXATION IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
STERILIZATION MATS
FDA 510(k)
FDA Class 2
·General Hospital
BIVONA CUSTOM TTS FLEXTEND TRACHEOSTOMY TUBE
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code JOH·June 6, 2013
COGNIS
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·July 23, 2011
COLLEAGUE VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 25, 2008
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