9 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PROMETEY, MODEL G1-03
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TomoTherapy Treatment Delivery System with iDMS
FDA UDI
ACCURAY INCORPORATED·M65810620710·TomoTherapy Treatment Delivery System with iDMS...
SOFTFORM SOFT TISSUE AUGMENTATION TUBE WITH INSERTION TOOL MODIFICATIONS FOR STRANDS AND SUTURE HOLES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ENT LASERVISION
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 14, 2025
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·April 16, 2013
TAUT ADAPT UNIVERSAL SEAL PORT, 5/12MM X 100MM
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code DTL·March 16, 2011
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Death
·BAXTER HEALTHCARE CORPORATION·Product code KDJ·September 4, 2014
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015