101 results
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50ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Handpiece
FDA UDI
HALT MEDICAL, INC·00854763006003·Disposable handpiece used for deliver RF energy...
Guidance handpiece cable
FDA UDI
HALT MEDICAL, INC·00854763006096·Connects the Guidance Handpiece to the Acessa G...
Pads
FDA UDI
HALT MEDICAL, INC·00854763006010·Dispersive pad connects to the generator
Handpiece cable
FDA UDI
HALT MEDICAL, INC·00854763006027·Cable connects the handpiece to the generator
Guidance field generator
FDA UDI
HALT MEDICAL, INC·00854763006065·The Table Top Field Generator (TTFG) generates ...
Pad cable
FDA UDI
HALT MEDICAL, INC·00854763006072·Cable connects the pads to the generator
Generator
FDA UDI
HALT MEDICAL, INC·00854763006034·RF Generator
Guidance controller
FDA UDI
HALT MEDICAL, INC·00854763006041·Guidance magnetic tracking controller
Guidance handpiece
FDA UDI
HALT MEDICAL, INC·00854763006089·Disposable handpiece connects to generator
Guidance ultrasound transducer sleeve
FDA UDI
HALT MEDICAL, INC·00854763006058·Sterile Disposable Guidance Ultrasound Transduc...
ACESSA HANDPIECE
FDA Adverse Event
Malfunction
·HALT MEDICAL, INC.·Product code HFG·January 31, 2014
ACESSA HANDPIECE
FDA Adverse Event
Malfunction
·HALT MEDICAL INC.·Product code HFG·March 20, 2014
GUIDANCE HANDPIECE
FDA Adverse Event
Malfunction
·HALT MEDICAL, INC.·Product code HFG·November 22, 2016
GUIDANCE HANDPIECE
FDA Adverse Event
Malfunction
·HALT MEDICAL, INC.·Product code HFG·July 29, 2016
ACESSA GUIDANCE HANDPIECE
FDA Adverse Event
Injury
·HALT MEDICAL, INC.·Product code HFG·July 27, 2016
ACESSA HANDPIECE
FDA Adverse Event
Malfunction
·HALT MEDICAL, INC.·Product code HFG·June 15, 2016
ACESSA
FDA Adverse Event
Malfunction
·HALT MEDICAL INC.·Product code GEI·November 1, 2013
ACESSA HANDPIECE
FDA Adverse Event
Malfunction
·HALT MEDICAL, INC.·Product code HFG·June 15, 2016
ACESSA HANDPIECE
FDA Adverse Event
Injury
·HALT MEDICAL, INC.·Product code HFG·June 2, 2015
Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid from a negative head height (when the IV fluid container is lower than the pump), and provides clinically accepted volumetric accuracy for all standard IV fluids, including blood, lipid, and Total Parenteral Nutrition (TPN). Model number: 621-300ES and 621-400ES. To deliver a broad range of drugs with use with the B. Braun Medical Inc. Horizon Pump IV Sets.
FDA Enforcement
Class I
·Terminated·B Braun Medical, Inc.·September 25, 2013