101 results · 50ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

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