12 results
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18ms
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Sources: EU EUDAMED, US FDA
STERILABELS
FDA 510(k)Trabecular Metal®
FDA UDI
Zimmer, Inc.·00889024139299·
Trabecular Metal®
FDA UDI
Zimmer, Inc.·00889024139305·
SELENITE BROTH
FDA 510(k)
FDA Class 1
·Microbiology
CEREBRAL TRACER 1500 & CT 1.0 SOFTWARE
FDA 510(k)
FDA Class 1
·Neurology
XIENCE PRIME SV EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·June 10, 2014
EASYTRAK 2
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code OJX·October 11, 2010
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·December 10, 2012
Zimmer Trabecular metal primary hip prosthesis femoral stem, press-fit, collarless, 12/14 neck taper - standard body -extended neck offset, size 15, 160 mm stem length, sterile, tivanium TI-6AL-4V alloy/tantalum, sterile; Cat. no. 00-7864-015-20 (00786401520).
FDA Recall
Terminated
·Zimmer Inc.·Product code LPH·August 2, 2006
1500T14 Cardiac Ablation System - Remote Control The 1500Tl4 Remote Control can control and operate the 1500Tl4 RF generator remotely via a connecting cable. It has a duplicate front panel controls and displays as of the generator's front panel, with the addition of an optical encoder knob which is used to select and changes the parameters.
FDA Recall
Terminated
·May 9, 2011
1500T12 Cool Path Ablation System - Generator The generator is a microprocessor-controlled device that produces a continuous unmodulated radiofrequency (RF) output of 485 kHz. The generator has a maximum power output of 100 Watts. The catheter delivers the RF power from the generator in a monopolar mode between its distal electrode (tip electrode) and a large indifferent electrode (dispersive pad or "DIP"), which is in compliance with ANSUAAMI Standard HF-18-60601-2-2. The Generator operates in Temperature Control mode only. The generator is a temperature controlled system, where temperature measured by the temperature sensor in the Therapy 1300 Series Steerable Ablation Catheter or other compatible catheters is monitored and the power delivered by the generator adjusts within the selected limits until the desired temperature is achieved. The generator's thermocouple temperature control circuitry is based on a Type T thermocouple. The front panel displays the actual real-time power output, impedance, duration, and measured tip electrode temperature. The amount and duration of RF power delivery is user selectable, The desired catheter tip electrode temperature is also user selectable. A low pass filter is enabled during ablation to permit recording of intracardiac electrograms and alternately disables the filter during stimulation (pacing). The output power of the Generator will shut off if the measured temperature exceeds 80C or if the measured temperature exceeds the user selected temperature set point by more than 5C for more than 3 seconds. The Generator has built-in safety features, which include a self test at power up and automatic RF power shut off if the measured tissue impedance falls below 50 Ohms or exceeds 300 Ohms or the preset impedance value for more than 2 seconds. The 1500Tl2 Cardiac Ablation Generator is only compatible with the Cool Point Irrigation Pump.
FDA Recall
Terminated
·May 9, 2011
1500T14 Cardiac Ablation System - Generator The 1500Tl4 Cardiac Ablation System operates in conjunction with a commercially available external Disposable Indifferent (Dispersive) Patch (DIP) electrode. The catheter delivers RF power in a monopolar mode between its distal electrode and the DIP electrode. The Generator incorporates a medical grade power supply. This power supply can be used for various line voltages and frequencies without any modifications. Utilizing microprocessor control, the Generator produces a continuous nonmodulated radio frequency (RF) output at 485 KHz. Its front panel displays the command power output, tissue impedance, and tissue temperature. The Generator measures root-mean-square (RMS) voltage, RMS current, and command power output by taking the average value of the product of voltage and current. This reflects the effective heating power delivered to the tissue from the catheter large electrode (tip electrode or other ablating electrodes). Impedance is calculated as RMS voltage divided by RMS current. The amount and duration of RF power delivery is user- selectable. The Generator has four (4) independent channels for monitoring the tissue temperature simultaneously using thermocouple sensor and i-channel (thermistor) for catheters using a thermistor sensor. The desired temperature is user-selectable when busing a catheter with a temperature sensor. If using a catheter with a temperature sensor, the output power of the Generator will shut off if the measured temperature exceeds 80C or if the measured temperature exceeds the user-selected temperature set point by more than 5C for greater than 3 seconds. If using a catheter with 4 temperature sensors, the output power of the Generator will shut off when the highest temperature detected from anyone of the temperature sensors is exceeds the preset temperature by more than 5C for greater than 3 seconds or exceeding 80C.The Generator has built-in safety features which include automatic RF power shutoff if the measured tissue impedance falls below 50 ohms or exceeds 300 ohms or the preset impedance value.
FDA Recall
Terminated
·May 9, 2011