295 results
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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RF Denervation Probe, 15 cm, temperature sensing electrodes designed for use in radiofrequency lesion procedures for the treatment of pain. Product Number: 7210272
FDA Recall
Terminated
·Smith & Nephew, Inc. Endoscopy Division·Product code GXI·January 19, 2007
AxioBionics Wearable TherapyFreeStep Sleeve (Right and Left) that includes 2-16 BioGel Velcro Electrodes in sizes: 2"x2", 2"x2.5", 2"x3", 2"x3.5", 2"x4", 2"x5", 2"x6", 2"x8", 1.5"x3", 1.5"x5", 1.5"x6", and 1"x1.5". Cutaneous electrode garments for neuromuscular electrical stimulation.
FDA Recall
Terminated
·Axiobionics, LLC·Product code GXY·May 27, 2011
Empi STIMC RE Self Adhesive electrodes. For use on TENS, NMES, FES. a DJO brand A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., electroencephalogram) or to apply electrical stimulation.
FDA Recall
Terminated
·Covidien LLC dba Uni-Patch·Product code GXY·February 9, 2012
Accurian RF Ablation, Cannula pk, Accurian, 100mm, 22G, 5mm, CS Product Number: AC0016 GTIN / UPN: 20763000153674 - Product Usage: (sterile, single-use) comprises an electrically insulated shaft, an active electrode for RF energy delivery, a hub with a female slip luer fitting, and a stylet with a color-coded cap to indicate gauge size. The ACCURIAN RF Cannula included in the ACCURIAN RF Ablation Platform intended for the creation of radiofrequency lesions in nervous tissue.
FDA Recall
Terminated
·Medtronic Sofamor Danek USA Inc·Product code GXI·June 8, 2020
Nitinol Thermocouple Electrode, 5cm - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tissue only.The Cosman Medical TCN Electrodes are temperature-sensing probes for use in the percutaneous treatment of pain.
FDA Recall
Terminated
·Boston Scientific Neuromodulation Corporation·Product code GXI·May 30, 2019
Nitinol TC Reusable Electrodes (TCN), Model Numbers: 1)TCN-10, 2) TCNK-10-R*, 3)TCN-10-3M, 4) TCNK-15, 5) TCN-15, 6) TCNK-15-C, 7) TCN-15-3M, 8) TCNK-15-R*, 9) TCN-20, 10) TCNK-20, 11) TCN-20-3M*, 12) TCNK-20-C*, 13) TCN-5, 14) TCNK-20-R*, 15) TCN-5-3M, 16) TCNK-5, 17) TCNK-10, 18) TCNK-5-C, 19) TCNK-10-C & 20) TCNK-5-R*. The TCN devices are indicated for use in radiofrequency (RF) heat lesioning of peripheral nerve tissue only.
FDA Recall
Terminated
·Cosman Medical, LLC·Product code GXI·July 5, 2017
RF Denervation Probe, 10 cm, temperature sensing electrodes designed for use in radiofrequency lesion procedures for the treatment of pain. Product Number: 7210271
FDA Recall
Terminated
·Smith & Nephew, Inc. Endoscopy Division·Product code GXI·January 19, 2007
Performa reusable and self-adhering TENS/NMES/FES stimulating electrodes, A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., electroencephalogram) or to apply electrical stimulation.
FDA Recall
Terminated
·Covidien LLC dba Uni-Patch·Product code GXY·February 9, 2012
RF Cannula, 100 mm,Curved 10 MM, 20 G, REF 0406-630-125 RX only, Disposable ( 10/pk) Product Usage: The Stryker RF Cannulae, in combination with the Stryker RF Generator/Multi- Gen and electrodes, are intended for coagulation of soft tissue in orthopedic, arthroscopic, spinal, and neurosurgical applications.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code GXI·July 17, 2012
DRAPE 9732722 TUBE STERILE O-ARM 20PK
FDA Recall
Terminated
·Medtronic Navigation, Inc.·Product code GXY·April 24, 2014
AxioBionics Wearable Therapy Upper Extremity BioSleeve (Right and Left) that includes 2-16 BioGel Velcro Electrodes in sizes: 2"x2", 2"x2.5", 2"x3", 2"x3.5", 2"x4", 2"x5", 2"x6", 2"x8", 1.5"x3", 1.5"x5", 1.5"x6", and 1"x1.5". Cutaneous electrode garments for neuromuscular electrical stimulation.
FDA Recall
Terminated
·Axiobionics, LLC·Product code GXY·May 27, 2011
Foam electrodes with Silver-Carbon construction: P/N 202-9271, Cat No. 400-898, 2" x 2" Electrode, Foam, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 202-9281, Cat No. 202-9281, 2" Round Electrode, Foam, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 202-9251, Cat No. 400-893, 3" Round Electrode, Foam AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 202-9291, Cat No. 400-892, 3" Round Electrode, Foam AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 202-9371, Cat No. 400-888, 2" x 3.5" Electrode, Foam AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 202-9491, Cat No. 400-869, 1.25" Round Electrode, Foam AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 202-9511, Cat No. 400-853, 3" x 5" Electrode, Foam AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 300-1541, Cat No. 300-154, 2" x 2.25" Electrode, Foam, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 300-1561, Cat No. 300-156, 2" Round Electrode, Foam, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 300-1611, Cat No. 300-161, 4" x 2.25" Electrode, Foam, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010, 22818 P/N 300-1631, Cat No. 300-163, 3" Round Electrode, Foam, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 400-8701, Cat No. 400-870, 2" x 4" Oval Electrode, Foam, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010. Cutaneous electrode.
FDA Recall
Terminated
·NAImco Inc dba Richmar Inc·Product code GXY·November 30, 2009
The Baylis LumbarCool Pain Management Kit consisting of: 1 LumbarCool Pain Management Probe, 3 LumbarCool Pain Management introducers, and 1 Pain Management Tube Kit. Model/Catalogue Number: LUK-17-150-4 The LumbarCool Pain Management System, a cooled radiofrequency pain management system, in combination with the Baylis Pain Management Generator-TD (PMG-TD), is indicated for use to create RF lesions in nervous tissue.
FDA Recall
Terminated
·Baylis Medical Corp·Product code GXI·May 12, 2010
RF Denervation Probe, 5cm, temperature sensing electrodes designed for use in radiofrequency lesion procedures for the treatment of pain. Part Number: 7210270
FDA Recall
Terminated
·Smith & Nephew, Inc. Endoscopy Division·Product code GXI·January 19, 2007
AxioBionics Wearable Therapy BioShorts that includes 2-16 BioGel Velcro Electrodes in sizes: 2"x2", 2"x2.5", 2"x3", 2"x3.5", 2"x4", 2"x5", 2"x6", 2"x8", 1.5"x3", 1.5"x5", 1.5"x6", and 1"x1.5". Cutaneous electrode garments for neuromuscular electrical stimulation.
FDA Recall
Terminated
·Axiobionics, LLC·Product code GXY·May 27, 2011
Nitinol Thermocouple Electrode, 15 cm, 3m Cable - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tissue only.The Cosman Medical TCN Electrodes are temperature-sensing probes for use in the percutaneous treatment of pain.
FDA Recall
Terminated
·Boston Scientific Neuromodulation Corporation·Product code GXI·May 30, 2019
Nitinol Thermocouple Electrode, 10 cm, 3m Cable - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tissue only.The Cosman Medical TCN Electrodes are temperature-sensing probes for use in the percutaneous treatment of pain.
FDA Recall
Terminated
·Boston Scientific Neuromodulation Corporation·Product code GXI·May 30, 2019
Foam Electrodes with Carbon construction: P/N 201-1261, Cat Nos.: 201-126, 203-678, and 400-856, 1.5" x 3.5" Electrode, Foam, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1271, Cat Nos.: 201-127, 202-093, 203-483, 203-565, 203-673, and 400-873, 2" x 2" Electrode, Foam, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1281, Cat Nos.: 201-128, 202-277, 203-675, and 400-873, 2" Round Electrode, Foam, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1291, Cat Nos.: 201-129, 203-677, and 400-882, 3" Round Electrode, Foam, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1301, Cat Nos.: 201-130, 203-679, and 400-855, 1.5" x 3.5" Electrode, Foam, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1371, Cat Nos.: 201-137, 202-278, 203-484, 203-681, and 400-880, 2" x 3.5" Electrode, Foam, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 202-5671, Cat No. 202-567, 2" x 2" Electrode, Foam, All Serial Numbers distributed between 11/01/2009 and 01/31/2010. Cutaneous electrode.
FDA Recall
Terminated
·NAImco Inc dba Richmar Inc·Product code GXY·November 30, 2009
Coolife Sinergy Radiofrequency Kit, SIK-17-75-4 (109971504); Kit used in conjunction with a Radiofrequency Generator to create radiofrequency lesions in nervous tissue.
FDA Recall
Terminated
·Halyard Health, Inc·Product code GXI·June 16, 2016
Nitinol Thermocouple Electrode, 15 cm - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tissue only.The Cosman Medical TCN Electrodes are temperature-sensing probes for use in the percutaneous treatment of pain.
FDA Recall
Terminated
·Boston Scientific Neuromodulation Corporation·Product code GXI·May 30, 2019