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Sources: EU EUDAMED, US FDA
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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 Enforcement
Class II
·Terminated·Covidien LLC dba Uni-Patch·December 19, 2012
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 Enforcement
Class II
·Terminated·Covidien LLC dba Uni-Patch·December 19, 2012
Reusable, non-sterile, self-adhering electrodes for use with TENS/NMES, . Made in the U.S.A. Cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.
FDA Enforcement
Class II
·Terminated·Covidien LLC dba Uni-Patch·December 19, 2012
Reusable, Self-Adhering TENS/NMES/FES electrodes Single Patient Use Only. An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram.
FDA Enforcement
Class II
·Terminated·Covidien LLC dba Uni-Patch·December 19, 2012
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
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
Reusable, Self-Adhering TENS/NMES/FES electrodes Single Patient Use Only. An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram.
FDA Recall
Terminated
·Covidien LLC dba Uni-Patch·Product code GXY·February 9, 2012
Reusable, non-sterile, self-adhering electrodes for use with TENS/NMES, . Made in the U.S.A. Cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.
FDA Recall
Terminated
·Covidien LLC dba Uni-Patch·Product code GXY·February 9, 2012
VITROS Chemistry Products-HCY Reagent packaged in a kit carton. Catalog# 6802002. Used to quantitatively measure total homocysteine (HCY) concentration in human serum and plasma.
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code LPS·April 1, 2013
Lingen SAMPLE Disposable Virus Sampling Kit pack, Item SAM ENI MTM-04, containing 2 tubes and 2 swabs/pack; and SAM ENI MTM04TUBE, containing 1 tube/pack.
FDA Recall
Terminated
·Mercedes Medical, Inc.·Product code QBD·June 10, 2021
VITROS Chemistry Products-HCY Reagent packaged in a kit carton. Catalog# 6802002. Used to quantitatively measure total homocysteine (HCY) concentration in human serum and plasma.
FDA Enforcement
Class II
·Terminated·Ortho-Clinical Diagnostics·June 26, 2013
Lingen SAMPLE Disposable Virus Sampling Kit pack, Item SAM ENI MTM-04, containing 2 tubes and 2 swabs/pack; and SAM ENI MTM04TUBE, containing 1 tube/pack.
FDA Enforcement
Class II
·Terminated·Mercedes Medical, Inc.·July 21, 2021
Crosslock DVR ePAK -Sterile, Ref 81180050, are complete surgical sets including plates, screws, and instruments for orthopedic fixation The Cross lock DVR ePAK Volar Rim Plates system is intended for fixation of fractures, mal unions, and osteotomies involving the distal radius. The DVR Wrist ePAK system is intended stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions of small bones of the hand, foot, radius, ulna, ankle, humerus, scapula and pelvis, particularly in osteopenic bone.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·March 16, 2016
Fischer Cone Biopsy Excisor - Lg - Shallow Model: 900-155
FDA Recall
Terminated
·Apple Medical Corporation·Product code HGI·March 10, 2006
Caspar Titanium Aneurysm Clip Appliers, Catalog No/Part #: FT420T, Casper Applier F/Mini Ti-Clipsstr 146 mm, Aesculap, Inc., Center Valley, PA. 18034
FDA Recall
Terminated
·Aesculap Inc·Product code HCI·November 1, 2007
Quantam 2000 Electrosurgical Generator, Part number 909075-05.
FDA Recall
Terminated
·CooperSurgical, Inc.·Product code HGI·October 16, 2019
Fischer Cone Biopsy Excisor Model: 900-158
FDA Recall
Terminated
·Apple Medical Corporation·Product code HGI·March 10, 2006
Fischer Cone Biopsy Excisor - Small Model: 900-150
FDA Recall
Terminated
·Apple Medical Corporation·Product code HGI·March 10, 2006
CooperSurgical LEEP RADIUS LOOP ELECTRODE (W 2.0 cm x D 1.0 cm D, 12 cm shaft ). Box of 5 Model Number(s): R2010 Intended Use: Diagnosis and treatment of non-invasive HPV-related or unrelated lesions of the lower genital tract.
FDA Recall
Terminated
·CooperSurgical, Inc.·Product code HGI·October 27, 2014
Fischer Cone Biopsy Excisor, Medium (5/Box); Model Number: 900-151
FDA Recall
Terminated
·CooperSurgical, Inc.·Product code HGI·March 12, 2018