38 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Dispersive Electrodes packaged in an 8x10 plastic container.
FDA Recall
Terminated
·Rita Medical Systems·Product code JOS·June 16, 2004
CONCEPT HEATWAVE Electrode 130 mm x 2.3 mm diameter, REF/Catalog Number CS-023, STERILE, Rx Only Product Usage: The HeatWave Electrode is intended to be used for electro-coagulation of soft tissue in shoulder, ankle, wrist, elbow and knee arthroscopic procedures.
FDA Recall
Terminated
·ConMed Corporation·Product code JOS·August 29, 2016
NOVAPLUS Electrosurgical Grounding Pads, Split with Cord Catalog No. 7179V
FDA Recall
Terminated
·Product code JOS·September 30, 2004
Colorado Electrodes Model #'s: COLN104A COLN112A and STRN103A Intended for precision cutting or dissecting and cauterizing soft tissue.
FDA Recall
Terminated
·Sterilmed Inc·Product code JOS·August 8, 2008
Leveen Coaccess Introducer Set. Disposable, monopolar, electrosurgical devices, intended for use in conjunction with BSC radiofrequency generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions.
FDA Recall
Terminated
·Boston Scientific Corporation·Product code JOS·September 17, 2012
Habib EUS RFA, 10mm electrode active tip, Material Number/UPN: 6500 - Product Usage: The Habib EUS RFA is indicated for coagulation and ablation of soft tissue when used in conjunction with compatible radiofrequency generator.
FDA Recall
Terminated
·Boston Scientific Corporation·Product code JOS·November 18, 2019
Leveen Coaccess Needle Electrode (3.5/15) and (4.0/15). Disposable, monopolar, electrosurgical devices, intended for use in conjunction with BSC radiofrequency generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions.
FDA Recall
Terminated
·Boston Scientific Corporation·Product code JOS·September 17, 2012
MIDAS TOUCH Electrosurgical/102 mm (4 inch) Blade Electrodes, Disposable, Sterile Single Use Device, Part #30-0012 and #30-0002. The electrodes are individually packaged in Tyvek bags with 12 packages per case.
FDA Recall
Terminated
·Olsen Medical·Product code JOS·August 29, 2006
Habib EUS RFA, 20mm electrode active tip, Material Number/UPN: 6700 - Product Usage: The Habib EUS RFA is indicated for coagulation and ablation of soft tissue when used in conjunction with compatible radiofrequency generator.
FDA Recall
Terminated
·Boston Scientific Corporation·Product code JOS·November 18, 2019
System 83 Plus Washer-Disinfector, Endoscope use, DOS based system, Custom Ultrasonics Inc., Buckingham, PA
FDA Recall
Terminated
·Custom Ultrasonics, Inc.·Product code KOG·February 11, 2008
CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquisition and computer aided chromosome analysis system which assists the operator in viewing chromosomes and looking for cellular anomalies. CytoVision enables a qualified Cytogeneticist to rapidly and accurately analyze the chromosome banding pattern.
FDA Recall
Terminated
·Leica Biosystems Richmond Inc.·Product code JOY·May 2, 2016
Ariol is an automated scanning microscope and image analysis system. It is intended for in vitro diagnostic use as an aid to the pathologist in the detection, classification, and counting of cells of interest based on particular color, intensity, size, pattern, and shape. This particular Ariol software application is intended to measure, count, and quantitate the percentage and intensity of positively stained nuclei in formalin-fixed paraffin-embedded tissue specimens immunohistochemically stained for Estrogens Receptors or Progesterone Receptors (ER/PR). ER/PR results are indicated for use as and aid in the management, prognosis, and prediction of therapy outcomes of breast cancer.
FDA Enforcement
Class III
·Terminated·Leica Biosystems Richmond Inc.·June 22, 2016
Glucose Hexokinase Liquid Reagent For the in vitro quantitative determination of Glucose in serum.
FDA Recall
Terminated
·JAS Diagnostics Inc.·Product code CGA·April 7, 2014
Drew Scientific DREW 3-PAC Reagent Kit containing: 5L Diluent, 750 mL Enzymatic Cleaner, and 125 mL Lysing Reagent.
FDA Recall
Terminated
·JAS Diagnostics Inc.·Product code GKZ·April 21, 2017
Glucose Hexokinase (Liquid) Reagent For the in vitro quantitative determination of Glucose in serum.
FDA Recall
Terminated
·JAS Diagnostics Inc.·Product code CFR·October 23, 2014
Glucose Hexokinase (Liquid) Reagent For the in vitro quantitative determination of Glucose in serum.
FDA Enforcement
Class II
·Terminated·JAS Diagnostics Inc.·December 24, 2014
Glucose Hexokinase Liquid Reagent For the in vitro quantitative determination of Glucose in serum.
FDA Enforcement
Class II
·Terminated·JAS Diagnostics Inc.·July 2, 2014
Drew Scientific DREW 3-PAC Reagent Kit containing: 5L Diluent, 750 mL Enzymatic Cleaner, and 125 mL Lysing Reagent.
FDA Enforcement
Class II
·Terminated·JAS Diagnostics Inc.·July 12, 2017
OptiMedica Catalys Precision Laser System, CE 0044 containing software cOS 5.00.33 Product Label for Serial Numbers: 44109015; 44106215; 44107315; and 44065613 label states "Manufactured for: OptiMedica Corporation 1310 Moffett Park Drive Sunnyvale, CA 94089 USA Product Label for Serial Numbers: 46120916; 46123116, 46124617; 46131418, and 46131618 label states "Manufactured for: OptiMedica Corporation 510 Cottonwood Drive Milpitas, CA 95035 USA The Catalys Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, phacofragmentation, and the creation of single plane and multi-plane arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure.
FDA Recall
Terminated
·Johnson & Johnson Surgical Vision Inc·Product code OOE·May 9, 2018
Drew Scientific Inc. Drew3-PAC. This D3 Reagent Pack includes: diluent reagent 5L, enzymatic cleaner 750 mL, and a lysing reagent 125 mL.
FDA Recall
Terminated
·Jas Diagnostics/Drew Scientific·Product code GKZ·March 10, 2016