29 results
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12ms
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Sources: EU EUDAMED, US FDA
The product is Pathfinder SL, version 1.6.0.3057 software used with the Spacelabs Healthcare Pathfinder SL Holter Analyzer, version 1.6.0. Product Usage: The Holter Analyzer analyzes information collected from ambulatory electrocardiogram recorders worn by patients and used to assist physicians in diagnosis and patient monitoring. In addition, incorrect QTc values are reported after moving the cursor. QTc values are timing events between labeled points of interest in the ECG signal that the physician can mark with the cursor. The software is used to edit a family of events and upon conclusion the software crashes with an error message.
FDA Recall
Terminated
·Spacelabs Healthcare, Llc·Product code DQK·May 11, 2012
IQecg IQiC Interface, Part Numbers: 4-100-1407, Software Version 6.0 IQecg is to be used, under the supervision of a Physician, to obtain Electrocardiograms from the human body surface.
FDA Recall
Terminated
·Brentwood Medical Technology Corp·Product code DSI·May 18, 2010
IQecg IQdevices SDK, Part Numbers: 4-100-1403, Software Version 8.3.2 Product Usage: IQecg is to be used, under the supervision of a Physician, to obtain Electrocardiograms from the human body surface.
FDA Recall
Terminated
·Brentwood Medical Technology Corp·Product code DSI·May 18, 2010
IQecg IQmanager Diagnostic Workstation, Part Numbers: 4-100-1200, Software Version 8.0.1, 8.3, 8.3.1, 8.3.2 IQecg is to be used, under the supervision of a Physician, to obtain Electrocardiograms from the human body surface.
FDA Recall
Terminated
·Brentwood Medical Technology Corp·Product code DSI·May 18, 2010
MARS Treatment Kit, Use only with MARS(R) Monitor 1TC, GAMBRO, Product Code 800541
FDA Recall
Terminated
·Baxter Healthcare Corporation·Product code FLD·December 21, 2017
Nonabsorbable Polypropylene Synthetic Suture-Deklene, DEK BL MF 0 TC-43 2N 48, Catalog #833-123
FDA Recall
Terminated
·Product code GAM·June 6, 2007
Various Types and Sizes of Polyethylene Synthetic Nonabsorable Sutures-Polyester, TEV GN BR 0 TC-43/HR 262N, Catalog #833-114
FDA Recall
Terminated
·Product code GAM·June 6, 2007
Various Sizes of Sterile Polygycolic Acid Synthetic Surgical Suture: Bondek, BON GN BR 0 GR19 1N7 USAB, Catalog #0500197-2, Bondek, BON GN BR 2-0 GRB 121N7"USAB, Catalog #0520127-2, Bondek, BON GNBR 3-0 DR17 1N7"USAB, Catalog #0530177-2, Bondek, BON GN BR 2-0 C-2/CST-4336, Catalog #833-136,Bondek, BON GN BR 0 TC-43 2N 48, Catalog #833-213, Bondek, BON GN BR 2-0 HS 36 1N27, Catalog # B2098G
FDA Recall
Terminated
·Product code GAM·June 6, 2007
Hemochron Jr. Whole Blood Microcoagulation System APTT Cuvette. For in vitro diagnostic coagulation test. Catalog number J103.
FDA Recall
Terminated
·ITC-Nexus Dx·Product code JPA·June 20, 2014
Surgicutt fully automated incision making device for bleeding time determination. ITC 8 Olsen Avenue, Edison, NJ 08820. 732.548.5700. www.itcmed.com. A subsidiary of Thoratec Corporation. The device is a spring loaded cam driven device that provides standardized incisions of 5 mm length and 1 mm depth. This fully automated instrument is used along with blotting paper for bleeding time determinations.
FDA Recall
Terminated
·ITC-Nexus Dx·Product code JCA·August 22, 2013
Hemochron Jr. Citrate APTT Cuvette 510(k) K014008 A unitized microcoagulation test intended to be used in performing a quantitative, one -stage APTT. The citrate APTT test is used for evaluation of low doses of heparin anticoagulant (up to 1.5 units/mL), depending upon individual patient heparin sensitivity.
FDA Recall
Terminated
·ITC-Nexus Dx·Product code GFO·December 19, 2013
HGBPROKIT which contains one meter and one container of 25 test strips. HGB TEST 100; HGB PRO TEST STRIPS -100, includes four containers of 25 test strips per container; International Technidyne Corporation The Hgb Pro Professional Hemoglobin Testing System Consists of a portable battery operated meter and single-use test strips for the quantitative measurement of total hemoglobin from capillary and venous whole blood. The Hgb Pro Professional Hemoglobin Testing System is designed for near patient testing in a professional facility and is not intended for home use.
FDA Recall
Terminated
·ITC-Nexus Dx, Inc.·Product code GKR·January 21, 2011
Accriva- APTT Cuvette for use on the Hemochron Jr. test system, catalog #J103, lot B6JCA012.
FDA Recall
Terminated
·Accriva Diagnostics Inc., dba ITC, dba Accumetrics·Product code JPA·April 22, 2016
3 Series Full Body Phototherapy Device with Smart Touch Control System, Model #SNBSM-0048.
FDA Recall
Terminated
·Daavlin Distributing Company·Product code FTC·September 1, 2003
HOUVA III Phototherapy System with DermaSense Technology comes on one skid within 10 cardboard boxes. A therapeutic product designed for individuals who require specific Ultraviolet radiation therapy for diagnosed skin disorders.
FDA Recall
Terminated
·National Biological Corp·Product code FTC·February 19, 2008
3 Series Full Body Phototherapy Device with Smart Touch Control System, Model #ANBSM-0048.
FDA Recall
Terminated
·Daavlin Distributing Company·Product code FTC·September 1, 2003
Dermalight 80 Model Number UVB-083, one unit per box. The Dermalight 80 is a Phototherapy light unit that provides ultraviolet radiation therapy for diagnosed skin disorders such as Psoriasis and Vitiligo.
FDA Recall
Terminated
·National Biological Corp·Product code FTC·April 8, 2013
3 Series Full Body Phototherapy Device with Smart Touch Control System, Models #PASNBSM-2424.
FDA Recall
Terminated
·Daavlin Distributing Company·Product code FTC·September 1, 2003
3 Series Full Body Phototherapy Device with Smart Touch Control System, Model All Touch Control System, Model #ASNBSM-2424 units manufactured between 6/5/03 and 4/30/04..
FDA Recall
Terminated
·Daavlin Distributing Company·Product code FTC·September 1, 2003
3 Series Full Body Phototherapy Device with Smart Touch Control System, Model #LNBH-0048.
FDA Recall
Terminated
·Daavlin Distributing Company·Product code FTC·September 1, 2003