16 results
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23ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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IDS Urine BETA CrossLaps ELISA, Catalog Number AC-05F1. Type of packaging: Cardboard Box containing plastic bottles. The Urine BETA CrossLaps¿ ELISA is an enzyme immunological test for the quantification of degradation products of C-terminal telopeptides of Type-I collagen in human urine. The Urine BETA CrossLaps¿ ELISA assay is intended for in vitro diagnostic use as an indication of human bone resorption as an aid in A. Monitoring bone resorption changes of 1) Anti-resorptive therapies in postmenopausal women: a) Hormone Replacement Therapies (HRT) with hormones and hormone like drugs b) Bisphosphonate therapies B. Predicting skeletal response (Bone Mineral Density) in postmenopausal women undergoing anti-resorptive therapies a) Hormone Replacement Therapies (HRT) with hormones and hormone like drugs b) Bisphosphonate therapies
FDA Enforcement
Class II
·Terminated·Immunodiagnostics Systems Ltd·October 17, 2012
Variant II beta-thalassemia Short Program Model Numbers 270-2103 (250 tests) and 270-2154 (500 tests), Bio-Rad Laboratories, Inc. in vitro diagnostic. The Variant II Hemoglobin testing system uses the principals of high performance liquid chromatography (HPLC) for the separation and determination of normal and abnormal hemoglobin.
FDA Enforcement
Class II
·Terminated·Bio-Rad Laboratories, Inc.·May 14, 2014
Variant II beta-thalassemia Short Program Model Numbers 270-2103 (250 tests) and 270-2154 (500 tests), Bio-Rad Laboratories, Inc. in vitro diagnostic. The Variant II Hemoglobin testing system uses the principals of high performance liquid chromatography (HPLC) for the separation and determination of normal and abnormal hemoglobin.
FDA Recall
Terminated
·Bio-Rad Laboratories, Inc.·Product code JPD·April 8, 2014
Mentor Smooth Round Becker 50 Expander, manufactured by Mentor, Irving, Texas
FDA Recall
Terminated
·Mentor Texas, Inc·Product code FTN·December 16, 2003
5mm x 30cm Hollow "Golf" Tip Ultrasonic Aspiration Probe, Model 5620-530, Catalog Number 5620-530.
FDA Recall
Terminated
·Mentor Texas, Inc·Product code MUU·July 27, 2007
Psi-Tec Syringe Pump Infiltration Tubing, 10'; 10/box; Part Number PT-INF-T; distributed by Mentor Texas, LP, Irving, TX 75038.
FDA Recall
Terminated
·Mentor Texas, Inc·Product code FPK·April 21, 2008
Autofuse Tubing, DIS SI; Part Number AFTU-DS; distributed by Mentor Texas, LP, Irving, TX 75038.
FDA Recall
Terminated
·Mentor Texas, Inc·Product code FPK·April 21, 2008
Lamis Tubing Set, 9'; 10/box; Part Number LAM-TUBING; distributed by Mentor Texas, LP, Irving, TX 75038.
FDA Recall
Terminated
·Mentor Texas, Inc·Product code FPK·April 21, 2008
Mentor Aseptic Transfer Set, Cat. #350-8400 (contains BD 60mL Luer-Lok Syringe). Aseptic transfer set manufactured by Mentor Texas, LP, Irving, TX 75038 (BD 60 mL Luer-Lok syringe manufactured by Becton Dickinson, Franklin Lakes, NJ 07417).
FDA Recall
Terminated
·Mentor Texas, Inc·Product code GAZ·August 22, 2008
Hi-Vac Tubing, 8'; 10/box; Part Number B-5558; distributed by Mentor Texas, LP, Irving, TX 75038.
FDA Recall
Terminated
·Mentor Texas, Inc·Product code FPK·April 21, 2008
Contour Genesis Aspiration Tubing, 12'; Part Number CG-PT-5558; distributed by Mentor Texas, LP, Irving, TX 75038.
FDA Recall
Terminated
·Mentor Texas, Inc·Product code BYY·April 21, 2008
Contour Genesis Infiltration Tubing, 13'; Part Number CG-INF-T; distributed by Mentor Texas, LP, Irving, TX 75038.
FDA Recall
Terminated
·Mentor Texas, Inc·Product code FPK·April 21, 2008
Psi-Tec Tubing, 12'; 10/box; Part Number PT-5558; distributed by Mentor Texas, LP, Irving, TX 75038.
FDA Recall
Terminated
·Mentor Texas, Inc·Product code FPK·April 21, 2008
Contour Genesis Inf/IR Tubing; Part Number CG-UT; distributed by Mentor Texas, LP, Irving, TX 75038.
FDA Recall
Terminated
·Mentor Texas, Inc·Product code FPK·April 21, 2008
Y Tubing Set, 9'; 10/box; Part Number LAM-Y; distributed by Mentor Texas, LP, Irving, TX 75038.
FDA Recall
Terminated
·Mentor Texas, Inc·Product code FPK·April 21, 2008
Irrigation Tubing, 25'; Part Number 5120-25; distributed by Mentor Texas, LP, Irving, TX 75038.
FDA Recall
Terminated
·Mentor Texas, Inc·Product code FPK·April 21, 2008