1,102 results
·
16ms
·
Sources: EU EUDAMED, US FDA
BARD Mesh Pre-shaped (1.8" x 4.0"/4.5cm x 10cm) Product code: 0112700 Intended use: Bard Pre-shaped mesh is a pre-shaped mesh constructed of knitted polypropylene monofilaments. It is indicated for the repair of inguinal hernia defects
FDA Recall
Terminated
·Davol, Inc., Sub. C. R. Bard, Inc.·Product code FTL·October 15, 2010
ARCHITECT B12 Reagent, list 06C09-22 (4 x 100 tests), 06C09-27 (1 x 100 tests); an in vitro diagnostic kit consisting of microparticles, conjugate, assay diluent, pre-treatment 1, pre-treatment 2, and pre-treatment 3; Abbott Laboratories, Abbott Park, IL 60064
FDA Recall
Terminated
·Abbott Laboratories MPG·Product code LIG·March 8, 2006
cobas p 612 pre-analytical system; Pre-analytical sample handling that includes de-capping, Aliquotting and sorting of samples for analysis.
FDA Recall
Terminated
·Roche Diagnostics Corporation·Product code JQP·December 27, 2016
cobas p 512 pre-analytical system Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis.
FDA Recall
Terminated
·Roche Diagnostics Operations, Inc.·Product code JQP·February 23, 2016
Pre Isotonic Personal Lubricant labeled PRE' Patient Lubricant. Product is used to lubricate vulvar and vaginal tissues to facilitate entry of diagnostic or therapeutic devices. Pre' Lubricant is acceptable for use to facilitate insertion of diagnostic or therapeutic devices during fertility interventions such as: embryo transfer, transvaginal collection of oocytes, intrauterine insemination and post coital testing. In addition, product may be used as a personal lubricant to supplement the body's own natural lubricating fluids.
FDA Recall
Terminated
·INGfertility, LLC·Product code NUC·September 22, 2008
Cordis Neurovascular Pre-Shaped PROWLER Infusion Catheters.
FDA Recall
Terminated
·Cordis Neurovascular, Inc.·Product code KRA·August 11, 2006
cobas p 501 Post-Analytical Unit calculator/data processing module, for clinical use Product Usage: The MODULAR PRE-ANALYTICS system is a fully automated system for sample pre-processing, including centrifuging, aliquoting, and barcode labeling, prior to analysis by MODULAR SYSTEMS analyzers.
FDA Recall
Terminated
·Roche Diagnostics Operations, Inc.·Product code JQP·July 15, 2016
Gingihue 15 Degree Pre-Angled Post Dental implants
FDA Recall
Terminated
·Biomet 3i, LLC·Product code NHA·November 25, 2015
Preformance 15 degrees pre-angled post Dental implants
FDA Recall
Terminated
·Biomet 3i, LLC·Product code NHA·November 25, 2015
Cordis Neurovascular Pre-Shaped Prowler Select Infusion Catheters.
FDA Recall
Terminated
·Cordis Neurovascular, Inc.·Product code KRA·August 11, 2006
Certain Gingihue 15 degree Pre- Angled Post Dental implants
FDA Recall
Terminated
·Biomet 3i, LLC·Product code NHA·November 25, 2015
Certain Preformance 15 degrees Pre-Angled Post Dental implants
FDA Recall
Terminated
·Biomet 3i, LLC·Product code NHA·November 25, 2015
Sierra Pre-Filled, Heparin Lock Flush Solution USP, 10 units/ml, Catalog #3003-06, NDC #64054-3003-06, 3mL Fill in a 6mL Syringe, 120/Case, For Single Use only, Sterile Solution Pathway, For IV Flush, Sierra Pre-Filled Inc., 455 W. Depot St. Angier, NC 27501
FDA Recall
Terminated
·AM2 PAT INC·Product code FOZ·December 11, 2007
Sierra Pre-Filled, Heparin Lock Flush Solution USP, 10 units/ml, Catalog #3005-02, NDC #64054-3005-02, 5mL Fill in a 12mL Syringe, 120/Case, For Single Use only, Sterile Solution Pathway, For IV Flush, Sierra Pre-Filled Inc., 455 W. Depot St. Angier, NC 27501
FDA Recall
Terminated
·AM2 PAT INC·Product code FOZ·December 11, 2007
Sierra Pre-Filled, Heparin Lock Flush Solution USP, 10 units/ml, Catalog #3005-06, NDC #64054-3005-06, 5mL Fill in a 6mL Syringe, 120/Case, For Single Use only, Sterile Solution Pathway, For IV Flush, Sierra Pre-Filled Inc., 455 W. Depot St. Angier, NC 27501
FDA Recall
Terminated
·AM2 PAT INC·Product code FOZ·December 11, 2007
Sierra Pre-Filled, Heparin Lock Flush Solution USP, 10 units/ml, Catalog #3003-02, NDC #64054-3003-02, 3mL Fill in a 12mL Syringe, 120/Case, For Single Use only, Sterile Solution Pathway, For IV Flush, Sierra Pre-Filled Inc., 455 W. Depot St. Angier, NC 27501
FDA Recall
Terminated
·AM2 PAT INC·Product code FOZ·December 11, 2007
BD Posiflush Pre-Filled Normal Saline Syringes Catalog Number: 306547
FDA Recall
Terminated
·Becton Dickinson & Company·Product code NGT·October 14, 2019
Sierra Pre-Filled, Normal Saline IV Flush, Catalog #0903-12, NDC #64054-0903-2, 3 mL Fill in a 12mL Syringe, 0.9% Sodium Chloride Injection USP, 120/Case, For Single Use only, Sterile Solution Pathway, For IV Flush, Sierra Pre-Filled Inc., 455 W. Depot St. Angier, NC 27501
FDA Recall
Terminated
·AM2 PAT INC·Product code FOZ·December 11, 2007
Sierra Pre-Filled, Normal Saline IV Flush, Catalog #0910-12, NDC #64054-0910-2, 10 mL Fill in a 12mL Syringe, 0.9% Sodium Chloride Injection USP, 120/Case, For Single Use only, Sterile Solution Pathway, For IV Flush, Sierra Pre-Filled Inc., 455 W. Depot St. Angier, NC 27501
FDA Recall
Terminated
·AM2 PAT INC·Product code FOZ·December 11, 2007
TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 12 MM, REF TRY-PS-45 12-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumor, spondylolisthesis, spinal stenosis, deformity (i.e., scoliosis, kyphosis, lordosis), pseudarthrosis, and failed previous fusions.
FDA Recall
Terminated
·SPINEART SA route de Pre bois 20 Case Postale·Product code KWQ·November 27, 2017