162 results · 14ms · Sources: EU EUDAMED, US FDA

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Gen-Probe Amplified Mycobacterium Tuberculosis Direct Test, Catalog number 1001,

FDA Recall
Terminated ·Gen Probe Inc·Product code NDZ·June 11, 2004

NDI Combo Test Pak Omega 3, Product K7616, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and blood specimen collection supplies, forms, and instructions. Blood specimen collection

FDA Recall
Terminated ·Heritage Labs International LLC·Product code KDT·January 9, 2011

NDI/Life Extension Microtainer Blood Kit, Product K7625, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and blood specimen collection supplies, forms, and instructions. Blood specimen collection

FDA Recall
Terminated ·Heritage Labs International LLC·Product code KDT·January 9, 2011

NDI Combo Test Pak Omega 3, Product K7618, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and blood specimen collection supplies, forms, and instructions. Blood specimen collection

FDA Recall
Terminated ·Heritage Labs International LLC·Product code KDT·January 9, 2011

Heritage Labs Nutrasource NDI (USA) DBS Kit, Product K7610, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and blood specimen collection supplies, forms, and instructions. Blood specimen collection

FDA Recall
Terminated ·Heritage Labs International LLC·Product code KDT·January 9, 2011

Plicator EPS Plication System Catalog Number: 160-01128R

FDA Recall
Terminated ·NDO Surgical, Inc.·Product code KOG·January 26, 2007

Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1. Intended for in vivo imaging.

FDA Recall
Terminated ·Optovue, Inc.·Product code HLI·May 14, 2013

Cyberonics VNS Therapy AspireHC Model 105 Generator, 26-0007-4000/3. The firm name on the label is CYBERONICS, INC., Houston, TX. Vagus nerve stimulator.

FDA Recall
Terminated ·LivaNova USA Inc·Product code LYJ·November 16, 2018

Cyberonics VNS Therapy AspireSR, Model 106 Generator, 26-0007-8400/1. The firm name on the label is CYBERONICS, INC., Houston, TX. Vagus nerve stimulator.

FDA Recall
Terminated ·LivaNova USA Inc·Product code LYJ·November 16, 2018

Optovue RTVue Optical Coherence Tomography (OCT), Model-RT100 with software versions 3.0.x.x and higher, with Normative Database, manufactured by Optovue, Fremont, CA The RTVue is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retina, retinal nerve fiber layer, optic disk, and for cornea and anterior eye scans as an aid in the diagnosis and management of retinal disease.

FDA Recall
Terminated ·Optovue Inc.·Product code OBO·January 8, 2010

Baxter HEP LOCK (Heparin Lock Flush Solution, USP) 10 u/mL-1mL vial, 25 Pack, NDC 0641-0392-25 (NDC 0641-0392-21; on vial), Baxter Healthcare Corporation, Deerfield, IL 60015

FDA Recall
Terminated ·Baxter Healthcare Corp. Rt.·Product code NZW·February 28, 2008

Baxter HEP-LOCK (Heparin Lock Flush Solution, USP) 10 u/mL-10 mL vial; 25 pack, NDC 0641-2438-45, (NDC 0641-2348-41; on vial), Baxter Healthcare Corporation, Deerfield, IL 60015

FDA Recall
Terminated ·Baxter Healthcare Corp. Rt.·Product code NZW·February 28, 2008

Baxter HEP-LOCK (Heparin Lock Flush Solution, USP), 10 units/mL-30 mL vial; 25 pack, NDC 0641-2442-45 (NDC 0641-2442-41; on vial), Baxter Healthcare Corporation, Deerfield, IL 60015

FDA Recall
Terminated ·Baxter Healthcare Corp. Rt.·Product code NZW·February 28, 2008

Baxter HEP-LOCK (Heparin Lock Flush Solution, USP) 100 units/mL-2 mL vial, 25 pack, NDC 0641-0387-25, (NDC 0641-0387-21; on vial), Baxter Healthcare Corporation, Deerfield, IL 60015

FDA Recall
Terminated ·Baxter Healthcare Corp. Rt.·Product code NZW·February 28, 2008

Baxter HEP-LOCK (Heparin Lock Flush Solution, USP) 100 units/mL-1 mL vial, 25 pack , NDC 0641-0389-25, (NDC 0641-0389-21: on vial), Baxter Healthcare Corporation, Deerfield, IL 60015

FDA Recall
Terminated ·Baxter Healthcare Corp. Rt.·Product code NZW·February 28, 2008

Baxter HEP-LOCK (Heparin Lock Flush Solution, USP) 100 units/mL-30 mL vial, 25 pack, NDC 0641-2443-45, (NDC 0641-2443-41; on vial), Baxter Healthcare Corporation, Deerfield, IL 60015

FDA Recall
Terminated ·Baxter Healthcare Corp. Rt.·Product code NZW·February 28, 2008

Baxter HEP-LOCK (Heparin Lock Flush Solution, USP) 100 units/mL-10 mL vial, 25 pack, NDC 0641-2436-45, (NDC 0641-2436-41; on vial), Baxter Healthcare Corporation, Deerfield, IL 60015

FDA Recall
Terminated ·Baxter Healthcare Corp. Rt.·Product code NZW·February 28, 2008

Baxter HEP-LOCK (Heparin Lock Flush Solution, USP), 10 u/mL-2 mL vial, 25 pack, NDC-0641-0393-25, (NDC-0641-0393-21; on vial), Baxter Healthcare Corporation, Deerfield, IL 60015

FDA Recall
Terminated ·Baxter Healthcare Corp. Rt.·Product code NZW·February 28, 2008

Baxter HEP-LOCK (Preservative-Free Heparin Lock Flush Solution, USP) 10 units/mL-1 mL vial, 25 pack, NDC 0641-0272-25 (NDC 0641-0272-21: on vial), Baxter Healthcare Corporation, Deerfield, IL 60015

FDA Recall
Terminated ·Baxter Healthcare Corp. Rt.·Product code NZW·February 28, 2008

Baxter HEP-LOCK (Preservative-Free Heparin Lock Flush Solution, USP) 100 units/mL-1 mL vial, 25 pack, NDC 0641-0273-25 (NDC 0641-0273-21; on vial), Baxter Healthcare Corporation, Deerfield, IL 60015

FDA Recall
Terminated ·Baxter Healthcare Corp. Rt.·Product code NZW·February 28, 2008