63 results · 29ms · Sources: EU EUDAMED, US FDA

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Burke Bariatric Bed, manufactured by Kinetic Concepts, Inc., San Antonio, TX, model number 7064

FDA Recall
Terminated ·Kinetic Concepts, Inc·Product code FNL·March 22, 2004

Custom Assemblies, Inc., Single Spike Tumescent Set w/o Chamber, Reorder Number CMS-1212NS Bulk

FDA Enforcement
Class II ·Terminated·Stradis Medical, LLC dba Stradis Healthcare·December 29, 2021

Argon Medical Devices Double Male LL Adapter, REF 040184800A, bulk, non-sterile. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.

FDA Enforcement
Class II ·Terminated·Argon Medical Devices, Inc·November 13, 2019

Custom Assemblies, Inc., Single Spike Tumescent Set w/o Chamber, Reorder Number CMS-1212NS Bulk

FDA Recall
Terminated ·Stradis Medical, LLC dba Stradis Healthcare·Product code FPA·October 28, 2021

0.10% BreathScan Alcohol Detector manufactured for WNCK, Inc., The Woodlands, TX by Howard Industries, Inc., Columbus, OH (crystals) and James Alexander Corp., Blairstown, NJ (general device assembly). Product sold in bulk and individually packaged. Bulk product (500-1000 units) distributed in unlabeled clear plastic bags. Individually packaged product packaged and sealed in clear plastic bags with labeling and sold in boxes containing 100 units/box.

FDA Recall
Terminated ·WNCK, Inc·Product code DJZ·November 30, 2005

Argon Medical Devices Double Male LL Adapter, REF 040184800A, bulk, non-sterile. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.

FDA Recall
Terminated ·Argon Medical Devices, Inc·Product code DRS·October 16, 2018

Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087301, .035/150cm, regular/straight/standard, sold as a single hydrophilic guidewire in bulk non-sterile packaging. Argon Medical Devices, Inc. Athens, TX 75751.

FDA Recall
Terminated ·Argon Medical Devices, Inc·Product code DQX·February 26, 2009

Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087302, .035/180cm, regular/straight/standard, sold as a single hydrophilic guidewire in bulk non-sterile packaging. Argon Medical Devices, Inc. Athens, TX 75751.

FDA Recall
Terminated ·Argon Medical Devices, Inc·Product code DQX·February 26, 2009

Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087316, .038/150 cm, regular/angled/standard, sold as a single hydrophilic guidewire in bulk non-sterile packaging. Argon Medical Devices, Inc. Athens, TX 75751.

FDA Recall
Terminated ·Argon Medical Devices, Inc·Product code DQX·February 26, 2009

Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087308, .035/180 cm, stiff/straight/standard, sold as a single hydrophilic guidewire in bulk non-sterile packaging. Argon Medical Devices, Inc. Athens, TX 75751.

FDA Recall
Terminated ·Argon Medical Devices, Inc·Product code DQX·February 26, 2009

Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087317, .038/180 cm, regular/angled/standard, sold as a single hydrophilic guidewire in bulk non-sterile packaging. Argon Medical Devices, Inc. Athens, TX 75751.

FDA Recall
Terminated ·Argon Medical Devices, Inc·Product code DQX·February 26, 2009

Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087304, .035/150 cm, regular/angled/standard, sold as a single hydrophilic guidewire in bulk non-sterile packaging. Argon Medical Devices, Inc. Athens, TX 75751.

FDA Recall
Terminated ·Argon Medical Devices, Inc·Product code DQX·February 26, 2009

Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087311, .035/180 cm, stiff/angled/standard, sold as a single hydrophilic guidewire in bulk non-sterile packaging. Argon Medical Devices, Inc. Athens, TX 75751.

FDA Recall
Terminated ·Argon Medical Devices, Inc·Product code DQX·February 26, 2009

Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087306, .035/300 cm, regular/angled/standard, sold as a single hydrophilic guidewire in bulk non-sterile packaging. Argon Medical Devices, Inc. Athens, TX 75751.

FDA Recall
Terminated ·Argon Medical Devices, Inc·Product code DQX·February 26, 2009

Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087303, .035/300 cm, regular/straight/standard, sold as a single hydrophilic guidewire in bulk non-sterile packaging. Argon Medical Devices, Inc. Athens, TX 75751.

FDA Recall
Terminated ·Argon Medical Devices, Inc·Product code DQX·February 26, 2009

Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087305, .035/180 cm, regular/angled/standard, sold as a single hydrophilic guidewire in bulk non-sterile packaging. Argon Medical Devices, Inc. Athens, TX 75751.

FDA Recall
Terminated ·Argon Medical Devices, Inc·Product code DQX·February 26, 2009

Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087315, .038/300 cm, regular/straight/standard, sold as a single hydrophilic guidewire in bulk non-sterile packaging. Argon Medical Devices, Inc. Athens, TX 75751.

FDA Recall
Terminated ·Argon Medical Devices, Inc·Product code DQX·February 26, 2009

Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087312, .035/300 cm, stiff/angled/standard, sold as a single hydrophilic guidewire in bulk non-sterile packaging. Argon Medical Devices, Inc. Athens, TX 75751.

FDA Recall
Terminated ·Argon Medical Devices, Inc·Product code DQX·February 26, 2009

Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087314, .038/180 cm, regular/straight/standard, sold as a single hydrophilic guidewire in bulk non-sterile packaging. Argon Medical Devices, Inc. Athens, TX 75751.

FDA Recall
Terminated ·Argon Medical Devices, Inc·Product code DQX·February 26, 2009

Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087309, .035/300 cm, stiff/straight/standard, sold as a single hydrophilic guidewire in bulk non-sterile packaging. Argon Medical Devices, Inc. Athens, TX 75751.

FDA Recall
Terminated ·Argon Medical Devices, Inc·Product code DQX·February 26, 2009