46 results
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28ms
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Sources: EU EUDAMED, US FDA
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Gammex Non-Latex Sensitive Neoprene Surgical Gloves Ansell Lanka (pvt) Ltd. Biyagama Export Processing Zone, Biyagama, Sri Lanka Ansell Healthcare Europe, N.V Internationaleiaan 55, 1070 Brussels, Belgium Manufactured for/ Fabrique' pour: Ansell Healthcare products LLC. 1635 Industrial Road Dothan, AL 36303, USA TEL USA- 1-800-952-9916 CAN- 1-844-494-7854 catalog #20277285
FDA Enforcement
Class II
·Terminated·Ansell Healthcare Products LLC·December 28, 2016
Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-7.0-18/38-45-RB-ANL0-HC Order Number/GPN: G44155 Intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
FDA Enforcement
Class II
·Terminated·Cook Inc.·December 22, 2021
Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-6.0-18/38-45-RB-ANL0-HC Order Number/GPN: G44154 Intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
FDA Enforcement
Class II
·Terminated·Cook Inc.·December 22, 2021
Sandel Healthcare Safety Devices Weighted Safety Scalpel 4# Disposable Safety Handle with #20 Blade Manufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth, CA 91311 USA Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Made in China Packaged in Mexico Ansell A manual surgical scalpel blade for making incisions in various general surgical procedures.
FDA Enforcement
Class II
·Terminated·Ansell Sandel Medical Industries LLC·January 15, 2014
Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle with #11 Blade Manufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth, CA 91311 USA Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Made in China Packaged in Mexico Ansell A manual surgical scalpel blade for making incisions in various general surgical procedures.
FDA Enforcement
Class II
·Terminated·Ansell Sandel Medical Industries LLC·January 15, 2014
Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle with #15 Blade Manufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth, CA 91311 USA Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Made in China Packaged in Mexico Ansell A manual surgical scalpel blade for making incisions in various general surgical procedures.
FDA Enforcement
Class II
·Terminated·Ansell Sandel Medical Industries LLC·January 15, 2014
Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle with #10 Blade Manufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth, CA 91311 USA Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Made in China Packaged in Mexico Ansell A manual surgical scalpel blade for making incisions in various general surgical procedures.
FDA Enforcement
Class II
·Terminated·Ansell Sandel Medical Industries LLC·January 15, 2014
Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Long Disposable Safety Handle with #10 Blade Manufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth, CA 91311 USA Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Made in China Packaged in Mexico Ansell A manual surgical scalpel blade for making incisions in various general surgical procedures.
FDA Enforcement
Class II
·Terminated·Ansell Sandel Medical Industries LLC·January 15, 2014
Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle with #11 Blade Manufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth, CA 91311 USA Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Made in China Packaged in Mexico Ansell A manual surgical scalpel blade for making incisions in various general surgical procedures.
FDA Enforcement
Class II
·Terminated·Ansell Sandel Medical Industries LLC·January 15, 2014
LifeStyles ZERO 10 uber-thin lubricated latex condoms. Mfd. for Ansell Healthcare Products LLC, Dothan, AL 96303. A sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections).
FDA Enforcement
Class II
·Terminated·Ansell Healthcare Products LLC·February 27, 2013
Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Long Disposable Safety Handle with #15 Blade Manufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth, CA 91311 USA Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Made in China Packaged in Mexico Ansell 2215-L Weighted Safety Scalpel, #3L Handle (8.75) with #15 Blade, Yellow Shield with TIME OUT¿ Sleeve (S) 12 per box; 8 boxes per case (96 total scalpels) A manual surgical scalpel blade for making incisions in various general surgical procedures.
FDA Enforcement
Class II
·Terminated·Ansell Sandel Medical Industries LLC·January 15, 2014
Powdered Surgical Gloves, labeled as: a. Baxter and Ansell brand Powdered Surgical Gloves b. Powdered Surgical Gloves included in ACS surgical convenience kits Health care personnel rely on medical gloves as barriers against transmission of infectious diseases and contaminants when conducting surgery, as well as when conducting more limited interactions with patients.
FDA Enforcement
Class II
·Terminated·American Contract Systems, Inc.·November 21, 2018
Lifestyles Pleasure Collection 30 Premium Lubricated Condoms Assortment of Ultra Sensitive, Flavors and Colors, Skyn, Thryll, Thyn, and Ultra Thin. UPC 0-70907-02625-0.
FDA Enforcement
Class II
·Terminated·Ansell Healthcare Products LLC·January 30, 2013
MICROFLEX Diamond Grip Examination Gloves, MF-300 - Product Usage: A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner s hand or finger to prevent contamination between patient and examiner.
FDA Enforcement
Class II
·Terminated·Ansell Healthcare Products LLC·October 14, 2020
NOVAPLUS GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: V20685255 through V20685290
FDA Enforcement
Class II
·Ongoing·Ansell Healthcare Products LLC·October 18, 2023
GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: 20685255 through 20685290
FDA Enforcement
Class II
·Ongoing·Ansell Healthcare Products LLC·October 18, 2023
Gammex Non-Latex PI Green PI-KARE Skin-friendly PI Technology polyisoprene surgical gloves 7 1/2
FDA Enforcement
Class II
·Ongoing·Ansell Healthcare Products LLC·April 6, 2022
Ossur, LIL Angel Vest, Part/ Description: 545100K/ LIL ANGEL VEST P2 KODEL; 545100L/ LIL ANGEL VEST P2 LAMBSWOOL; 545100S/ LIL ANGEL VEST P2 SORBATEX; 545150K/ LIL ANGEL VEST P3 KODEL; 545150L/ LIL ANGEL VEST P3 LAMBSWOOL; 545150S/ LIL ANGEL VEST P3 SORBATEX
FDA Enforcement
Class II
·Terminated·Ossur Americas·March 20, 2019
8500M Handheld Pulse Oximeter
FDA Enforcement
Class II
·Terminated·Nonin Medical, Inc·April 5, 2017
Ring Transjugular Intrahepatic Access Set Product Usage: The Ring Transjugular Intrahepatic Access Sets are intended for transjugular liver access in diagnostic and interventional procedures. The Ring Transjugular Intrahepatic Access Set consists of the following components: Flexor RTPS Guiding Sheath, needle, catheter, Dilator, Torcon NB Advantage Catheter, Van Andel Dilatation Catheter, Curved Newton Wire Guide, Amplatz Extra Stiff Wire Guide.
FDA Enforcement
Class II
·Terminated·Cook Inc.·July 29, 2015