510 results
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12ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class I
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Medical Action Industries Inc. Pack Cath BHH, REF: BHCA49K, Sterile EO, Rx Only, QTY: 5/Case
FDA Enforcement
Class I
·Ongoing·Medical Action Industries, Inc. 306·May 13, 2026
Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid from a negative head height (when the IV fluid container is lower than the pump), and provides clinically accepted volumetric accuracy for all standard IV fluids, including blood, lipid, and Total Parenteral Nutrition (TPN). Model number: 621-300ES and 621-400ES. To deliver a broad range of drugs with use with the B. Braun Medical Inc. Horizon Pump IV Sets.
FDA Enforcement
Class I
·Terminated·B Braun Medical, Inc.·September 25, 2013
STERILE SAMPLE BUILD; REF: SAMP0147; Packaged for Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform medical procedures.
FDA Enforcement
Class I
·Terminated·Medline Industries, Inc.·March 5, 2014
STERILE SAMPLE BUILD; REF: SAMP0144; Packaged for Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform medical procedures..
FDA Enforcement
Class I
·Terminated·Medline Industries, Inc.·March 5, 2014
CATH PACK; REF: DYNJ40904; Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform medical procedures.
FDA Enforcement
Class I
·Terminated·Medline Industries, Inc.·March 5, 2014
CATH TRAY; REF: DYNJ41101; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform angiography medical procedures.
FDA Enforcement
Class I
·Terminated·Medline Industries, Inc.·March 5, 2014
STERILE SAMPLE CATH LAB PACK; REF: SAMP0213; Packaged for Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform medical procedures.
FDA Enforcement
Class I
·Terminated·Medline Industries, Inc.·March 5, 2014
CATH PACK; REF: DYNJ41103; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform angiography medical procedures.
FDA Enforcement
Class I
·Terminated·Medline Industries, Inc.·March 5, 2014
ANGIOGRAPHY PACK; REF: DYNJ26855D; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform angiography medical procedures.
FDA Enforcement
Class I
·Terminated·Medline Industries, Inc.·March 5, 2014
CATH ANGIOGRAPHY DRAPE PACK; REF: DYNJ40851; Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform medical procedures.
FDA Enforcement
Class I
·Terminated·Medline Industries, Inc.·March 5, 2014
ANGIO PACK #2; REF: DYNJ39185; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform angiography medical procedures.
FDA Enforcement
Class I
·Terminated·Medline Industries, Inc.·March 5, 2014
CATH LAB CUSTOM PACK; REF: DYNJ40926; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform angiography medical procedures.
FDA Enforcement
Class I
·Terminated·Medline Industries, Inc.·March 5, 2014
HEART CATH CUSTOM PACK; REF: DYNJ39747A; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform angiography medical procedures.
FDA Enforcement
Class I
·Terminated·Medline Industries, Inc.·March 5, 2014
Brand Name: AFX" Introducer System, Model Number S17-45. Lot Numbers: 1079840, 1079843, 1079844, 1079845. Product Usage: The AFX Introducer System is intended for use to facilitate the introduction of catheters and other medical devices into the vasculature and to minimize blood loss associated with such introduction.
FDA Enforcement
Class I
·Terminated·Endologix Inc·June 19, 2013
Ultra-Myossage Lotion 1-gallon bottle, REF: 4262; Myossage Lotion 1-gallon bottle, REF: 4210, located in the following DJO, LLC / DJO FRANCE kits:
FDA Enforcement
Class I
·Ongoing·DJO, LLC·October 13, 2021
Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; List Number 16027-01 Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes, blood and blood products for parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural
FDA Enforcement
Class I
·Terminated·Hospira Inc.·October 31, 2012
Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; List Number 16026-01 Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes, blood and blood products for parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural
FDA Enforcement
Class I
·Terminated·Hospira Inc.·October 31, 2012
EcoGel 200 - RED Medical Supplies Clear Ultrasound Gel, Model No. 250UG-CMU
FDA Enforcement
Class I
·Ongoing·Red Medical Supplies·October 20, 2021
EcoGel 200 - RED Medical Supplies Blue Ultrasound Gel, Model No. 250UG-BMU
FDA Enforcement
Class I
·Ongoing·Red Medical Supplies·October 20, 2021
EcoGel 100 - RED Medical Supplies Green Ultrasound Gel, Model No. 250UG-GLU
FDA Enforcement
Class I
·Ongoing·Red Medical Supplies·October 20, 2021