8 results
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6ms
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Sources: EU EUDAMED, US FDA
M-4 Mechanism Set 16 mm and M-4 Mechanism Set 19 mm A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusion of a patient. the Universal Nut is a component of a Herbst Appliance
FDA Enforcement
Class II
·Terminated·Specialty Appliance Works, Inc.·April 29, 2015
MOST Options" System (MOST) HINGED TIB INS SZ 1 16MM HINGED TIB INS SZ 4 6MM M HINGED TIB INS SZ 4 9MM M HINGED TIB INS SZ 4 16MM MOST PROX TIB INS 6MM
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·March 26, 2014
SOMATOM Force, System x-ray, tomography, computed
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·December 14, 2016
LMA Esophageal Intubation Detector (EID), Catalog Number EID100 The device is used to assist verification of placement of the endotracheal tube or esophageal/tracheal double lumen tube. This device is to be used as an adjunct to assess intubation. Its purpose is not to eliminate clinical judgment
FDA Enforcement
Class II
·Terminated·LMA North America Inc·July 25, 2012
Magellan Hypodermic Safety Needle, 25 G x 5/8" (0.508 mm x 1.6 cm). A single lumen needle intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. Product Code: 8881850558
FDA Enforcement
Class II
·Terminated·Cardinal Health 200, LLC·March 24, 2021
Magellan 3 mL Syringe with Hypodermic Safety Needle, 25 G x 5/8" (0.508 mm x 1.6 cm). A single lumen needle intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. Product Code: 8881833558
FDA Enforcement
Class II
·Terminated·Cardinal Health 200, LLC·March 24, 2021
Integra Ojemann Cortical Stimulator; Product / Catalogue No: OCS2. Intended for intraoperative cortical stimulation mapping procedures.
FDA Enforcement
Class II
·Terminated·Integra Burlington MA, Inc.·April 10, 2013
LIFESTREAM Balloon Expandable Vascular Covered Stent . BARD PERIPHERAL VASCULAR. 6mm X 26mm X 80 Recommended Introducer 6F (2.00mm) NP 8atm (811 kPa) Recommended Guide wire .035" (0.89mm) RBP 12 atm (1216 kPa) RX Only Lot numbers begins with CMA or CMB. Product Code Stent Diameter Stent length Catheter Length LSM0800626 6mm 26 mm 80 cm LSM1350626 6 mm 26 mm 135 cm LSM0800637 6 mm 37 mm 80 cm LSM1350637 6 mm 37 mm 135 cm LSM0800726 7 mm 26 mm 80 cm LSM1350726 7 mm 26 mm 135 cm Product Usage: The LIFESTREAM Balloon Expandable Vascular Covered Stent is indicated for the treatment of atherosclerotic lesions in common and external iliac arteries with reference vessel diameters between 4.5 mm and 12.0 mm, and lesions lengths up to 100mm.
FDA Enforcement
Class II
·Terminated·Bard Peripheral Vascular Inc·December 25, 2019