100 results
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8ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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OSCOR ADELANTE BREEZEWAY 10F C55¿ S61CM D66CM Catalog # AB101072 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
FDA Enforcement
Class II
·Terminated·Oscor, Inc.·December 28, 2016
Edwards Pressure Monitoring Kit with TruWave disposable pressure transducer. A sterile, single-use kit that monitors pressures when attached to pressure monitoring catheters. For use on patients requiring intravascular, intracranial, or intrauterine pressure monitoring.
FDA Enforcement
Class II
·Terminated·Edward Lifesciences, Llc·September 23, 2015
Foot Pack, part number AMS3637
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
Extremity Tray, Kit number AMS1200(B and AMS1200(C convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016
Accurus 2500 Standalone Vitreous Probe REF 8065741018; Accurus 23 GA Standalone Vitreous Probe REF 8065750821; Accurus 25+ 2500 CPM Standalone Vitreous Probe REF 8065751122; Anterior Accurus Probe with Infusion Needle REF 8065803650; Single Use Sterile Probes Rx only. Intended to provide the surgeon with a single-use probe for performing vitrectomy surgical procedures while using the Alcon Accurus vitrectomy console.
FDA Enforcement
Class II
·Terminated·Alcon Research, Ltd.·July 8, 2015
Arthroscopy Pack, part number AMS2938 Arthroscopy Pack, part number AMS3639 Arthroscopy Pack, part number AMS4765 Arthroscopy Pack, part number PSS1799 Arthroscopy Pack, part number PSS1845(A
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
Total Joint Pack, part number 006358-6
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
Ocular Plastic Pack, Kit number AMS3868 and AMS3868(A convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016
Zenostar MT Color A3 60ml, art. no. 681052. Product Usage: For coloring dental porcelain
FDA Enforcement
Class II
·Terminated·Ivoclar Vivadent, Inc.·October 12, 2016
Zenostar MT Color B1 60ml, art. no. 681055. Product Usage: For coloring dental porcelain
FDA Enforcement
Class II
·Terminated·Ivoclar Vivadent, Inc.·October 12, 2016
OSCOR ADELANTE BREEZEWAY 10F C70¿ S61CM D66CM Catalog # AB101073 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
FDA Enforcement
Class II
·Terminated·Oscor, Inc.·December 28, 2016
Affixus Hip Fracture Nail, 125 DEG 11MM X 180MM
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·February 7, 2018
Affixus Hip Fracture Nail, 130 DEG 11MM X 180MM
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·February 7, 2018
Affixus Hip Fracture Nail, 130 DEG 9MM X 180MM
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·February 7, 2018
Lap/Pelviscopy Pack, Kit number AMS4151, PSS3256, PSS3256(A convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016
Affixus Hip Fracture Nail, RH 130 DEG 11MM X 400MM
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·February 7, 2018
Affixus Hip Fracture Nail, LH 125 DEG 9MM X 440MM
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·February 7, 2018
Affixus Hip Fracture Nail, RH 125 DEG 9MM X 460MM
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·February 7, 2018
Affixus Hip Fracture Nail, RH 125 DEG 11MM X 440MM
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·February 7, 2018
Affixus Hip Fracture Nail, LH 125 DEG 9MM X 260MM
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·February 7, 2018