30 results
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19ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024
Pacific Medical GE Corometrics Nautilus Ultrasound, 5700 (Old Style), FFCM5660
FDA Enforcement
Class II
·Ongoing·Pacific Medical Group Inc.·February 12, 2020
Pacific Medical GE Corometrics Nautilus Ultrasound Transducer w/wing 5700LAX, FFCM5260
FDA Enforcement
Class II
·Ongoing·Pacific Medical Group Inc.·February 12, 2020
Pacific Medical Philips M1356A Ultrasound Transducer with belt/wire knob, FFPH5250
FDA Enforcement
Class II
·Ongoing·Pacific Medical Group Inc.·February 12, 2020
Pacific Medical GE Corometrics Nautilus Ultrasound Transducer w/knob, 5700HAX, FFCM5205
FDA Enforcement
Class II
·Ongoing·Pacific Medical Group Inc.·February 12, 2020
AlboGraft Woven with Collagen, Straight 30x24 Catalog Number: ATC3024 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
FDA Enforcement
Class I
·Terminated·LeMaitre Vascular, Inc.·July 31, 2013
AlboGraft Knitted with Collagen, Bifurcate 14x08 Catalog Number: AMC1408 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
FDA Enforcement
Class I
·Terminated·LeMaitre Vascular, Inc.·July 31, 2013
AlboGraft Knitted with Collagen, Straight 60x08 Catalog Number: AMC6008 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
FDA Enforcement
Class I
·Terminated·LeMaitre Vascular, Inc.·July 31, 2013
AlboGraft Woven with Collagen, Straight 15x30 Catalog Number: ATC1530 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
FDA Enforcement
Class I
·Terminated·LeMaitre Vascular, Inc.·July 31, 2013
AlboGraft Woven with Collagen, Straight 15x26 Catalog Number: ATC1526 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
FDA Enforcement
Class I
·Terminated·LeMaitre Vascular, Inc.·July 31, 2013
AlboGraft Knitted with Collagen, Bifurcate 18x09 Catalog Number: AMC1809 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
FDA Enforcement
Class I
·Terminated·LeMaitre Vascular, Inc.·July 31, 2013
AlboGraft Woven with Collagen, Straight 30x16 Catalog Number: ATC3016 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
FDA Enforcement
Class I
·Terminated·LeMaitre Vascular, Inc.·July 31, 2013
AlboGraft Knitted with Collagen, Straight 60x06 Catalog Number: AMC6006 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
FDA Enforcement
Class I
·Terminated·LeMaitre Vascular, Inc.·July 31, 2013
AlboGraft Woven with Collagen, Straight 30x26 Catalog Number: ATC3026 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
FDA Enforcement
Class I
·Terminated·LeMaitre Vascular, Inc.·July 31, 2013
AlboGraft Knitted with Collagen, Straight 40x07 Catalog Number: AMC4007 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
FDA Enforcement
Class I
·Terminated·LeMaitre Vascular, Inc.·July 31, 2013
AlboGraft Woven with Collagen, Straight 30x18 Catalog Number: ATC3018 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
FDA Enforcement
Class I
·Terminated·LeMaitre Vascular, Inc.·July 31, 2013
AlboGraft Knitted with Collagen, Straight 15x06 Catalog Number: AMC1506 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
FDA Enforcement
Class I
·Terminated·LeMaitre Vascular, Inc.·July 31, 2013
AlboGraft Knitted with Collagen, Straight 40x08 Catalog Number: AMC4008 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
FDA Enforcement
Class I
·Terminated·LeMaitre Vascular, Inc.·July 31, 2013
AlboGraft Knitted with Collagen, Bifurcate 20x10Catalog Number: AMC2010 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
FDA Enforcement
Class I
·Terminated·LeMaitre Vascular, Inc.·July 31, 2013
AlboGraft Knitted with Collagen, Bifurcate 18x10 Catalog Number: AMC1810 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
FDA Enforcement
Class I
·Terminated·LeMaitre Vascular, Inc.·July 31, 2013