54 results
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14ms
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Sources: EU EUDAMED, US FDA
Achilles Express Bone Sonometer
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·October 16, 2019
Achilles Insight Bone Sonometer
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·October 16, 2019
lnvatec SpA brand Diver C.E., Model/Catalog Numbers: DVR010014145, DVR011014145, Product is manufactured by lnvatec SpA, Roncadelle, Italy, and distributed by Invatec, Inc., Bethlehem, PA and by Medtronic Endovascular Therapies, Santa Rosa, CA The Diver C.E. product is an aspiration catheter indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system.
FDA Enforcement
Class II
·Terminated·Invatec Llc·June 12, 2013
G7 DUAL MOBILITY LINER 44MM F Product Usage: Intended for use in hip arthroplasty cases which involves the removal of the damaged joint and tissues to be replaced with artificial prosthesis. The result of the procedure is to relieve pain and restore a sense of normal function and mobility to the damaged joint.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·February 21, 2018
Sofia 2 Analyzer Catalog Number 20299 Sofia 2 is a bench top analyzer intended to be used with Cassette-based immunofluorescent in vitro diagnostic assays . Sofia 2 is intended for professional and laboratory use.
FDA Enforcement
Class II
·Terminated·Quidel Corporation·April 4, 2018
BodyGuard Microset REF A120-003XYVA, Sterile EO, Tubing: 150 in. (380 cm), Prime Vol: approx. 8ml Product Usage: The BodyGuard Infusion Pump System is designed to transfer medication and fluids intravenously.
FDA Enforcement
Class I
·Terminated·CME America, LLC·March 18, 2020
CME America BodyGuard Infusion Pump System, All models of BG 323, BG 121, BG 545, BG CV545, BG 575, BG CV575, and CMExpress
FDA Enforcement
Class I
·Terminated·CME America, LLC·March 25, 2020
BodyGuard 323 pump, models 100-510PXSI, 100-516PXS, 100-517PXS, 100-518PXS, 100-603XSA and 100-603XSAP
FDA Enforcement
Class II
·Terminated·CME America, LLC·February 25, 2015
Germ Terminator, Toothbrush Steam Sterilization for Oral Health. Model GT100. The Germ Terminator uses steam heat to sanitize two manual toothbrushes or two toothbrush heads. Water is poured into a reservoir in the device's housing. The steam cycle is followed by a drying cycle.
FDA Enforcement
Class II
·Terminated·Ceg Enterprises Llc·June 29, 2016
BodyGuard Microset For Use with the BodyGuard Infusion Pump *** Tubing: 110 in. (280 cm) - Blue Stripe - Product Usage: The system is intended for patients who require maintenance medications, PCA therapy, parenteral nutritional fluids, and general IV fluid therapy in hospital and home care environments.
FDA Enforcement
Class II
·Terminated·CME America, LLC·May 13, 2020
BodyGuard Microset with Filter, REF: A120-160XSFE
FDA Enforcement
Class I
·Terminated·CME America, LLC·July 22, 2020
BodyGuard Microset, REF: A120-003XS2YV
FDA Enforcement
Class I
·Terminated·CME America, LLC·July 22, 2020
BodyGuard Microset, REF: A120-112XSFK
FDA Enforcement
Class I
·Terminated·CME America, LLC·July 22, 2020
Standard BodySet with Needleless Connectors, REF: A120-125XS
FDA Enforcement
Class I
·Terminated·CME America, LLC·July 22, 2020
BodyGuard Microset, REF: A120-160GCFA
FDA Enforcement
Class I
·Terminated·CME America, LLC·July 22, 2020
CMExpress Needleless Y Site Microbore Set, REF: A120-160CYNVK
FDA Enforcement
Class I
·Terminated·CME America, LLC·July 22, 2020
BodyGuard Microset, REF: A120-161XYB
FDA Enforcement
Class I
·Terminated·CME America, LLC·July 22, 2020
CMExpress Microbore Sets, REF: A120-160C2YRV
FDA Enforcement
Class I
·Terminated·CME America, LLC·July 22, 2020
CMExpress Microbore Sets, REF: A120-161C
FDA Enforcement
Class I
·Terminated·CME America, LLC·July 22, 2020
BodyGuard Microset, REF: A100-163XESV
FDA Enforcement
Class I
·Terminated·CME America, LLC·July 22, 2020