55 results
·
18ms
·
Sources: EU EUDAMED, US FDA
Filters
FDA Enforcement
×
COOK MEDICAL Cook Staged Extubation Set: Reference Part Number C-CAE-14.0-83-EXTU, Order Number G24073
FDA Enforcement
Class II
·Ongoing·Cook Incorporated·April 15, 2026
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
Dimension(R) Mass Creatine Kinase MB Isozyme Calibrator (RC420) The Mass Creatine Kinase MB isozyme Calibrator is an in vitro diagnostic product intended to be used to calibrate the Creatine Kinase MB Isozyme method for the Dimension(R) clinical chemistry system with heterogeneous immunoassay module.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·August 14, 2013
BD Care Coordination Engine (CCE) Infusion Adapter, Safety Management Software
FDA Enforcement
Class I
·Ongoing·CareFusion 303, Inc.·March 19, 2025
Cue Health COVID-19 Test Cartridge REF 2900005 Cue COVID-19 Test Cue COVID-19 Test for Home and Over The Counter (OTC)
FDA Enforcement
Class II
·Ongoing·CUE HEALTH INC·October 23, 2024
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
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
BodyGuard Microset with Needleless Adaptor, REF: A120-003XSNY
FDA Enforcement
Class I
·Terminated·CME America, LLC·July 22, 2020