16 results
·
13ms
·
Sources: EU EUDAMED, US FDA
Filters
FDA Enforcement
×
a. ABBOTT RAPID DX N AMERICA LLC Alere Rapid Test Kit Alere Fertility Test hCG Pregnancy Test Urine Sample 30 Tests, Model Number: 92210. b. ABBOTT RAPID DX N AMERICA LLC Alere Rapid Test Kit Alere hCG Dipstick Fertility Test hCG Pregnancy Test Urine Sample 50 Tests Model Number: 92211.
FDA Enforcement
Class II
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·August 31, 2022
ABBOTT RAPID DX N AMERICA LLC MULTI ANALYTE LVL1&2250UL CHOLS CONTROL
FDA Enforcement
Class II
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·June 4, 2025
ABBOTT RAPID DX N AMERICA LLC, TEST CHOLESTEC LDXLIPID PROFILE (10/BX 50BX/CS) CASSETTES.
FDA Enforcement
Class II
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·June 4, 2025
ABBOTT RAPID DX N AMERICA LLC CHOLESTECH LDX LIPID PROFILE+GLUCOSE (10/BX 50BX/CS) TEST.
FDA Enforcement
Class II
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·June 4, 2025
ABBOTT RAPID DX N AMERICA LLC HBA1C HEMOGLOBIN AFINION GLYCTD (15TST/BX) TEST KIT.
FDA Enforcement
Class II
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·June 4, 2025
Abbott Rapid Dx N America LLC Reproductive Endocrinology Control Set McKesson Consult" Pregnancy (hCG) Testing Positive Level / Negative Level 2 X 4 mL
FDA Enforcement
Class II
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·March 27, 2024
TTDEYE (brand) Radial Pink, B16112110 - Product Usage: Colored contact lenses
FDA Enforcement
Class II
·Ongoing·Chengdu Ai Qin E-commerce Co., Ltd·August 5, 2020
TTDEYE (brand) Devil Red, B16112201 - Product Usage: Colored contact lenses
FDA Enforcement
Class II
·Ongoing·Chengdu Ai Qin E-commerce Co., Ltd·August 5, 2020
TTDEYE (brand) Radial Brown, B16112109 - Product Usage: Colored contact lenses
FDA Enforcement
Class II
·Ongoing·Chengdu Ai Qin E-commerce Co., Ltd·August 5, 2020
TTDEYE (brand) Black Starshine, B16112100 - Product Usage: Colored contact lenses
FDA Enforcement
Class II
·Ongoing·Chengdu Ai Qin E-commerce Co., Ltd·August 5, 2020
TTDEYE (brand) Diamonds Starlight, B16112203 - Product Usage: Colored contact lenses
FDA Enforcement
Class II
·Ongoing·Chengdu Ai Qin E-commerce Co., Ltd·August 5, 2020
TTDEYE (brand) Flower Grey, B16112231 - Product Usage: Colored contact lenses
FDA Enforcement
Class II
·Ongoing·Chengdu Ai Qin E-commerce Co., Ltd·August 5, 2020
TTDEYE (brand) Flower Brown, B16112210 - Product Usage: Colored contact lenses
FDA Enforcement
Class II
·Ongoing·Chengdu Ai Qin E-commerce Co., Ltd·August 5, 2020
Vivid q N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·December 28, 2022
LightSpeed QX/I (4-slice MDAS) LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST system - The GE Discovery ST system is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery ST is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning. The Discovery ST system can also be used as a stand-alone head and whole body multi-slice computed tomography (CT) diagnostic imaging system. LightSpeed Pro16 - The Lightspeed 5.0 CT Scanner System is indicated for head and whole body X-ray computed tomography applications. 16 Slice BGO PET/CT System - The GE Discovery XR and XA Systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery XR and XA are to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. These devices can also assist in radiotherapy planning. The Discovery XR and XA can also be used as stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging systems. 6 Slice BGO PET/CT System - The GE Discovery LS System is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery LS is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning. The Discovery LS can also be used as a stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging system.
FDA Enforcement
Class II
·Terminated·GE Medical Systems, LLC·March 16, 2016
GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system
FDA Enforcement
Class II
·Ongoing·GE Healthcare GmbH·December 24, 2025