19 results
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17ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·January 14, 2026
AXIOM Luminos TF, AXIOM Iconos R100, AXIOM Iconos R200 and AXIOM Luminos dRF
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·January 25, 2023
Apollo DRF, Model Number 9784220831 - Product Usage: The remote controlled table Apollo DRF is an X-ray equipment that allows to perform general radiographic and fluoroscopic examinations. The system is a fixed position type. The movements of the table and tube support are motorized and remote-controlled. Medical purpose is the diagnosis, visualization and documentation of various human diseases or injuries.
FDA Enforcement
Class II
·Ongoing·Villa Sistemi Medicali S.P.A.·January 8, 2020
Luminos Agile Max, Luminos dRF Max, and LUMINOS Lotus Max
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·January 25, 2023
Luminos dRF Max (VE10, VF10, VF11)
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·May 31, 2023
Luminos dRF Max- Intended to visualize anatomical structures by converting an x-ray pattern into a visible image. Model Number: 10762471
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·August 14, 2024
EasyDiagnost Eleva DRF, Release 5, used to acquire, process, store, display and export digital radiographic images.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·November 15, 2023
Juno DRF; Model: 709020 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures.
FDA Enforcement
Class II
·Ongoing·Villa Radiology Systems LLC·February 1, 2017
Apollo DRF: Model: 9784220831 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures.
FDA Enforcement
Class II
·Ongoing·Villa Radiology Systems LLC·February 1, 2017
Luminos dRF with software VD10- A diagnostic imaging system for radiographic and fluoroscopic studies Model Number: 10094200
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·March 1, 2023
Luminos dRF Max with software VE10, VF10, VF11- A diagnostic imaging system for radiographic and fluoroscopic studie Model Number:10762471
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·March 1, 2023
Juno DRF, Model Number 709020 - Product Usage: General. multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures.
FDA Enforcement
Class II
·Ongoing·Villa Sistemi Medicali S.P.A.·January 8, 2020
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BASIC CL PACK-LF DYNJ87052 BASIC PACK DYNJ83976 BASIC SET UP PACK DYNJ80700 CORONARY ANGIOGRAPHY PACK (N) DYNJ42136B CSTM ANGIO KIT - S VASC1109 CV PACK DYNJ46301C DR F PACK DYNJ41253B ENSEMBLE HEMORROIDES DYNJ56311A G TAVR PACK DYNJ61006 IR MINOR PACK DYNJ44139C MAJOR PLUS PACK DYNJ905160N MAXIMUM BARRIER BUNDLE PACK DYNJ35216C PCI PACK TBRHSC-LF DYNJ41941D PERC PACK-LF DYNJ0774759P PERIPHERAL ANGIOGRAPHY PK DYNJ42094B PROCEDURE PACK DYNJ55063B PTCA PACK DYNJ55359B ROBOTIC PACK DYNJ908706C SPECIAL PROCEDURES TRAY DYNJ41174A SYRINGE WIRE KIT SANFORD SAMPC0644 WPH EP PACK DYNJ62745 X-RAY PACK DYNJ44295G
FDA Enforcement
Class II
·Ongoing·Medline Industries, LP·April 29, 2026
Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number: EIA-4568 Product Description: T4 Total ELISA
FDA Enforcement
Class III
·Ongoing·DRG International, Inc.·August 13, 2025
DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361
FDA Enforcement
Class II
·Ongoing·DRG International, Inc.·January 22, 2025
17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro diagnostic measurement of 17-OH Progesterone (17-OHP) in serum or plasma Model/Catalog Number: EIA-1292
FDA Enforcement
Class III
·Ongoing·DRG International, Inc.·November 6, 2024
Product Name: Salivary Testosterone ELISA Model/Catalog Number: SLV-3013 Product Description: An enzyme immunoassay for the quantitative in vitro diagnostic measurement of free active testosterone in saliva.
FDA Enforcement
Class III
·Ongoing·DRG International, Inc.·August 21, 2024
Total Thyroxine (T4) ELISA; REF EIA-1781
FDA Enforcement
Class II
·Ongoing·DRG International, Inc.·December 8, 2021
Philips Respironics V60 Ventilator-Intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Model Number: R1053618 and R1076709. These are retrofitted device.
FDA Enforcement
Class II
·Ongoing·DRE Medical Group Inc·July 5, 2023