22 results · 14ms · Sources: EU EUDAMED, US FDA

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DeRoyal AMG Suction Connector Tubing REF: 71-2083, 71-C506, 71-C510, 71-C512, 71-C520, Tubing is intended for fluid movement

FDA Enforcement
Class II ·Ongoing·DeRoyal Industries Inc·February 26, 2025

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

Radiography 7300 C; Model Number: 712037;

FDA Enforcement
Class II ·Ongoing·Philips Medical Systems DMC GmbH·November 19, 2025

CombiDiagnost PCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, fluoroscopic, general purpose.

FDA Enforcement
Class II ·Ongoing·Philips Medical Systems Gmbh, DMC·February 26, 2020

CombiDiagnost GCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, fluoroscopic, general purpose.

FDA Enforcement
Class II ·Ongoing·Philips Medical Systems Gmbh, DMC·February 26, 2020

DigitalDiagnost 4 Flex / Value. radiography and fluoroscopy system

FDA Enforcement
Class II ·Ongoing·Philips Medical Systems DMC GmbH·July 20, 2022

ProxiDiagnost N90. radiography and fluoroscopy system

FDA Enforcement
Class II ·Ongoing·Philips Medical Systems DMC GmbH·July 20, 2022

CombiDiagnost R90 Software Version R1.0 and R1.1

FDA Enforcement
Class II ·Ongoing·Philips Medical Systems Gmbh, DMC·September 8, 2021

DigitalDiagnost 4 High Performance. radiography and fluoroscopy system

FDA Enforcement
Class II ·Ongoing·Philips Medical Systems DMC GmbH·July 20, 2022

DigitalDiagnost C90 High Performance. radiography and fluoroscopy system

FDA Enforcement
Class II ·Ongoing·Philips Medical Systems DMC GmbH·July 20, 2022

DigitalDiagnost C90 Flex/Value/Chest/ER. radiography and fluoroscopy system

FDA Enforcement
Class II ·Ongoing·Philips Medical Systems DMC GmbH·July 20, 2022

CombiDiagnost R90; Model Number: 709031;

FDA Enforcement
Class II ·Ongoing·Philips Medical Systems DMC GmbH·November 19, 2025

DigitalDiagnost 4 (1) High Performance, (2) Flex/Value; Model Number: (1) 712031, (2) 712032;

FDA Enforcement
Class II ·Ongoing·Philips Medical Systems DMC GmbH·November 19, 2025

Precision CRF; Model Number: 706400;

FDA Enforcement
Class II ·Ongoing·Philips Medical Systems DMC GmbH·November 19, 2025

ProxiDiagnost N90; Model Number: 706110;

FDA Enforcement
Class II ·Ongoing·Philips Medical Systems DMC GmbH·November 19, 2025

DigitalDiagnost C90 (1) High Performance, (2) Flex/Value/Chest/ER; Model Number: (1) 712034, (2) 712035;

FDA Enforcement
Class II ·Ongoing·Philips Medical Systems DMC GmbH·November 19, 2025