16 results
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7ms
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Sources: EU EUDAMED, US FDA
Wayson Hydrocolloid Models: 1) MJ BANDAGE HYDROCOLLOID HEEL OVAL 6CT, Model Number: MJ18004V2; 2) MJ BANDAGE HYDROCOLLOID ALL PURP 10CT, Model Number: MJ18005V2; 3) MJ BNDG HYDROCOLLOID FINGER TOE 8CT, Model Number: MJ76126V2; 4) WALMART,BANDAGE,HYDROCOLLOID,HEEL,6CT, Model Number: WAL1901; 5) WALMART,HYDROCOLLOID,TOE,8CT, Model Number: WAL1902;
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·April 16, 2025
Stryker TMJ Unilateral Implant, REF: GHG010, consisting of the following components: Ref: CHG010AM, Anatomical Bone Model, Accessory, REF: CHG010RF, Glenoid Fossa Component, Right, REF: CHG010RM, Mandibular Component, Right.
FDA Enforcement
Class II
·Ongoing·TMJ Solutions Inc·October 2, 2024
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