212 results
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12ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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Mighty Bliss Electric Heating Pad, Large (12 x 24 ) Grey Electric Heating Pad, PE-MtyBls-HeatPad-12x24-Gry-V2
FDA Enforcement
Class I
·Ongoing·Whele LLC DBA Perch·November 30, 2022
AQUABILITI AQUASTAT 0.9% Sodium Chloride Injection syringe, USP, 5mL in 12mL, REF 2T0805; and 3mL in 12mL, REF 2T0807, intermediate cartons containing 100 syringes, shipping cases containing 400 syringes, Rx, Sterile.
FDA Enforcement
Class II
·Ongoing·MRP, LLC dba Aquabiliti·February 28, 2024
Mighty Bliss Electric Heating Pad, Extra-Large (20 x 24 ) Blue Electric Heating Pad, MB-002
FDA Enforcement
Class I
·Ongoing·Whele LLC DBA Perch·November 30, 2022
Mighty Bliss Electric Heating Pad, Large (12 x 24 ) Blue Electric Heating Pad, MB-001
FDA Enforcement
Class I
·Ongoing·Whele LLC DBA Perch·November 30, 2022
Radiography 7300 C; Model Number: 712037;
FDA Enforcement
Class II
·Ongoing·Philips Medical Systems DMC GmbH·November 19, 2025
Power Injectable CT Port insertion kits - Product Usage: is an implantable access device designed to provide repeated access to the vascular system.
FDA Enforcement
Class II
·Ongoing·Medical Components, Inc dba MedComp·March 17, 2021
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
NavitrackER Kit A: Knee, Model Number 20-8000-000-07,
FDA Enforcement
Class II
·Ongoing·Orthosoft, Inc. dba Zimmer CAS·March 9, 2022
Clip COVID Rapid Antigen Test Kit (25-pack), Catalog Number: MDL002
FDA Enforcement
Class II
·Ongoing·LUMINOSTICS, INC dba CLIP HEALTH·October 19, 2022
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