38 results · 7ms · Sources: EU EUDAMED, US FDA

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GEO Instrument Kit for EPS Plate, REF: 70120001, part of the GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System

FDA Enforcement
Class II ·Ongoing·GRAMERCY EXTREMITY ORTHOPEDICS·April 26, 2023

CareFusion V.Mueller GENESIS SMALL, SHALLOW CONT. 21 X 7" (53.3 X 17.8CM) 3" (7.6CM) DEEP STERRAD COMPATIBLE, REF CD4-3ST

FDA Enforcement
Class II ·Ongoing·Carefusion 2200 Inc·November 23, 2022

Nanoplasty 3D Bunion Correction System Implant, Model Number: SK57. System contains the 01-00066 1st Metatarsal Plate as a component.

FDA Enforcement
Class II ·Ongoing·Treace Medical Concepts, Inc.·September 4, 2024

CareFusion V.Mueller GENESIS MINI CONTAINER 10-1/2 X 7-1/2" (26.7X19.0CM) 3" (7.6CM) DEEP STERRAD COMPATIBLE, REF CD0-3ST

FDA Enforcement
Class II ·Ongoing·Carefusion 2200 Inc·November 23, 2022

CareFusion V.Mueller GENESIS LARGE, SHALLOW CONT. 28 X 11" (71.1 X 27.9CM) 3" (7.6CM) DEEP, PERFORATED STERRAD COMPATIBLE, REF CD5-3ST

FDA Enforcement
Class II ·Ongoing·Carefusion 2200 Inc·November 23, 2022

BD Pyxis Mini Main REF: 349 Medication cabinet

FDA Enforcement
Class II ·Ongoing·CareFusion 303, Inc.·June 10, 2026

BD Pyxis MedStation ES REF: 323 Medication cabinet

FDA Enforcement
Class II ·Ongoing·CareFusion 303, Inc.·June 10, 2026

BD Pyxis MedStation 4000 REF: 303 Medication cabinet

FDA Enforcement
Class II ·Ongoing·CareFusion 303, Inc.·June 10, 2026

BD Pyxis MedBank Tower REF: 1145-00 Medication cabinet

FDA Enforcement
Class II ·Ongoing·CareFusion 303, Inc.·June 10, 2026

BD Pyxis Anesthesia Station ES REF: 327 Medication cabinet

FDA Enforcement
Class II ·Ongoing·CareFusion 303, Inc.·June 10, 2026

BD Pyxis MedStation ES Tower REF: 352 Medication cabinet

FDA Enforcement
Class II ·Ongoing·CareFusion 303, Inc.·June 10, 2026

BD Pyxis Anesthesia Station 4000 REF: 338 Medication cabinet

FDA Enforcement
Class II ·Ongoing·CareFusion 303, Inc.·June 10, 2026

BD Pyxis MedBank Mini REF: 1147-00 Medication cabinet

FDA Enforcement
Class II ·Ongoing·CareFusion 303, Inc.·June 10, 2026

Ritmed Neurological Sponges, Description/REF: 0.5x0.5in, Non-Sterile/55992C; 0.5x1.0in, Non-Sterile/55993C; 0.5x3.0in, Non-Sterile/55994C; 0.75x0.75in, Non-Sterile/55995C; 1.0x1.0in, Non-Sterile/55996C; 1.0x3.0in, Non-Sterile/55997C; 0.5x1.5in, Non-Sterile/55998C

FDA Enforcement
Class II ·Ongoing·AMD Medicom Inc.·June 24, 2026

St. Jude Medical Agilis NxT Steerable Introducer, REF 408309

FDA Enforcement
Class II ·Ongoing·St. Jude Medical·July 24, 2024

CardioMEMS Patient Electronic System (PES), Model Number CM1100. Used for wirelessly measuring and monitoring pulmonary artery pressure and heart rate.

FDA Enforcement
Class II ·Ongoing·St. Jude Medical·November 15, 2023

CardioMEMS HF System PA Sensor and Delivery System, Model Number CM2000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which physicians use to initiate or modify heart failure treatment.

FDA Enforcement
Class II ·Ongoing·St. Jude Medical·March 15, 2023

CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which physicians use to initiate or modify heart failure treatment.

FDA Enforcement
Class II ·Ongoing·St. Jude Medical·March 15, 2023

CardioMEMS HF System Patient Electronics System (PES), Model number CM1000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which physicians use to initiate or modify heart failure treatment.

FDA Enforcement
Class II ·Ongoing·St. Jude Medical·March 15, 2023

CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3100, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which physicians use to initiate or modify heart failure treatment.

FDA Enforcement
Class II ·Ongoing·St. Jude Medical·March 15, 2023