199 results
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7ms
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Sources: EU EUDAMED, US FDA
Life2000 Ventilator, Product Code: MS-01-0118, which is contained in the Life2000 Ventilator System, with Product Codes BT-20-0002, BT-20-0002A and BT-20-0002AP. The Life2000 ventilation system includes the Life2000 ventilator which has its individual label.
FDA Enforcement
Class I
·Ongoing·Baxter Healthcare Corporation·July 3, 2024
HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Product Usage: Is intended to repair the driveline cable once an electrical break has been identified. These repairs are limited to the portion of the driveline that is outside the patient boundary (exit side).
FDA Enforcement
Class I
·Ongoing·HeartWare Inc·May 20, 2015
HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Product Usage: Is intended to repair the driveline cable once an electrical break has been identified. These repairs are limited to the portion of the driveline that is outside the patient boundary (exit side).
FDA Enforcement
Class I
·Ongoing·Heartware·May 3, 2017
Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, 2.1mm Diameter / 14 Gauge, containing 6 inner boxes labeled REF 911761, Disposable Biopsy Needle Kit for Leksell Stereotactic System. Each inner box of REF 911761 contains a Tyvek bag labeled REF 912465, Disposable Biopsy Needle and Aspirator Tube.
FDA Enforcement
Class I
·Ongoing·Elekta Instrument AB·April 24, 2024
CereLink ICP Monitor; Catalog No. 826820, 826820P. Intracranial pressure monitor.
FDA Enforcement
Class I
·Ongoing·Integra LifeSciences Corp.·August 3, 2022
Baxter Novum IQ Large Volume Pump, Product Code REF 40700BAXUS
FDA Enforcement
Class I
·Ongoing·Baxter Healthcare Corporation·August 20, 2025
Baxter EXACTAMIX Inlet, Vented, Syringe Inlet, REF H938176, for use in a pharmaceutical compounding device
FDA Enforcement
Class I
·Ongoing·Baxter Healthcare Corporation·September 25, 2024
Baxter EXACTAMIX Inlet, Vented, High Volume Inlet, REF H938174, for use in a pharmaceutical compounding device
FDA Enforcement
Class I
·Ongoing·Baxter Healthcare Corporation·September 25, 2024
Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175, for use in a pharmaceutical compounding device
FDA Enforcement
Class I
·Ongoing·Baxter Healthcare Corporation·September 25, 2024
Baxter EXACTAMIX Inlet, Non-Vented, High Volume Inlet, REF H938173, for use in a pharmaceutical compounding device
FDA Enforcement
Class I
·Ongoing·Baxter Healthcare Corporation·September 25, 2024
MEDLINE beds labeled as: Full Electric Lightweight Homecare Bed, REF MDR107003L
FDA Enforcement
Class I
·Ongoing·Medline Industries, LP·January 28, 2026
MEDLINE beds labeled as: Semi Electric Lightweight Homecare Bed, REF MDR107002L
FDA Enforcement
Class I
·Ongoing·Medline Industries, LP·January 28, 2026
MEDLINE beds labeled as: Full Electric Low Basic Homecare Bed, REF MDR107003ELO
FDA Enforcement
Class I
·Ongoing·Medline Industries, LP·January 28, 2026
MEDLINE beds labeled as: Full Electric Low Lightweight Homecare Bed, REF MDR107003LO
FDA Enforcement
Class I
·Ongoing·Medline Industries, LP·January 28, 2026
MEDLINE beds labeled as: 1) Semi Electric Basic Homecare Bed, REF MDR107002E; 2) Semi Electric Basic Homecare Bed, 4-pack,REF MDR107002E-4
FDA Enforcement
Class I
·Ongoing·Medline Industries, LP·January 28, 2026
MEDLINE beds labeled as: 1) Full Electric Basic Homecare Bed, REF MDR107003E; 2) Full Electric Basic Homecare Bed, 4-pack,REF MDR107003E-4.
FDA Enforcement
Class I
·Ongoing·Medline Industries, LP·January 28, 2026
Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, Diameter / 14 Gauge, containing 6 inner boxes labeled REF 911761, Disposable Biopsy Needle Kit for Leksell Stereotactic System. Each inner box of REF 911761 contains a Tyvek bag labeled REF 912465, Disposable Biopsy Needle and Aspirator Tube. The system is used for for localization and diagnosis of intracranial disorders and their surgical treatment including radiosurgery and stereotactic radiation therapy.
FDA Enforcement
Class I
·Ongoing·Elekta Instrument AB·November 13, 2024
MEGADYNE MEGA 2000 Patient Return Electrode. used during electrosurgery
FDA Enforcement
Class I
·Ongoing·Megadyne Medical Products, Inc.·July 5, 2023
MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. used during electrosurgery
FDA Enforcement
Class I
·Ongoing·Megadyne Medical Products, Inc.·July 5, 2023
MEGADYNE MEGA SOFT Reusable Patient Return Electrode. used during electrosurgery
FDA Enforcement
Class I
·Ongoing·Megadyne Medical Products, Inc.·July 5, 2023