127 results
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17ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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BD Alaris PCU REF 8015
FDA Enforcement
Class I
·Ongoing·CareFusion 303, Inc.·November 15, 2023
BD Care Coordination Engine (CCE) Infusion Adapter, Safety Management Software
FDA Enforcement
Class I
·Ongoing·CareFusion 303, Inc.·March 19, 2025
BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software
FDA Enforcement
Class I
·Ongoing·CareFusion 303, Inc.·March 19, 2025
BD Alaris" Pump Module model 8100 UDI-DI code: 10885403810046 The BD AlarisTM System with Guardrails" Suite MX is a modular infusion pump and monitoring system for the continuous or intermittent administration of fluids to adult, pediatric, and neonatal patients through clinically accepted routes of administration: intravenous (IV), intra-arterial (IA), subcutaneous, epidural, or irrigation of fluid spaces. The BD AlarisTM System includes the PC Unit (PCU) and one or more of the following: Pump Module, Syringe Module, end-tidal CO2 (EtCO2) Module, Auto-ID Module, patient-controlled analgesia (PCA) Module, and associated software applications.
FDA Enforcement
Class II
·Ongoing·CareFusion 303, Inc.·February 4, 2026
Acu-Loc and Acu-Loc 2 bone plates, screws and accessories for the following REF: 70-0045 Acu-Loc VDU Plate Standard, Left; 70-0045-S Acu-Loc VDU Plate Standard, Left; 70-0046 Acu-Loc VDU Plate Standard, Right; 70-0046-S Acu-Loc VDU Plate Standard, Right; 70-0047 Acu-Loc VDU Plate Long, Left; 70-0047-S Acu-Loc VDU Plate Long, Left; 70-0048 Acu-Loc VDU Plate Long, Right; 70-0048-S Acu-Loc VDU Plate Long, Right; 70-0055 Acu-Loc Dorsal Plate, Standard, left; 70-0055-S Acu-Loc Dorsal Plate, Standard, left; 70-0056 Acu-Loc Dorsal Plate, Standard, Right; 70-0056-S Acu-Loc Dorsal Plate, Standard, Right; 70-0057 Acu-Loc Dorsal Plate, Narrow, Left; 70-0057-S Acu-Loc Dorsal Plate, Narrow, Left; 70-0058 Acu-Loc Dorsal Plate, Narrow, Right; 70-0058-S Acu-Loc Dorsal Plate, Narrow, Right; 70-0331 Divergent Radial Styloid Plate; 70-0331-S Divergent Radial Styloid Plate; 70-0334 Volar Lunate Suture Plate; 70-0334-S Volar Lunate Suture Plate; 70-0335 Dorsal Rim Buttress Plate, Right; 70-0335-S Dorsal Rim Buttress Plate, Right; 70-0336 Dorsal Rim Buttress Plate, Left; 70-0336-S Dorsal Rim Buttress Plate, Left; 70-0337 Dorsal Lunate Plate, Right; 70-0337-S Dorsal Lunate Plate, Right; 70-0338 Dorsal Lunate Plate, Left;
FDA Enforcement
Class II
·Ongoing·Acumed LLC·March 6, 2024
1688 Camera Control Unit (CCU), Catalog number:1688010000. Used in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery wherever a laparoscope/endoscope/arthroscope/sinuscope is used.
FDA Enforcement
Class II
·Ongoing·Stryker Corporation·March 16, 2022
Plum Duo Precision IV Pump, 40002-0403
FDA Enforcement
Class II
·Ongoing·ICU Medical, Inc.·June 17, 2026
Plum Duo Infusion Pump, 40002-0401
FDA Enforcement
Class II
·Ongoing·ICU Medical, Inc.·June 17, 2026
Plum Solo Precision IV Pump, 40001-0401
FDA Enforcement
Class II
·Ongoing·ICU Medical, Inc.·June 17, 2026
Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros; ChemoLock; Syringe Transfer Set w/MicroClave, ChemoLock Port, REF: CL3960
FDA Enforcement
Class II
·Ongoing·ICU Medical, Inc.·May 27, 2026
ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)
FDA Enforcement
Class II
·Ongoing·ICU Medical, Inc.·January 28, 2026
Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG
FDA Enforcement
Class II
·Ongoing·ICU Medical Inc.·January 21, 2026
Portex Spinal Tray, Item No. A3729-24 A3595
FDA Enforcement
Class II
·Ongoing·ICU Medical Inc.·January 21, 2026
LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02
FDA Enforcement
Class II
·Ongoing·ICU Medical, Inc.·December 31, 2025
ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001 (Philippines)
FDA Enforcement
Class II
·Ongoing·ICU Medical, Inc.·January 28, 2026
ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021003 (Philippines)
FDA Enforcement
Class II
·Ongoing·ICU Medical, Inc.·January 28, 2026
Plum Duo Infusion System, List Number 40002-04-01
FDA Enforcement
Class II
·Ongoing·ICU Medical, Inc.·January 21, 2026
Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000
FDA Enforcement
Class II
·Ongoing·ICU Medical, Inc.·January 28, 2026
LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02
FDA Enforcement
Class II
·Ongoing·ICU Medical, Inc.·December 31, 2025
ICU Medical ChemoLock Closed Vial Spike w/Skirt, 5 Units REF: CL-80S-5
FDA Enforcement
Class II
·Ongoing·ICU Medical, Inc.·November 5, 2025