27 results
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8ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class I
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GE Nuclear Medicine 600/800 series systems, specifically: a) BRIVO B615 3/8 inch DHP BJG NR, b) BRIVO 615 3/8 inch, c) BRIVO B615 3/8 inch DHP BJG NR, d) B615 with new rotor, e) BRIVO B615 3/8 inch BJG, f) BRIVO B615 3/8 inch DHP BJG NR, g) B615 with new rotor; Emission Computed Tomography System
FDA Enforcement
Class I
·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·February 15, 2023
GE Nuclear Medicine 600/800 series systems, specifically: a) 830, b) 830 / Dismount, c) 830 /, d) 830 / 5842894-20, e) 830 / Dismount / 50HZ, f) 830 / Dismount / 60HZ, g) 830 3/8 inch Detector, h) 830 BJ, i) 830 BJ / 5144407, j) 830 BJ / Dismount, k) 830 ES DEM, l) 830 NM Cyber Defense Configuration Gantry 3/8 inch, m) 830 NM Gantry 3/8 inch, n) 830 NM Gantry 5/8 inch, o) 870 DR NM GANTRY FINAL - NEW ROTOR, p) B615 to D630 UPG, q) D630 NM GANTRY, r) D630 NM GANTRY 3/8 inch WITH NEW ROTOR - MEA, s) D630 NM Gantry 3/8 inch, t) D630 NM GANTRY FINAL ASSEMBLY_, u) D630 with new rotor, v) D630 with new rotor/ 5144407 / Dismount, w) D630 with new rotor/ Dismount, x) DISCOVERY D630 X 3/8 inch, y) DISCOVERY D630 X 3/8 inch, z) DISCOVERY D630 X 3/8 inch, aa) DISCOVERY D630 x 3/8 inch BHW, bb) DISCOVERY D630 X 3/8 inch BJG, cc) DISCOVERY D630 X 3/8 inch MEA, dd) DISCOVERY NM 830 3/8 inch, ee) DISCOVERY NM 830 3/8 inch, ff) NM 830 3/8 inch, gg) NM 830 3/8 inch BJ, hh) NM 830 ES, ii) NM DISCOVERY D630 3/8 inch, jj) NUC GOLDSEAL D630 X 3/8 inch. Emission Computed Tomography System
FDA Enforcement
Class I
·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·February 15, 2023
Fisher & Paykel Healthcare reusable breathing circuit. Non-heated breathing circuit, 1.8m or 6 feet in length. Oxygen therapy delivery system for adult patient.
FDA Enforcement
Class I
·Terminated·Fisher & Paykel Healthcare, Ltd.·January 9, 2013
Infant Nasal CPAP (continuous positive airway pressure) Prong, Nasal. CPAP Prongs (10 pack): Model No. BC3020-10, BC3520-10, BC4030-10, BC4540-10, BC5040-10, BC5050-10, BC5550-10, BC5560-10, BC6060-10, BC6070-10, BC6570-10. Bubble CPAP Starter Kits: Model No. BC461-SK, BC471-SK, BC490-SK, BC491-SK, BC492-SK. The Nasal CPAP Prongs connect to the FPH FlexiTrunk Patient Interface.
FDA Enforcement
Class I
·Terminated·Fisher & Paykel Healthcare, Ltd.·May 28, 2014
CPAP Mask Cushion, Model Nos. PB781S, PB781M, PB781L, 781S, 781M and 781L Product Usage: A CPAP mask is attached to an end user s face and a CPAP machine, to treat end users with sleep apnea. The replacement cushion is a non-durable component that requires replacement every 3 - 6 months. The cushion is used for both comfort and to provide a seal between the face and the mask.
FDA Enforcement
Class I
·Terminated·Compass Health Brands (Corporate Office)·August 29, 2018
BD Alaris infusion Pump Module 8100, REF: 8100; KIT, BEZEL ASSY 8100BD, REF: 49000437; KIT ASSY ONE PIECE BEZEL 8100, REF: 49000270. Used with the following new and updated documents: BD Alaris Infusion System Inspection Safety Reminder, Part: BD-163124, Revision: 00; Cleaning and Disinfecting Procedure, Part: P00000864; Cleaning and Disinfecting Quick Reference Guide
FDA Enforcement
Class I
·Ongoing·CareFusion 303, Inc.·November 26, 2025
HeartMate¿ II LVAS with Pocket Controller; 107801 - HMII PUMP & POCKET CTRL ONLY UDI:00813024011286 Intended to provide hemodynamic support in patients with end-stage, refractory left ventricular heart failure; intended for use inside or outside the hospital.
FDA Enforcement
Class I
·Terminated·Thoratec Corporation·May 31, 2017
HeartMate¿ II LVAS with Pocket Controller; 106015 - HMII LVAD SEALED KIT-PCTRL, NA UDI: 00813024011224 Intended to provide hemodynamic support in patients with end-stage, refractory left ventricular heart failure; intended for use inside or outside the hospital.
FDA Enforcement
Class I
·Terminated·Thoratec Corporation·May 31, 2017
Replacement Battery List Number SUB0000594 and SUB0000864 found in Plum A+ & Plum A+3 Infusion Systems, Pump List Numbers: 11005, 11971, 12391, 12618, 20678, 20679, 20792, 60529, 12348, 11973. OUS units marketed with the following descriptions: Plum A+ Mednet TM Firmware New 13.6 Span, Plum A+3, PLUM A+3 INFUSION PUMPS and Plum A+3 Wireless Refurb, PLUM A+, PLUM A+ Infusion System, PlumA+3IV Pump Multi 1' Set
FDA Enforcement
Class I
·Ongoing·ICU Medical Inc·August 21, 2024
HAMILTON-G5, with software versions less than or equal to 2.60 The HAMILTON-G5/S1 ventilators are designed for intensive care ventilation of adult and pediatric patients, and optionally infant and neonatal patients. The device is intended for use in the hospital and institutional environment where health care professionals provide patient care.
FDA Enforcement
Class I
·Terminated·Hamilton Medical AG·July 17, 2019
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
GE Nuclear Medicine 600/800 series systems, specifically: a) 870, b) 870 DR 3/8 inch NM GANTRY WITH NEW ROTOR - MEA, c) 870 DR / Dismount, d) 870 DR / Dismount / 60HZ, e) 870 DR 3/8 inch WSO, f) 870 DR 3/8 inch NM Gantry, g) 870 DR 3/8 inch, h) 870 DR 3/8 inch CH, i) 870 DR 5/8 inch NM GANTRY, j) 870 DR BJ / Dismount, k) 870 DR CyberDefense 3/8 inch NM Gantry, l) 870 DR NM GANTRY FINAL - NEW ROTOR, m) 870 DR China, n) D670 NM GANTRY WITH NEW ROTOR, o) D670 DR 3/8 inch 16 SL, p) D670 DR 3/8 inch MEA, q) D670 DR 3/8 inch, r) D670 DR 3/8 inch 16SL, s) D670 DR 3/8 inch 16SL NR, t) D670 DR 3/8 inch BJ, u) D670 DR 3/8 inch MEA, v) D670 DR NM Gantry 3/8 inch, w) D670 DR NM Gantry 5/8 inch, x) D670 DR with new rotor, y) D670 ES NM Gantry 3/8 inch, z) D670 ES NM/CT 3/8 inch O540+ NM Gantry, aa) D670 ES NM/CT DR 3/8 inch, bb) D670 GANTRY, cc) D670 PRO NM Gantry 3/8 inch, dd) D670 PRO NM GANTRY 3/8 inch, ee) DISC NM/CT670 DR 3/8 inch, ff) DISC NM/CT870 DR 3/8 inch, gg) DISC NM/CT870 DR 3/8 inch, hh) DISC NM/CT870 DR 5/8 inch, ii) DISCOVERY 670 (TANDEM), jj) DISCOVERY NM 670, kk) DISCOVERY NM/CT 670 3/8 inch PRO, ll) DISCOVERY NM/CT 670 3/8 inch PRO NR, mm) HP Z420 WS Config 1 Hardware Specs Take 3 - E5-1620-8G-1TB-NVS, nn) NM/CT 870 DR, oo) NM/CT 870 DR 3/8 inch CYBER DEFENCE, pp) NM/CT 870 DR 3/8 inch WSO, qq) NM/CT 870 DR O540 3/8 inch, rr) NM/CT 870 DR O540 3/8 inch BJ, ss) NM/CT 870 DR O540 5/8 inch, tt) NM/CT 870 ES 3/8 inch, uu) NM/CT 870DR China for China, vv) NM/CT870 DR 3/8 inch O540, ww) NM/CT D870 DR O540 3/8 inch, xx) TANDEM DISCOVERY 670 INT; Emission Computed Tomography System
FDA Enforcement
Class I
·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·February 15, 2023
AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm; Material Number (UPN): M00553680;
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·February 11, 2026
AXIOS Stent and Electrocautery-Enhanced Delivery System - 8mm x 8mm; Material Number (UPN): M00553690;
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·February 11, 2026
Medpro Elastomeric Infusion Pump. AccuFlux, Model # CT-0020-100H. Product Usage: The devices are intended for patients requiring intravenous, percutaneous, subcutaneous, intra-operative sites or epidural administration of medications. It is the responsibility of the user to ensure that the medication is prepared and administered accordance with the drug manufacturers package insert. The devices deliver controlled amounts of medication directly to the intraoperative site for pain management and or antibiotic administration. The devices infuse the medication at an hourly flow rate. Medications are infused intraoperatively and postoperatively through intramuscular or subcutaneous routes. The devices are also intended for controlled delivery of local anesthetics in close proximity to nerves for post operative regional anesthesia and pain management. Routes of administration may be intraoperative or percutaneous. It is for continuous infusion of medications for general infusion use, including antibiotic delivery and chemotherapy.
FDA Enforcement
Class I
·Terminated·First Medical Source LLC·December 5, 2012
*HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 8mm x 8mm; Material Number (UPN): M00553530;
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·February 11, 2026
InstaTrak with Multiple Dataset Navigation, 892.2050 System, Image Processing System, Model Number IT3500 Plus. Product Usage: Usage: The system is an aid to locate anatomical structures during open or percutaneous surgical procedures. It is indicated for use in medical conditions that may benefit from the use of stereotactic surgical technique. The system provides a reference to rigid anatomical structures such as sinus, skull, long bone, or vertebra, which are visible on medical images such as CT, MR, or X-ray.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·July 18, 2012
MiniMed 630G Insulin Pump, REF: MMT-1515, MMT-1714, MMT-1715, MMT-1754, MMT-1755; MiniMed 700G Insulin Pump, REF: MMT-1800, MMT-1801, MMT-1805, MMT-1850, MMT-1851
FDA Enforcement
Class I
·Ongoing·Medtronic MiniMed, Inc.·October 9, 2024
HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm; Material Number (UPN): M00553520;
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·February 11, 2026
MiniMed Insulin Pump Device. MiniMed 670G, REF: MMT-1580, MMT-1581, MMT-1582, MMT-1780, MMT-1781, MMT-1782, MMT-1740, MMT-1741, MMT-1742, MMT-1760, MMT-1761, MMT-1762; MiniMed 770G, REF: MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892; MiniMed 780G, REF: MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, MMT-1896
FDA Enforcement
Class I
·Ongoing·Medtronic MiniMed, Inc.·October 9, 2024