48 results
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15ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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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 Recall
Open, Classified
·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 4, Hayozma St Tirat Carmel Israel·Product code KPS·December 19, 2022
GlideScope Go Monitors
FDA Recall
Open, Classified
·Verathon, Inc.·Product code CCW·July 1, 2021
#1 MAC F/O LARYNGOSCOPE; F/O Laryngoscope Set-MAC; F/O Laryngoscope Set-MAC W/LED
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code CCW·May 17, 2022
125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of supplemental oxygen. Models: 125D, 125D-XB
FDA Recall
Open, Classified
·DeVilbiss Healthcare LLC·Product code CAW·September 19, 2022
DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK, 1025KS, and 1025KS-AR
FDA Recall
Open, Classified
·DeVilbiss Healthcare LLC·Product code CAW·March 9, 2023
JMC5A Ni/TruAire-5 Oxygen Concentrator, Model: O2C5L
FDA Recall
Open, Classified
·JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD No·Product code CAW·December 9, 2024
Brand Name: GlideScope Core 15-inch FHD Model/Catalog Number: 0570-0437 Software Version: Core 15 FHD v1.7 and earlier Product Description: Serialized Monitor
FDA Recall
Open, Classified
·Verathon, Inc.·Product code CCW·April 29, 2024
McGrath Mac Video Laryngoscope, REF: 300-000-000 , Non-Sterile, Rx Only
FDA Recall
Open, Classified
·Covidien·Product code CCW·July 9, 2024
BritePro Solo Single-Use Fiber Optic Handle and Blade Refs: 040-331U (Mac 1), 040-332U (Mac 2), 040-333U (Mac 3), 040-335U (Mac 3.5) 040-334U (Mac 4), 040-341U (Miller 1), 040-342U (Miller 2), 040-343U (Miller 3), 040-344U (Miller 4), 040-361U (Phillips 1), 040-362U (Phillips 2)
FDA Recall
Open, Classified
·Flexicare Medical (Dongguan) Ltd. Hengli Town No. B-15 Xicheng; Henglizhen Dongguan China·Product code CCW·July 11, 2025
McGRATH X3 Disposable Laryngoscope Blades-used with the McGRATH MAC Video Laryngoscope to aid the intubation of the trachea Code: X3-002-000 (Individual Unit); X3-003-000 (Carton of 10 Units) - Product Usage: is a tool used to aid the intubation of the trachea. As a rigid laryngoscope it holds and shapes the anatomy allowing a clear view of the larynx and entrance to the trachea.
FDA Recall
Open, Classified
·Medtronic, PLC·Product code CCW·January 28, 2020
DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q
FDA Recall
Open, Classified
·DeVilbiss Healthcare LLC·Product code CAW·November 18, 2022
iGo2 DC Car Adapter to be used with iGo2 Portable Oxygen Concentrator Systems. Power cord allows the user to operate the device in a vehicle.
FDA Recall
Open, Classified
·Medical Depot Inc.·Product code CAW·April 11, 2025
BritePro Solo Mini with Pro Miller Blade Size 1.5, REF:040-02-0415U
FDA Recall
Open, Classified
·Flexicare Medical (Dongguan) Ltd. Hengli Town No. B-15 Xicheng; Henglizhen Dongguan China·Product code CCW·July 11, 2025
BritePro Solo Single-Use Fiber Optic Laryngoscope Handle Refs:040-310AU and 040-310U
FDA Recall
Open, Classified
·Flexicare Medical (Dongguan) Ltd. Hengli Town No. B-15 Xicheng; Henglizhen Dongguan China·Product code CCW·July 11, 2025
GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S
FDA Recall
Open, Classified
·Ohio Medical Corporation·Product code CAW·May 8, 2025
McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx Only
FDA Recall
Open, Classified
·Covidien·Product code CCW·August 10, 2023
Britepro Solo Stubby Single-Use Fiber Optic Laryngoscope Handle REF:040-03-0000U
FDA Recall
Open, Classified
·Flexicare Medical (Dongguan) Ltd. Hengli Town No. B-15 Xicheng; Henglizhen Dongguan China·Product code CCW·July 11, 2025
Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Canada specific model)
FDA Recall
Open, Classified
·Invacare Corporation·Product code CAW·June 10, 2022
McGRATH" MAC EMS Video Laryngoscope, REF: 300-200-000 , Non-Sterile, Rx Only
FDA Recall
Open, Classified
·Covidien·Product code CCW·July 9, 2024
Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly
FDA Recall
Open, Classified
·Covidien·Product code CCW·July 9, 2024