170 results
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16ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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Software version 5.3 in: RAPIDPoint 500e Blood Gas System (USA) Siemens Material Number: 11416751 RAPIDPoint 500e Blood Gas System (China) 11416752; RAPIDPoint 500e Blood Gas System (Japan) 11416754; RAPIDPoint 500e Blood Gas System (ROW) 11416755 ;
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics Inc·July 3, 2024
RAPIDPOINT 500 Blood Gas System
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics Inc·December 6, 2023
RAPIDPOINT 500e Blood Gas System
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics Inc·December 6, 2023
a. SporView Culture Set SporView Sterilization Biological Indicator Kit Steam / EO Gas / Dry Heat / Chemical Vapor Model Number: CS-020 b. SPORVIEW CULTURE SET SporView Sterilization Biological Indicator Kit Steam / EO Gas / Dry Heat / Chemical Vapor Model Number: CS-100
FDA Enforcement
Class III
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·October 5, 2022
IntelliVue G7m Anesthesia Gas Module, Product Number 866173
FDA Enforcement
Class II
·Ongoing·Philips North America·October 9, 2024
Mixing Fleas for SAFE-T-FILL Blood Gas Capillaries, Model 07 9503
FDA Enforcement
Class II
·Ongoing·ASP Global, LLC. dba Anatomy Supply Partners, LLC.·November 26, 2025
Philips Respironics V60 Ventilator-Intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Model Number: R1053618 and R1076709. These are retrofitted device.
FDA Enforcement
Class II
·Ongoing·DRE Medical Group Inc·July 5, 2023
Panorama 1.0T HFO, Magnetic Resonance (MR) System; Model Numbers 781250 and 781350. Philips Magnetic Resonance (MR) systems are Medical Electrical Systems for use as a diagnostic device.
FDA Enforcement
Class I
·Ongoing·Philips North America Llc·December 20, 2023
SAFE-T-FILL Magnetic Rings for SAFE-T-FILL Blood Gas Capillaries, Model 07 9502
FDA Enforcement
Class II
·Ongoing·ASP Global, LLC. dba Anatomy Supply Partners, LLC.·November 26, 2025
SafeStar 90 Plus Filter. Bidirectionally breathing system filter.
FDA Enforcement
Class I
·Ongoing·Draeger, Inc.·August 6, 2025
SafeStar 60A Plus Filter. Bidirectionally breathing system filter.
FDA Enforcement
Class I
·Ongoing·Draeger, Inc.·August 6, 2025
SafeStar 55 Plus Filter. Bidirectionally breathing system filter.
FDA Enforcement
Class I
·Ongoing·Draeger, Inc.·August 6, 2025
HME TwinStar HEPA Plus Filter. Bidirectionally breathing system filter.
FDA Enforcement
Class I
·Ongoing·Draeger, Inc.·August 6, 2025
IntelliVue G7m Anesthesia Gas Module, Model no. 866173, Firmware Version 04.12.00, System Codes 453564477391, 453564477401, 866173
FDA Enforcement
Class II
·Ongoing·Philips North America, LLC·July 29, 2020
Atlan, Gas Machine for Anesthesia or Analgesia, Catalog numbers 8621500 (Atlan A350) and 8621600 (Atlan A350 XL)
FDA Enforcement
Class II
·Ongoing·Draegerwerk Ag & Co. Kgaa·February 7, 2024
BD GasPak EZ Campy Pouch System. Catalog Number: 260685. for microbiologic use
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·May 6, 2026
BD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic use
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·May 6, 2026
Aespire 100. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.
FDA Enforcement
Class I
·Ongoing·Datex-Ohmeda, Inc.·October 30, 2024
Welch Allyn Life2000 Ventilation System, REF MS-01-0118, within exterior carton codes: 1) BT-20-0002, 2) BT-20-0002A, 3) BT-20-0002AP, 4) BT-20-0007, 5) BT-20-0011, and 6) RMS010118CP
FDA Enforcement
Class I
·Ongoing·Baxter Healthcare Corporation·October 30, 2024
Iso-Gard Filter S, Tethered Cap, REF: a) 19211T, OUS only; b) 19212T, OUS only; Microbial medical gas filter, single-use
FDA Enforcement
Class I
·Ongoing·TELEFLEX LLC·October 26, 2022