INM - BEUDAMED

MAQUET, SERVO Humidifier 163, Rx Only, Inmed Mfg. Sdn Bhd. Catalog No: XKC01-06-8125-8, Model No. 01-06-8125-8. A heat and moisture condenser (artificial nose) is a device intended to be positioned over a tracheotomy (a surgically created opening in the throat) or tracheal tube (a tube inserted into the trachea) to warm and humidify gases breathed in by a patient.

FDA Enforcement

Class I ·Terminated·Teleflex Medical·February 18, 2015

GE Nuclear Medicine 600/800 series systems, specifically: a) 870 CZT O540+ Gantry 7.25mm, b) D670 CZT Gantry 7.25mm, c) DISCOV NM/CT 870 CZT, d) Discovery NMCT 670 CZT O540+, e) NM/CT 870 CZT CYBER DEFENCE, f) NM/CT 870 CZT O540, g) NM/CT 870 CZT WSO, h) NM/CT 870 CZT, i) NM/CT 870 CZT O540+ 7.25MM; 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) 850, b) 850 / Dismount, c) 850 3/8 inch NM Gantry, d) 860 / Dismount, e) 860 3/8 inch NM Gantry, f) 860 5/8 inch NM Gantry, g) 860 BJ, h) NM 830 3/8 inch BJ, i) NM/CT 850 3/8 inch BJ, j) NM/CT 850 3/8 inch ROW, k) NM/CT 850 3/8 inch ROW_, l) NM/CT 850 CT 850 3/8 inch, m) NM/CT 850 ES 3/8 inch, n) NM/CT 850 ES 3/8 inch ROW, o) NM/CT 860 3/8 inch, p) NM/CT 860 3/8 inch BJ, q) NM/CT 860 3/8 inch ROW, r) NM/CT 860 ADVANCE, s) NM/CT 860 advance 3/8 inch NM Gantry, t) NM/CT 860 BEYOND, u) NM/CT 860 beyond 3/8 inch NM Gantry, v) NM/CT 860 China for China, w) NM/CT 860 CT 860 3/8 inch, x) NM/CT 860 ES 3/8 inch, y) NM/CT 860 ES 3/8 inch ROW, z) NM/CT 850 3/8 inch, aa) NM/CT 850 ES 3/8 inch ROW, bb) NM/CT 860 3/8 inch CH, cc) XELERIS 4 DR WORKSTATION; Emission Computed Tomography System

FDA Enforcement

Class I ·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·February 15, 2023

Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.

FDA Enforcement

Class I ·Ongoing·Abiomed, Inc.·June 24, 2026

Atlan A350XL. Model Number: 8621600. anesthesia workstation

FDA Enforcement

Class I ·Ongoing·Draeger, Inc.·June 10, 2026

Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 3. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK. 4. Impella Controller, Packaged, US; Product Code: 0042-0000-US.

FDA Enforcement

Class I ·Ongoing·Abiomed, Inc.·June 3, 2026

Rolls of label stock used with the Omnicell i.v.Station. 1. Part Number 258920028, LABEL, STERILE, IVSTATION SYRINGE (40MMX40MM). 2. Part Number 258900029, LABEL, STERILE, IVSTATION SYRINGE (20MMX40MM). Model/Catalog Number: IVS-RBT-001. i.v.STATION is an automation device used for preparation and compounding of IV medications, which also applies labels to compounded preparations for identification and traceability.

FDA Enforcement

Class I ·Ongoing·Omnicell, Inc.·May 20, 2026

Atlan A350. Model Number: 8211500. anesthesia workstation

FDA Enforcement

Class I ·Ongoing·Draeger, Inc.·June 10, 2026

Automated Impella Controller (AIC); Product Code: 0042-0000-US;

FDA Enforcement

Class I ·Ongoing·Abiomed, Inc.·June 3, 2026

WHILL Model C2, with software versions before HMI: 2.22 / MC: 1.13; device is an indoor/outdoor battery-operated 2-wheel drive (rear-wheel drive) powered wheelchair.

FDA Enforcement

Class I ·Ongoing·WHILL, INC.·May 6, 2026

WHILL Model F, with software versions before HMI: 2.23 / MC: 1.05; the device is an indoor/outdoor, foldable battery-operated 2-wheel drive (rear-wheel drive) powered wheelchair.

FDA Enforcement

Class I ·Ongoing·WHILL, INC.·May 6, 2026

Impella RP Flex with SmartAssist. Product Code: 1000323.

FDA Enforcement

Class I ·Ongoing·Abiomed, Inc.·March 11, 2026

Automated Impella Controller (AIC), labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 3. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK. 4. Impella Controller, Packaged, US; Product Code: 0042-0000-US. 5. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU. 6. Impella Optical Controller, Packaged, UK; Product Code: 0042-0010-UK. 7. Optical AIC w/Impella Connect, Pack'd, CA; Product Code: 0042-0040-CA. 8. Optical AIC w/Impella Connect, Pack'd, EU; Product Code: 0042-0040-EU. 9. Optical, AIC, Impella Connect, Pkgd, AU; Product Code: 0042-0040-AU.

FDA Enforcement

Class I ·Ongoing·Abiomed, Inc.·April 8, 2026

Impella RP with SmartAssist. Product Code: 0046-0035.

FDA Enforcement

Class I ·Ongoing·Abiomed, Inc.·March 11, 2026

Impella RP. Product Code: 0046-0011.

FDA Enforcement

Class I ·Ongoing·Abiomed, Inc.·March 11, 2026

ErgoStar CM 55, Model/Catalog Number: MP01855, Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a mechanically ventilated patient.

FDA Enforcement

Class I ·Ongoing·Draeger, Inc.·December 17, 2025

ErgoStar CM 45, Model/Catalog Number: MP01845, Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a mechanically ventilated patient.

FDA Enforcement

Class I ·Ongoing·Draeger, Inc.·December 17, 2025

ErgoStar CM 60, Model/Catalog Number: MP01860, Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a mechanically ventilated patient.

FDA Enforcement

Class I ·Ongoing·Draeger, Inc.·December 17, 2025

Draeger Vapor 2000. Unheated, calibrated anesthetic vaporizer.

FDA Enforcement

Class I ·Ongoing·Draeger, Inc.·December 31, 2025

Draeger Vapor 3000. Unheated, calibrated anesthetic vaporizer.

FDA Enforcement

Class I ·Ongoing·Draeger, Inc.·December 31, 2025