Ambu USA

CLOSEOUT LETTER Ambu USA MARCS-CMS 661617 — June 04, 2025 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA Electronic Mail Product: Medical Devices Recipient: Recipient Name Steven Block Recipient Title President Ambu USA 6721 Columbia Gateway Drive, Suite 200 Columbia , MD 21046 United States stbl@ambu.com Issuing Office: Center for Devices and Radiological Health United States Secondary Issuing Offices United States Dear Mr. Block: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 661617), dated August 16, 2023. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections. This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means. Sincerely, /S/ Matthew G. Hillebrenner Deputy Director Office of Product Evaluation and Quality Center for Devices and Radiological Health Cc: Kleve Heavin, VP Noblesville Operations, King Systems Content current as of: 06/16/2025 Regulated Product(s) Medical Devices