Hill-Rom Manufacturing, Inc.
Hill-Rom Manufacturing, Inc. holds FDA 510(k) medical device clearances, first cleared 2002, most recent 2008, with 2 FDA device recalls on record.
Top product codes for Hill-Rom Manufacturing, Inc.
FDA recalls by Hill-Rom Manufacturing, Inc.
- Z-0484-2021 — Life2000 Ventilation System, including Life2000 Ventilator and Life2000 Compressor, Model MS-01-0118 - Product Usage: use in home and institutional settings and is not intended for ambulance or air transport.
- Z-0192-2018 — Monarch Airway Clearance System, Model 1000, Product Numbers: PMACS1NA (has blue tooth capability only) and PMACS1WI (has WIFI capability). The firm name on the label is Hill-Rom Services Pte. Ltd., Singapore. The Monarch Airway Clearance System, Model 1000, is intended to provide Airway Clearance Therapy and promote bronchial drainage where external manipulation of the thorax is the physicians choice of treatment. It is indicated for patients having difficulty with secretion clearance or the presence of atelectasis caused by mucus plugging.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Hill-Rom Manufacturing, Inc.
- K080226 — NAVICARE -WATCHCHILD OBSTETRICAL DATA MANAGEMENT SYSTEM (NAVICARE -WATCHCHILD), MODEL P2912
- K032772 — MODIFICATION TO WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM (ALSO REFERRED TO AS) THE WATCHCHILD SYSTEM
- K031387 — ISOLETTE INFANT INCUBATOR, MODEL C2000E
- K014094 — MODIFICATION TO THE WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.