Draeger Medical Systems, Inc.
Draeger Medical Systems, Inc. holds FDA 510(k) medical device clearances, first cleared 2003, most recent 2026, with 12 FDA device recalls on record.
Top product codes for Draeger Medical Systems, Inc.
FDA recalls by Draeger Medical Systems, Inc.
10 most recent of 12- Z-1066-2025 — Infinity Central Station. Model Number: MS26800 The Infinity CentralStation (ICS) is intended for centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical environment. Centralized monitoring involves the display and management of data from networked patient monitors including the annunciation of visual and audible physiologic parameter alarms at a central monitoring workstation.
- Z-2189-2024 — Infinity Acute Care System (IACS) Monitoring System, Infinity M500 with Power, Model No. MS20407. Rev 20, 21, and 23
- Z-1992-2023 — Draeger Softbed Resuscitaire and/or Birthing Room Warmer with Scale [Model(s): RW82VHA-1, RW82VHA-1C, RW82VHA-1D, RW82-1, RW82-1C, RW82-1D, WBR82-1 and WBR82-1C]
- Z-1472-2023 — Draeger Infinity M300 and M300+, for use with the ICS to monitor ECG and pulse oximetry on ambulatory and non-ambulatory adult and pediatric patients using wireless communication over the Infinity patient monitoring network,
- Z-1471-2023 — Draeger Infinity CentralStation (ICS), centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical environment, Software versions VG2.1.3 and lower
- Z-1365-2022 — Draeger Globe-Trotter and Globe-Trotter IC, Model numbers MS20508 and MS20509. neonatal transport system
- Z-2047-2018 — Draeger Jaundice Meter JM-105 The device is intended for use in hospitals, clinics or doctor s offices under a physician s supervision / direction to assist clinicians in monitoring of newborn infants. The device is not intended as a standalone for diagnosis of hyperbilirubinemia. It is to be used in conjunction with other clinical signs and laboratory measurements. The Jaundice Meter is not intended for home use. The Jaundice Meter may only be used at the sternum measurement site for Physician s office applications.
- Z-2046-2018 — Draeger Jaundice Meter JM-103 The device is intended for use in hospitals, clinics or doctor s offices under a physician s supervision / direction to assist clinicians in monitoring of newborn infants. The device is not intended as a standalone for diagnosis of hyperbilirubinemia. It is to be used in conjunction with other clinical signs and laboratory measurements. The Jaundice Meter is not intended for home use. The Jaundice Meter may only be used at the sternum measurement site for Physician s office applications
- Z-1440-2014 — Draeger Oxylog 3000 plus ventilators, emergency and transport ventilator. Part number: 5704833
- Z-1298-2014 — Draeger PS500 Power Supply Unit of the Infinity ACS Workstation Critical Care (Evita Infinity V500), Evita V500 and /or Babylog VN500 Ventilators, used for ventilation during short term transport of patients within a hospital.
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 Draeger Medical Systems, Inc.
- K260579 — Infinity® Acute Care System (IACS) VG8.1
- K243606 — Babyroo TN300
- K240312 — Infinity CentralStation Wide
- K233834 — Infinity Gateway Suite
- K231477 — Infinity CentralStation Wide, Infinity M300, Infinity M300+
- K230278 — Babyroo TN300
- K203579 — Infinity Gateway Suite
- K203088 — Infinity Acute Care System (IACS) Monitoring System
- K201764 — Infinity Acute Care System (IACS) Monitoring Solution
- K200859 — Infinity M300
- K182977 — Isolette 8000 Plus
- K172656 — BiliLux
- K151860 — Infinity CentralStation Wide
- K141756 — INFINITY EXPLORER SOFTWARE, C700 FOR IT PATIENT VICINITY WORKSTATION
- K133175 — DRAEGER JAUNDICE METER JM-105
- K141565 — GLOBE-TROTTER GT5400
- K130711 — INFINITY CENTRALSTATION WITH INFINITY M300
- K120642 — RESUSCITAIRE WITH AUTOBREATH
- K113798 — INFINITY ACUTE CARE SYSTEM, INFINITY MCABLE- MASIMO RAINBOW SET
- K113206 — NANOBLUTM 500
- K103625 — OXYLOG 3000 PLUS WORKSTATION, OXYLOG 3000 PLUS BASIC DEVICE
- K102968 — INFINITY CNAP SMARTPOD
- K093788 — INFINITY ACUTE CARE SYSTEM (IACS) MONITORING SOLUTION
- K082888 — INFINITY NELLCOR OXIMAX SMARTPOD, MODEL MS23997
- K073113 — INFINITY PICCO POD, MODEL MS16734
- K070566 — INFINITY DELTA/DELTA XL/ KAPPA/ GAMMA X XL/ VISTA XL/ SC7000/SC8000/ SC9000XL
- K061379 — INFINITY TELESMART TELEMETRY SYSTEM
- K061329 — INFINITY MASIMO SET SP02 POD
- K060039 — INFINITY DELTA AND KAPPA SERIES MONITORS WITH VF6 MODIFICATIONS
- K060223 — INFINITY MULTIVIEW INFINITY TELEMETRY SYSTEM
- K060254 — MODIFICATION TO INFINITY EXPLORER
- K053484 — INFINITY GAMMA / GAMMAXL, INFINITY VISTA
- K051658 — INFINITY ALPHA
- K051628 — INFINITY MONITORS WITH SCIO MODIFICATIONS
- K050974 — DRAEGER MEDICAL INFORMATION BUS (MIB, MIB II, MIB DUO) PROTOCOL CONVERTERS
- K042904 — INFINITY KAPPA XLT
- K043439 — INFINITY MODULAR MONITORS WITH VF5 MODIFICATIONS (DELTA/KAPPA/DELTA XL/VISTA XL/GAMMA X XL AND SC 7000/8000/9000XL
- K043549 — INFINITY GATEWAY SUITE, VF4
- K042656 — INFINITY GAMMA/GAMMAXL AND VISTA WITH VF5
- K042003 — INFINITY TRIDENT NMT POD
- K033957 — INFINITY MODULAR MONITORS VF4 MODIFICATIONS WITH SCIO, MODELS DELTA, DELTA XL, KAPPA, SC 8000, SC 7000, SC 9000XL
- K040945 — MODIFICATION TO INFINITY EXPLORER
- K041087 — INFINITY GAMMA
- K040188 — INFINITY GAMMAXL AND SC 6802XL WITH THE SCIO GAS MODULE
- K033694 — INFINITY MODULAR MONITORS VF4 MODIFICATIONS
- K033807 — INFINITYEDICAL INFORMATION BUS (MIB/MIB II AND MIB DUO) PROTOCOL CONVERTER
- K033600 — INFINITY GAMMAXL
- K032537 — DRAEGER MICRO2+ AND MASIMO MINISAT
- K033305 — INFINITY MULTIVIEW INFINITY TELEMETRY SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.