Draeger Medical, Inc.
Draeger Medical, Inc. holds FDA 510(k) medical device clearances, first cleared 1977, most recent 2004, with 78 FDA device recalls on record.
Top product codes for Draeger Medical, Inc.
FDA recalls by Draeger Medical, Inc.
10 most recent of 78- Z-0667-2025 — Brand Name: Atlan Product Name: Atlan A300 Model/Catalog Number: 8211300 The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates.
- Z-0668-2025 — Brand Name: Atlan Product Name: Atlan A300XL Model/Catalog Number: 8621400 The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates.
- Z-0305-2025 — Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Component: Not applicable
- Z-0304-2025 — Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Component: Not applicable
- Z-1512-2024 — Dr¿ger Perseus A500 Anesthesia Workstation
- Z-2248-2023 — Carina Sub-Acute Care Ventilator
- Z-2018-2023 — Oxylog 3000 Plus emergency and transport ventilator
- Z-1455-2023 — Ventstar Coax 180, MP03374
- Z-1460-2023 — Anesthesia Circuit Kit Coax HEPA, MP17102
- Z-1458-2023 — Anesthesia Set Coax 180, MP03384
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, Inc.
- K042607 — PRIMUS US
- K042419 — FABIUS GS/FABIUS TIRO ANESTHESIA SYSTEM
- K042276 — D-VAPOR
- K042086 — FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEM
- K041622 — MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEM
- K040847 — MODIFICATION TO VAMOS ANESTHETIC GAS MONITOR
- K033498 — NARKOMED 6400, MODEL NM6400
- K030624 — MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM
- K031400 — FABIUS TIRO ANESTHESIA SYSTEM
- K022031 — NARKOMED MRI-2 ANESTHESIA SYSTEM, MODEL NM-MRI-2
- K011404 — FABIUS GS ANESTHESIA SYSTEM, MODEL FABIUS GS
- K012139 — VAMOS ANESTHETIC GAS MONITOR
- K003579 — NARKOMED MRI-2, MODEL NM-MRI-2
- K001488 — NARKOMED MRI , NM-MRI
- K993826 — NARKOMED 6000
- K983635 — JULIAN ANESTHESIA WORKSTATION, MODEL # JULIAN
- K980208 — DIVAN ANESTHESIA VENTILATOR
- K980553 — NARKOMED 6000 MODEL NUMBER NM6000
- K981773 — DRAGER-VAPOR 19.3
- K980886 — BABYTHERM 8000 LDR
- K981472 — DRAGER-VAPOR 19.1 W/PLUG SYSTEM S PLUS
- K973949 — PERIOPERATIVE DATA MANAGEMENT SYSTEM
- K974193 — NARKOMED ULTRASONIC FLOW SENSOR
- K972848 — NARKOMED MRI ANESTHESIA SYSTEM
- K973051 — DRAGER-VAPOR 19.1 W/PLUG SYSTEM S PLUS
- K971923 — DRAGER-VAPOR 2000
- K971425 — NARKOMED M ANESTHESIA SYSTEM (M)
- K963994 — NARKOMED GS ANESTHESIA SYSTEM
- K953228 — NARKOMED AV2+ ANESTHESIA VENTILATOR
- K945463 — PENDANT MOUNT NARKOMED 2C ANESTHESIUA SYSTEM
- K930351 — NARKOMED 2C ANESTHESIA SYSTEM
- K913995 — VITALERT 3000 MONITORING SYSTEM
- K912533 — NARKOMED AV-E VENTILATOR
- K901713 — NARKOMED 4 ANESTHESIA SYSTEM
- K900937 — O.R. DATA MANAGER
- K900328 — NARKOMED 2B ANESTHESIA SYSTEM
- K900329 — NARKOMED 3 ANESTHESIA SYSTEM
- K882031 — VITALERT 2000 VITAL SIGNS MONITOR
- K873380 — VITALERT 1000 MONITORING SYSTEM
- K874415 — PRESSURE LIMIT CONTROL
- K874371 — ASCENDING VENTILATOR BELLOWS
- K873194 — SPECTRAMED RESPIRATORY GAS ANALYZER
- K873549 — PEDIATRIC BELLOWS
- K871886 — MODIFIED SPHYGMOMED NON-INVASIVE BLOOD PRES. MONIT
- K862427 — MODIFIED DRAGER SPHYGMOMED
- K864447 — NARKOMED 2B ANESTHESIA SYSTEM
- K864806 — ANESTHESIA RECORDER
- K864431 — PEDIATRIC BELLOWS
- K864034 — OPEN RESERVOIR SCAVENGER
- K862426 — PULSE OXIMETER
- K861720 — MODIFIED BAROMED BREATHING PRESSURE MONITOR
- K861170 — NARKOMED 3 ANESTHESIA SYSTEM (MODIFIED)
- K853926 — NEOCARE MODEL 800 INFANT RADIANT WARMER
- K853435 — NARKOMED 3 ANESTHESIA SYSTEM
- K851658 — CAPNOMED
- K851620 — SPIROMED 2
- K851621 — BOOM ARM
- K851704 — THERMOMED
- K840162 — DRAGER SPHYGMOMED
- K840279 — DRAGER BAROMED
- K833147 — CENTRALERT
- K834085 — DRAGER PEEP SYSTEM D
- K831301 — PEEP SYSTEM D
- K831237 — SPIROMED RESPIROMETER
- K831238 — OXYMED
- K822218 — NARKOMED 2A ANESTHESIA MACHINE
- K821650 — DRAGER VAPOR 19.1 ANESTHETIC VAPORIZERS
- K802168 — DRAGER AV2 ANESTHESIA VENTILATOR
- K802707 — DRAGER PEEP CONTROL SYSTEM
- K802090 — DRAGER PRESSURE MONITOR, SELF-DIAGNOSTIC
- K800764 — DRAGER ORMC
- K790333 — NAD SCAVENGING RELIEF VALVE
- K790334 — DRAGER ORM
- K771989 — CONTINUOUS FLOW ANESTHESIA MACHINE
- K771899 — VAPOR 19
- K771034 — HI-MID CURCUIT
- K770554 — NARKOMED ANESTHESIA MACHINE
- K761199 — AIRWAY PRESSURE MONITOR
Data sourced from openFDA. This site is unofficial and independent of the FDA.