CBK
GE DATEX-OHMEDA ENGSTROM CARESTATION
- Advisory panel
- Anesthesiology
- Total cleared
- 503
Adverse events under product code CBK
product code CBK- Death
- 736
- Injury
- 3,628
- Malfunction
- 98,786
- Other
- 4
- Total
- 103,154
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code CBK
1–100 of 503- K251888 — VPAP Pediatric Face Mask
- K232365 — Vivo 45 LS
- K252173 — F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size A (ONIV117A); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size B (ONIV117B); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size C (ONIV117C); F&P OptiNIV ONIV117-F Hospital Vented Full Face Mask with optional Expiratory Filter Compatible with Single-limb Circuits - Size A (ONIV117A-F); F&P OptiNIV ONIV117-F Hospital Vented Full
- K243767 — SV600, SV800 Ventilator
- K251133 — AVEA disposable expiratory filter/water trap (11790)
- K243394 — AF531 Oro-Nasal SE Face Mask
- K233486 — 731 Series Ventilator
- K223120 — Ventoux VC2; Ventoux VC3
- K241135 — RESPOND(R) Ventilator
- K241943 — Mojo Full Face Non-Vented Mask; Veraseal 2 Full Face Non-Vented Mask; Veraseal 2 Full Face AAV Non-Vented Mask
- K232836 — Family of DIMAR DMAX NIV masks
- K240807 — VM-2000
- K241520 — Mojo 2 Full Face Non-Vented Mask; Mojo 2 Full Face AAV Non-Vented Mask; Veraseal 3 Full Face Non-Vented Mask; Veraseal 3 Full Face AAV Non-Vented Mask
- K231778 — Nihon Kohden NKV-550 Series Ventilator System
- K213098 — Panther 5
- K220107 — Mindray SV600 Ventilator, Mindray SV800 Ventilator
- K222644 — Nihon Kohden NKV-440 Ventilator System
- K222024 — Evita V800, Evita V600
- K222207 — Babylog VN800, Babylog VN600
- K201082 — LTV2 Series Ventilators
- K210384 — CARESCAPE R860
- K201874 — Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1
- K203449 — F&P Visairo NIV Mask Range
- K201306 — HAMILTON-C3
- K202970 — Ventway Sparrow
- K201658 — Hamilton-C6
- K193056 — Puritan Bennett 980 Series Ventilator System
- K192604 — Servo-air 4.0 Ventilator System
- K193228 — Hamilton-G5
- K192307 — Nihon Kohden NKV-550 Series Ventilator System
- K183364 — Bellavista
- K181216 — HAMILTON-T1, HAMILTON-C1
- K180295 — Hamilton-G5
- K190533 — Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask, Veraseal 3 Full Face Non-Vented Mask, Veraseal 3 Full Face AAV Non-Vented
- K181166 — Trilogy Evo
- K181170 — Trilogy Evo Universal
- K180098 — SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1
- K180779 — Savina 300
- K181695 — Nihon Kohden NKV-550 Series Ventilator System
- K173973 — TV-100
- K172875 — Astral 100/150
- K173060 — F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version
- K162738 — Puritan Bennett 980 Ventilator System
- K170037 — Breathe Technologies Life2000 Ventilation System
- K162832 — 731 Series Ventilators
- K163127 — bellavista 1000
- K161450 — HAMILTON-C3
- K162877 — VOCSN Unified Respiratory System
- K153046 — HAMILTON-MR1
- K152068 — Astral 100/150
- K143035 — Flight 60 Ventilator
- K151252 — Puritan Bennett 840 Series Ventilator System
- K151814 — SERVO-U Ventilator System, SERVO-n Ventilator System
- K151901 — AirView
- K150638 — AF541 SE Full Face Mask
- K140939 — HAMILTON-T1,HAMILTON-C1
- K141943 — BREATHE TECHNOLOGIES LIFE2000 VENTILATION SYSTEM
- K142679 — CARESCAPE R860
- K140575 — ENGSTROM CARESTATION, ENGSTROM PRO
- K121886 — SAVINA 300 SAVINA 300, COUNTRY VARIANTS
- K123149 — SERVO-I VENTILATOR SYSTEM
- K133868 — ASTRAL VENTILATOR
- K130171 — FLIGHT 60 VENTILATOR
- K131252 — PURITAN BENNETT 980 SERIES VENTILATOR SYSTEM
- K122438 — HAMILTON-MR1
- K130178 — INSPIRATION VENTILATOR SYSTEM 5I/7I
- K131774 — HAMILTON-G5
- K120931 — CRITICAL CARE VENTILATOR
- K122560 — VERSALVENT MODEL V1 HYPERBARIC CHAMBER VENTILATOR MODEL V1
- K123637 — HAMILTON-C3
- K113743 — EVOLUTION 3E VENTILATOR
- K120146 — QUARK SERIES
- K121225 — HAMILTON-C2
- K121891 — NEWPORT AURA VENTILATOR
- K121379 — PNEUTON MINI VENTILATOR PNEUTON MINI NON-INVASIVE VENTILATION (NIV) KIT ACCESSORY
- K120639 — PERFORMAX PEDIATRIC SE TOTAL FACE MASK
- K120726 — FLIGHT 60 VENTILATOR
- K112754 — IVENT101
- K112729 — BLEASE700/900 SERIES VENTILATORS
- K120574 — HAMILTON-C1
- K120670 — HAMILTON-T1
- K113051 — SPACELABS ARKON ANESTHESIA WORKSTATION
- K111473 — UNI-VENT (R) MODEL 731 SERIES PORTABLE CRITICAL CARE VENTILATOR
- K112006 — HAMILTON-TC1
- K111595 — NEUMOVENT GRAPHNET
- K110083 — V200 VENTILATOR WITH APRV MODE, ESPRIT VENTILATOR WITH APRV MODE
- K111146 — NEWPORT HT70 VENTILATOR
- K103803 — HAMILTON-G5
- K111683 — FLIGHT 60 VENTILATOR
- K111610 — TRILOGY SERIES VENTILATOR WITH OXIMETRY
- K103625 — OXYLOG 3000 PLUS WORKSTATION, OXYLOG 3000 PLUS BASIC DEVICE
- K111116 — ENGSTROM CARESTATION, ENGSTROM PRO, MODELS 1505-9000-000, 1505-9003-000
- K110795 — V200 INTELLI-TRAK OPTION
- K102120 — NIPPV SILICONE FACE MASK, NIPPV ECONOMY FACE MASK, NIPPV SILICONE NASAL MASK MODEL 10212, 10222, 10202
- K103211 — AVEA VENTILATOR
- K103318 — UNI-VENT 731 SERIES MODEL EMV+ PORTABLE CRITICAL CARE VENTILATOR
- K101850 — SPACELABS BLEASESIRIUS ANESTHESIA WORKSTATION
- K101643 — MODEL LTV 1100 VENTILATOR
- K102775 — HAMILTON-C2
- K102054 — V200 VENTILATOR
Data sourced from openFDA. This site is unofficial and independent of the FDA.