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TPLC
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Device
analyzer, gas, carbon-dioxide, gaseous-phase
Regulation Description
Carbon dioxide gas analyzer.
Product Code
CCK
Regulation Number
868.1400
Device Class
2
Premarket Reviews
Manufacturer
Decision
BEIJING KINGST COMMERCIAL & TRADE CO.,LTD.
SUBSTANTIALLY EQUIVALENT
2
COVIDIEN
SUBSTANTIALLY EQUIVALENT
1
COVIDIEN LLC
SUBSTANTIALLY EQUIVALENT
2
DRAEGERWERK AG & CO. KGAA
SUBSTANTIALLY EQUIVALENT
1
ENDURE INDUSTRIES INC
SUBSTANTIALLY EQUIVALENT
1
ENGINEERED MEDICAL SYSTEMS INC.
SUBSTANTIALLY EQUIVALENT
1
GE HEALTHCARE FINLAND OY
SUBSTANTIALLY EQUIVALENT
1
INVENTEUR, LLC
SUBSTANTIALLY EQUIVALENT
1
MASIMO CORPORATION
SUBSTANTIALLY EQUIVALENT
1
MEDITERA TIBBI MALZEME SAN. VE TIC. A.S.
SUBSTANTIALLY EQUIVALENT
1
ORIDION MEDICAL 1987 LTD.
SUBSTANTIALLY EQUIVALENT
1
PNEUMA THERAPEUTICS, INC.
SUBSTANTIALLY EQUIVALENT
1
SOUTHMEDIC INC.
SUBSTANTIALLY EQUIVALENT
1
UNIMED MEDICAL SUPPLIES, INC.
SUBSTANTIALLY EQUIVALENT
1
VYAIRE MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
2302
2302
2021
2272
2272
2022
2475
2475
2023
1638
1638
2024
1216
1216
2025
262
262
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
3411
3411
Communication or Transmission Problem
2790
2790
Crack
2430
2430
Corroded
1022
1022
Failure to Calibrate
948
948
Appropriate Term/Code Not Available
942
942
Incorrect, Inadequate or Imprecise Result or Readings
710
710
Device Alarm System
659
659
Computer Software Problem
562
562
Contamination
530
530
Failure of Device to Self-Test
486
486
No Device Output
470
470
Loose or Intermittent Connection
429
429
No Apparent Adverse Event
416
416
Calibration Problem
393
393
Circuit Failure
300
300
Insufficient Information
294
294
Device Sensing Problem
175
175
Output Problem
166
166
Physical Resistance/Sticking
126
126
Failure to Read Input Signal
109
109
Missing Information
68
68
Display Difficult to Read
68
68
Display or Visual Feedback Problem
67
67
Application Program Freezes, Becomes Nonfunctional
62
62
Incorrect Measurement
56
56
Misassembled
49
49
Low Readings
44
44
Unable to Obtain Readings
44
44
High Readings
39
39
Peeled/Delaminated
38
38
Pumping Stopped
36
36
Failure to Power Up
31
31
Degraded
28
28
Application Program Problem
28
28
Naturally Worn
26
26
Failure to Cycle
23
23
Electrical /Electronic Property Problem
23
23
Temperature Problem
21
21
Image Display Error/Artifact
18
18
Device Markings/Labelling Problem
15
15
No Display/Image
15
15
Mechanical Problem
13
13
False Alarm
12
12
Erratic or Intermittent Display
12
12
Power Problem
12
12
Noise, Audible
11
11
Device Ingredient or Reagent Problem
11
11
Unexpected Shutdown
11
11
Use of Device Problem
11
11
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
7118
7118
No Patient Involvement
2965
2965
Insufficient Information
129
129
No Consequences Or Impact To Patient
78
78
No Information
55
55
No Known Impact Or Consequence To Patient
25
25
Unintended Extubation
14
14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
8
8
Cardiac Arrest
5
5
Unspecified Tissue Injury
4
4
Low Oxygen Saturation
2
2
Respiratory Failure
2
2
Superficial (First Degree) Burn
1
1
Death
1
1
Hypoventilation
1
1
Respiratory Arrest
1
1
Foreign Body In Patient
1
1
Chest Pain
1
1
Discomfort
1
1
Laceration(s)
1
1
Pain
1
1
Anxiety
1
1
Cough
1
1
Hypoxia
1
1
Extubate
1
1
Respiratory Insufficiency
1
1
Bruise/Contusion
1
1
Lethargy
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Covidien Llc
II
Dec-01-2020
2
GE Healthcare, LLC
I
Jan-10-2020
3
Nihon Kohden America Inc
II
Nov-06-2024
4
Oridion Medical 1987 Ltd.
II
Mar-17-2025
5
Smiths Medical ASD, Inc.
II
Mar-20-2025
6
Southmedic, Inc.
II
Jul-24-2021
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