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TPLC
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show TPLC since
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2024
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Device
cuff, tracheal tube, inflatable
Product Code
BSK
Regulation Number
868.5750
Device Class
2
Premarket Reviews
Manufacturer
Decision
ARM MEDICAL DEVICES, INC.
SUBSTANTIALLY EQUIVALENT
1
AW TECHNOLOGIES APS
SUBSTANTIALLY EQUIVALENT
1
BIOVO TECHNOLOGIES LTD.
SUBSTANTIALLY EQUIVALENT
1
COVIDIEN LLC
SUBSTANTIALLY EQUIVALENT
1
HAMILTON MEDICAL AG
SUBSTANTIALLY EQUIVALENT
1
HOSPITECH RESPIRATION LTD.
SUBSTANTIALLY EQUIVALENT
4
INSTRUMENTATION INDUSTRIES, INC.
SUBSTANTIALLY EQUIVALENT
1
JOAN SPIEGEL, MD
SUBSTANTIALLY EQUIVALENT
1
KAL-MED LLC
SUBSTANTIALLY EQUIVALENT
1
SPIRITUS TECHNOLOGIES LLC
SUBSTANTIALLY EQUIVALENT
1
TELEFLEX MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
TIANJIN MEDIS MEDICAL DEVICE CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
TRACOE MEDICAL GMBH
SUBSTANTIALLY EQUIVALENT
2
VENNER MEDICAL (SINGAPORE) PTE LTD
SUBSTANTIALLY EQUIVALENT
1
VENTLAB CORP.
SUBSTANTIALLY EQUIVALENT
1
VORTRAN MEDICAL TECHNOLOGY 1, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
5
5
2015
1
1
2016
1
1
2017
3
3
2018
4
4
2019
2
2
2020
1
1
2021
9
9
2022
4
4
2023
51
51
2024
98
98
Device Problems
MDRs with this Device Problem
Events in those MDRs
Gas/Air Leak
99
99
Unable to Obtain Readings
31
31
Break
9
9
Insufficient Information
8
8
Loose or Intermittent Connection
4
4
Pressure Problem
3
3
Material Deformation
3
3
Inflation Problem
3
3
Display or Visual Feedback Problem
3
3
Detachment Of Device Component
3
3
Disconnection
2
2
Connection Problem
2
2
Human-Device Interface Problem
2
2
Mechanical Jam
2
2
Deflation Problem
2
2
Material Split, Cut or Torn
1
1
Leak/Splash
1
1
Positioning Problem
1
1
Failure to Zero
1
1
Fail-Safe Problem
1
1
Air Leak
1
1
Use of Device Problem
1
1
Component Missing
1
1
Infusion or Flow Problem
1
1
Device Emits Odor
1
1
Product Quality Problem
1
1
Installation-Related Problem
1
1
Appropriate Term/Code Not Available
1
1
Device Dislodged or Dislocated
1
1
Fracture
1
1
Entrapment of Device
1
1
Incomplete or Inadequate Connection
1
1
Mechanical Problem
1
1
Unintended Deflation
1
1
Inadequate Instructions for Healthcare Professional
1
1
No Audible Alarm
1
1
Incorrect, Inadequate or Imprecise Result or Readings
1
1
Fluid/Blood Leak
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
153
153
Extubate
8
8
Insufficient Information
4
4
Hypoxia
3
3
No Known Impact Or Consequence To Patient
2
2
Cardiac Arrest
2
2
Low Oxygen Saturation
2
2
Complaint, Ill-Defined
1
1
Death
1
1
No Information
1
1
Dyspnea
1
1
Nasal Obstruction
1
1
Increased Respiratory Rate
1
1
Bronchospasm
1
1
Respiratory Insufficiency
1
1
Ventilator Dependent
1
1
Unintended Extubation
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Covidien
II
Sep-29-2023
2
H & H Associates
I
Oct-01-2013
3
Hamilton Medical, Inc.
II
Jan-12-2018
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