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TPLC
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Device
apparatus, gas-scavenging
Product Code
CBN
Regulation Number
868.5430
Device Class
2
Premarket Reviews
Manufacturer
Decision
ANESTHETIC GAS RECLAMATION, INC.
SUBSTANTIALLY EQUIVALENT
1
AXON MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
G. DUNDAS CO.,INC.
SUBSTANTIALLY EQUIVALENT
1
PARKER HANNIFIN CORPORATION
SUBSTANTIALLY EQUIVALENT
1
SEDATION SYSTEMS LLC
SUBSTANTIALLY EQUIVALENT
1
TELEFLEX MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
3
MDR Year
MDR Reports
MDR Events
2015
1
1
2020
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Material Integrity Problem
1
1
Therapeutic or Diagnostic Output Failure
1
1
Premature Discharge of Battery
1
1
Device Operates Differently Than Expected
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
2
2
No Consequences Or Impact To Patient
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Dynasthetics LLC
II
May-16-2023
2
Maquet Cardiovascular Us Sales, Llc
II
Feb-27-2015
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