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TPLC
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show TPLC since
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Device
vapocoolant device
Product Code
MLY
Device Class
Unclassified
Premarket Reviews
Manufacturer
Decision
623 MEDICAL, LLC
SUBSTANTIALLY EQUIVALENT
1
CRYOSCIENCE NORTH AMERICA, INC.
SUBSTANTIALLY EQUIVALENT
1
GEBAUER COMPANY
SUBSTANTIALLY EQUIVALENT
2
ITW CONTAMINATION CONTROL ELECTRONICS
SUBSTANTIALLY EQUIVALENT
1
NUANCE MEDICAL, LLC
SUBSTANTIALLY EQUIVALENT
3
1. K162218
Pain Freeze™, Medium Stream Spray, Model #2101; Pa
...
2. K172203
CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stre
...
3. K232674
PainFreeze II
OCCAM DESIGN
SUBSTANTIALLY EQUIVALENT
1
VAPOCOOLSHOT, INC.
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2014
2
2
2015
3
3
2016
1
1
2018
2
2
2022
2
2
2024
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
4
4
Improper or Incorrect Procedure or Method
2
2
Fire
2
2
Off-Label Use
1
1
Burst Container or Vessel
1
1
Unintended Ejection
1
1
Device Operates Differently Than Expected
1
1
Output Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Partial thickness (Second Degree) Burn
3
3
Full thickness (Third Degree) Burn
2
2
Superficial (First Degree) Burn
2
2
No Information
1
1
Cryogenic Burn
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Asthma
1
1
Burn(s)
1
1
Edema
1
1
Pain
1
1
Burning Sensation
1
1
No Consequences Or Impact To Patient
1
1
Discomfort
1
1
Reaction, Injection Site
1
1
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