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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device unit, cryosurgical, accessories
Regulation Description Cryosurgical unit and accessories.
Product CodeGEH
Regulation Number 878.4350
Device Class 2


Premarket Reviews
ManufacturerDecision
ATRICURE, INC.
  SUBSTANTIALLY EQUIVALENT 1
BOVIE MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
BRYMILL CRYOGENIC SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
C2 THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 6
COOL RENEWAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
CRYOFOS MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 1
CSA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 9
ERBE ELEKTROMEDIZIN GMBH
  SUBSTANTIALLY EQUIVALENT 2
ERBE USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
GALIL MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 5
GALIL MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 1
GALIL MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 2
HEALTHTRONICS
  SUBSTANTIALLY EQUIVALENT 2
HEALTHTRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ICECURE MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
NUANCE MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
PRESTIGE BRANDS, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Device Operates Differently Than Expected 218
Appropriate Term/Code Not Available 199
Insulation 172
Adverse Event Without Identified Device or Use Problem 162
Defective Device 17
Failure to Fire 16
Thermal Decomposition of Device 14
Insufficient Information 11
Gas Leak 11
Fire 8
Device Operational Issue 7
No Apparent Adverse Event 7
Needle 7
Misconnection 6
Computer Software Problem 5
Connection Problem 5
Activation Problem 5
Device Displays Incorrect Message 5
Electrical /Electronic Property Problem 4
Insufficient Cooling 4
Difficult or Delayed Activation 3
Detachment of Device or Device Component 3
Noise, Audible 3
Material Rupture 3
Inflation Problem 2
Blocked Connection 2
Computer Operating System Problem 2
Material Twisted/Bent 2
Leak/Splash 2
Unsealed Device Packaging 2
Infusion or Flow Problem 2
Temperature Problem 1
Application Interface Becomes Non-Functional Or Program Exits Abnormally 1
Display or Visual Feedback Problem 1
Restricted Flow rate 1
Device Maintenance Issue 1
Increase in Pressure 1
Device Inoperable 1
Component Missing 1
Malposition of Device 1
Pressure Problem 1
No Display/Image 1
Probe 1
Human-Device Interface Problem 1
Output Problem 1
Display 1
Burst Container or Vessel 1
Difficult or Delayed Positioning 1
Material Fragmentation 1
Device Difficult to Program or Calibrate 1
Incorrect Interpretation of Signal 1
Device Damaged Prior to Use 1
Device Handling Problem 1
Break 1
Gas Output Problem 1
Free or Unrestricted Flow 1
Material Integrity Problem 1
Operating System Becomes Nonfunctional 1
Missing Value Reason 1
Shaft 1
Bent 1
Material Separation 1
Tear, Rip or Hole in Device Packaging 1
Crack 1
Device Disinfection Or Sterilization Issue 1
Filter 1
Partial Blockage 1
Improper Flow or Infusion 1
Total Device Problems 946

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II Jul-21-2020
2 C2 Therapeutics, Inc. II Jun-05-2018
3 C2 Therapeutics, Inc. II Mar-15-2017
4 CSA Medical II Apr-23-2015
5 CSA Medical II Jan-07-2015
6 CooperSurgical, Inc. II Apr-16-2015
7 Galil Medical, Inc. II Nov-14-2019
8 PENTAX of America Inc II May-14-2019
9 PENTAX of America Inc II Mar-01-2019

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