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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device dura substitute
Regulation Description Dura substitute.
Product CodeGXQ
Regulation Number 882.5910
Device Class 2


Premarket Reviews
ManufacturerDecision
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 1
COLLAGEN MATRIX, INC.
  SUBSTANTIALLY EQUIVALENT 2
INTEGRA
  SUBSTANTIALLY EQUIVALENT 1
INTEGRA LIFESCIENCES CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON PROFESSIONALS, INC.
  SUBSTANTIALLY EQUIVALENT 1
LEMAITRE VASCULAR, INC
  SUBSTANTIALLY EQUIVALENT 1
LEMAITRE VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
RTI SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Adverse Event Without Identified Device or Use Problem 101
Appropriate Term/Code Not Available 27
Insufficient Information 15
Device Operates Differently Than Expected 11
Fluid Leak 7
Hole In Material 7
Leak / Splash 6
Product Quality Problem 6
Separation Failure 5
Torn Material 5
Poor Quality Image 3
Degraded 3
Material Puncture / Hole 2
Use of Device Problem 2
Contamination / decontamination Problem 2
Device Appears to Trigger Rejection 2
Failure To Adhere Or Bond 2
Material Integrity Problem 2
Material Disintegration 2
Sticking 2
Device Contamination With Biological Material 2
Material Separation 2
Unsealed Device Packaging 2
Break 2
Shelf Life Exceeded 2
Microbial Contamination of Device 1
Defective Device 1
Device Expiration Issue 1
Material Rupture 1
Off-Label Use 1
Device remains implanted 1
Repair 1
Patient Device Interaction Problem 1
Detachment Of Device Component 1
Difficult to Remove 1
Patient-Device Incompatibility 1
Y-Piece Connector 1
Device Inoperable 1
Improper or Incorrect Procedure or Method 1
Compatibility Problem 1
Component Missing 1
Tip 1
No Apparent Adverse Event 1
Material Split, Cut or Torn 1
Seal 1
Total Device Problems 242

Recalls
Manufacturer Recall Class Date Posted
1 Synthes (USA) Products LLC II Oct-11-2018

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