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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device mesh, surgical
Regulation Description Surgical mesh.
Product CodeFTM
Regulation Number 878.3300
Device Class 2


Premarket Reviews
ManufacturerDecision
ACELL, INC
  SUBSTANTIALLY EQUIVALENT 1
ACELL, INC.
  SUBSTANTIALLY EQUIVALENT 3
ALLERGAN, INC.
  SUBSTANTIALLY EQUIVALENT 2
COLORADO THERAPEUTICS LLC
  SUBSTANTIALLY EQUIVALENT 2
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 5
CURASEAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
FLEXTRONICS INTERNATIONAL USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
INTEGRA LIFESCIENCES CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
LIFECELL CORP.
  SUBSTANTIALLY EQUIVALENT 2
MIROMATRIX MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
TEI BIOSCIENCES INC.
  SUBSTANTIALLY EQUIVALENT 1
TISSUE REGENIX GROUP PLC
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Adverse Event Without Identified Device or Use Problem 802
Appropriate Term/Code Not Available 613
Insufficient Information 265
Migration or Expulsion of Device 214
Patient Device Interaction Problem 38
Material Erosion 29
Migration 26
Degraded 23
Device Operates Differently Than Expected 22
Loss of or Failure to Bond 21
Material Split, Cut or Torn 14
Material Integrity Problem 14
Defective Device 14
Material Perforation 13
Product Quality Problem 11
Other (for use when an appropriate device code cannot be identified) 9
Microbial Contamination of Device 7
Material Rupture 7
Contamination During Use 7
Material Disintegration 6
Material Deformation 6
Split 5
Detachment of Device or device Component 5
Break 5
Device Appears to Trigger Rejection 5
Device Contamination With Biological Material 4
Hole In Material 4
Detachment Of Device Component 3
Mechanics Altered 3
Device Dislodged or Dislocated 3
No Apparent Adverse Event 3
Delamination 2
Failure To Adhere Or Bond 2
Flaked 2
Entrapment of Device 2
Incorrect, Inadequate or Imprecise Result or Readings 2
Torn Material 2
Device Contamination with Chemical or Other Material 2
Device Emits Odor 2
Material Too Rigid or Stiff 1
Incomplete or Missing Packaging 1
Device Issue 1
Failure to Form Staple 1
Device Packaging Compromised 1
Material Protrusion / Extrusion 1
Ring 1
Leak / Splash 1
Peeled / Delaminated 1
Unintended Movement 1
Shelf Life Exceeded 1
Failure to Unfold or Unwrap 1
Device Expiration Issue 1
Tear, Rip or Hole in Device Packaging 1
Calcified 1
Patient-Device Incompatibility 1
Human-Device Interface Problem 1
Difficult to Open or Close 1
Explanted 1
Use of Device Problem 1
Total Device Problems 2237

Recalls
Manufacturer Recall Class Date Posted
1 ACell, Inc II Mar-21-2019
2 AROA Biosurgery, LTD. II Nov-09-2018
3 AZIYO BIOLOGICS II Oct-04-2019

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