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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device mesh, surgical, polymeric
Regulation Description Surgical mesh.
Product CodeFTL
Regulation Number 878.3300
Device Class 2


Premarket Reviews
ManufacturerDecision
ARISTE MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 1
DAVOL INC.
  SUBSTANTIALLY EQUIVALENT 2
DAVOL INC., SUBSIDIARY OF C. R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
DAVOL INC., SUBSIDIARY OF C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 2
DEEP BLUE MEDICAL ADVANCES, INC.
  SUBSTANTIALLY EQUIVALENT 4
ETHICON, INC.
  SUBSTANTIALLY EQUIVALENT 1
MAST BIOSURGERY
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC - SOFRADIM PRODUCTION
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 2
SOFRADIM PRODUCTION
  SUBSTANTIALLY EQUIVALENT 5
XIROS LTD
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2020 18814 18822
2021 16284 16291
2022 11439 11445
2023 8025 8025
2024 8566 8581
2025 3141 3158

Device Problems MDRs with this Device Problem Events in those MDRs
Defective Device 38588 38589
Patient Device Interaction Problem 27759 27760
Adverse Event Without Identified Device or Use Problem 22312 22321
Insufficient Information 13867 13867
Mechanics Altered 3831 3831
Patient-Device Incompatibility 3531 3536
Migration or Expulsion of Device 2713 2717
Material Deformation 1094 1095
Appropriate Term/Code Not Available 733 764
Material Split, Cut or Torn 693 693
Migration 692 693
Material Integrity Problem 441 441
Degraded 260 260
Detachment of Device or Device Component 157 158
Break 84 84
Therapeutic or Diagnostic Output Failure 80 80
Delivered as Unsterile Product 74 74
Material Separation 67 67
Device Appears to Trigger Rejection 65 65
Expiration Date Error 63 63
Device Markings/Labelling Problem 57 57
Material Protrusion/Extrusion 51 52
Loss of or Failure to Bond 50 50
Device Contamination with Chemical or Other Material 50 50
Material Erosion 39 41
Product Quality Problem 36 36
Improper or Incorrect Procedure or Method 31 31
Use of Device Problem 31 31
Material Twisted/Bent 28 29
Material Disintegration 24 24
Packaging Problem 22 22
Output Problem 22 22
Microbial Contamination of Device 17 17
Tear, Rip or Hole in Device Packaging 17 17
Off-Label Use 16 16
Unsealed Device Packaging 16 16
Difficult or Delayed Positioning 13 13
Device Dislodged or Dislocated 13 14
Contamination 12 12
Unraveled Material 12 12
Failure to Osseointegrate 11 11
Entrapment of Device 10 10
Device Contaminated During Manufacture or Shipping 10 10
Material Fragmentation 9 9
Difficult to Insert 9 9
Structural Problem 9 9
Difficult to Remove 8 8
Material Frayed 8 8
No Apparent Adverse Event 7 7
Unintended Movement 6 6

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 29840 29860
Insufficient Information 26951 26952
Injury 15679 15679
Hernia 15513 15534
Adhesion(s) 13142 13161
Unspecified Tissue Injury 10645 10645
Inflammation 6700 6702
Unspecified Infection 6585 6590
Disability 5532 5532
Scar Tissue 4505 4506
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4452 4456
Emotional Changes 3856 3856
Discomfort 3766 3766
Obstruction/Occlusion 3495 3500
Abdominal Pain 3305 3307
Distress 2679 2679
Abscess 2458 2460
Nausea 2417 2417
Seroma 2354 2355
Fistula 1502 1505
No Clinical Signs, Symptoms or Conditions 1319 1319
Diarrhea 1310 1310
Swelling/ Edema 1270 1271
Abdominal Distention 1166 1166
Decreased Appetite 1157 1157
Erosion 1143 1143
Hematoma 1123 1123
Fluid Discharge 1060 1061
Chills 1051 1051
Impaired Healing 1001 1001
Hemorrhage/Bleeding 992 992
Nerve Damage 949 951
Purulent Discharge 924 924
Weight Changes 871 871
Foreign Body Reaction 849 850
Failure of Implant 820 823
No Code Available 781 781
Vomiting 751 751
Necrosis 744 744
Fibrosis 699 699
Ascites 653 653
Perforation 634 634
Not Applicable 629 629
Nodule 573 573
Bacterial Infection 556 556
Constipation 550 551
Muscle Weakness 536 536
Scarring 451 451
Erythema 448 449
Deformity/ Disfigurement 429 429

Recalls
Manufacturer Recall Class Date Posted
1 Chamberlain Technologies LLC II Jun-17-2025
2 Covidien Llc II Feb-22-2021
3 Covidien, LP II Feb-27-2023
4 Davol, Inc. II Jul-27-2023
5 Ethicon, Inc. II Dec-03-2020
6 W.L. Gore & Associates, Inc. II Aug-06-2024
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