Atlas FDA

FTL

336 FDA 510(k) clearances · Product code

89 daysmedian time to decision
252 days90th percentile
336clearances measured

FDA profile

Official device name
Mesh, Surgical, Polymeric
Device class
Class II (moderate risk)
Regulation
21 CFR 878.3300
Medical specialty
General, Plastic Surgery
Flags
Implant
Adverse events (MAUDE)
2021: 16,284 · 2022: 11,439 · 2023: 8,025 · 2024: 8,582 · 2025: 3,575 · 2026: 2,007
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030) (K253956)Sofradim Production2026-05-21
Parietene™ Flat Sheet Mesh (K253125)Medtronic - Sofradim Production2025-10-24
Onflex™ Mesh (K251955)Davol Inc., Subsidiary of C. R. Bard, Inc.2025-07-24
Bard® Mesh; Bard® Mesh Pre-Shaped (K251557)Davol, Inc.2025-06-12
Parietene™ Macroporous Mesh (PPM5050 ) (K250869)Sofradim Production2025-04-23
Bard Soft Mesh; Bard Soft Mesh Pre-Shaped (K250098)Davol, Inc.2025-04-09
ProGrip™ Self-Gripping Polypropylene Mesh (K243315)Sofradim Production2025-01-17
3DMax Light Mesh (K241250)Davol Inc., Subsidiary of C. R. Bard, Inc.2024-06-14
Progrip™ Self-Gripping Polypropylene Mesh (K232373)Sofradim Production2024-01-18
Bard 3DMax Mesh (K233402)Davol Inc., Subsidiary of C. R. Bard, Inc.2023-11-01
T-Line® Hernia Mesh (K232924)Deep Blue Medical Advances, Inc.2023-10-18
Pitch PaSoft Tissue Reinforcement Device (K230671)Xiros, Ltd.2023-05-31
T-Line Hernia Mesh (K230227)Deep Blue Medical Advances, Inc.2023-02-23
Parietene Macroporous Mesh (K223218)Sofradim Production2022-12-02
T-Line Hernia Mesh (K221556)Deep Blue Medical Advances, Inc.2022-11-28
ProGrip Self-Gripping Polypropylene Mesh (K220540)Covidien2022-09-22
Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device (K220091)Xiros, Ltd.2022-08-26
Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D 3D Anatomical Mesh, Versatex Monofilament Mesh (K220586)Sofradim Production2022-06-22
ARISTE AB Mesh (K211132)Ariste Medical, LLC2022-03-18
Pitch-Patchs (K211563)Xiros, Ltd.2021-08-13
SurgiWrap FROST (K200918)Mast Biosurgery2021-01-07
VICRYL Mesh (K201143)ETHICON, Inc.2020-08-06
3DMax MID Anatomical Mesh (K200818)C.R. Bard, Inc.2020-07-17
TYRX Neuro Absorbable Antibacterial Envelope (Medium), TYRX Neuro Absorbable Antibacterial Envelope (Large) (K192636)Medtronic, Inc.2020-04-08
T-Line Hernia Mesh (K193144)Deep Blue Medical Advances, Inc.2020-03-30
TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large) (K192389)Medtronic, Inc.2020-03-27
Dextile Anatomical Mesh (K192443)Sofradim Production2019-12-06
VICRYL Mesh (K191373)ETHICON, Inc.2019-10-22
FlexBand Plus (K192112)International Life Sciences2019-09-27
Exogenesis Hernia Mesh (K191545)Exogenesis Corporation2019-09-26
Phasix ST Mesh with Echo 2 Positioning System (K182008)C.R. Bard, Inc.2018-12-14
Endoform Reconstructive Template - Non Absorbable (K181935)Aroa Biosurgery , Ltd.2018-12-04
DynaMesh-POSTERIOR (K182087)Feg Textiltechnik Forschungs- Und Entwicklungsgesellschaft2018-10-31
Polydioxanone Surgical Scaffold (K181094)Lntegra Lifesciences2018-08-02
PROLENE (Polypropylene) 3D Patch (K181268)ETHICON, Inc.2018-07-26
ULTRAPRO Mesh and ULTRAPRO ADVANCED (K180910)ETHICON, Inc.2018-07-02
PROLENE Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh, PROLENE (Polypropylene) Hernia System, Non-absorbable Synthetic Surgical Mesh (K180829)ETHICON, Inc.2018-06-28
TYRX Neuro Absorbable Antibacterial Envelope (medium); TYRX Neuro Absorbable Antibacterial Envelope (large) (K180122)Medtronic, Inc.2018-06-07
VitaMESH Macroporous PP Surgical Mesh (K172636)Proxy Biomedical , Ltd.2018-04-30
TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large) (K180030)Medtronic, Inc.2018-04-24
Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh), Parietex Composite Mesh (PCO and PCO-OS references), Parietex Optimized Composite Mesh (PCO-X, PCO-FX and PCO-OSX references) (K173796)Sofradim Production2018-03-09
Duatene bilayer mesh (K172395)Sofradim Production2018-02-01
PROLENE Soft Polypropylene Mesh (K172089)ETHICON, Inc.2017-10-05
Reperen Surgical Mesh (K170134)Iconlab, Inc.2017-08-09
Parietene DS Composite Mesh (K163212)Sofradim Production2017-06-29
GORE SYNECOR Preperitoneal Biomaterial (K163576)W. L. Gore & Associates, Inc.2017-05-11
VENTRALIGHT ST Mesh with ECHO 2 Positioning System 11cm (4.5”) Circle, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 10cm x 15cm (4”x 6”) Ellipse, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm (6”) Circle, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm x 20cm (6”x8”) Ellipse, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm x 25cm (6”x10”) Oval (K170294)C. R. Bard2017-05-01
PROLENE Soft Polypropylene Mesh (K163152)ETHICON, Inc.2017-03-11
DynaMesh-VENTRAL (K161550)Feg Textiltechnik Forschungs- Und Entwicklungsgesellschaft2016-12-22
Endoform Reconstructive Template (K153632)Aroa Biosurgery Limited (Formerly Mesynthes Limited)2016-06-16
Small PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Medium PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Large PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Extra Large PerFix Light Plug with 6 x 13.5 cm HydroLight onlay (K153236)C.R. Bard, Inc.2016-05-13
GORE SYNECOR Biomaterial (K152609)W. L. Gore & Associates, Inc.2015-12-11
TYRX Neuro Antibacterial Envelope (K152678)Tyrx, Inc.2015-11-17
C-QUR, C-QUR FX, C-QUR TacShield, C-QUR V-Patch, C-QUR CentriFX, C-QUR Mosaic (K151386)Atrium Medical Corporation2015-10-22
ECHO 2.0 LAP SYSTEM with VENTRALIGHT ST MESH (K143743)C.R. Bard, Inc.2015-09-18
ProLite Mesh, ProLite Ultra Mesh, ProLoop Mesh Plug (K151437)Atrium Medical Corporation2015-08-27
ULTRAPRO ADVANCED Macroporous Partically Absorbable Mesh (K150906)Ehicon, Inc.2015-07-24
Versatex Monofilament Mesh (K150091)Sofradim Production2015-05-26
Insightra Freedom Ventral Hernia Repair System (K142192)Insightra Medical2015-05-07
TYRX Neuro Absorbable Antibacterial Envelope (K150291)Medtronic Tyrx, Inc.2015-03-27
Modified ONFLEX Mesh (K142706)C.R. Bard, Inc.2015-03-25
ONFLEX Mesh (K142711)C.R. Bard, Inc.2015-03-20
Progrip Laparoscopic Self-Fixating Mesh (K143386)Sofradim Production2015-03-13
TYRX Neuro Absorbable Antibacterial Envelope (K142611)Medtronic Tyrx, Inc.2014-12-31
Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight Mesh), Parietex Composite Mono PM Mesh (new name: Parietex Composite Parastomal Mesh), Parietex Composite Ventral Patch, Symbotex Composite Mesh (K142908)Sofradim Production2014-11-14
Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester Mesh), Parietex Plug and Patch (new name : Parietex Plug and Patch System), Progrip Laparoscopic Self-Fixating Mesh (K142900)Sofradim Production2014-10-28
ETHICON PHYSIOMESH OPEN FLEXIBLE COMPOSITE MESH DEVICE (K141560)ETHICON, Inc.2014-10-23
PARIETENE MACROPOROUS MESH (K142091)Sofradim Production2014-10-17
PREMIUM (K133889)Cousin Biotech Sas2014-09-04
X-REPAIR (K141394)Synthasome2014-08-06
X-REPAIRSL (K141499)Synthasome, Inc.2014-07-02
FREEDOM INGUINAL HERNIA REPAIR IMPLANT-25MM/40MM/40MM WITH EXTENDED DISK (K140967)Insightra Medical2014-06-10
ULTRAPRO COMFORT PLUG (K133198)ETHICON, Inc.2014-05-30
PROGRIP SELF-GRIPPING POLYPROPYLENE MESH, PARIETENE FLAT SHEET MESH (K140941)Sofradim Production2014-05-07
BARD VENTRALEX HERNIA PATCH (K132441)C.R. Bard, Inc.2013-12-13
AIGIS RX N (MEDIUM), AIGIS RX N (LARGE) (K132699)Tyrx, Inc.2013-11-26
COVAMESH (K130428)Biomup S.A.2013-10-25
DYNAMESH -CICAT (K131530)Feg Textiltechnik Forschungs-Und Entwicklungsgesel2013-10-23
SYMBOTEX(TM) COMPOSITE MESH (K131969)Sofradim Production2013-08-22
AIGIS RX N MEDIUM; AIGIS RX N LARGE (K131007)Tyrx, Inc.2013-07-10
AIGIS RX R PM/ AIGIS RX R ICD (K130943)Tyrx, Inc.2013-05-20
VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM (K130968)C.R. Bard, Inc.2013-05-01
MEDLINX SURGICAL MESH (K120844)Medlinx Acala Pte, Ltd.2012-12-13
PROGRIP LAPAROSCOPIC SELF-FIXATING MESH (K123479)Sofradim Production2012-12-11
COMPOSIX L/P MESH WITH ECHO PS POSITIONING SYSTEM VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM (K122436)C.R. Bard, Inc.2012-11-02
FREEDOM INGUINAL HERNIA IMPLANT (K113552)Insightra Medical2012-08-23
VENTRIO LIGHT HERNIA PATCH WITH TRM ANTIMICROBIAL COATING (K113229)C.R. Bard, Inc.2012-07-20
TIO2MESH TM (K113311)Biocer Entwicklungs GmbH2012-07-17
PROGRIP LAPARSCOPIC SELF-FIXATING MESH (K120897)Sofradim Production2012-06-29
SURGIMESH XB - SKIRTED (K120025)Aspide Medical2012-06-26
PARIETEX COMPOSITE VENTRAL PATCH (K120506)Sofradim Production2012-06-13
C-QUR RPM MESH (K121070)Atrium Medical Corp.2012-04-26
HYBRID GRAFT (K111695)Cook Biotech, Inc.2012-04-02
TORNIER COLLAGEN COATED BIOFIBER SCAFFOLD (K111337)Tornier, Inc.2012-01-25
BIOMERIX COMPOSITE SURGICAL MESH (K112499)Biomerix Corporation2011-12-23
BIOMERIX ASSURE (K112567)Biomerix Corporation2011-12-23
RENASYS AB ABOMINAL DRESSING KIT (K112784)Smith & Nephew, Inc.2011-11-22
PAIRETEX OPTIMIZED COMPOSITE MESH (PCO-FX REFRENCES) (K110663)Sofradim Production2011-08-11
HYDROFIX SURGICAL SHEET (K100313)Mimedx Group, Inc.2011-06-14
VITAMESH (TM) BLUE LIGHTWEIGHT MACROPOROUS PP SURGICAL MESH (K111121)Proxy Biomedical , Ltd.2011-05-13
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Every clearance here is in the API, with alerts when new ones post.