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Data / Medical devices / Mesh, Surgical / United States

FDA-registered makers of Mesh, Surgical in the United States: 42 establishments

42 establishments in the United States are registered with the FDA to make Mesh, Surgical (product code FTM). 30 have a 510(k) clearance or PMA approval on file and 7 have a recall event. FDA data exported November 2, 2026.

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Device
Mesh, Surgical
Product code
FTM
Country
United States

Makers of Mesh, Surgical in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Cook Biotech, Inc.West Lafayette, IN, United StatesManufacturer12June 21, 2017010api.fda.gov
Integra LifeSciences CorporationPrinceton, NJ, United StatesComplaint file establishment, Specification developer7February 7, 2019000api.fda.gov
SYNOVIS LIFE TECHNOLOGIES, INC. (A Subsidiary of Baxter International Inc.)Saint Paul, MN, United StatesManufacturer7April 7, 2023040api.fda.gov
Tela Bio, Inc.Malvern, PA, United StatesComplaint file establishment, Manufacturer, Specification developer6June 3, 2025000api.fda.gov
Lifecell CorpBranchburg, NJ, United StatesManufacturer5February 24, 2017000api.fda.gov
Lifecell Corp.Branchburg, NJ, United StatesComplaint file establishment, Manufacturer5February 24, 2017020api.fda.gov
Depuy Orthopaedics, Inc.Warsaw, IN, United StatesManufacturer4September 4, 2007000api.fda.gov
Integra LifeSciences Braintree Inc.Braintree, MA, United StatesManufacturer4February 16, 2017010api.fda.gov
Alafair Biosciences, Inc.Austin, TX, United StatesComplaint file establishment, Manufacturer, Specification developer3October 29, 2021000api.fda.gov
DSM Biomedical, Inc.Exton, PA, United StatesContract manufacturer, Manufacturer3February 7, 2011000api.fda.gov
RTI Surgical, Inc. (dba RTI Biologics, Inc.)Alachua, FL, United StatesSpecification developer3October 27, 2014000api.fda.gov
Acell, Inc.Columbia, MD, United StatesManufacturer2February 7, 2019020api.fda.gov
Boston Scientific CorporationRoswell, GA, United StatesManufacturer, Specification developer2August 12, 2026010api.fda.gov
Collagen Matrix, Inc.Mahwah, NJ, United StatesContract manufacturer, Repackager or relabeler2January 8, 2013000api.fda.gov
Synthes (USA) Products LLCWest Chester, PA, United StatesComplaint file establishment, Specification developer2March 13, 2019000api.fda.gov
Boston Scientific Corp., Marina Bay Cust. Fulfillment CenterQuincy, MA, United StatesManufacturer1August 12, 2026000api.fda.gov
Collagen Matrix, Inc.Oakland, NJ, United StatesContract manufacturer, Manufacturer, Specification developer1May 15, 2008000api.fda.gov
Colorado Therapeutics LLCLouisville, CO, United StatesManufacturer1October 25, 2017000api.fda.gov
Cook IncorporatedBloomington, IN, United StatesComplaint file establishment, Manufacturer1May 28, 1998000api.fda.gov
Davol Inc., Sub. C.R. Bard, Inc.Warwick, RI, United StatesComplaint file establishment, Specification developer1April 28, 2014010api.fda.gov
Integra Lifesciences CorporationPlainsboro, NJ, United StatesManufacturer1February 3, 2006000api.fda.gov
Lemaitre Vascular, Inc.Burlington, MA, United StatesManufacturer1June 15, 2004000api.fda.gov
LeMaitre Vascular Inc.Billerica, MA, United StatesManufacturer1June 15, 2004000api.fda.gov
Medtronic NeurosurgeryFort Worth, TX, United StatesSpecification developer1January 12, 1993000api.fda.gov
Organogenesis Inc.Canton, MA, United StatesManufacturer1November 2, 2004000api.fda.gov
Reprise Biomedical, Inc.Plymouth, MN, United StatesManufacturer1March 31, 2014000api.fda.gov
S. Jackson, Inc.Alexandria, VA, United StatesManufacturer1September 25, 1997000api.fda.gov
Smith & Nephew Inc.Andover, MA, United StatesSpecification developer1January 8, 2013000api.fda.gov
Stellen Medical, LLCSaint Paul, MN, United StatesContract manufacturer, Manufacturer1October 14, 2011000api.fda.gov
Tisgenx, Inc.Irvine, CA, United StatesComplaint file establishment, Manufacturer1June 18, 2019000api.fda.gov
AllosourceCentennial, CO, United StatesContract manufacturer0000api.fda.gov
Amcor Flexibles, CommerceCommerce, CA, United StatesContract manufacturer0000api.fda.gov
Bard Shannon LimitedHumacao, PR, United StatesContract manufacturer0000api.fda.gov
Bridgemed Solutions, Inc.Irvine, CA, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
COLLAGEN SOLUTIONS/TISSX LLC d/b/a EvergenEden Prairie, MN, United StatesContract manufacturer0000api.fda.gov
Collagen Matrix, IncAllendale, NJ, United StatesContract manufacturer0000api.fda.gov
Embody, Inc.Norfolk, VA, United StatesManufacturer0000api.fda.gov
Fesarius TherapeuticsNew York, NY, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Micro Precision SwissSanta Ana, CA, United StatesContract manufacturer0000api.fda.gov
Tybr Health, Inc.Houston, TX, United StatesComplaint file establishment, Specification developer0000api.fda.gov
VWR Chemicals, LLCSolon, OH, United StatesContract manufacturer0000api.fda.gov
Viant Medical, Inc.Grand Rapids, MI, United StatesContract manufacturer0000api.fda.gov

Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.