Skip to the page
Get started – free

Data / Medical devices / Instrument, Biopsy / United States

FDA-registered makers of Instrument, Biopsy in the United States: 73 establishments

73 establishments in the United States are registered with the FDA to make Instrument, Biopsy (product code KNW). 40 have a 510(k) clearance or PMA approval on file and 9 have a recall event. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers of this device in the United StatesWatch these makers
Device
Instrument, Biopsy
Product code
KNW
Country
United States

Makers of Instrument, Biopsy in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Bard Peripheral Vascular, Inc.Tempe, AZ, United StatesComplaint file establishment, Specification developer18August 14, 20260170api.fda.gov
Argon Medical Devices Inc.Athens, TX, United StatesContract manufacturer, Manufacturer, Repackager or relabeler13July 1, 2022061api.fda.gov
Devicor Medical Products, Inc.Cincinnati, OH, United StatesSpecification developer11March 4, 2026010api.fda.gov
Argon Medical Devices, Inc.Wheeling, IL, United StatesContract manufacturer, Manufacturer, Repackager or relabeler9November 1, 2005000api.fda.gov
Devicor Medical Products, Inc. Warehouse/Distribution/Service CenterBlue Ash, OH, United StatesRemanufacturer, Repackager or relabeler8March 4, 2026000api.fda.gov
Ranfac Corp.Avon, MA, United StatesContract manufacturer, Manufacturer8September 18, 2020000api.fda.gov
Hologic, Inc.Marlborough, MA, United StatesComplaint file establishment, Specification developer6April 10, 2018040api.fda.gov
RLS Interventional Inc. DBA InradGrand Rapids, MI, United StatesManufacturer6April 29, 2025000api.fda.gov
Busse Hospital DisposablesHauppauge, NY, United StatesManufacturer, Repackager or relabeler5December 22, 2015000api.fda.gov
Cook IncorporatedBloomington, IN, United StatesComplaint file establishment, Manufacturer, Specification developer5February 28, 2017000api.fda.gov
Merit Medical Systems, Inc.South Jordan, UT, United StatesManufacturer, Specification developer5August 28, 2020010api.fda.gov
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer5December 17, 2014010api.fda.gov
Stryker Puerto Rico, LLC.Arroyo, PR, United StatesManufacturer, Repackager or relabeler4February 26, 2018000api.fda.gov
Stryker InstrumentsPortage, MI, United StatesComplaint file establishment, Specification developer4February 26, 2018000api.fda.gov
Avitus Orthopaedics, IncShelton, CT, United StatesSpecification developer3March 31, 2021010api.fda.gov
Remington Medical, Inc.Alpharetta, GA, United StatesManufacturer, Repackager or relabeler3July 12, 2019050api.fda.gov
Uro-1, Inc.Greensboro, NC, United StatesManufacturer3November 29, 2023000api.fda.gov
Vascular Solutions LLCMaple Grove, MN, United StatesSpecification developer3December 17, 2014000api.fda.gov
Arthrex, Inc.Naples, FL, United StatesSpecification developer2November 19, 2021000api.fda.gov
Carefusion 2200, Inc.Vernon Hills, IL, United StatesComplaint file establishment, Specification developer2September 11, 2017000api.fda.gov
Izi Medical Products LLCOwings Mills, MD, United StatesManufacturer2February 28, 2017000api.fda.gov
Surgentec LLCBoca Raton, FL, United StatesManufacturer2April 24, 2025000api.fda.gov
Teleflex LLC (NADC)Olive Branch, MS, United StatesManufacturer, Repackager or relabeler2December 17, 2014000api.fda.gov
Advance Medical Designs, Inc.Marietta, GA, United StatesManufacturer, Repackager or relabeler1November 1, 1989000api.fda.gov
Cardinal HealthHazelwood, MO, United StatesSpecification developer1December 10, 1998000api.fda.gov
Cook IncorporatedSpencer, IN, United StatesManufacturer1July 22, 2004000api.fda.gov
CovidienNorth Haven, CT, United StatesContract manufacturer, Manufacturer, Repackager or relabeler, Specification developer1December 1, 1997000api.fda.gov
Hologic, Inc.Newark, DE, United StatesManufacturer1March 29, 2017000api.fda.gov
Highridge Medical, LLCWestminster, CO, United StatesSpecification developer1November 7, 2005000api.fda.gov
Hologic, Inc.Marlborough, MA, United StatesManufacturer1October 6, 2004000api.fda.gov
K2M, Inc.Leesburg, VA, United StatesManufacturer, Specification developer1January 5, 2016010api.fda.gov
Mermaid Medical A/S (FL Site)University Park, FL, United StatesComplaint file establishment, Specification developer1May 27, 2011000api.fda.gov
Praxis Medical LLCTampa, FL, United StatesSpecification developer1March 31, 2020000api.fda.gov
Riverpoint Medical LLCPortland, OR, United StatesComplaint file establishment, Manufacturer1September 24, 2009000api.fda.gov
Remington Medical, Inc.Alpharetta, GA, United StatesManufacturer1July 12, 2019000api.fda.gov
Spectra Medical Devices, LLCWilmington, MA, United StatesSpecification developer1January 21, 2015000api.fda.gov
Stryker SpineAllendale, NJ, United StatesComplaint file establishment, Manufacturer, Specification developer1December 18, 2015000api.fda.gov
TeleMed SystemsNorthborough, MA, United StatesSpecification developer1January 21, 1998000api.fda.gov
Varian Medical Systems, IncAustin, TX, United StatesManufacturer1June 16, 2023000api.fda.gov
Varian Medical Systems, Inc.Shoreview, MN, United StatesSpecification developer1June 16, 2023000api.fda.gov
Arthrex Logistic CenterFort Myers, FL, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Arthrex Manufacturing Inc.Pendleton, SC, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Arthrex, Inc.Ave Maria, FL, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Avnet, Inc. (Avnet Logistics)Chandler, AZ, United StatesContract manufacturer0000api.fda.gov
Bard Shannon LimitedHumacao, PR, United StatesContract manufacturer0000api.fda.gov
BiosealPlacentia, CA, United StatesContract manufacturer0000api.fda.gov
C.R. Bard, Inc.Covington, GA, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Carefusion 2200, Inc.Mannford, OK, United StatesContract manufacturer0000api.fda.gov
CEA Medical Manufacturing, Inc.Colorado Springs, CO, United StatesContract manufacturer0000api.fda.gov
Dymax, Corp.Zelienople, PA, United StatesContract manufacturer0000api.fda.gov
Endo-Therapeutics, Inc.Clearwater, FL, United StatesManufacturer0000api.fda.gov
Insert Molding Solutions, Inc.Cumming, GA, United StatesContract manufacturer0000api.fda.gov
Itw FiltertekHebron, IL, United StatesContract manufacturer0000api.fda.gov
Kimball Solutions - IndianapolisIndianapolis, IN, United StatesContract manufacturer0000api.fda.gov
Lavelle Medical LLCWestford, MA, United StatesContract manufacturer0000api.fda.gov
Linemaster Switch Corp.Woodstock, CT, United StatesContract manufacturer0000api.fda.gov
Medron, LLCSalt Lake City, UT, United StatesContract manufacturer0000api.fda.gov
Midwest Products And EngineeringMilwaukee, WI, United StatesContract manufacturer0000api.fda.gov
Millstone Medical Outsourcing LLC.Fall River, MA, United StatesContract manufacturer0000api.fda.gov
Minnetronix, Inc.Saint Paul, MN, United StatesContract manufacturer0000api.fda.gov
Modo IncHillsboro, OR, United StatesContract manufacturer0000api.fda.gov
Millstone Medical Outsourcing LLCOlive Branch, MS, United StatesContract manufacturer0000api.fda.gov
Modo Inc.Tualatin, OR, United StatesContract manufacturer0000api.fda.gov
Needle Specialty ProductsBoyle, MS, United StatesContract manufacturer0000api.fda.gov
Nortech Systems, Inc.Milaca, MN, United StatesContract manufacturer0000api.fda.gov
Olive Branch Distribution CenterOlive Branch, MS, United StatesContract manufacturer0000api.fda.gov
Phoenix Medical Products, Inc.Mountain City, TN, United StatesContract manufacturer0000api.fda.gov
Plexus Corp.Buffalo Grove, IL, United StatesContract manufacturer0000api.fda.gov
R.K. ManufacturingDanbury, CT, United StatesContract manufacturer0000api.fda.gov
Steripack Usa (limited) LLCLakeland, FL, United StatesContract manufacturer0000api.fda.gov
Spartronics Watertown LLCWatertown, SD, United StatesContract manufacturer0000api.fda.gov
Tegra Medical - Dartmouth, MADartmouth, MA, United StatesContract manufacturer0000api.fda.gov
Viant AS&O Holdings, LLCLaconia, NH, 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.