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Data / Medical devices / Passer / United States

FDA-registered makers of Passer in the United States: 54 establishments

54 establishments in the United States are registered with the FDA to make Passer (product code HWQ). 3 have a 510(k) clearance or PMA approval on file and 3 have a recall event. FDA data exported November 2, 2026.

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Device
Passer
Product code
HWQ
Country
United States

Makers of Passer in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Smith & Nephew Inc.Andover, MA, United StatesSpecification developer2May 5, 1993000api.fda.gov
Smith & Nephew Inc.Mansfield, MA, United StatesManufacturer, Specification developer2May 5, 1993000api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer1May 5, 1993000api.fda.gov
Ad-Tech Medical Instrument Corp.Oak Creek, WI, United StatesManufacturer0000api.fda.gov
ARCH Medical Solutions - WarsawWarsaw, IN, United StatesContract manufacturer0000api.fda.gov
Arthrex, Inc.Naples, FL, United StatesSpecification developer0000api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Arthrex, Inc.Ave Maria, FL, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
ArthroCare CorporationAustin, TX, United StatesSpecification developer0000api.fda.gov
Biomet, Inc.Warsaw, IN, United StatesManufacturer0040api.fda.gov
Bradshaw Medical Inc.Kenosha, WI, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Cadence Device, Inc.Cranberry Township, PA, United StatesContract manufacturer0000api.fda.gov
Classic Wire Cut Company, Inc.Valencia, CA, United StatesContract manufacturer0000api.fda.gov
Culver Tool & EngineeringPlymouth, IN, United StatesContract manufacturer0000api.fda.gov
Dunamis Medical LLCGreenville, AL, United StatesManufacturer, Specification developer0000api.fda.gov
Eptam West LLCColorado Springs, CO, United StatesContract manufacturer0000api.fda.gov
Fort Wayne Metals Research Products, LLCFort Wayne, IN, United StatesContract manufacturer0000api.fda.gov
Holmed LLCAttleboro, MA, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Instrumental Machine & Development, Inc.Warsaw, IN, United StatesContract manufacturer0000api.fda.gov
Instrumed International Inc dba Avalign German Specialty InstrumentsSchaumburg, IL, United StatesContract manufacturer, Repackager or relabeler0000api.fda.gov
Integra LifeSciences Production CorporationMansfield, MA, United StatesSpecification developer0000api.fda.gov
Janco, Inc.Rollinsford, NH, United StatesContract manufacturer, Repackager or relabeler0000api.fda.gov
Life Science OutsourcingSomersworth, NH, United StatesContract manufacturer0000api.fda.gov
Linvatec CorporationLargo, FL, United StatesManufacturer0010api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Microport Orthopedics Inc.Arlington, TN, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Medartis Inc.Warsaw, IN, United StatesContract manufacturer0000api.fda.gov
Medline ReNewalRedmond, OR, United StatesReprocessor0010api.fda.gov
Orthofix Us LLCLewisville, TX, United StatesSpecification developer0000api.fda.gov
Orthopediatrics, CorpWarsaw, IN, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Parcus Medical, L.L.C.Sarasota, FL, United StatesManufacturer, Specification developer0000api.fda.gov
Phoenix Instruments, Inc.Lisle, IL, United StatesContract manufacturer0000api.fda.gov
Pioneer Surgical Technology, Inc.Marquette, MI, United StatesManufacturer0000api.fda.gov
Primo Medical Group, INCStoughton, MA, United StatesContract manufacturer0000api.fda.gov
Renovo, Inc.Bend, OR, United StatesReprocessor0000api.fda.gov
Riverpoint Medical LLCPortland, OR, United StatesManufacturer0000api.fda.gov
Siesta Medical, Inc.Los Gatos, CA, United StatesManufacturer0000api.fda.gov
Smith & Nephew Inc.Oklahoma City, OK, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer0000api.fda.gov
Stryker EndoscopySan Jose, CA, United StatesSpecification developer0000api.fda.gov
Suretek MedicalGreenville, SC, United StatesReprocessor0000api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer0000api.fda.gov
Synthes (USA) Products LLCWest Chester, PA, United StatesSpecification developer0000api.fda.gov
Toby OrthopaedicsMiami, FL, United StatesManufacturer0000api.fda.gov
TORNIER Inc.Columbia City, IN, United StatesSpecification developer0000api.fda.gov
Tornier, Inc.Bloomington, MN, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Trimed, Inc.Santa Clarita, CA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Teleflex LLC (NADC)Olive Branch, MS, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Vericel CorporationCambridge, MA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Wright Engineered Plastics, Inc.Santa Rosa, CA, United StatesContract manufacturer0000api.fda.gov
Wright Medical Technology, Inc.Arlington, TN, United StatesManufacturer0000api.fda.gov
Wright Medical Technology, Inc.Arlington, TN, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Zimmer, Inc.Warsaw, IN, United StatesManufacturer, Repackager or relabeler0000api.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.