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Data / Medical devices / Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece

Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece (ERL): 78 FDA-registered makers in 16 countries

78 establishments in 16 countries are registered with the FDA to make Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece (product code ERL, Class 2, 21 CFR 874.4250). 22 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 91 510(k) clearances under this code, the latest on July 3, 2025, and lists 13 recall events (0 Class I). FDA data exported November 3, 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 every maker of this deviceMakers in the United StatesWatch this device
Product code
ERL
Device class
2
Regulation
874.4250
Medical specialty
Ear, Nose, Throat

Makers by country

CountryMakers
United States38
Germany10
Switzerland9
Malaysia3
Ireland2
Austria2
China2
Japan2
United Kingdom2
Dominican Republic2
Turkey1
Costa Rica1
Nicaragua1
Mexico1
Italy1
France1

Makers of Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Medtronic Xomed, Inc.Jacksonville, FL, United StatesComplaint file establishment, Manufacturer10August 14, 2015030api.fda.gov
Stryker InstrumentsPortage, MI, United StatesComplaint file establishment, Specification developer9June 9, 2021000api.fda.gov
Gyrus ACMI, Inc.Brooklyn Park, MN, United StatesComplaint file establishment, Manufacturer, Specification developer6January 19, 2022000api.fda.gov
Karl Storz Se & Co KGTUTTLINGEN Baden-Wurttemberg, GermanySpecification developer5October 22, 2020000api.fda.gov
Bien-Air Surgery SALe Noirmont Jura, SwitzerlandExporter to the US, Foreign private label distributor, Manufacturer, Specification developer3November 2, 2022010api.fda.gov
Stryker Puerto Rico, LLC.Arroyo, PR, United StatesContract manufacturer, Manufacturer3May 1, 2012000api.fda.gov
Synthes GMBHZuchwil Solothurn, SwitzerlandSpecification developer3March 27, 2018000api.fda.gov
The Anspach Effort, Inc.Palm Bch Gdns, FL, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer3March 27, 2018060api.fda.gov
Gyrus Acmi, Inc.Bartlett, TN, United StatesManufacturer2June 10, 2016000api.fda.gov
Sanmed Medikal Otomotiv Tekstil Ticaret Limited SirketiIstanbul, TurkeyExporter to the US, Manufacturer2September 5, 2008000api.fda.gov
Stryker Ireland Ltd. Instruments Division, Innovation CentreCarrigtwohill Cork(County), IrelandSpecification developer2May 1, 2012000api.fda.gov
W&H Dentalwerk Buermoos GMBHBUERMOOS Salzburg, AustriaManufacturer2July 3, 2025000api.fda.gov
W&H Dentalwerk Buermoos GMBH - Site 2BUERMOOS Salzburg, AustriaManufacturer2July 3, 2025000api.fda.gov
Grace Medical, Inc.Memphis, TN, United StatesManufacturer1August 25, 2016000api.fda.gov
Gyrus Acmi, Inc.Westborough, MA, United StatesSpecification developer1January 19, 2022000api.fda.gov
Interscope, Inc.Northbridge, MA, United StatesManufacturer1December 13, 2019000api.fda.gov
Jabil Circuit (Shanghai) Ltd.Shanghai, ChinaContract manufacturer, Exporter to the US1August 14, 2015000api.fda.gov
Karl Storz Se & Co. KGTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer, Repackager or relabeler1March 24, 1995000api.fda.gov
Medtronic Powered Surgical SolutionsFort Worth, TX, United StatesManufacturer, Specification developer1September 5, 2008000api.fda.gov
Nakanishi Inc.Kanuma Tochigi, JapanContract manufacturer, Manufacturer1September 17, 2008000api.fda.gov
Stryker EndoscopySan Jose, CA, United StatesManufacturer1July 20, 1995000api.fda.gov
Zethon LtdASTON CLINTON Buckinghamshire, United KingdomManufacturer1March 14, 2024000api.fda.gov
3D MEDICAL MANUFACTURING, INC. (dba Tecomet)Riviera Beach, FL, United StatesContract manufacturer0000api.fda.gov
A.handte Medizintechnik GMBH & Co. KGTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
ABBOTT GmbHWiesbaden Hesse, GermanyManufacturer0000api.fda.gov
Abnox AGCham Zug, SwitzerlandContract manufacturer0000api.fda.gov
Acclarent, Inc.Irvine, CA, United StatesSpecification developer0000api.fda.gov
Benchmark Electronics, Inc.Winona, MN, United StatesContract manufacturer0000api.fda.gov
Benchmark Electronics, Inc.Rochester, MN, United StatesContract manufacturer0000api.fda.gov
Bruetsch Technology AGBeringen Schaffhausen, SwitzerlandContract manufacturer0000api.fda.gov
Biomerics AlajuelaAlajuela, Costa RicaContract manufacturer0000api.fda.gov
Cadence Device, Inc.Cranberry Township, PA, United StatesContract manufacturer0000api.fda.gov
CEA Global Dominicana d.b.a. Nissha Medical TechnologiesSan Pedro de Macoris, Dominican RepublicContract manufacturer0000api.fda.gov
Command Medical Nicaragua SAManagua, NicaraguaContract manufacturer0000api.fda.gov
Command Medical Products, LLC.Ormond Beach, FL, United StatesContract manufacturer0000api.fda.gov
Consolidated Medical Equipment CompanyChihuahua, MexicoContract manufacturer0000api.fda.gov
Covidien- Santo Domingo, Dominican RepublicContract manufacturer0000api.fda.gov
Eberle GmbH & Co. KGWURMBERG Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Force Engineering Co.ltdUtsunomiya Tochigi, JapanContract manufacturer0000api.fda.gov
Frueh Verpackungstechnik AGFehraltorf Zurich, SwitzerlandContract manufacturer0000api.fda.gov
Guangdong Jinme Medical Technology Co., Ltd.Foshan Guangdong, ChinaManufacturer0000api.fda.gov
Hager & Meisinger GMBHNEUSS North Rhine-Westphalia, GermanyContract manufacturer0000api.fda.gov
Jabil Inc. (Brandywine)W Chester, PA, United StatesContract manufacturer0000api.fda.gov
Jabil Inc. (Elmira)Horseheads, NY, United StatesContract manufacturer0000api.fda.gov
Jabil Inc. (Monument)Monument, CO, United StatesContract manufacturer0000api.fda.gov
Jabil Switzerland Manufacturing GmbH (Bettlach)Bettlach Solothurn, SwitzerlandContract manufacturer0000api.fda.gov
Jabil Tuttlingen Manufacturing GmbHTuttlingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
K2M, Inc.Leesburg, VA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Karl Storz Se & Co. KGNEUHAUSEN OBECK Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Kimball Solutions - IndianapolisIndianapolis, IN, United StatesContract manufacturer0000api.fda.gov
Kimball Solutions Jasper, Inc.Jasper, IN, United StatesContract manufacturer0000api.fda.gov
Linemaster Switch Corp.Woodstock, CT, United StatesContract manufacturer0000api.fda.gov
Linvatec CorporationLargo, FL, United StatesSpecification developer0000api.fda.gov
Mectron S.P.A.CARASCO Genova, ItalyManufacturer0000api.fda.gov
Medtronic Puerto Rico Operations Co., HumacaoHumacao, PR, United StatesManufacturer0000api.fda.gov
Mi3 LimitedBlackburn Lancashire, United KingdomContract manufacturer0000api.fda.gov
Millstone Medical Outsourcing LLC.Fall River, MA, United StatesContract manufacturer0000api.fda.gov
Nico CorporationIndianapolis, IN, United StatesSpecification developer0000api.fda.gov
Nouvag AGGOLDACH Sankt Gallen, SwitzerlandManufacturer0000api.fda.gov
Nypro Inc (Maple Grove)Maple Grove, MN, United StatesContract manufacturer0000api.fda.gov
Orchid UniqueBridgeport, MI, United StatesContract manufacturer0000api.fda.gov
Paragon Medical, Inc.Pierceton, IN, United StatesContract manufacturer0000api.fda.gov
Precision Edge Surgical Products CompanySault Sainte Marie, MI, United StatesContract manufacturer0000api.fda.gov
Primo Medical Group, INCStoughton, MA, United StatesContract manufacturer0000api.fda.gov
Primo Medical Group, IncW Bridgewater, MA, United StatesContract manufacturer0000api.fda.gov
R.H. Cross Enterprises, Inc.Portage, MI, United StatesContract manufacturer0000api.fda.gov
Richard Wolf GMBHKNITTLINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Satelec-Acteon GroupMERIGNAC Gironde, FranceManufacturer0000api.fda.gov
Storz Endoskop Produktions GMBHSchaffhausen, SwitzerlandContract manufacturer0000api.fda.gov
Straits Orthopaedics (MFG) Sdn BhdSimpang Ampat Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
Straits Orthopaedics (MFG) Sdn BhdPerai Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
Straits Orthopaedics (MFG) Sdn BhdBandar Cassia Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
Stryker Ireland Ltd., Instruments DivisionCARRIGTWOHILL, CO.CORK Munster, IrelandContract manufacturer0000api.fda.gov
Stryker Leibinger GMBH & Co. KGFREIBURG Baden-Wurttemberg, GermanyComplaint file establishment, Manufacturer0000api.fda.gov
Stryker Manufacturing KalamazooPortage, MI, United StatesContract manufacturer0000api.fda.gov
SYNTHES GMBH / Synthes Produktions GmbHOberdorf, Baselland Basel-Landschaft, SwitzerlandManufacturer0000api.fda.gov
Synthes (USA) Products LLCWest Chester, PA, United StatesSpecification developer0000api.fda.gov
Vaupell Midwest Molding and ToolingConstantine, MI, United StatesContract manufacturer0000api.fda.gov

Updated July 3, 2025. 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.