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Data / Medical devices / Motor, Drill, Pneumatic

Motor, Drill, Pneumatic (HBB): 29 FDA-registered makers in 8 countries

29 establishments in 8 countries are registered with the FDA to make Motor, Drill, Pneumatic (product code HBB, Class 2, 21 CFR 882.4370). 13 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 27 510(k) clearances under this code, the latest on March 6, 2026, and lists 14 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
HBB
Device class
2
Regulation
882.4370
Medical specialty
Neurology

Makers by country

CountryMakers
United States16
Switzerland3
Malaysia3
Germany2
Ireland2
Turkey1
Nicaragua1
United Kingdom1

Makers of Motor, Drill, Pneumatic

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 Powered Surgical SolutionsFort Worth, TX, United StatesManufacturer3March 23, 2017080api.fda.gov
Stryker InstrumentsPortage, MI, United StatesComplaint file establishment, Specification developer3May 22, 2015000api.fda.gov
Aesculap AGTUTTLINGEN, DONAU Baden-Wurttemberg, GermanyManufacturer2November 9, 2018010api.fda.gov
Synthes GMBHZuchwil Solothurn, SwitzerlandSpecification developer2April 14, 2010000api.fda.gov
The Anspach Effort, Inc.Palm Bch Gdns, FL, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler2April 14, 2010030api.fda.gov
Adeor Medical AGValley Bavaria, GermanyComplaint file establishment, Specification developer1March 6, 2026000api.fda.gov
Medtronic Puerto Rico Operations Co., HumacaoHumacao, PR, United StatesManufacturer1March 18, 2002000api.fda.gov
Medtronic Sofamor Danek Usa, Inc.Memphis, TN, United StatesManufacturer1August 24, 2010000api.fda.gov
Medtronic Sofamor Danek Usa, Inc.Memphis, TN, United StatesSpecification developer1August 24, 2010000api.fda.gov
Sanmed Medikal Otomotiv Tekstil Ticaret Limited SirketiIstanbul, TurkeyExporter to the US, Manufacturer1March 18, 2002000api.fda.gov
SYNTHES GMBH / Synthes Produktions GmbHOberdorf, Baselland Basel-Landschaft, SwitzerlandManufacturer1April 14, 2010000api.fda.gov
Stryker Ireland Ltd. Instruments Division, Innovation CentreCarrigtwohill Cork(County), IrelandSpecification developer1October 26, 2006000api.fda.gov
Synthes GMBHSelzach Solothurn, SwitzerlandManufacturer1April 14, 2010000api.fda.gov
3D MEDICAL MANUFACTURING, INC. (dba Tecomet)Riviera Beach, FL, United StatesContract manufacturer0000api.fda.gov
Command Medical Nicaragua SAManagua, NicaraguaContract manufacturer0000api.fda.gov
Kimball Solutions - IndianapolisIndianapolis, IN, United StatesContract manufacturer0000api.fda.gov
Linvatec CorporationLargo, FL, United StatesManufacturer0000api.fda.gov
Medtronic Navigation, Inc.Lafayette, CO, United StatesSpecification developer0000api.fda.gov
Medtronic Xomed, Inc.Jacksonville, FL, United StatesManufacturer0000api.fda.gov
Orchid UniqueBridgeport, MI, United StatesContract manufacturer0000api.fda.gov
Paragon Medical, Inc.Pierceton, IN, United StatesContract manufacturer0000api.fda.gov
Paragon Medical - DaytonDayton, OH, United StatesContract 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 Manufacturing KalamazooPortage, MI, United StatesContract manufacturer0000api.fda.gov
Vaupell Midwest Molding and ToolingConstantine, MI, United StatesContract manufacturer0000api.fda.gov
Zethon LtdASTON CLINTON Buckinghamshire, United KingdomManufacturer0000api.fda.gov

Updated March 6, 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.