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Data / Medical devices / Saw, Powered, And Accessories

Saw, Powered, And Accessories (HAB): 47 FDA-registered makers in 11 countries

47 establishments in 11 countries are registered with the FDA to make Saw, Powered, And Accessories (product code HAB, Class 1, 21 CFR 878.4820). 1 of them has a 510(k) clearance or PMA approval on file and 4 have a recall event. The FDA has issued 2 510(k) clearances under this code, the latest on October 19, 2001, and lists 7 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
HAB
Device class
1
Regulation
878.4820
Medical specialty
General, Plastic Surgery

Makers by country

CountryMakers
United States26
Germany7
Switzerland3
Mexico2
China2
Austria2
Spain1
United Kingdom1
India1
Japan1
South Korea1

Makers of Saw, Powered, And Accessories

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
Linvatec CorporationLargo, FL, United StatesManufacturer, Specification developer1October 19, 2001000api.fda.gov
Aesculap AGTUTTLINGEN, DONAU Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Alira Medical Devices LLCRancho Cucamonga, CA, United StatesSpecification developer0000api.fda.gov
Arthrex, Inc.Naples, FL, United StatesSpecification developer0010api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Arthrex GmbHMunich Bavaria, GermanySpecification developer0000api.fda.gov
Arthrex Manufacturing Inc.Pendleton, SC, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Arthrex, Inc.Ave Maria, FL, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Baeramed Instrumente GMBHSCHWENNINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Brasseler U.S.A. Medical, LLCSavannah, GA, United StatesContract manufacturer, Manufacturer0000api.fda.gov
CelesticaValencia Valencia(Province), SpainContract manufacturer0000api.fda.gov
Contract Medical Manufacturing, LLCOxford, CT, United StatesManufacturer0000api.fda.gov
Consolidated Medical Equipment CompanyChihuahua, MexicoContract manufacturer0000api.fda.gov
Depuy Intl., Ltd.Leeds, United KingdomManufacturer, Specification developer0000api.fda.gov
Depuy Orthopaedics, Inc.Warsaw, IN, United StatesManufacturer, Manufacturer for export, Repackager or relabeler, Specification developer0000api.fda.gov
Dongguan Kaiser Technology Co., LtdDongguan city Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Heinrich Medizintechnik GMBHStuttgart Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Highridge Medical, LLCWestminster, CO, United StatesSpecification developer0000api.fda.gov
Industrias Apson S.A de C.VAGUA PRIETA Sonora, MexicoContract manufacturer0000api.fda.gov
Mahe Medical UsaLaramie, WY, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Manman Manufacturing Company Private LimitedPune Maharashtra, IndiaManufacturer0000api.fda.gov
Medcare Solutions GMBHEmmingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Micutec AGZug, SwitzerlandSpecification developer0000api.fda.gov
Millstone Medical Outsourcing LLC.Fall River, MA, United StatesContract manufacturer0000api.fda.gov
Medline ReNewalRedmond, OR, United StatesReprocessor0000api.fda.gov
Millstone Medical Outsourcing LLCOlive Branch, MS, United StatesContract manufacturer0000api.fda.gov
Nakanishi Inc.Kanuma Tochigi, JapanManufacturer0000api.fda.gov
Nouvag AGGOLDACH Sankt Gallen, SwitzerlandManufacturer0000api.fda.gov
Olive Branch Distribution CenterOlive Branch, MS, United StatesContract manufacturer0000api.fda.gov
Princeton Medical Group, Inc.Franklin, TN, United StatesSpecification developer0000api.fda.gov
Reda Instrumente GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
RZ Medizintechnik GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Saeshin Precision Co., Ltd.Daegu, South KoreaManufacturer0000api.fda.gov
Shanghai Medical Instruments (group) Ltd. Corp.Shanghai, ChinaManufacturer0000api.fda.gov
Smith & Nephew Inc.Oklahoma City, OK, United StatesManufacturer0000api.fda.gov
Smith & Nephew Inc.Andover, MA, United StatesSpecification developer0010api.fda.gov
Smith & Nephew Inc.Mansfield, MA, United StatesManufacturer0000api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer, Repackager or relabeler0010api.fda.gov
Symmetry Medical Manufacturing IncClaypool, IN, United StatesContract manufacturer0000api.fda.gov
Symmetry Medical Manufacturing Inc.Warsaw, IN, United StatesContract manufacturer0000api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer0000api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer0000api.fda.gov
Stryker InstrumentsPortage, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
W&H Dentalwerk Buermoos GMBHBUERMOOS Salzburg, AustriaContract manufacturer0000api.fda.gov
W&H Dentalwerk Buermoos GMBH - Site 2BUERMOOS Salzburg, AustriaContract manufacturer0000api.fda.gov
Zimmer Surgical SA1228 Plan Les Ouates Geneve, SwitzerlandManufacturer0000api.fda.gov
Zimmer Surgical, Inc.Dover, OH, United StatesManufacturer0010api.fda.gov

Updated October 19, 2001. 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.