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Data / Medical devices / Instrument, Microsurgical

Instrument, Microsurgical (GZX): 102 FDA-registered makers in 14 countries

102 establishments in 14 countries are registered with the FDA to make Instrument, Microsurgical (product code GZX, Class 1, 21 CFR 882.4525). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 13 510(k) clearances under this code, the latest on July 20, 1993, and lists 1 recall event (0 Class I). 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.

Product code
GZX
Device class
1
Regulation
882.4525
Medical specialty
Neurology

Makers by country

CountryMakers
Germany51
United States24
Pakistan8
China6
Japan2
Mexico2
France2
Poland1
South Africa1
India1
Brazil1
Malaysia1
Sweden1
Belgium1

Makers of Instrument, Microsurgical

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
A. BETZLER GmbH & Co. KGTUTTLINGEN-NENDINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
A. Milazzo Medizintechnik GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Ackermann Instrumente GMBHRIETHEIM, WEILHEIM Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Adeor Medical AGValley Bavaria, GermanyComplaint file establishment, Specification developer0000api.fda.gov
Aesculap AGTUTTLINGEN, DONAU Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Aesculap Chifa SP. Z O.O.NOWY TOMYSL Wielkopolskie, PolandContract manufacturer0000api.fda.gov
Apex Medical, Inc.Malvern, PA, United StatesManufacturer, Specification developer0000api.fda.gov
Asanus Medizintechnik GMBHNEUHAUSEN OBECK Baden-Wurttemberg, GermanyManufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Asol Co.,ltdhuaian Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Bema-Gmbh & Co. KGEMMINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
BISELLI Medical Instruments GmbH & Co. KGIRNDORF Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Carl Teufel GMBH & Co. KGLIPTINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Charmant, Inc.Sabae-City, Fukui-Pref., JapanManufacturer0000api.fda.gov
Clarus Medical, LLC.Minneapolis, MN, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Coba Biomedical Pty (ltd)Bloemfontein Free State, South AfricaContract manufacturer0000api.fda.gov
Dausch Medizintechnik GmbHWURMLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Denzel Medical GmbH & Co. KGNEUHAUSEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
EFINGER INSTRUMENTS GmbH & Co. KGSPAICHINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
FEHLING INSTRUMENTS GmbHKARLSTEIN Bavaria, GermanyManufacturer0000api.fda.gov
Fetzer Medical GMBH & Co.kgTuttlingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Fetzer Surgical, LLCScottsdale, AZ, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Frank MuellerMoessingen Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Falcon Surgical Co. (Pvt.) Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Faulhaber Pinzetten KGFRITTLINGEN Baden-Wurttemberg, GermanyContract manufacturer, Manufacturer0000api.fda.gov
Fischer Surgical Inc.Imperial, MO, United StatesManufacturer0000api.fda.gov
Garish ApparelsWazirabad Punjab, PakistanManufacturer0000api.fda.gov
Geister Medizintechnik GMBHTUTTLINGEN Baden-Wurttemberg, GermanyManufacturer, Repackager or relabeler0000api.fda.gov
Geomed Medizin-Technik GMBH & Co. KGTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Georg Alber GMBH & Co. KGRENQUISHAUSEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Guenter Bissinger Medizintechnik GMBHTENINGEN Baden-Wurttemberg, GermanyContract manufacturer, Manufacturer0000api.fda.gov
Guenter Stoffel Medizintechnik GMBHWURMLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Gesco Healthcare Private LimitedCHENNAI, Tamil Nadu, IndiaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Hafner Chirurgische InstrumenteBALGHEIM Baden-Wurttemberg, GermanyContract manufacturer, Manufacturer0000api.fda.gov
HARMAC MEDICAL PRODUCTS, INC./H3 de Tijuana, S. de RL de C.V.Tijuana Baja California, MexicoContract manufacturer0000api.fda.gov
Hebumedical GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer, Manufacturer0000api.fda.gov
Hermann Medizintechnik GMBHFRIDINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Hexamed Pvt LtdSialkot Punjab, PakistanContract manufacturer, Manufacturer0000api.fda.gov
HGR Instrumente GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Hilbro (pvt) Ltd.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Hilbro International (pvt) LimitedSIALKOT Punjab, PakistanContract manufacturer, Manufacturer0000api.fda.gov
Huaian Wolfram Surgical InstrumentsHuaian Jiangsu, ChinaManufacturer0000api.fda.gov
Hotry Co.,LtdBeijing, ChinaExporter to the US, Manufacturer0000api.fda.gov
ITM Industria de Tecnologias Medicas LTDACANOAS Rio Grande do Sul, BrazilManufacturer0000api.fda.gov
Industrias Apson S.A de C.VAGUA PRIETA Sonora, MexicoContract manufacturer0000api.fda.gov
Instrumed GmbH dba Avalign German Specialty InstrumentsTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer, 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
Karl Klappenecker GMBH & Co. KGTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Karl Storz Se & Co KGTUTTLINGEN Baden-Wurttemberg, GermanySpecification developer0000api.fda.gov
Karl Storz Se & Co. KGTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Karl Storz Se & Co. KGNEUHAUSEN OBECK Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Kirwan Surgical Products, LLC.Marshfield, MA, United StatesManufacturer0000api.fda.gov
KLS Martin Se & Co. KGFridingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
KLS Martin Malaysia Sdn. Bhd.Simpang Ampat Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
KLS Martin SE & Co. KGMuhlheim/Donau Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
KLS-Martin L.P.Jacksonville, FL, United StatesSpecification developer0000api.fda.gov
Logan Instruments, LLCBraintree, MA, United StatesContract manufacturer0000api.fda.gov
Mclean Medical & ScientificSaint Paul, MN, United StatesContract manufacturer0000api.fda.gov
Medicon, E.G.TUTTLINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Mediplast ABMALMO Skane, SwedenManufacturer0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0000api.fda.gov
Mian Shahid Corp.MUZAFFAR PUR, SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Microma Martin Alber GMBH & Co. KGIRNDORF Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Microqore Medical GMBHAach Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Moria S.A.MASSY Hauts-de-Seine, FranceSpecification developer0000api.fda.gov
Millstone Medical Outsourcing LLCOlive Branch, MS, United StatesContract manufacturer0000api.fda.gov
Moria S.ABourbon l'Archambault Allier, FranceContract manufacturer0000api.fda.gov
Omt, LLCFort Lauderdale, FL, United StatesSpecification developer0000api.fda.gov
Peter Lazic GMBHTUTTLINGEN Baden-Wurttemberg, GermanySpecification developer0000api.fda.gov
Pfau Medizinische Instrumente GMBHWANFRIED Hesse, GermanyContract manufacturer0000api.fda.gov
Phoenix Instruments, Inc.Lisle, IL, United StatesContract manufacturer0000api.fda.gov
PMT Corp.Chanhassen, MN, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Primo Medical Group, IncW Bridgewater, MA, United StatesContract manufacturer0000api.fda.gov
Qsa Surgical (pvt) Ltd.SIALKOT Punjab, PakistanContract manufacturer0000api.fda.gov
Raimund Wenzler GMBH, Instrumenten-ManufakturBALGHEIM Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
RZ Medizintechnik GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer, Manufacturer0000api.fda.gov
S.U.A. Martin GMBH & Co.RIETHEIM-WEILHEIM Baden-Wurttemberg, GermanyContract manufacturer, Manufacturer0000api.fda.gov
Scanlan International, Inc.Saint Paul, MN, United StatesManufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Shanghai Medical Instruments (group) Ltd. Corp.Shanghai, ChinaManufacturer0000api.fda.gov
Signus Medizintechnik GMBHALZENAU Bavaria, GermanyComplaint file establishment, Manufacturer0000api.fda.gov
SIMMANK GmbH & Co.KGTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Smi Medical Instruments GMBH & Co.kgNEUHAUSEN OB ECK Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
SPIEGELBERG GmbH & Co. KGHamburg, GermanyExporter to the US, Manufacturer0000api.fda.gov
STERIS CorporationSaint Louis, MO, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Stork Instrumente GMBHEmmingen-Liptingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
SUBAN Instruments Germany GmbHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Surgical Instrument Manufacturers, LLCFenton, MO, United StatesContract manufacturer0000api.fda.gov
Surgical Instruments Belgium SAGEMBLOUX Namur, BelgiumContract manufacturer0000api.fda.gov
Synergetics, Inc.O Fallon, MO, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Takayama Instrument Inc.Taito-ku Tokyo, JapanComplaint file establishment, Manufacturer0000api.fda.gov
Tontarra Medizintechnik GMBHWURMLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.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
Teufel & Gerlach GmbHTuttlingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Vitalitec Int'l., Inc.Plymouth, MA, United StatesSpecification developer0000api.fda.gov
Weba Medizintechnik GMBH & Co.BALGHEIM Baden-Wurttemberg, GermanyContract manufacturer, Manufacturer0000api.fda.gov
Willy Storz GMBHRietheim-Weilheim Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Win Wings Corp.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Xinhua Surgical Instrument Co. Ltd.ZIBO Shandong, ChinaManufacturer0000api.fda.gov
Z-Medical GMBH & Co. KGTuttlingen Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Zumax Medical Co, Ltd.Suzhou,Jiangsu, ChinaManufacturer0000api.fda.gov

Updated July 20, 1993. 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.