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Data / Medical devices / Depressor, Metal Tongue, Surgical

Depressor, Metal Tongue, Surgical (KBL): 89 FDA-registered makers in 12 countries

89 establishments in 12 countries are registered with the FDA to make Depressor, Metal Tongue, Surgical (product code KBL, Class 1, 21 CFR 874.4420). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on August 16, 1982, and lists 0 recall events (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
KBL
Device class
1
Regulation
874.4420
Medical specialty
Ear, Nose, Throat

Makers by country

CountryMakers
Pakistan38
Germany19
United States14
China7
India3
France2
Malaysia1
Poland1
Australia1
Mexico1
Brazil1
Hungary1

Makers of Depressor, Metal Tongue, Surgical

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.handte Medizintechnik GMBH & Co. KGTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Acheron Instruments (pvt.) Ltd.LAHORE Punjab, PakistanManufacturer0000api.fda.gov
Aesculap AGTUTTLINGEN, DONAU Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
ALVI ExpoSialkot Punjab, PakistanManufacturer0000api.fda.gov
Asanus Medizintechnik GMBHNEUHAUSEN OBECK Baden-Wurttemberg, GermanyManufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Avilign MedicalSialkot Punjab, PakistanContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
B. Ali ImpexSIALKOT, Punjab, PakistanManufacturer0000api.fda.gov
B. Braun Medical Industries Sdn. Bhd.PENANG Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
Bauer Und Haselbarth-Chirurg GMBHELLERAU Schleswig-Holstein, GermanyContract manufacturer, Manufacturer0000api.fda.gov
Bear-Ent, LLCMalvern, PA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Beijing ZKSK Technology Co., Ltd.beijing, ChinaContract manufacturer, Manufacturer0000api.fda.gov
BH Medical Products Co., LtdChangzhou City Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Biomet MicrofixationJacksonville, FL, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Bausch & Lomb IncorporatedManchester, MO, United StatesManufacturer0000api.fda.gov
Choose Surgical InstrumentsSialkot Punjab, PakistanManufacturer0000api.fda.gov
CM Instrumente GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Comfort Surgical InstrumentsSialkot Punjab, PakistanManufacturer0000api.fda.gov
Crown Surgical Corp.Sialkot Punjab, PakistanExporter to the US, Manufacturer0000api.fda.gov
Daddy D ProSialkot Punjab, PakistanManufacturer0000api.fda.gov
Diligent Medical ServicesSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Dimeda Instrumente GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Doctor DevicesSialkot Punjab, PakistanManufacturer0000api.fda.gov
Elmed Instruments (pvt). Ltd.SIALKOT Punjab, PakistanContract manufacturer0000api.fda.gov
Eltek Instruments (pvt.) Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Empire Surgical Instruments CompanySialkot Punjab, PakistanExporter to the US, Manufacturer0000api.fda.gov
Fetzer Medical GMBH & Co.kgTuttlingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Fabryka Narzedzi Medycznych CHIRMED Marcin Dyner Spolka KomandytowaRUDNIKI K/CZESTOCHOWY Slaskie, PolandManufacturer0000api.fda.gov
Falcon Surgical Co. (Pvt.) Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Fischer Surgical Inc.Imperial, MO, United StatesManufacturer0000api.fda.gov
Garish ApparelsWazirabad Punjab, PakistanManufacturer0000api.fda.gov
Glorious Mercantile Corp. (pvt) Ltd.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Greens Surgicals Private LimitedVadodara Gujarat, IndiaManufacturer0000api.fda.gov
Gulmag InternationalSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Gesco Healthcare Private LimitedCHENNAI, Tamil Nadu, IndiaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Hangzhou Rollmed Co.,ltd.Hangzhou Zhejiang, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Hebumedical GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer, Manufacturer0000api.fda.gov
Hexamed Pvt LtdSialkot Punjab, PakistanContract manufacturer, Manufacturer0000api.fda.gov
Hilbro (pvt) Ltd.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Hilbro International (pvt) LimitedSIALKOT Punjab, PakistanContract manufacturer, Manufacturer0000api.fda.gov
Hive International Pvt Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Inka Surgical InstrumentsJandakot Western Australia, AustraliaSpecification developer0000api.fda.gov
Integra Microfrance SASSAINT AUBIN LE MONIAL Auvergne-Rhone-Alpes, FranceManufacturer, Repackager or relabeler0000api.fda.gov
Industrias Apson S.A de C.VAGUA PRIETA Sonora, MexicoContract 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
KLS Martin Se & Co. KGFridingen Baden-Wurttemberg, GermanyContract 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
Kohler Medizintechnik GmbHSTOCKACH Baden-Wurttemberg, GermanyContract manufacturer, Manufacturer0000api.fda.gov
Little Doctor Electronic(nantong) Co.,ltdNantong Jiangsu, ChinaSpecification developer0000api.fda.gov
M.J. Instruments Company (pvt) Ltd.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Mattes Instrumente GMBHTuttlingen-Nendingen Baden-Wurttemberg, GermanyManufacturer, Repackager or relabeler0000api.fda.gov
Medcave Private LimitedSialkot Punjab, PakistanManufacturer0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0000api.fda.gov
Meed Skills SurgicalSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Metro MedicalSialkot Punjab, PakistanManufacturer, Repackager or relabeler0000api.fda.gov
Mian Shahid Corp.MUZAFFAR PUR, SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Oury-Guye & FilsNOGENT Haute-Marne, FranceContract manufacturer0000api.fda.gov
Phoenix Instruments, Inc.Lisle, IL, United StatesContract manufacturer0000api.fda.gov
Qsa Surgical (pvt) Ltd.SIALKOT Punjab, PakistanContract manufacturer0000api.fda.gov
Quality Concept (pvt) Ltd.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Richard Wolf GMBHKNITTLINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Rudolf Storz GMBHEMMINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Schobell Industrial LtdaRio Claro Sao Paulo, BrazilManufacturer0000api.fda.gov
Shanghai Fly Medical Devices Co., Ltd.Minhang District Shanghai, ChinaManufacturer0000api.fda.gov
Shanghai Medical Instruments (group) Ltd. Corp.Shanghai, ChinaManufacturer0000api.fda.gov
Sitec (pvt.) Ltd.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
SpeedwayIndia Delhi, IndiaManufacturer0000api.fda.gov
STERIS CorporationSaint Louis, MO, United StatesManufacturer0000api.fda.gov
SUBAN Instruments Germany GmbHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
SUBAN Instruments Hungary Co.DEBRECEN Hajdu-Bihar, HungaryContract manufacturer0000api.fda.gov
Surgicon Pvt LtdSialkot Punjab, PakistanManufacturer0000api.fda.gov
SurgicraftsSialkot Punjab, PakistanManufacturer0000api.fda.gov
SurgiscapeSialkot Punjab, PakistanManufacturer0000api.fda.gov
SurjexSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Stengelin Medical GmbHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
T.A. Walthem & CompanySialkot Punjab, PakistanManufacturer0000api.fda.gov
Tekno Medical Optik-Chirurgie GMBHTUTTLINGEN-Nendingen Baden-Wurttemberg, GermanyManufacturer, Repackager or relabeler0000api.fda.gov
Towne Brothers (pvt.), Ltd.SIALKOT Punjab, PakistanManufacturer0000api.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
Volgo Care International (private) LimitedSialkot Punjab, PakistanContract manufacturer, Manufacturer, Remanufacturer, Repackager or relabeler0000api.fda.gov
WILDmedical GmbHTuttlingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Win Wings Corp.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Weco Manufacturing Group-HenriettaRochester, NY, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Xinhua Surgical Instrument Co. Ltd.ZIBO Shandong, ChinaManufacturer0000api.fda.gov
Zain's Medical ImageSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Zepf Medical Instruments GMBHSEITINGEN-OBERFLACHT Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov

Updated August 16, 1982. 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.