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Data / Medical devices / Knife, Ent

Knife, Ent (KTG): 63 FDA-registered makers in 11 countries

63 establishments in 11 countries are registered with the FDA to make Knife, Ent (product code KTG, 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 5 510(k) clearances under this code, the latest on August 30, 1982, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
KTG
Device class
1
Regulation
874.4420
Medical specialty
Ear, Nose, Throat

Makers by country

CountryMakers
Germany26
United States16
Pakistan11
Japan2
China2
United Kingdom1
Mexico1
India1
France1
Vietnam1
Turkey1

Makers of Knife, Ent

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
Ackermann Instrumente GMBHRIETHEIM, WEILHEIM Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Aesculap AGTUTTLINGEN, DONAU Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
AlframedSialkot Punjab, PakistanExporter to the US, Manufacturer0000api.fda.gov
Alira Medical Devices LLCRancho Cucamonga, CA, United StatesSpecification developer0000api.fda.gov
Asanus Medizintechnik GMBHNEUHAUSEN OBECK Baden-Wurttemberg, GermanyManufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Bear-Ent, LLCMalvern, PA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Bailey Instruments LtdManchester, United KingdomManufacturer0000api.fda.gov
Bausch & Lomb IncorporatedManchester, MO, United StatesManufacturer0000api.fda.gov
Beaver-Visitec International, Inc.Waltham, MA, United StatesSpecification developer0000api.fda.gov
Beaver-Visitec International, Inc.Ciudad Juarez Chihuahua, MexicoContract manufacturer0000api.fda.gov
Charmant, Inc.Sabae-City, Fukui-Pref., JapanManufacturer0000api.fda.gov
CM Instrumente GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Comfort Surgical InstrumentsSialkot Punjab, PakistanManufacturer0000api.fda.gov
Dimeda Instrumente GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Evonos GMBH & Co. KGTuttlingen Baden-Wurttemberg, 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
Falcon Surgical Co. (Pvt.) Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Fischer Surgical Inc.Imperial, MO, United StatesManufacturer0000api.fda.gov
Gesco Healthcare Private LimitedCHENNAI, Tamil Nadu, IndiaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Hafner Chirurgische InstrumenteBALGHEIM Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Hebumedical GMBHTUTTLINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Heinrich Medizintechnik GMBHStuttgart 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
Integra Microfrance SASSAINT AUBIN LE MONIAL Auvergne-Rhone-Alpes, FranceManufacturer, Repackager or relabeler0000api.fda.gov
Instrumed GmbH dba Avalign German Specialty InstrumentsTUTTLINGEN Baden-Wurttemberg, GermanyManufacturer0000api.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
Integra Pain ManagementWest Valley City, UT, United StatesManufacturer0000api.fda.gov
JEDMED Instrument CompanySaint Louis, MO, United StatesContract manufacturer, Repackager or relabeler0000api.fda.gov
Karl Storz Se & Co KGTUTTLINGEN Baden-Wurttemberg, GermanySpecification developer0000api.fda.gov
Karl Storz Se & Co. KGNEUHAUSEN OBECK Baden-Wurttemberg, GermanyContract manufacturer0000api.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
Mani, Inc. (head Office)UTSUNOMIYA Tochigi, JapanManufacturer0000api.fda.gov
Mecmed MedicalSialkot Punjab, PakistanManufacturer0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0000api.fda.gov
Mani Hanoi Co. LtdThai Nguyen Province, VietnamContract manufacturer0000api.fda.gov
Nopa Instruments, Medizintechnik GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Phoenix Instruments, Inc.Lisle, IL, United StatesContract manufacturer0000api.fda.gov
PMS GmbHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Qsa Surgical (pvt) Ltd.SIALKOT Punjab, PakistanContract manufacturer0000api.fda.gov
Richard Wolf GMBHKNITTLINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Rudolf Medical GMBH + Co. KGFRIDINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Scharf Tools Ihracat Ithalat Limited SirketiFatih Istanbul, TurkeyExporter to the US, Manufacturer0000api.fda.gov
Schmid Medizintechnik GMBHWURMLINGEN Baden-Wurttemberg, GermanyContract manufacturer, Manufacturer0000api.fda.gov
Shanghai Medical Instruments (group) Ltd. Corp.Shanghai, ChinaManufacturer0000api.fda.gov
SIMMANK GmbH & Co.KGTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Sinntech Medical (private) LimitedSialkot Punjab, PakistanManufacturer0000api.fda.gov
Spiggle & Theis Medizintechnik GMBHOVERATH North Rhine-Westphalia, GermanyManufacturer, Repackager or relabeler0000api.fda.gov
STERIS CorporationSaint Louis, MO, United StatesSpecification developer0000api.fda.gov
SUBAN Instruments Germany GmbHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Swengg CoSialkot Punjab, PakistanManufacturer0000api.fda.gov
Seid Medical GmbHDENKINGEN 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
Win Wings Corp.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Xinhua Surgical Instrument Co. Ltd.ZIBO Shandong, ChinaManufacturer0000api.fda.gov
e.l. zepf GmbHTUTTLINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov

Updated August 30, 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.