Medical device makers in Turkey: 85 FDA-registered establishments

Name: FDA-registered medical device makers in Turkey
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

85 establishments in Turkey are registered with the FDA to make medical devices for the US market, listing 314 device types. 25 have a 510(k) clearance or PMA approval on file and 1 has a recall event. 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.

Get makers in Turkey Watch these makers

TurkeyCountry

Device types made here

Device types with the most registered makers in this country.

Device	Product code	Makers
Garment, Protective, For Incontinence	EYQ	5
Tape And Bandage, Adhesive	KGX	4
Joint, Knee, External Brace	ITQ	4
Pad, Menstrual, Unscented	HHD	4
Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)	DWL	4
Orthopedic Manual Surgical Instrument	LXH	3
Gauze / Sponge,Nonresorbable For External Use	NAB	3
Splint, Hand, And Components	ILH	3
Sling, Arm	ILI	3
Orthosis, Lumbar	IQE	3
Stocking, Medical Support (For General Medical Purposes)	FQL	3
Orthosis, Limb Brace	IQI	3
Table, Operating-Room, Ac-Powered	FQO	3
Joint, Ankle, External Brace	ITW	3
Support, Hernia	EXN	3
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2
Syringe, Piston	FMF	2
Stimulator, Nerve	ETN	2
Implant, Endosseous, Root-Form	DZE	2
Abutment, Implant, Dental, Endosseous	NHA	2
Set, Administration, Intravascular	FPA	2
Accessories, Implant, Dental, Endosseous	NDP	2
Transducer, Ultrasonic, Diagnostic	ITX	2
Kit, Surgical Instrument, Disposable	KDD	2
Knife, Ophthalmic	HNN	2
Pad, Eye	HMP	2
Drape, Surgical, Exempt	PUI	2
Dressing, Wound, Hydrogel Without Drug And/Or Biologic	NAE	2
Cover, Mattress (Medical Purposes)	FMW	2
Non-Surgical Gown	OEA	2
Fiber, Medical, Absorbent	FRL	2
Tray, Surgical, Instrument	FSM	2
Tubing, Pressure And Accessories	BYX	2
Mask, Oxygen	BYG	2
Connector, Airway (Extension)	BZA	2
Apparatus, Suction, Operating-Room, Wall Vacuum Powered	GCX	2
Nebulizer, Medicinal, Non-Ventilatory (Atomizer)	CCQ	2
Set, Tubing And Support, Ventilator (W Harness)	BZO	2
Circuit, Breathing (W Connector, Adaptor, Y Piece)	CAI	2
Mouthpiece, Breathing	BYP	2
Prosthesis, Breast, External, No Adhesive	NOJ	2
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	DWF	2
Apparatus, Suction, Single Patient Use, Portable, Nonpowered	GCY	2
Collector, Ostomy	EXB	2
Gown, Surgical	FYA	2
Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua	QKR	2
Orthosis, Cervical-Thoracic, Rigid	IQF	2
Enema Kit	FCE	2
Anti Fog Solution And Accessories, Endoscopy	OCT	2
Material, Tooth Shade, Resin	EBF	2
Material, Impression Tray, Resin	EBH	2
Protector, Skin Pressure	FMP	2
Cover, Limb	IPM	2
Truss, Umbilical	EXM	2
Lamp, Surgical	FTD	2
Table, Examination, Medical, Powered	LGX	2
Orthosis, Sacroiliac, Soft	IPW	2
Orthosis, Cervical	IQK	2
Splint, Extremity, Non-Inflatable, External, Non-Sterile	NOC	2
Orthosis, Truncal/Orthosis, Limb	MRI	2
Orthosis, Rib Fracture, Soft	IPX	2
Insoles, Medical	KYS	2
Splint, Clavicle	IQJ	2
Splint, Abduction, Congenital Hip Dislocation	IOZ	2
Screw, Fixation, Bone	HWC	1
Fastener, Fixation, Nondegradable, Soft Tissue	MBI	1
Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use	JQC	1
Washer, Bolt Nut	HTN	1
Platelet And Plasma Separator For Bone Graft Handling	ORG	1
Laparoscope, General & Plastic Surgery	GCJ	1
Blade, Saw, General & Plastic Surgery, Surgical	GFA	1
Camera, Surgical And Accessories	KQM	1
Instrument, Manual, Surgical, General Use	MDM	1
Reamer	HTO	1
Appliance, Fixation, Spinal Interlaminal	KWP	1
Plate, Fixation, Bone	HRS	1
Intervertebral Fusion Device With Bone Graft, Lumbar	MAX	1
Intervertebral Fusion Device With Bone Graft, Cervical	ODP	1
Thoracolumbosacral Pedicle Screw System	NKB	1
Orthopedic Stereotaxic Instrument	OLO	1
Rod, Fixation, Intramedullary And Accessories	HSB	1
Accessory, Surgical Apparel	LYU	1
Drills, Burrs, Trephines & Accessories (Simple, Powered)	HBE	1
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	ERL	1
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	KCT	1
Motor, Drill, Pneumatic	HBB	1
Light, Surgical, Instrument	FSQ	1
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	LXG	1
Device, Intravascular Catheter Securement	KMK	1
Needle, Hypodermic, Single Lumen	FMI	1
Instrument, Biopsy	KNW	1
Instrument, Surgical, Non-Powered	HAO	1
Bottle, Collection, Vacuum	KDQ	1
Knife, Surgical	EMF	1
Tube, Tracheal (W/Wo Connector)	BTR	1
Sponge, Ophthalmic	HOZ	1
Endoscopic Guidewire, Gastroenterology-Urology	OCY	1
Catheters, Suction, Tracheobronchial	BSY	1
Pump, Infusion	FRN	1
Holder, Needle; Orthopedic	HXK	1

Makers in Turkey

Best documented first: most 510(k) clearances and PMA approvals.

Maker	Location	Device types	510(k) clearances	PMA approvals	Recall events	Source
Sanmed Medikal Otomotiv Tekstil Ticaret Limited Sirketi	Istanbul, Turkey	52	108	1	0	api.fda.gov
Diafarma Ecza Deposu Ve Medikal Dis Ticaret Dis Tic Ltd Sti	Istanbul, Turkey	87	103	3	0	api.fda.gov
Asset Medikal Tasarim San. Tic. A.S.	istanbul, Turkey	3	7	0	0	api.fda.gov
Meditera Tibbi Malzeme Sanayi ve Ticaret A.S.	Tire Izmir, Turkey	22	7	0	0	api.fda.gov
Imicryl Dis Malzemeleri Sanayi Ve Ticaret A.S.	Konya, Turkey	41	6	0	0	api.fda.gov
Lansinoh Laboratories Saglik Gerecleri Tasarim SanTicLtdSti	Izmir, Turkey	3	5	0	0	api.fda.gov
Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urun	ESENYURT Istanbul, Turkey	7	4	0	1	api.fda.gov
Mikron Makina Sanayi Ve Ticaret Ltd. Sti.	Ivedik Ankara, Turkey	26	3	0	0	api.fda.gov
Geotek Medikal Ve Saglik Hiz. Ltd. Sti	Ankara, Turkey	2	2	0	0	api.fda.gov
Metko Medikal ve Tibbi Cihazlar Dis Ticaret Sanayi A.S.	Ankara, Turkey	2	2	0	0	api.fda.gov
Set Medikal Sanayi Ve Ticaret Anonim Sirketi	esenyurt Istanbul, Turkey	4	2	0	0	api.fda.gov
Smart Alfa Teknoloji Sanayi Ve Ticaret Anonim Sirketi	Ankara, Turkey	2	2	0	0	api.fda.gov
3bfab Teknoloji Anonim Sirketi	Istanbul, Turkey	6	1	0	0	api.fda.gov
Alerkan Ltd	Saray-Kazan Ankara, Turkey	1	1	0	0	api.fda.gov
Aygun Surgical Instruments Co.,inc.	Kutlukent, Samsun, Turkey	1	1	0	0	api.fda.gov
Biosys Biyomedikal Muhendislik Sanayi Ve Ticaret Anonim Sirketi	Cankaya Ankara, Turkey	1	1	0	0	api.fda.gov
Bimed Teknik Aletler Sanayi & Ticaret A.S.	Beylikduzu Istanbul, Turkey	1	1	0	0	api.fda.gov
Dort-A Tip Malz San Ith Ihr Tic Ltd Sti	Ankara, Turkey	1	1	0	0	api.fda.gov
Dti Implant Systems	Kocaeli, Turkey	4	1	0	0	api.fda.gov
Elde Medikal Sanayi Ve Ticaret Anonim Sirketi	Umraniye Istanbul, Turkey	1	1	0	0	api.fda.gov
Medcare Saglik Urunleri Sanayi Ve Ticaret Anonim Sirketi	Izmir, Turkey	4	1	0	0	api.fda.gov
Occlutech Tibbi Urunler San.ve Tic. Ltd. Sti	Bakirkoy Istanbul, Turkey	1	0	1	0	api.fda.gov
Rigicon AS	Bakirkoy Istanbul, Turkey	7	1	0	0	api.fda.gov
Sanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Limited Sirketi	Izmir, Turkey	2	1	0	0	api.fda.gov
XERA Medikal Sistemleri ve Teknoloji Ltd. Sti.	Yenimahalle Ankara, Turkey	1	1	0	0	api.fda.gov
Alkan Ayakkabi Ve Deri Mam. San Ve Tic. Ltd. Sti.	Istanbul , Arnavutkoy, Turkey	1	0	0	0	api.fda.gov
Banat Firca Ve Plastik San.a.s.	Arnavutkoy Istanbul, Turkey	1	0	0	0	api.fda.gov
Bi7tech Ilac Tibbi Cihazlar Ve Saglik Hizmetleri Anonim Sirketi	SARIYER Istanbul, Turkey	1	0	0	0	api.fda.gov
Bicakcilar Tibbi Cihazlar Sanayi Ve Ticaret A.S.	ESENYURT Istanbul, Turkey	3	0	0	0	api.fda.gov
Bilkim Ltd Co.	Izmir, Turkey	1	0	0	0	api.fda.gov
Bionest Protez Ortez Rehabilitasyon Malzemeleri Sanayi Ticaret Anonim Sirketi	YUNUSEMRE Manisa, Turkey	1	0	0	0	api.fda.gov
Biopark Medikal Sanayi Ve Ticaret Anonim Sirketi	Kocaeli, Turkey	2	0	0	0	api.fda.gov
Boni Kimya San. Ve Tic. Ltd. Sti.	Esenyurt Istanbul, Turkey	2	0	0	0	api.fda.gov
Cansin Saglik Gerecleri Sanayi Ve Ticaret A.S.	Gebze Kocaeli, Turkey	14	0	0	0	api.fda.gov
Disera Tibbi Malzeme Lojistik Sanayi Tic. A.S.	Tire Izmir, Turkey	4	0	0	0	api.fda.gov
Earteknik Isitme Ve Odiometri Cihazlari San. Ve Tic. A.S	Ergene Tekirdag, Turkey	2	0	0	0	api.fda.gov
Essity Hijen Urunleri Sanayi Ve Ticaret A.S.	Kartepe Kocaeli, Turkey	1	0	0	0	api.fda.gov
Etkin Tibbi Cihazlar San. Ve Tic. A.S.	Cigli Izmir, Turkey	2	0	0	0	api.fda.gov
Exocube Biyoteknoloji Anonim Sirketi	Istanbul, Turkey	2	0	0	0	api.fda.gov
Epsilon Elektronik Sanayi ve Ticaret AS	Istanbul, Turkey	3	0	0	0	api.fda.gov
FB Saglik Tekstil Dis Ticaret Ltd. Sti	Esenyurt Istanbul, Turkey	1	0	0	0	api.fda.gov
Filip Albert Amram Jaws Gida Sanayi Ve Ticaret Sirketi	Gaziemir Izmir, Turkey	1	0	0	0	api.fda.gov
Future Vision For Import And Export Of Medical And Pharmaceutical Products Limited	Istanbul, Turkey	1	0	0	0	api.fda.gov
Gentug Tekstil Urunleri A.S.	Istanbul, Turkey	1	0	0	0	api.fda.gov
Global Biyomedikal Saglik Hizmetleri Sanayi Ve Ticaret Limited Sirketi	BAHCELIEVLER Istanbul, Turkey	4	0	0	0	api.fda.gov
Gokler Group	Sivas, Turkey	8	0	0	0	api.fda.gov
Hayat Kimya A.S.	Basiskele Kocaeli, Turkey	4	0	0	0	api.fda.gov
Inceler Medikal Saglik Hiz. San. Ltd. Sti.	ankara, Turkey	2	0	0	0	api.fda.gov
Inci Dental Tibbi Malzeme Sanayi Ve Ticaret Limited Sirketi	Istanbul, Turkey	1	0	0	0	api.fda.gov
Ipek Idrofil Pamuk San. Ve Tic. A.S.	Istanbul, Turkey	1	0	0	0	api.fda.gov
Jetweels Medikal Sanayi Ve Dis Ticaret Ltd Sti	Esenyurt Istanbul, Turkey	1	0	0	0	api.fda.gov
Konfort Ozel Saglik Hizmetleri Tibbi Malz. San Ve Tic Ltd Sti	Eskisehir, Turkey	1	0	0	0	api.fda.gov
Kosemed Ortopedi Sanayi Ve Ticaret Ithalat Ihracat Anonim Sirketi	Salihli Manisa, Turkey	10	0	0	0	api.fda.gov
Kurtsan Pharmaceuticals, Inc.	Bandirma Balikesir, Turkey	2	0	0	0	api.fda.gov
Lidersan Saglik	Gaziantep, Turkey	1	0	0	0	api.fda.gov
Maquet Cardiopulmonary Medikal Teknik San. Tic.ltd. Sti.	Konyaalti Antalya, Turkey	3	0	0	0	api.fda.gov
Mavera Tibbi Cihazlar Anonim Sirketi	Ankara, Turkey	1	0	0	0	api.fda.gov
Megasan Medikal Gaz Sistemleri Tibbi Alet Ve Cihazlar San. Tic. A. S.	Cankiri, Turkey	5	0	0	0	api.fda.gov
Nuve Sanayi Malzemeleri Imalat Ve Ticaret A.S.	Ankara, Turkey	9	0	0	0	api.fda.gov
Oculera Saglik Teknolojileri A.S.	Ankara, Turkey	8	0	0	0	api.fda.gov
Oliga Makina Elektronik Ithalat Ihracat Sanayi Ve Ticaret Limited Sirketi (LLC)	Ankara, Turkey	1	0	0	0	api.fda.gov
Ortolog Medikal Sanayi Ve Ticaret A.S.	Yenimahalle Ankara, Turkey	1	0	0	0	api.fda.gov
Oruba Medikal Teknoloji Arge Ic Ve Dis Ticaret Anonim Sirket	Ankara, Turkey	1	0	0	0	api.fda.gov
Ozuufuk Tekstil Ith. Ihr. San. Ve Tic. Ltd. Sti	Istanbul, Turkey	1	0	0	0	api.fda.gov
Pergo Medikal Ve Ilac Sanayi Anonim Sirketi	Izmir, Turkey	7	0	0	0	api.fda.gov
Plasti-Med Plastik Medikal Urunler San. Ve Tic. Ltd. Sti.	Tuzla Istanbul, Turkey	28	0	0	0	api.fda.gov
Predo Saglik Urunleri Sanayi Ve Ticaret Anonim Sirketi	SEHITKAMIL Gaziantep, Turkey	4	0	0	0	api.fda.gov
R-Vent Medikal Uretim A.S.	TORBALI Izmir, Turkey	1	0	0	0	api.fda.gov
SANKO Tekstil Isletmeleri San. ve Tic. A.S. - ISKO Subesi	Bursa, Turkey	2	0	0	0	api.fda.gov
Sayan Tibbi Aletler Paz. San. Ve Tic. Ltd. Sti.	Bornova Izmir, Turkey	1	0	0	0	api.fda.gov
Scharf Tools Ihracat Ithalat Limited Sirketi	Fatih Istanbul, Turkey	16	0	0	0	api.fda.gov
Seyitler Kimya Sanayi A.S.	Manisa, Turkey	1	0	0	0	api.fda.gov
SF Trade Teknik Tekstil A.S.	Gaziemir Izmir, Turkey	3	0	0	0	api.fda.gov
Stemc Biyoteknoloji Anonim Sirketi	Kagithane Istanbul, Turkey	2	0	0	0	api.fda.gov
Sumer Uluslararasi San. Ve Tic. A.S.	Sincan Ankara, Turkey	3	0	0	0	api.fda.gov
Su Biyomedikal Sistemler Ve Saglik Hiz. San. ve Tic. A. S.	Tekirdag, Turkey	12	0	0	0	api.fda.gov
THI Medikal Sanayi Ticaret A.S	Menderes Izmir, Turkey	2	0	0	0	api.fda.gov
Uzman Cerrahi Aletler Ozkan Seyhan	Samsun, Turkey	1	0	0	0	api.fda.gov
Uzumcu Tibbi Cihaz Ve Medikal Gaz Sistemleri San. Tic. A.S.	Ankara, Turkey	4	0	0	0	api.fda.gov
Virtual Trutrends Tek.bil.ilt.sis.san.dan.egt.ve Tic.ltd.sti.	ankara, Turkey	1	0	0	0	api.fda.gov
Vizor Ortopedi Medikal Urunleri Pazarlama Ithalat Ihracat Sanayi Ve Ticaret Ltd Sti	KUCUKCEKMECE Istanbul, Turkey	21	0	0	0	api.fda.gov
Variteks Ortopedi Sanayi A.S.	Catalca Istanbul, Turkey	23	0	0	0	api.fda.gov
Wellspect Medikal A.S.	Kahramankazan Ankara, Turkey	4	0	0	0	api.fda.gov
Yeni Biyoteknoloji Anonim Sirketi	BALCOVA Izmir, Turkey	5	0	0	0	api.fda.gov
Yilmaz Bio Medikal	gaziantep, Turkey	3	0	0	0	api.fda.gov

Updated November 2, 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.