Medical device makers in Poland: 68 FDA-registered establishments

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

68 establishments in Poland are registered with the FDA to make medical devices for the US market, listing 366 device types. 20 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.

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PolandCountry

Device types made here

Device types with the most registered makers in this country.

Device	Product code	Makers
Screw, Fixation, Bone	HWC	5
Electrosurgical, Cutting & Coagulation & Accessories	GEI	5
Orthopedic Manual Surgical Instrument	LXH	5
Tape And Bandage, Adhesive	KGX	4
Bit, Drill	HTW	3
Rod, Fixation, Intramedullary And Accessories	HSB	3
System, Test, Blood Glucose, Over The Counter	NBW	3
Syringe, Antistick	MEG	3
Retractor	GAD	3
Oximeter	DQA	3
Frame, Spectacle	HQZ	3
Walker, Mechanical	ITJ	3
Lift, Patient, Non-Ac-Powered	FSA	3
Table, Powered	INQ	3
Audiometer	EWO	2
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	HWE	2
Apparatus, Traction, Non-Powered	HST	2
Accessories, Arthroscopic	NBH	2
Blade, Saw, General & Plastic Surgery, Surgical	GFA	2
Instrument, Manual, Surgical, General Use	MDM	2
Plate, Fixation, Bone	HRS	2
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	KTT	2
Multi-Analyte Controls, All Kinds (Assayed)	JJY	2
Calibrator, Multi-Analyte Mixture	JIX	2
Glucose Oxidase, Glucose	CGA	2
Electrode, Ion Specific, Potassium	CEM	2
Electrode, Ion-Specific, Chloride	CGZ	2
Electrode, Ion Specific, Sodium	JGS	2
Single (Specified) Analyte Controls (Assayed And Unassayed)	JJX	2
Nitroprusside, Ketones (Urinary, Non-Quant.)	JIN	2
Glucose Dehydrogenase, Glucose	LFR	2
Electrode, Ion Specific, Calcium	JFP	2
System, Hemoglobin, Automated	GKR	2
Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	CHL	2
Acid, Lactic, Enzymatic Method	KHP	2
Assay, Fetal Hemoglobin	KQI	2
Electrode, Ion Based, Enzymatic, Creatinine	CGL	2
Assay, Carboxyhemoglobin	GHS	2
Bilirubin (Total And Unbound) In The Neonate Test System	MQM	2
Needle, Hypodermic, Single Lumen	FMI	2
Tubes, Vials, Systems, Serum Separators, Blood Collection	JKA	2
Tubes, Gastrointestinal (And Accessories)	KNT	2
Dura Substitute	GXQ	2
Curette, Surgical, General Use	FZS	2
Scissors, General, Surgical	LRW	2
Mirror, Mouth	EAX	2
Forceps	HTD	2
Garment, Protective, For Incontinence	EYQ	2
Tray, Surgical, Instrument	FSM	2
Handle, Scalpel	GDZ	2
Scaler, Periodontic	EMN	2
Holder, Needle, Gastroenterologic	FHQ	2
Instrument, Ligature Tucking, Orthodontic	ECP	2
Forceps, Rongeur, Surgical	EMH	2
Elevator, Surgical, Dental	EMJ	2
Mallet	HXL	2
Screwdriver	HXX	2
Gauge, Depth	HTJ	2
Speculum, Vaginal, Metal	HDF	2
Pliers, Surgical	HTC	2
Cable, Electrode	IKD	2
Bed, Ac-Powered Adjustable Hospital	FNL	2
Sunglasses (Non-Prescription Including Photosensitive)	HQY	2
Otoscope	ERA	2
Oximeter, Ear	DPZ	2
Aid, Transfer	IKX	2
Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature	QRK	2
Multiple Use Blood Lancet For Single Patient Use Only	QRL	2
Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	JIL	2
Chair, Adjustable, Mechanical	INN	2
Cushion, Flotation	KIC	2
Full-Montage Standard Electroencephalograph	GWQ	2
Monitor, Carbon-Dioxide, Cutaneous	LKD	2
Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia	KLK	2
Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia	LPP	2
Agent, Absorbable Hemostatic, Collagen Based	LMF	2
Sterilizer, Steam	FLE	2
Perimeter, Automatic, Ac-Powered	HPT	2
Table, Instrument, Powered, Ophthalmic	HRJ	2
Hand, External Limb Component, Powered	IQZ	2
Calibrator, Hearing Aid / Earphone And Analysis Systems	ETW	2
Table, Mechanical	INW	2
Electrode, Cutaneous	GXY	2
Stimulator, Auditory, Evoked Response	GWJ	2
Cushion, Earphone (For Audiometric Testing)	ETT	2
Pin, Fixation, Smooth	HTY	1
Washer, Bolt Nut	HTN	1
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	KWS	1
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	HSD	1
Syringe, Piston	FMF	1
Laparoscope, General & Plastic Surgery	GCJ	1
Arthroscope	HRX	1
Medical Device Data System	OUG	1
Dressing, Wound, Drug	FRO	1
Reamer	HTO	1
Nail, Fixation, Bone	JDS	1
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	LZO	1
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	LPH	1
Intervertebral Fusion Device With Bone Graft, Lumbar	MAX	1
Filler, Bone Void, Calcium Compound	MQV	1

Makers in Poland

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

Maker	Location	Device types	510(k) clearances	PMA approvals	Recall events	Source
Ascensia Diabetes Care Poland Sp. z o.o.	Warszawa Mazowieckie, Poland	10	24	2	0	api.fda.gov
Htl-Strefa S.A.	OZORKOW Lodzkie, Poland	8	18	0	0	api.fda.gov
DGS Diagnostics Sp. z o.o	Kolbaskowo Zachodniopomorskie, Poland	26	12	0	0	api.fda.gov
ArjoHuntleigh Polska Sp. zo.o.	Poznan Wielkopolskie, Poland	23	11	0	11	api.fda.gov
Clinico Medical Sp. z o.o.	Blonie/Miekinia Dolnoslaskie, Poland	15	8	0	0	api.fda.gov
RR Donnelley GTS Poland Sp. z o.o.	Lodz Lodzkie, Poland	5	6	1	0	api.fda.gov
Medicalgorithmics S.A.	WARSAW Mazowieckie, Poland	5	5	0	0	api.fda.gov
Berger & Kraft	RASZYN Mazowieckie, Poland	4	4	0	0	api.fda.gov
Radiometer Solutions Sp. z o.o.	Stargard Zachodniopomorskie, Poland	25	4	0	0	api.fda.gov
Solventum Poland Manufacturing SP. ZO.O	Wroclaw Dolnoslaskie, Poland	7	3	0	0	api.fda.gov
Getinge IC Production Poland sp. z o.o.	Plewiska Wielkopolskie, Poland	2	2	0	0	api.fda.gov
Align Technology AFAB Poland Sp. z o.o.	Wroclaw Dolnoslaskie, Poland	4	1	0	0	api.fda.gov
Carnamedica SP Z O O	Warszawa Mazowieckie, Poland	2	1	0	0	api.fda.gov
Demant Operations Poland Sp. z o.o.	Mierzyn Zachodniopomorskie, Poland	9	1	0	0	api.fda.gov
Demant Technology Centre Sp. z o.o.	Warsaw Mazowieckie, Poland	1	1	0	0	api.fda.gov
Enbio Technology SP. Z.O.O.	Gdynia Pomorskie, Poland	1	1	0	0	api.fda.gov
Inoris Medical SP. Z O.O.	Kowary Dolnoslaskie, Poland	2	1	0	0	api.fda.gov
LiNA Medical Polska sp. z o.o	Tarnowo Podgorne Wielkopolskie, Poland	16	1	0	0	api.fda.gov
PAUL HARTMANN Manufacturing Sp. z o.o.	Libidza Dolnoslaskie, Poland	3	1	0	0	api.fda.gov
Steripack Medical Poland SP. Z O.O.	Jelcz-Laskowice Dolnoslaskie, Poland	20	1	0	0	api.fda.gov
3M Poland Manufacturing SP. Z O.O	WROCLAW Dolnoslaskie, Poland	2	0	0	0	api.fda.gov
3Shape Poland Sp. zo.o	Szczecin Zachodniopomorskie, Poland	3	0	0	0	api.fda.gov
Aesculap Chifa SP. Z O.O.	NOWY TOMYSL Wielkopolskie, Poland	42	0	0	0	api.fda.gov
Aether Biomedical SP. Z O.O.	Poznan Wielkopolskie, Poland	2	0	0	0	api.fda.gov
AMETEK Poland sp. z o.o.	Siechnice Dolnoslaskie, Poland	13	0	0	0	api.fda.gov
Antar SP. J.	Warszawa Mazowieckie, Poland	9	0	0	0	api.fda.gov
APOLLO IMPLANT COMPONENTS Sp. z o.o.	Pabianice Lodzkie, Poland	1	0	0	0	api.fda.gov
Avantor Performance Materials Poland S.A.	Gliwice Slaskie, Poland	5	0	0	0	api.fda.gov
Bester Medical System SP. Z O. O.	Nowa Deba Podkarpackie, Poland	10	0	0	0	api.fda.gov
BHH Mikromed	Dabrowa Gornicza Slaskie, Poland	7	0	0	0	api.fda.gov
BOWA POLSKA Sp. z o o	Suchy Las, Zlotkowo Wielkopolskie, Poland	1	0	0	0	api.fda.gov
Biovico sp. z o.o.	Wladyslawowo Pomorskie, Poland	1	0	0	0	api.fda.gov
CALYX MEDICAL Sp. Z.O.O.	Wroclaw Dolnoslaskie, Poland	4	0	0	0	api.fda.gov
Clunas AG	Tarnowo Podgorne Wielkopolskie, Poland	3	0	0	0	api.fda.gov
CX Engineering SP. Z O.O.	Balice Malopolskie, Poland	1	0	0	0	api.fda.gov
Ensinger Composites Machining SP. Z O.O.	Dobra Zachodniopomorskie, Poland	3	0	0	0	api.fda.gov
ESSITY OPERATION POLAND Sp.Z o. o.	Olawa, Poland Slaskie, Poland	1	0	0	0	api.fda.gov
Etac Poland SP. Z O.O.	Tczew Pomorskie, Poland	6	0	0	0	api.fda.gov
Fideltronik Poland SP. Z O.O.	Sucha Beskidzka Malopolskie, Poland	12	0	0	0	api.fda.gov
Frey Spolka Jawna	PIASECZNO Mazowieckie, Poland	5	0	0	0	api.fda.gov
Fabryka Narzedzi Medycznych CHIRMED Marcin Dyner Spolka Komandytowa	RUDNIKI K/CZESTOCHOWY Slaskie, Poland	44	0	0	0	api.fda.gov
Ferrosan Medical Devices Sp. z o.o.	Szczecin Zachodniopomorskie, Poland	2	0	0	0	api.fda.gov
Fludra Sp. z.o.o.	Sroda Wielkopolska Wielkopolskie, Poland	3	0	0	0	api.fda.gov
Good Medica Sp.zo.o.	Wroclaw Dolnoslaskie, Poland	3	0	0	0	api.fda.gov
Icb Pharma Tomasz Swietoslawski Pawel Swietoslawski	JAWORZNO Slaskie, Poland	1	0	0	0	api.fda.gov
Jago-Pro SP. Z O.O.	JAWORZNO Slaskie, Poland	3	0	0	0	api.fda.gov
Kikgel	Ujazd Opolskie, Poland	1	0	0	0	api.fda.gov
Kimball Electronics Poland Sp.z o.o	Tarnowo Podgorne Wielkopolskie, Poland	36	0	0	0	api.fda.gov
Liw Lewant Fabryka Wyrobow Z Tworzyw Sztucznych SP Z O O	Bielawa Dolnoslaskie, Poland	2	0	0	0	api.fda.gov
MBL Poland SP. Z O.O.	Piotrkow Trybunalski Lodzkie, Poland	1	0	0	0	api.fda.gov
MDT SP. Z O.O.	KRAKOW Malopolskie, Poland	5	0	0	0	api.fda.gov
Meden-Inmed, SP. Z O.O.	Koszalin Zachodniopomorskie, Poland	3	0	0	0	api.fda.gov
Metier Medical SP. Z O.O.	ZRODLA Dolnoslaskie, Poland	2	0	0	0	api.fda.gov
Materialise S.A.	Bielany Wroclawskie Dolnoslaskie, Poland	1	0	0	0	api.fda.gov
Nolato Stargard Sp. z o.o.	Stargard Zachodniopomorskie, Poland	3	0	0	0	api.fda.gov
Nordes Sp. z o.o.	Wroclaw Dolnoslaskie, Poland	4	0	0	0	api.fda.gov
OPTOPOLTechnology Sp. z o.o.	Zawiercie Slaskie, Poland	1	0	0	0	api.fda.gov
Ovvo Optics Spolka Z O.O.	Bielawa Dolnoslaskie, Poland	3	0	0	0	api.fda.gov
Ossur Polska Sp. z o.o	Doluje Zachodniopomorskie, Poland	1	0	0	0	api.fda.gov
Pro-Project	Okszow Lubuskie, Poland	1	0	0	0	api.fda.gov
Reha-Bed SP. Z O.O.	Czeladz Slaskie, Poland	1	0	0	0	api.fda.gov
Radiometer Sp. z o.o	Stargard Zachodniopomorskie, Poland	22	0	0	0	api.fda.gov
SP Medical SP z o o	Zdunska Wola, Poland	1	0	0	0	api.fda.gov
Stryker Poland Manufacturing Sp. z o.o.	Skawina Malopolskie, Poland	12	0	0	0	api.fda.gov
Technomex	Gliwice Slaskie, Poland	2	0	0	0	api.fda.gov
Torunskie Zaklady Materialow Opatrunkowych S.A.	Torun Kujawsko-Pomorskie, Poland	1	0	0	0	api.fda.gov
Ushio Poland SP. z o.o	Blonie Mazowieckie, Poland	1	0	0	0	api.fda.gov
Verdent Ltd.	LODZ Lodzkie, Poland	8	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.