Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005587147

FEI Number

3005587147

Entity Name

Fabryka Narzedzi Medycznych CHIRMED Marcin Dyner Spolka Komandytowa

City/State/Country

RUDNIKI K/CZESTOCHOWY Slaskie, PL

Establishment Address

UL. MSTOWSKA 8 A, RUDNIKI K/CZESTOCHOWY Slaskie 42-240, PL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Fabryka Narzedzi Medycznych CHIRMED Marcin Dyner Spolka Koma (Owner Number: 9023253)

Owner / Operator Contact Address

UL. MSTOWSKA 8 A, --, RUDNIKI K/CZESTOCHOWY, PL-NOTA 42-240, PL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Cartridge Syringe CHIRMED Wrench CHIRMED Catheter Dilator CHIRMED Screwdriver CHIRMED General & Plastic Surgery Spatula Periodontic Probe CHIRMED Elevator CHIRMED Dental Needle CHIRMED Surgical Rongeur Forceps CHIRMED Clamp CHIRMED General Purpose Dental Tray CHIRMED Orthodontic Wire CHIRMED Mallet CHIRMED Scalpel Handle CHIRMED Dental Operative Excavator CHIRMED Periodontic Knife CHIRMED Heart Stabilizer CHIRMED Surgical Metal Tongue Depressor CHIRMED Surgical Dental Elevator CHIRMED Periodontic Hoe CHIRMED Mouth Gag CHIRMED External Facial Fracture Appliance CHIRMED General Surgical Scissors CHIRMED Metal Vaginal Speculum CHIRMED Orthopedic Needle Holder CHIRMED Forceps CHIRMED Surgical General Use Curette CHIRMED Dental Implant Surgical Tray CHIRMED One-Piece Scalpel CHIRMED Orthodontic Ligature Tucking Instrument Periodontic Scaler CHIRMED Restorative Instrument CHIRMED Non-Surgical Tongue Depressor Dental Dressing Forceps CHIRMED Retractor CHIRMED

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EJI	Syringe, Cartridge	Dental	Class 2	872.6770	2024-05-13
HXC	Wrench	Orthopedic	Class 1	888.4540	2014-12-18
GCC	Dilator, Catheter	General, Plastic Surgery	Class 1	878.4200	2014-12-18
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2014-12-18
GAF	Spatula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2006-02-01
EIX	Probe, Periodontic	Dental	Class 1	872.4565	2024-05-13
HTE	Elevator	General, Plastic Surgery	Class 1	878.4800	2006-02-01
DZM	Needle, Dental	Dental	Class 1	872.4730	2024-05-13
EMH	Forceps, Rongeur, Surgical	Dental	Class 1	872.4565	2024-05-13
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2010-12-17
OFX	General Purpose Dental Tray	Dental	Class 1	872.6640	2024-05-15
DZC	Wire, Orthodontic	Dental	Class 1	872.5410	2006-02-01
HXL	Mallet	General, Plastic Surgery	Class 1	878.4800	2014-12-18
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2024-05-13
EKC	Excavator, Dental, Operative	Dental	Class 1	872.4565	2024-05-13
EMO	Knife, Periodontic	Dental	Class 1	872.4565	2016-08-24
MWS	Stabilizer, Heart	Cardiovascular	Class 1	870.4500	2008-12-15
KBL	Depressor, Metal Tongue, Surgical	Ear, Nose, Throat	Class 1	874.4420	2014-12-18
EMJ	Elevator, Surgical, Dental	Dental	Class 1	872.4565	2016-08-24
EMQ	Hoe, Periodontic	Dental	Class 1	872.4565	2016-08-24
KBN	Gag, Mouth	Ear, Nose, Throat	Class 1	874.4420	2015-12-22
FYI	Appliance, Facial Fracture, External	General, Plastic Surgery	Class 1	878.3250	2010-12-17
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2012-12-27
HDF	Speculum, Vaginal, Metal	Obstetrics/Gynecology	Class 1	884.4520	2014-12-18
HXK	Holder, Needle; Orthopedic	Orthopedic	Class 1	888.4540	2010-12-17
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2006-02-01
FZS	Curette, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2014-12-18
OFY	Dental Implant Surgical Tray	Dental	Class 1	872.3980	2024-05-15
GDX	Scalpel, One-Piece	General, Plastic Surgery	Class 1	878.4800	2006-02-01
ECP	Instrument, Ligature Tucking, Orthodontic	Dental	Class 1	872.4565	2014-12-18
EMN	Scaler, Periodontic	Dental	Class 1	872.4565	2024-05-13
OFW	Restorative Instrument And Component Tray	Dental	Class 2	872.3690	2024-05-15
FMA	Depressor, Tongue, Non-Surgical	General Hospital	Class 1	880.6230	2006-02-01
EFL	Forceps, Dressing, Dental	Dental	Class 1	872.4565	1995-11-06
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2006-02-01

Official Correspondent

No official correspondent registered.

US Agent Details

Bogdan Pukszta Email: promega@sbcglobal.net Phone: (773) 5051639

Related Public Records

Same Entity

Fabryka Narzedzi Medycznych CHIRMED Marcin Dyner Spolka Koma

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K112640	Ormco Corp.	HYPERELASTIC WIRE	2011-11-16
K852723	The Huxley Instrument Corp.	FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420	1985-07-15
K873512	Arthropedics, Inc.	SERRATED GRASPING FORCEPS, RIGHT	1987-11-02
K851721	Artiberia	1200/1 TO 1240/15 VARIOUS TYPES OF DENTAL SCALERS	1985-07-02
K922626	Andronic Devices, Ltd.	ADEPT INSTRUMENT POSITIONING ACCESSORY	1992-10-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0039-2018	Teleflex Medical	1	Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) REF 352957 e) REF 352952 : Reusable surgical knife handles, which are intended for use with blades which are inserted into a slot in the handle.
Z-0034-2012	X Spine Systems Inc	1	Axle Interspinous Fusion System Torque Driver Handle, Model #: X060-0323, Lot # 525941, S/Ns 001-017, Lot # 525942, S/Ns 001-050, Mfr. By: Bradshaw Medical Inc., Kenosha, WI 53144 The Axle Torque Driver Handle is used to lock the set screw into the locking plate.
Z-0031-2014	Aesculap, Inc.	1	UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.

Similar Registrations

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1058726	RUMEX INTERNATIONAL CO.	Tampa, FL, US
2183301	PATTERSON DENTAL SUPPLY, INC.	ST. PAUL, MN, US
3008242564	Septodont, Inc	Lancaster, PA, US
3012507533	Integra Canada ULC	Oakville Ontario, CA
8040278	Falcon Surgical Co. (Pvt.) Ltd.	Sialkot Punjab, PK

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005587147. Last updated year: 2026. Please use registration number 3005587147 when referencing this establishment in official correspondence.