MKA MEDIKAL IC VE DIS TICARET SANAYI LIMITED SIRKETI

FDA Device Registration & Listing · Cankaya Ankara, TR · Registration 3014279513

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3014279513
FEI Number
3014279513
Entity Name
MKA MEDIKAL IC VE DIS TICARET SANAYI LIMITED SIRKETI
City/State/Country
Cankaya Ankara, TR
Establishment Address
Ilkbahar Mahallesi, 620 Sokak No 5, Cankaya Ankara 06550, TR
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
MKA MEDIKAL IC VE DIS TICARET SANAYI LIMITED SIRKETI (Owner Number: 10057109)
Owner / Operator Contact Address
Ilkbahar Mahallesi, 620 Sokak No 5, Cankaya, TR-06 06550, TR
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2025-04-30
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2025-04-09
OQY Intrauterine Tamponade Balloon Obstetrics/Gynecology Class 2 884.4530 2018-03-03
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2025-11-26
GAN Suture, Absorbable, Synthetic General, Plastic Surgery Class 2 878.4830 2018-03-03
GAM Suture, Absorbable, Synthetic, Polyglycolic Acid General, Plastic Surgery Class 2 878.4493 2018-03-03
GDW Staple, Implantable General, Plastic Surgery Class 2 878.4750 2025-08-24
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2025-04-21
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2018-03-03
LKF Cannula, Manipulator/Injector, Uterine Obstetrics/Gynecology Class 2 884.4530 2018-03-03
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2018-04-08
FGB Ureteroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2018-04-08
HET Laparoscope, Gynecologic (And Accessories) Obstetrics/Gynecology Class 2 884.1720 2018-04-08
OCW Endoscopic Tissue Approximation Device Gastroenterology, Urology Class 2 876.1500 2025-04-21
GDW Staple, Implantable General, Plastic Surgery Class 2 878.4750 2025-04-21
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2018-03-03
HGI Electrocautery, Gynecologic (And Accessories) Obstetrics/Gynecology Class 2 884.4120 2018-03-03
LFL Instrument, Ultrasonic Surgical Unknown Class U N/A 2018-03-03
CEC Radioimmunoassay, Free Thyroxine Clinical Chemistry Class 2 862.1695 2018-04-05
JLW Radioimmunoassay, Thyroid-Stimulating Hormone Clinical Chemistry Class 2 862.1690 2018-04-05
LFL Instrument, Ultrasonic Surgical Unknown Class U N/A 2018-04-05
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2025-04-09
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2018-04-08
ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece Ear, Nose, Throat Class 2 874.4250 2025-09-25
FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve Gastroenterology, Urology Class 2 876.5820 2018-04-08
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2025-06-16
FDF Colonoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2018-04-08
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2018-03-03
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2018-04-08
FZP Clip, Implantable General, Plastic Surgery Class 2 878.4300 2025-06-03
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2018-04-08
KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System Gastroenterology, Urology Class 2 876.5860 2018-03-03
LFL Instrument, Ultrasonic Surgical Unknown Class U N/A 2018-03-03
KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System Gastroenterology, Urology Class 2 876.5860 2018-06-28
GAG Stapler, Surgical General Hospital Class 2 878.4740 2018-03-03
GDW Staple, Implantable General, Plastic Surgery Class 2 878.4750 2018-03-03
ETN Stimulator, Nerve Ear, Nose, Throat Class 2 874.1820 2018-04-12
GAN Suture, Absorbable, Synthetic General, Plastic Surgery Class 2 878.4830 2018-03-03
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2018-04-08
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2018-03-03
GAW Suture, Nonabsorbable, Synthetic, Polypropylene General, Plastic Surgery Class 2 878.5010 2018-03-03
HIG Insufflator, Hysteroscopic Obstetrics/Gynecology Class 2 884.1700 2018-04-08
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2025-04-21
KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System Gastroenterology, Urology Class 2 876.5860 2018-04-08
GAM Suture, Absorbable, Synthetic, Polyglycolic Acid General, Plastic Surgery Class 2 878.4493 2025-11-26
FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2018-04-08
GAM Suture, Absorbable, Synthetic, Polyglycolic Acid General, Plastic Surgery Class 2 878.4493 2025-09-15
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2018-04-05
FZP Clip, Implantable General, Plastic Surgery Class 2 878.4300 2018-02-23
FIP Subsystem, Water Purification Gastroenterology, Urology Class 2 876.5665 2018-04-08
NTN Led Light Source Gastroenterology, Urology Class 2 876.1500 2018-04-08
FCW Light Source, Fiberoptic, Routine Gastroenterology, Urology Class 2 876.1500 2018-04-08
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2018-03-03
FED Endoscopic Access Overtube, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2018-04-08
FEC Obturator, For Endoscope Gastroenterology, Urology Class 2 876.1500 2018-04-08
FFL Dislodger, Stone, Basket, Ureteral, Metal Gastroenterology, Urology Class 2 876.4680 2018-04-08
FGA Kit, Nephroscope Gastroenterology, Urology Class 2 876.1500 2018-04-08
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2025-04-24
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2025-07-28
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2018-04-08
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2018-04-11
LKF Cannula, Manipulator/Injector, Uterine Obstetrics/Gynecology Class 2 884.4530 2018-02-27
GAW Suture, Nonabsorbable, Synthetic, Polypropylene General, Plastic Surgery Class 2 878.5010 2018-03-03
LFL Instrument, Ultrasonic Surgical Unknown Class U N/A 2018-03-03
EZQ Pouch, Colostomy Gastroenterology, Urology Class 1 876.5900 2018-04-08
MOV Catheters, Salpingography Obstetrics/Gynecology Class 2 884.4530 2018-03-03
HBB Motor, Drill, Pneumatic Neurology Class 2 882.4370 2026-06-09
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2018-04-05
FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve Gastroenterology, Urology Class 2 876.5820 2018-04-08
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2018-05-17
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2018-04-08
FTT Camera, Still, Surgical General, Plastic Surgery Class 1 878.4160 2018-04-05
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2018-04-08
GDO Applier, Surgical, Clip General, Plastic Surgery Class 1 878.4800 2018-07-31
FDP Apparatus, Pneumoperitoneum, Automatic Gastroenterology, Urology Class 2 876.1500 2018-03-03
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2018-04-08
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2018-04-05
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2025-04-24
GAM Suture, Absorbable, Synthetic, Polyglycolic Acid General, Plastic Surgery Class 2 878.4493 2018-03-03
MTD Catheter, Intracardiac Mapping, High-Density Array Cardiovascular Class 2 870.1220 2025-05-14
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2018-04-08
NTN Led Light Source Gastroenterology, Urology Class 2 876.1500 2018-04-08
FCW Light Source, Fiberoptic, Routine Gastroenterology, Urology Class 2 876.1500 2018-04-08
OXO Image-Intensified Fluoroscopic X-Ray System, Mobile Radiology Class 2 892.1650 2018-02-23
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2018-02-23
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2018-02-23
HIF Insufflator, Laparoscopic Obstetrics/Gynecology Class 2 884.1730 2018-04-05
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2018-04-08
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2018-04-08
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2018-04-08
FCG Biopsy Needle Gastroenterology, Urology Class 2 876.1075 2018-03-03
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2018-03-03
GDW Staple, Implantable General, Plastic Surgery Class 2 878.4750 2018-02-28
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2018-04-08
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2018-04-08
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2018-04-08
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2018-04-08
OCW Endoscopic Tissue Approximation Device Gastroenterology, Urology Class 2 876.1500 2025-04-30
GDW Staple, Implantable General, Plastic Surgery Class 2 878.4750 2018-06-28
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2018-04-08
FGC Urethroscope Gastroenterology, Urology Class 2 876.1500 2018-04-08
FBP Telescope, Rigid, Endoscopic Gastroenterology, Urology Class 2 876.1500 2018-04-08
BTR Tube, Tracheal (W/Wo Connector) Anesthesiology Class 2 868.5730 2018-02-23

Official Correspondent

Mustafa Akin

US Agent Details

Yasemen Celik Business: REGGAE REGISTERED AGENTS INC. Email: admin@registate.com Phone: (302) 8428687

Related Public Records

Same Entity

MKA MEDIKAL IC VE DIS TICARET SANAYI LIMITED SIRKETI
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
K220540 Covidien ProGrip Self-Gripping Polypropylene Mesh 2022-09-22
K062348 Medtronic Neurosurgery TIMESH SELF DRILLING SCREW 2006-09-08
K063244 Arc Surgical, LLC ARC SURGICAL BONE REDUCTION SCREW 2006-12-27
K972722 Orthopedic Designs, Inc. ULTIMATE COMPRESSION SCREW SYSTEM 1998-01-23
K192974 Tyber Medical, LLC Tyber Medical Trauma Screw 2020-01-08

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0014-2014 Synthes USA HQ, Inc. 2
Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016 Ortho Solutions Inc 330 Franklin Tnpk 2
Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Z-0027-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0043-2018 MicroPort Orthopedics Inc. 2
MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R Product Usage: MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014279513. Last updated year: 2026. Please use registration number 3014279513 when referencing this establishment in official correspondence.
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