SANMED MEDIKAL OTOMOTIV TEKSTIL TICARET LIMITED SIRKETI

FDA Device Registration & Listing · Istanbul, TR · Registration 3014479313

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
3014479313
FEI Number
3014479313
Entity Name
SANMED MEDIKAL OTOMOTIV TEKSTIL TICARET LIMITED SIRKETI
City/State/Country
Istanbul, TR
Establishment Address
NO:4 MIMAR SINAN MAHALLESI NAMIK KEMAL CADDESI AYDIN SOKAK, ATASEHIR 34762, Istanbul (Anatolia) Turkey, Istanbul 34758, TR
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
SANMED MEDIKAL OTOMOTIV TEKSTIL TICARET LIMITED SIRKETI (Owner Number: 10089530)
Owner / Operator Contact Address
NO:4 MIMAR SINAN MAHALLESI NAMIK KEMAL CADDESI AYDIN SOKAK, ATASEHIR 34762, Istanbul (Anatolia) Turkey, Istanbul, TR-34 34758, TR
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

Staple, Implantable ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONS0LE (IPC) ENDO CLIP III 5MM CLIP APPLIER Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Electrosurgical, Cutting & Coagulation & Accessories Stimulator, Nerve MDT VersaOne Optical Trocar with Fixation Balloon Cannula VersaOne Universal Fixation Balloon Cannula CATHETER, CORONARY, ATHERECTOMY BS Mesh, Surgical, Polymeric MDT ORIGIN BLUNT TIP SURGICAL TROCAR Midas Rex LigaSure Exact Dissector, Nano-coated Premium Surgiclip; Endo Clip; AcuClip BURR HOODS AND TOGAS Shiley Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection Device Laparoscope, General & Plastic Surgery MEDTRONIC PROTACK Endoscopic Tissue Approximation Device ABSORBATACK FIXATION DEVICES Staple, Implantable AUTOSUTURE PROTACK; TACKER SYSTEM Open Sealer/Divider, Nano-coated Electrosurgical, Cutting & Coagulation & Accessories MDT LigaSure Impact Curved, Large Jaw Electrode Electrosurgical, Cutting & Coagulation & Accessories MEDTRONIC INSTRUMENT TRACKER Electrosurgical, Cutting & Coagulation & Accessories MEDTRONIC Mesh, Surgical, Polymeric VersaOne Bladed Trocar, Ligasure Blunt Tip Sealer/Divider Endoscopic Tissue Approximation Device MDT LF1823; LigaSure™ Blunt Tip, Laparoscopic Sealer/Divider Nano-coated Ligasure Blunt Tip, Sealer/Divider, Nano-coated LigaSure™ Blunt Tip Open Sealer/Divider Nano-coated LF1837 and LF1844 VersaOne POLYHESIVE PATIENT RETURN ELECTRODE RELIATACK ARTICULATING RELOADABLE FIXATION DEVICE WITH STANDARD PURCHASE ABSORBLE TACKS shiley Sonicision Battery Charger, Sonicision Battery Insertion Guide Sonicision Reusable Generator, Sonicision Reusable Battery Pack Sonicision Curved Jaw Dissectors (multiple lengths) Mesh, Surgical, Polymeric MDT SHILEY NEONATAL TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY T Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh) Parietex Composite Mesh (PCO and PCO-OS references) Parietex Optimized Composite Mesh (PCO-X, PCO-FX and PCO-OSX references) Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh), Parietex Plug and Patch (new name : Parietex Plug and Patch System) Progrip Laparoscopic Self-Fixating Mesh LPG1510AR LAPAROSCOPIC SELF-FIXATING MESH Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester Mesh) LPG1510AL LAPAROSCOPIC SELF-FIXATING MESH SILS STITCH ENDOSCOPIC SUTURING DEVICE Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece MDT Nano-coated LigaSure Maryland Jaw Thoracic Sealer/Divider One-step Sealing LigaSure™ Maryland Jaw Laparoscopic Sealer/Divider One-step Sealing, Nano-coated, LF1937 and LF1944 Orthopedic Stereotaxic Instrument MEDTRONIC Staple, Implantable Stapler, Surgical Covidien Stapler Shiley ENDOBAG STRYKER STRI-SHIELD FLYTE TOGAS Prisma flex Laparoscope, General & Plastic Surgery MEDTRONIC Motor, drill, pneumatic EEA Stapler Tri-Staple 2 Reinforced Reload AUTO SUTUREMENDOSCOPIC CLAMP SFS Stapler; Signet Appose Skin Staplers; ConcordeMultifire Premium skin stapler; McKesson Skin Staplers 35 REGULAR; McKesson Skin Staplers 35 WIDE ADT FLEX TRACH W TG CUFF Laparoscope, General & Plastic Surgery MEDTRONIC VLOC9ABSORBABLE Laparoscope, General & Plastic Surgery COVIDIEN Spacemaker Pro Access and Dissector System Electrosurgical, Cutting & Coagulation & Accessories MEDTRONIC FLYTE HOOD Probe Staple, Implantable VERSAPORT V2 BLADELESS OPTIICAL TROCAR AND/OR VERSAPORT BLADELESS OPTICAL TROCAR Easycap II AUTO SUTURE SURGICAL STAPLES Covidien Endo GIA Ultra Universal stapler Endo GIA Tm Reinforced Reload with Tn-Staple Tm Technology ENDO GIA(TM) STAPLERS, DST SERIES(TM) GIA(TM) STAPLERS DST SERIES(TM) TA(TM) STAPLERS Blade LIGASURE VESSEL SEALING SYSTEM. LIGASURE INSTRUMENTS LigaSure Atlas™ Tissue Fusion Open Instrument, LS1020 LigaSure Atlas™ Tissue Fusion Laparoscopic Instrument, LS1037 iBur hubs and cutting accessories LIGATING LOOP Mesh, Surgical, Polymeric MDT LigaSure Retractable L-Hook Laparoscopic Sealer/Divider Ligasure Small Jaw Tissue Fusion Instrument Mesh, Surgical, Polymeric MDT Mesh, Surgical, Polymeric MEDTRONIC V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE Laparoscope, General & Plastic Surgery MEDTRONIC Tube, Tracheal (W/Wo Connector) MDT PREPERITONEAL DISTENTION BALLOON SYSTEM Laparoscope, General & Plastic Surgery MDT Pneumoperitoneum Needle SSVO PHONATE(TM) SHILEY SPEAKING VALVE WITH OXYGEN PORT Signia Instrument, Manual,Surgical,General Use PlasmaBlade X 3S, PlasmaBlade X 4 Laparoscope, General & Plastic Surgery MDT Peak Surgical Plasma Blade

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GDW Staple, Implantable General, Plastic Surgery Class 2 878.4750 2023-12-14
ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece Ear, Nose, Throat Class 2 874.4250 2025-08-14
FZP Clip, Implantable General, Plastic Surgery Class 2 878.4300 2024-03-27
GDO Applier, Surgical, Clip General, Plastic Surgery Class 1 878.4800 2024-03-27
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2023-12-14
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2023-12-14
ETN Stimulator, Nerve Ear, Nose, Throat Class 2 874.1820 2023-12-14
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2024-06-25
MCX Catheter, Coronary, Atherectomy Unknown Class 3 N/A 2023-12-14
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2023-12-14
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2024-06-25
HBE Drills, Burrs, Trephines & Accessories (Simple, Powered) Neurology Class 2 882.4310 2025-06-03
HSZ Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2025-06-03
HBB Motor, Drill, Pneumatic Neurology Class 2 882.4370 2025-06-03
HBC Motor, Drill, Electric Neurology Class 2 882.4360 2025-06-03
ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece Ear, Nose, Throat Class 2 874.4250 2025-06-03
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2024-06-25
FZP Clip, Implantable General, Plastic Surgery Class 2 878.4300 2024-06-25
DZJ Driver, Wire, And Bone Drill, Manual Dental Class 2 872.4120 2024-10-31
FXY Hood, Surgical General, Plastic Surgery Class 2 878.4040 2024-11-01
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2024-11-01
BTR Tube, Tracheal (W/Wo Connector) Anesthesiology Class 2 868.5730 2024-09-24
LFL Instrument, Ultrasonic Surgical Unknown Class U N/A 2024-06-25
GAB Needle, Suturing, Disposable General, Plastic Surgery Class 1 878.4800 2023-12-14
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2023-12-14
GDW Staple, Implantable General, Plastic Surgery Class 2 878.4750 2023-12-14
OCW Endoscopic Tissue Approximation Device Gastroenterology, Urology Class 2 876.1500 2023-12-14
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2023-12-14
GXZ Electrode, Needle Neurology Class 2 882.1350 2024-11-18
IKT Electrode, Needle, Diagnostic Electromyograph Physical Medicine Class 2 890.1385 2024-11-18
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2024-11-18
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2023-12-14
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2024-09-30
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2023-12-14
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2023-12-14
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2025-03-10
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2024-06-25
OCW Endoscopic Tissue Approximation Device Gastroenterology, Urology Class 2 876.1500 2023-12-14
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2024-03-27
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2025-03-10
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2024-06-25
GDW Staple, Implantable General, Plastic Surgery Class 2 878.4750 2024-06-25
JOH Tube Tracheostomy And Tube Cuff Anesthesiology Class 2 868.5800 2025-03-06
LFL Instrument, Ultrasonic Surgical Unknown Class U N/A 2024-06-25
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2023-12-14
JOH Tube Tracheostomy And Tube Cuff Anesthesiology Class 2 868.5800 2024-11-18
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2024-06-25
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2024-05-08
OCW Endoscopic Tissue Approximation Device Gastroenterology, Urology Class 2 876.1500 2024-06-25
ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece Ear, Nose, Throat Class 2 874.4250 2023-12-14
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2024-06-25
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2024-03-27
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2023-12-14
GAG Stapler, Surgical General Hospital Class 2 878.4740 2023-12-14
GDW Staple, Implantable General, Plastic Surgery Class 2 878.4750 2023-12-14
JOH Tube Tracheostomy And Tube Cuff Anesthesiology Class 2 868.5800 2024-10-14
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2026-02-18
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2024-06-25
KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System Gastroenterology, Urology Class 2 876.5860 2024-11-18
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2023-12-14
HBB Motor, Drill, Pneumatic Neurology Class 2 882.4370 2023-12-14
GAG Stapler, Surgical General Hospital Class 2 878.4740 2025-06-03
GDW Staple, Implantable General, Plastic Surgery Class 2 878.4750 2025-06-03
OXC Mesh, Surgical, Absorbable, Staple Line Reinforcement General, Plastic Surgery Class 2 878.3300 2024-06-25
GDW Staple, Implantable General, Plastic Surgery Class 2 878.4750 2024-06-25
HDA Forceps, Obstetrical Obstetrics/Gynecology Class 2 884.4400 2024-06-25
GDT Staple, Removable (Skin) General, Plastic Surgery Class 1 878.4760 2024-06-25
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2024-09-11
JOH Tube Tracheostomy And Tube Cuff Anesthesiology Class 2 868.5800 2024-11-18
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2023-12-14
GAM Suture, Absorbable, Synthetic, Polyglycolic Acid General, Plastic Surgery Class 2 878.4493 2025-03-11
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2023-12-14
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2023-12-14
FXY Hood, Surgical General, Plastic Surgery Class 2 878.4040 2024-10-31
ETN Stimulator, Nerve Ear, Nose, Throat Class 2 874.1820 2024-11-18
GDW Staple, Implantable General, Plastic Surgery Class 2 878.4750 2023-12-14
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2024-06-25
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2024-11-18
GDW Staple, Implantable General, Plastic Surgery Class 2 878.4750 2025-03-10
GDW Staple, Implantable General, Plastic Surgery Class 2 878.4750 2024-03-27
HBE Drills, Burrs, Trephines & Accessories (Simple, Powered) Neurology Class 2 882.4310 2024-11-18
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2024-11-18
HRX Arthroscope Orthopedic Class 2 888.1100 2024-11-18
HBC Motor, Drill, Electric Neurology Class 2 882.4360 2024-11-18
KFK Saw, Pneumatically Powered General, Plastic Surgery Class 1 878.4820 2024-11-18
EQJ Bur, Ear, Nose And Throat Ear, Nose, Throat Class 1 874.4140 2024-11-18
ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece Ear, Nose, Throat Class 2 874.4250 2024-11-18
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2024-03-27
HBE Drills, Burrs, Trephines & Accessories (Simple, Powered) Neurology Class 2 882.4310 2024-11-01
ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece Ear, Nose, Throat Class 2 874.4250 2024-11-01
GAL Suture, Absorbable, Natural General, Plastic Surgery Class 2 878.4830 2025-09-15
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2023-12-14
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2024-06-25
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2024-08-20
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2023-12-14
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2023-12-14
GAM Suture, Absorbable, Synthetic, Polyglycolic Acid General, Plastic Surgery Class 2 878.4493 2025-03-10
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2023-12-14
BTR Tube, Tracheal (W/Wo Connector) Anesthesiology Class 2 868.5730 2023-12-14
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2024-06-25
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2023-12-14
FHO Pneumoperitoneum Needle Gastroenterology, Urology Class 2 876.1500 2023-12-14
BTO Tube, Tracheostomy (W/Wo Connector) Anesthesiology Class 2 868.5800 2024-11-18
GDW Staple, Implantable General, Plastic Surgery Class 2 878.4750 2024-11-15
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2023-12-14
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2024-06-25
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2023-12-14
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2024-08-20

Official Correspondent

No official correspondent registered.

US Agent Details

Manoj Zacharias Business: Liberty Management Group Ltd. Email: office@libertymanagement.us Phone: (630) 2702921

Related Public Records

Same Entity

SANMED MEDIKAL OTOMOTIV TEKSTIL TICARET 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
K131563 Opus Ksd, Inc. SUBQ IT! BIOABSORBABLE SKIN CLOSURE SYSTEM 2014-04-09
K131705 Covidien, Formerly US Surgical A Divison of Tyco H ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY 2013-07-01
K103263 Covidien, Formerly US Surgical A Divison of Tyco H ENDO GIA SINGLEUSE DUET TRS RELOAD WITH TRI0STAPLE TECHNOLOGY 2010-11-22
K130717 Covidien, Formerly US Surgical A Divison of Tyco H ENDO GIA RELOAD 2013-04-18
K221006 Covidien GIA Stapler with Tri-Staple Technology 2022-04-29

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0001-2021 N/A 2
Endo GIA Auto Suture Gray Universal Articulating Loading Unit 30 mm - 2.0 mm, Item Code 030450 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Z-0002-2021 N/A 2
Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 2.5 mm, Item Code 030451 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Z-0003-2021 N/A 2
Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 3.5 mm, Item Code 030452 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Z-0004-2021 N/A 2
Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 2.0 mm, Item Code 030453 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Z-0005-2021 N/A 2
Endo GIA Auto Suture Universal Loading Unit 45 mm - 2.5mm, Item Code 030454 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014479313. Last updated year: 2026. Please use registration number 3014479313 when referencing this establishment in official correspondence.
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