Data / Medical devices / Turkey / Burak Global Ic Ve Dis Tic Ltd Sti
Burak Global Ic Ve Dis Tic Ltd Sti: FDA-registered device maker in Kocasinan Kayseri, Turkey, 94 510(k) clearances and 3 PMA approvals
Burak Global Ic Ve Dis Tic Ltd Sti is registered with the FDA (registration 3014461810) in Kocasinan Kayseri, Turkey. It lists 54 device types. The FDA files 94 510(k) clearances and 3 PMA approvals under its listings, the newest dated June 14, 2024. Registered through 2026. 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.
- FDA registration number
- 3014461810
- Address
- Sahabiye Mh. Ahmet Pasa Cd. Ahmet Pasa Is Merk. No: 16/701, Kocasinan Kayseri, Turkey, 38015
- Owner or operator
- BURAK GLOBAL IC VE DIS TIC LTD STI (10058392)
- Roles
- Exporter to the US
- First device listed
- September 11, 2018
- Registered through
- 2026
- Brand names listed
- 120MM SURGINEEDLE, 176643, 176645, 2MM DILATOR & CANNULA, 770G, 8556H, AG SCD DRS, AQ Foam and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 14, 2024 | K241250 | 3DMax Light Mesh | FTL | Substantially Equivalent | Davol Inc., Subsidiary of C. R. Bard, Inc. | accessdata.fda.gov |
| November 1, 2023 | K233402 | Bard 3DMax Mesh | FTL | Substantially Equivalent | Davol Inc., Subsidiary of C. R. Bard, Inc. | accessdata.fda.gov |
| June 30, 2022 | K220634 | NC TREK NEO Coronary Dilatation Catheter | LOX | Substantially Equivalent | Abbott Vascular | accessdata.fda.gov |
| December 16, 2021 | K202818 | Voyant Fine Fusion Device (EB230) | GEI | Substantially Equivalent | Applied Medical | accessdata.fda.gov |
| April 15, 2021 | K210235 | Verrata PLUS Pressure Guide Wire | DQX | Substantially Equivalent | Volcano Corporation | accessdata.fda.gov |
| June 5, 2020 | K201212 | Voyant Open Fusion Device | GEI | Substantially Equivalent | Applied Medical Resources Corp. | accessdata.fda.gov |
| March 22, 2019 | K182861 | Shiley Neonatal/Pediatric Tracheostomy Tube | JOH | Substantially Equivalent | Covidien | accessdata.fda.gov |
| August 24, 2018 | K180040 | NC TREK RX Coronary Dilatation Catheter; NC TREK OTW Coronary Dilatation Catheter; TREK RX Coronary Dilatation Catheter; TREK OTW Coronary Dilatation Catheter; MINI TREK RX Coronary Dilatation Catheter; MINI TREK OTW Coronary Dilatation Catheter; MINI TREK II OTW Coronary Dilatation Catheter | LOX | Substantially Equivalent | Abbott Vascular | accessdata.fda.gov |
| June 21, 2018 | K181085 | LigaSure Maryland Jaw Thoracic Sealer/Divider One-step Sealing, Nano-coated | GEI | Substantially Equivalent | Covidien | accessdata.fda.gov |
| March 28, 2018 | K173489 | GYN-Pump PH304 | HIG | Substantially Equivalent | W.O.M. World of Medicine GmbH | accessdata.fda.gov |
| April 21, 2017 | K170869 | LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coated | GEI | Substantially Equivalent | Covidien | accessdata.fda.gov |
| April 18, 2017 | K163523 | ECHELON CIRCULAR Powered Stapler | GDW | Substantially Equivalent | Ethicon Endo-Surgery, LLC | accessdata.fda.gov |
| November 14, 2016 | K162941 | Ligasure Blunt Tip, Sealer/Divider, Nano-coated | GEI | Substantially Equivalent | Covidien | accessdata.fda.gov |
| April 5, 2016 | K153258 | Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocars | NLM | Substantially Equivalent | Surgical Instrument Service and Savings (Dba Medline Renewal | accessdata.fda.gov |
| September 14, 2015 | K143644 | Premium Surgiclip¿; Endo Clip¿; AcuClip¿ | FZP | Substantially Equivalent | Covidien | accessdata.fda.gov |
| July 2, 2015 | K151548 | VersaOne Bladed Trocar, VersaOne Bladeless Trocar | GCJ | Substantially Equivalent | Covidien | accessdata.fda.gov |
| June 18, 2015 | K151356 | Spacemaker Pro Access and Dissector System | GCJ | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| February 24, 2015 | K142296 | Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Disposable Inner Cannula | JOH | Substantially Equivalent | Covidien | accessdata.fda.gov |
| October 28, 2014 | K142900 | Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester Mesh), Parietex Plug and Patch (new name : Parietex Plug and Patch System), Progrip Laparoscopic Self-Fixating Mesh | FTL | Substantially Equivalent | Sofradim Production | accessdata.fda.gov |
| October 10, 2014 | K142014 | SOFIA DISTAL ACCESS CATHETER | DQY | Substantially Equivalent | MicroVention, Inc. | accessdata.fda.gov |
| April 22, 2014 | K140560 | ECHELON FLEX POWERED PLUS ARTICULATING ENDOSCOPIC LINEAR CUTTER, 60MM, STANDARD, ECHELON FLEX POWERED PLUS ARTICULATING | GDW | Substantially Equivalent | Ethicon Endo-Surgery, LLC | accessdata.fda.gov |
| December 13, 2013 | K132015 | TRUCLEAR MORCELLATION SYSTEM AND TRUCLEAR MORCELLATORS | HIH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| December 6, 2013 | K133356 | PROLENE POLYPROPYLENE NONABSORBABLE SUTURE | GAW | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| December 3, 2013 | K133202 | HEM-O-LOK LIGATING CLIP | FZP | Substantially Equivalent | Teleflex Medical | accessdata.fda.gov |
| October 17, 2013 | K132612 | HARMONIC ACE+ SHEARS 23 CM LENGTH WITH ADVANCED HEMOSTASIS, HARMONIC ACE + LAPAROSCOPIC SHEARS 36 CM LENGTH WITH ADVANCE | LFL | Substantially Equivalent | Ethicon Endo-Surgery, LLC | accessdata.fda.gov |
| August 22, 2013 | K131969 | SYMBOTEX(TM) COMPOSITE MESH | FTL | Substantially Equivalent | Sofradim Production | accessdata.fda.gov |
| June 6, 2013 | K123481 | AQUACEL AG FOAM HYDROFIBER FOAM DRESSING WITH SILVER, ADHESIVE AND NON ADHESIVE | FRO | Substantially Equivalent | Convatec, Inc. | accessdata.fda.gov |
| March 14, 2013 | K130435 | VERSAPORT V2 BLADELESS OPTICAL TROCAR | GCJ | Substantially Equivalent | Covidien, Formerly US Surgical A Divison of Tyco H | accessdata.fda.gov |
| February 8, 2013 | K113268 | ALEXIS O WOUND PROTECTOR/RETRACTOR | KGW | Substantially Equivalent | Applied Medical Resources Corp. | accessdata.fda.gov |
| January 31, 2013 | K123196 | PALINDROME PRECISION H CHRONIC CATHETER, PALINDROME PRECISION SI CHRONIC CATHETER, PALINDROME PRECISION HSI CHRONIC CATH | MSD | Substantially Equivalent | Covidien | accessdata.fda.gov |
| December 19, 2012 | K122321 | BASIXCONPAK ANALOG INFLATION SYRINGE | MAV | Substantially Equivalent | Merit Medical Ireland, Ltd. | accessdata.fda.gov |
| October 23, 2012 | K123109 | ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE | GDW | Substantially Equivalent | Covidien | accessdata.fda.gov |
| August 22, 2012 | K121550 | HARMONIC ACE LAPAROSCOPIC 5MM DIAMETER SHEARS 36CM LENGTH + ADAPTIVE TISSUE TECHNOLOGY | LFL | Substantially Equivalent | Ethicon Endo-Surgery, LLC | accessdata.fda.gov |
| October 25, 2011 | K111825 | ENDO GIA(TM) STAPLERS, DST SERIES(TM) GIA(TM) STAPLERS, DST SERIES(TM) TA(TM) STAPLERS | GDW | Substantially Equivalent | Covidien, Formerly US Surgical A Divison of Tyco H | accessdata.fda.gov |
| September 1, 2011 | K112349 | VERSAPORT V2 BLADELESS OPTIICAL TROCAR AND/OR VERSAPORT BLADELESS OPTICAL TROCAR | GCJ | Substantially Equivalent | Covidien, Formerly US Surgical A Divison of Tyco H | accessdata.fda.gov |
| May 24, 2011 | K111153 | SORBAFIX (TM) ABSORBABLE FIXATION SYSTEM, PERMAFIX (TM) FIXATION SYSTEM | GDW | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| March 25, 2011 | K110699 | LIGAMAX 5 | FZP | Substantially Equivalent | Ethicon Endo-Sugery, LLC | accessdata.fda.gov |
| February 10, 2011 | K103101 | HI-TORQUE BALANCE MIDDLEWEIGHT ELITE | DQX | Substantially Equivalent | Abbott Vascular-Cardiac Therapies | accessdata.fda.gov |
| July 15, 2010 | K101851 | VENTRALIGHT ST MESH | FTL | Substantially Equivalent | Davol Inc., Sub. C. R. Bard, Inc. | accessdata.fda.gov |
| June 23, 2010 | K101116 | HI-TORQUE PILOT 50 AND 150 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE WHISPER LS AND MS GUIDE WIRE WITH | DQX | Substantially Equivalent | Abbott Vascular-Cardiac Therapies | accessdata.fda.gov |
| May 10, 2010 | K100257 | VLOC9ABSORBABLE WOUND CLOSURE DEVICE | GAM | Substantially Equivalent | Surgical Devices, A Division of Tyco Healthcare | accessdata.fda.gov |
| April 7, 2010 | K093845 | ETHICON SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE, MODEL STRAP25 | GDW | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| February 17, 2010 | K100242 | AUTO SUTURE ENDO CLIP III5MM CLIP ADAPTER | FZP | Substantially Equivalent | Surgical Devices, A Division of Tyco Healthcare | accessdata.fda.gov |
| December 16, 2009 | K091034 | AQUACEL AG SURGICAL | FRO | Substantially Equivalent | Convatec | accessdata.fda.gov |
| December 8, 2009 | K092032 | BARD PERFIX LIGHT PLUG, MODELS 0117050, 0117060, 0117070, 0117080, 0117150, 0117160 | FTL | Substantially Equivalent | Davol Inc., Sub. C. R. Bard, Inc. | accessdata.fda.gov |
| November 5, 2009 | K093296 | ALEXIS LAPAROSCOPIC SYSTEM | KGW | Substantially Equivalent | Applied Medical Resources Corp. | accessdata.fda.gov |
| September 15, 2009 | K092577 | ETHICON ENDO-SURGERY LINEAR CUTTER 55MM (NTLC55),SELECTABLE CARTRIDGE 55 / 75MM (SR55/75) ,LINEAR CUTTER 75MM (NTLC75) | GDW | Substantially Equivalent | Ethicon Endo-Surgery, LLC | accessdata.fda.gov |
| May 14, 2009 | K090470 | AUTOSUTURE PROTACK; TACKER SYSTEM; ABSORBATACK FIXATION DEVICES | OCW | Substantially Equivalent | Covidien | accessdata.fda.gov |
| April 22, 2009 | K091087 | MODIFICATION TO V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE | GAM | Substantially Equivalent | Surgical Devices, Tyco Healthcare Group LP | accessdata.fda.gov |
| February 4, 2009 | K083781 | EEA HEMORRHOID STAPLER & ACCESSORIES | GDW | Substantially Equivalent | Surgical Devices, A Global Business Unit Covidien | accessdata.fda.gov |
| November 20, 2007 | K072286 | BIS EEG VISTA MONITOR SYSTEM AND BISX | OLW | Substantially Equivalent | Aspect Medical Systems, Inc. | accessdata.fda.gov |
| October 5, 2007 | K072674 | KII TROCAR SYSTEM | GCJ | Substantially Equivalent | Applied Medical Resources Corp. | accessdata.fda.gov |
| January 9, 2007 | K062907 | ALEXIS WOUND RETRACTOR | KGW | Substantially Equivalent | Applied Medical Resources | accessdata.fda.gov |
| October 23, 2006 | K062850 | AUTOSUTURE CIRCULAR EEA SURGICAL STAPLERS | GDW | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc | accessdata.fda.gov |
| September 1, 2006 | K062326 | AUTOSUTURE MODIFIED VERSAPORT TROCAR WITH FIXATION SLEEVE | GCJ | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc | accessdata.fda.gov |
| August 24, 2006 | K062169 | APPLIED LAPAROSCOPIC DISPOSABLE MONOPOLAR SCISSORS | HET | Substantially Equivalent | Applied Medical Resources Corp. | accessdata.fda.gov |
| July 14, 2006 | K061037 | PDS PLUS ANTIBACTERIAL SUTURE | NEW | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| April 7, 2006 | K060629 | GELPORT BLUNT TIP TROCAR SYSTEM | GCJ | Substantially Equivalent | Applied Medical Resources Corp. | accessdata.fda.gov |
| March 13, 2006 | K053268 | PVS 2000 SYNCHRO2 GUIDEWIRE | DQX | Substantially Equivalent | Boston Scientific - Precision Vascular | accessdata.fda.gov |
| January 19, 2006 | K060051 | SPECIMEN RETRIEVAL SYSTEM | GCJ | Substantially Equivalent | Applied Medical Resources Corp. | accessdata.fda.gov |
| June 29, 2005 | K050845 | MONOCRYL PLUS ANTIBACTERIAL SUTURE | GAM | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| June 16, 2005 | K051416 | SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND INNER CANNULA | JOH | Substantially Equivalent | Mallinckrodt Medical | accessdata.fda.gov |
| December 10, 2004 | K043298 | BLUE ORTHOCORD SUTURE | NEW | Substantially Equivalent | Depuy Mitek | accessdata.fda.gov |
| October 27, 2004 | K041669 | VERITAS DRY COLLAGEN MATRIX, VERITAS DRY OR VERITAS PSD | FTM | Substantially Equivalent | Synovis Surgical Innovations | accessdata.fda.gov |
| September 24, 2004 | K042412 | MODIFIED SPACEMAKER SYSTEM | GCJ | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc | accessdata.fda.gov |
| March 12, 2004 | K040295 | APPLIED LAPAROSCOPIC MONOPOLAR SCISSORS | HET | Substantially Equivalent | Applied Medical Resources Corp. | accessdata.fda.gov |
| October 30, 2003 | K032676 | ENDOPATH BLADELESS TROCAR, ENDOPATH BLUNT TIP TROCAR, ENDOPATH DILATING TIP TROCAR | GCJ | Substantially Equivalent | Ethicon Endo-Surgery, Inc. | accessdata.fda.gov |
| August 13, 2003 | K031616 | IUR FLUID MANAGEMENT SYSTEM | HIG | Substantially Equivalent | W.O.M. World of Medicine AG | accessdata.fda.gov |
| September 13, 2002 | K022269 | COATED VICRYL* (POLYGLACTIN 910) SUTURE | GAM | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| June 5, 2002 | K020779 | PROXIMATE AND ENDOPATH LINEAR CUTTERS AND STAPLERS | GDW | Substantially Equivalent | Ethicon Endo-Surgery, Inc. | accessdata.fda.gov |
| March 7, 2002 | K012891 | OXIMAX PULSE OXIMETRY SYSTEM WITH N-595 PULSE OXIMETER AND OXIMAX SENSORS AND CABLES (AKA ACCESSORIES) | DQA | Substantially Equivalent | Nellcor Puritan Bennett, Inc. | accessdata.fda.gov |
| September 6, 2001 | K012539 | VERASTEP | GCJ | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc | accessdata.fda.gov |
| April 9, 2001 | K010909 | NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE | GAW | Substantially Equivalent | Tyco Healthcare Group LP | accessdata.fda.gov |
| December 8, 2000 | K001895 | AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER | GDW | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc | accessdata.fda.gov |
| March 7, 2000 | K994428 | E7512 PREMIE REM POLYHESIVE II PATIENT RETURN ELECTRODE | GEI | Substantially Equivalent | Valleylab, Inc. | accessdata.fda.gov |
| December 18, 1998 | K983536 | PROXIMATE CURVED AND STRAIGHT INTRALUMINAL STAPLERS | GDW | Substantially Equivalent | Ethicon Endo-Surgery, Inc. | accessdata.fda.gov |
| December 18, 1996 | K964072 | MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYED | GAN | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| October 4, 1996 | K962173 | SHIKEY TRACHEOSTOMY TUBES AND ACCESSORIES | JOH | Substantially Equivalent | Mallinckrodt Medical | accessdata.fda.gov |
| September 24, 1996 | K963359 | INSUFFLATION NEEDLE | HET | Substantially Equivalent | Applied Medical Resources | accessdata.fda.gov |
| December 20, 1995 | K954853 | AUTO SUTURE SUTURE CLOSURE | GCJ | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc | accessdata.fda.gov |
| May 3, 1995 | K951589 | MANUAL SURGICAL INSRUMENT | GEI | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc | accessdata.fda.gov |
| February 27, 1995 | K945407 | SSVO PHONATE(TM) SHILEY SPEAKING VALVE WITH OXYGEN PORT | BTO | Substantially Equivalent | Mallinckrodt Medical Tpi, Inc. | accessdata.fda.gov |
| January 9, 1995 | K946173 | STAINLESS STEEL, GUT, POLY (GLYCOLIDE/L-LACTIDE) POLYAMIDE, POLYPROPYLENE, POLY (ETHYLENE TEREPHTHALATE) AND SILK | GAQ | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| March 16, 1994 | K934738 | AUTOSUTURE ENDOSCOPIC SUTURING DEVICE | OCW | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc | accessdata.fda.gov |
| January 26, 1994 | K935426 | PREPERITONEAL DISTENTION BALLOON SYSTEM | GCJ | Substantially Equivalent | Origin Medsystems, Inc. | accessdata.fda.gov |
| July 9, 1993 | K924011 | ORIGIN BLUNT TIP SURGICAL TROCAR | GCJ | Substantially Equivalent | Origin Medsystems, Inc. | accessdata.fda.gov |
| February 1, 1993 | K922123 | AUTO SUTURE DISPOSABLE ENDOSCOPIC SPECIMEN POUCH | GCI | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc | accessdata.fda.gov |
| December 24, 1990 | K904588 | AUTO SUTURE(R) MODIFIED ENDOSCOPIC LIGATING LOOP | GAL | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc | accessdata.fda.gov |
| October 30, 1990 | K904578 | MODIFICATION AUTO SUTURE(R) ENDOSCOPIC CLAMP | GET | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc | accessdata.fda.gov |
| October 11, 1990 | K903205 | AUTO SUTURE(R) ENDOSCOPIC CLAMP | HDA | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc | accessdata.fda.gov |
| November 5, 1986 | K864102 | LIGACLIP 20/20* MULTIPLE CLIP APPLIER | FZP | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| October 2, 1986 | K863330 | DISPOSABLE PNEUMOPERITONEUM NEEDLE | FHO | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc | accessdata.fda.gov |
| March 8, 1983 | K830503 | LIGACLIP TITANIUM LIGATING CLIP | FZP | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| August 4, 1977 | K771219 | BRONCHO-CATH | BTS | Substantially Equivalent | Mallinckrodt Critical Care | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| September 26, 2006 | P050038 | ARISTA AH ABSORBABLE HEMOSTAT | LMG | 40 | July 15, 2026 | accessdata.fda.gov |
| May 10, 1996 | P950022 | TVL(TM) LEAD SYSTEM | LWS | 145 | June 26, 2026 | accessdata.fda.gov |
| August 26, 1976 | N17600 | AVITENE (MICROFIBRILLAR COLLAGEN HOMOSTAT) | LMF | 43 | July 15, 2026 | accessdata.fda.gov |
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Updated July 15, 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.