Data / Medical devices / Turkey / Cardimed Asia Medikal Sanayi Ve Ticaret Ltd Sti
Cardimed Asia Medikal Sanayi Ve Ticaret Ltd Sti: FDA-registered device maker in Maltepe Istanbul, Turkey, 86 510(k) clearances and 7 PMA approvals
Cardimed Asia Medikal Sanayi Ve Ticaret Ltd Sti is registered with the FDA (registration 3015453963) in Maltepe Istanbul, Turkey. It lists 61 device types. The FDA files 86 510(k) clearances and 7 PMA approvals under its listings, the newest dated March 21, 2025. Registered through 2026. FDA data exported November 3, 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
- 3015453963
- Address
- Cevizli Mah. Tansel Cad. No:12-18 Bulut Plaza D:32-33-34, Maltepe Istanbul, Turkey, 34846
- Owner or operator
- Cardimed Asia Medikal Sanayi ve Ticaret Ltd Sti (10060492)
- Roles
- Exporter to the US
- First device listed
- July 18, 2019
- Registered through
- 2026
- Brand names listed
- Accessories, arthroscopic, Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass, BIT, DRILL, CATHETER, ASSISTED REPRODUCTION, CATHETER, INTRAVASCULAR, DIAGNOSTIC, CATHETER, IRRIGATION, CATHETER, PERCUTANEO, CATHETER, PERCUTANEOUS 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 |
|---|---|---|---|---|---|---|
| March 21, 2025 | K242289 | Excelsior XT-27 Microcatheter, Excelsior XT-27 Flex Microcatheter, Excelsior XT-27 Pre-Shaped Microcatheter, Excelsior XT-27 Flex Pre-Shaped Microcatheter | QJP | Substantially Equivalent | Stryker Neurovascular | accessdata.fda.gov |
| January 17, 2024 | K233730 | Footprint Mini PK, 3.5mm Suture Anchor | MBI | Substantially Equivalent | Smith & Nephew | accessdata.fda.gov |
| June 30, 2023 | K230156 | 5F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide Catheter, 8F Launcher Guide Catheter | DQY | Substantially Equivalent | Medtronic Vascular | accessdata.fda.gov |
| March 24, 2023 | K220212 | BD Vacutainer® Push Button Blood Collection Set, BD Vacutainer® Push Button Blood Collection Set with Pre-Attached Holder | JKA | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| June 22, 2022 | K220586 | Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D 3D Anatomical Mesh, Versatex Monofilament Mesh | FTL | Substantially Equivalent | Sofradim Production | accessdata.fda.gov |
| November 16, 2021 | K212455 | InZone Detachment System | HCG | Substantially Equivalent | Stryker Neurovascular | accessdata.fda.gov |
| July 1, 2021 | K211411 | Penumbra System (RED 68 Reperfusion Catheter) | NRY | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| April 19, 2021 | K203495 | Arthrex SwiveLock Anchor | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| February 1, 2021 | K203393 | FAST-FIX FLEX | GAT | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| May 12, 2019 | K183515 | MR8 Drill System, Midas Rex MR8 ClearView Tools | HBC | Substantially Equivalent | Medtronic Powered Surgical Solutions | accessdata.fda.gov |
| March 21, 2019 | K182918 | Ballast 088 Long Sheath | DQY | Substantially Equivalent | Balt USA, LLC | accessdata.fda.gov |
| March 12, 2019 | K183232 | Double ENDOBUTTON Fixation Device | HTN | Substantially Equivalent | Smith and Nephew, Inc. | accessdata.fda.gov |
| May 8, 2018 | K173831 | Glidesheath Slender | DYB | Substantially Equivalent | Terumo Medical Corporation | accessdata.fda.gov |
| April 23, 2018 | K180499 | Reprocessed LigaSure Maryland Jaw Sealer/Divider | NUJ | Substantially Equivalent | Stryker Sustainability Solutions | accessdata.fda.gov |
| February 1, 2018 | K171662 | Open-End Ureteral Catheter, Open-End Ureteral Catheter Sof-Flex, EchoTip Open-End Ureteral Catheter, Open-End Flexi-Tip Ureteral Catheter, Flexi-Tip Ureteral Catheter (Closed End), Whistle Tip Ureteral Catheter, Round Tip Ureteral Catheter, Spiral Tip Ureteral Access Catheter, Pediatric Ureteral Catheter | KOD | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| December 21, 2017 | K172321 | Shepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauterine Insemination Catheters | MQF | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| October 6, 2017 | K172097 | Reprocessed Ethicon Bladeless Trocars; Reprocessed Ethicon Universal Trocar Sleeves | NLM | Substantially Equivalent | Renovo, Inc. | accessdata.fda.gov |
| May 15, 2017 | K170312 | IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw handpieces,Triton electric high torque handpiece, Attachments and surgical dissecting tools | HBC | Substantially Equivalent | Medtronic Powered Surgical Solutions | accessdata.fda.gov |
| April 21, 2017 | K170869 | LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coated | GEI | Substantially Equivalent | Covidien | accessdata.fda.gov |
| March 8, 2017 | K163654 | VersaOne fascial closure system bladed trocar, VersaOne fascial closure system bladeless trocar, VersaOne fascial closure system optical trocar | GCJ | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| September 16, 2016 | K161804 | LigaSure Retractable L-Hook Laparoscopic Sealer/Divider | GEI | Substantially Equivalent | Covidien | accessdata.fda.gov |
| September 15, 2016 | K162047 | LigaSure Impact Curved, Large Jaw, Open Sealer/Divider, Nano-coated | GEI | Substantially Equivalent | Covidien | accessdata.fda.gov |
| August 19, 2016 | K161287 | DxTerity, DxTerity TRA, DxTerity Angio-Kit, DxTerity EZ-Pak, DxTerity TRA Angio-Kit, DxTerity TRA EZ-Pak | DQO | Unknown | Medtronic Vascular | accessdata.fda.gov |
| May 12, 2016 | K160254 | GORE DrySeal Flex Introducer Sheath | DYB | Substantially Equivalent | W. L. Gore & Associates, Inc. | accessdata.fda.gov |
| January 28, 2016 | K153186 | Adjustable Fixation Device | MBI | Substantially Equivalent | Arthrocare Corp. | accessdata.fda.gov |
| October 19, 2015 | K150232 | Radifocus Optitorque Angiographic Catheter | DQO | Substantially Equivalent | Ashitaka Factory of Terumo Corp. | accessdata.fda.gov |
| July 2, 2015 | K151548 | VersaOne Bladed Trocar, VersaOne Bladeless Trocar | GCJ | Substantially Equivalent | Covidien | accessdata.fda.gov |
| March 13, 2015 | K143386 | Progrip Laparoscopic Self-Fixating Mesh | FTL | Substantially Equivalent | Sofradim Production | accessdata.fda.gov |
| November 14, 2014 | K142565 | Excelsior XT-17 Microcatheter, Excelsior XT-17 Flex Microcatheter, Excelsior XT-17 Pre-Shaped Microcatheter, Excelsior XT-17 Flex Pre-Shaped Microcatheter | DQY | Substantially Equivalent | Stryker Neurovascular | accessdata.fda.gov |
| October 30, 2014 | K142869 | Premium Surgiclip III | FZP | Substantially Equivalent | Covidien | accessdata.fda.gov |
| October 10, 2014 | K142014 | SOFIA DISTAL ACCESS CATHETER | DQY | Substantially Equivalent | MicroVention, Inc. | accessdata.fda.gov |
| January 16, 2014 | K133727 | Q-FIX SUTURE ANCHOR, 1.8MM; Q-FIX SUTURE ANCHOR, 2.8MM; DRILL, DRILL GUIDE AND OBTURATOR, 1.8MM & 2.8MM, FIRSTPASS SUTU | MBI | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| December 13, 2013 | K132441 | BARD VENTRALEX HERNIA PATCH | FTL | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| August 7, 2013 | K130608 | QUADCUT | HAW | Substantially Equivalent | Medtronic Navigation, 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 |
| 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 |
| October 22, 2012 | K122984 | ATLAS GOLD PTA DILATATION CATHETER | LIT | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| October 18, 2012 | K121861 | SMITH & NEPHEW ULTRA FAST-FIX MENISCAL REPAIR SYSTEM, SMITH & NEPHEW ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEM, SMITH & N | GAT | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| September 7, 2012 | K122301 | GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVE | DTL | Substantially Equivalent | Vascular Solutions Zerusa , Ltd. | accessdata.fda.gov |
| January 20, 2012 | K113294 | SMITH & NEPHEW HEALICOIL PK SUTURE ANCHOR | MBI | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| December 19, 2011 | K112990 | ACL TIGHTROPE,ACL TIGHTROPE DUUBLE BUNDLE | HTY | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| November 23, 2011 | K113163 | PENUMBRA SYSTEM MAX | NRY | Substantially Equivalent | Penumbra, Inc. | 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 |
| July 19, 2011 | K111380 | NEURON MAX SYSTEM | DQY | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| June 3, 2011 | K111442 | V-LOC 180 ABSORBABLE RELOAD, V-LOC PBT NON-ABSORBABLE RELOAD, ENDO STITCH (TM) ENDOSCOPIC SUTURING DEVICE, SILS (TM)... | GAM | Substantially Equivalent | Covidien, Formerly US Surgical A Divison of Tyco H | accessdata.fda.gov |
| March 23, 2011 | K101928 | VENTRALEX ST HERNIA PATCH | FTL | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| February 11, 2011 | K103386 | MEDTRONIC VASCULAR - HUB MATERIAL MODIFICATION TO THE 5F AND 8F LAUNCHER(R) GUIDE CATHETERS | DQY | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| February 10, 2011 | K103101 | HI-TORQUE BALANCE MIDDLEWEIGHT ELITE | DQX | Substantially Equivalent | Abbott Vascular-Cardiac Therapies | accessdata.fda.gov |
| January 10, 2011 | K103110 | MINI TREK(TM) RX AND TREK(TM) RX CORONARY DILATATION CATHETER MINI TREK(TM) OTW AND TREK(TM) OTW DILATATION CATHETER | LOX | Substantially Equivalent | Abbott Vascular-Cardiac Therapies | accessdata.fda.gov |
| November 10, 2010 | K103052 | V-LOC(TM) NONABSORBABLE WOUND CLOSURE DEVICE | GAT | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| August 6, 2010 | K101542 | HEADWAY 17 ADVANCED MICROCATHETER | DQY | Substantially Equivalent | MicroVention, Inc. | accessdata.fda.gov |
| July 13, 2010 | K100826 | PENUMBRA CATHERER 025 | DQY | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| May 10, 2010 | K100257 | VLOC9ABSORBABLE WOUND CLOSURE DEVICE | GAM | Substantially Equivalent | Surgical Devices, A Division of Tyco Healthcare | accessdata.fda.gov |
| December 17, 2009 | K093397 | TRAXCESS 14EX GUIDEWIRE AND TRAXCESS DOCKING WIRE | DQX | Substantially Equivalent | MicroVention, Inc. | accessdata.fda.gov |
| December 15, 2009 | K093228 | SMITH & NEPHEW TWINFIX ULTRA PK SUTURE ANCHOR | MBI | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| December 9, 2009 | K093750 | ECHELON MICRO CATHETER, MARATHON MICRO CATHETER, NAUTICA MICRO CATHETER ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER, REBA | KRA | Substantially Equivalent | Ev3, Inc. | accessdata.fda.gov |
| November 5, 2009 | K093160 | HEADWAY 21 MICROCATHETER, MODEL: MC212150S | DQY | Substantially Equivalent | MicroVention, Inc. | 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 |
| December 10, 2008 | K083306 | MODIFICATION TO ARTHROCARE ARTHROWANDS | GEI | Substantially Equivalent | Arthrocare Corp. | accessdata.fda.gov |
| April 23, 2008 | K080358 | PLLA, HA SCREW | HWC | Substantially Equivalent | Smith & Nephew Inc., Endoscopy Div. | accessdata.fda.gov |
| April 17, 2008 | K080863 | TRAXCESS 0.014 HYDROPHILIC GUIDEWIRE | DQX | Substantially Equivalent | MicroVention, Inc. | accessdata.fda.gov |
| April 27, 2007 | K063695 | RUNTHROUGH NS | DQX | Substantially Equivalent | Terumo Medical Corp. | 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 |
| July 12, 2006 | K061363 | AGILIS NXT STEERABLE INTRODUCER | DYB | Substantially Equivalent | St Jude Medical | accessdata.fda.gov |
| March 13, 2006 | K053268 | PVS 2000 SYNCHRO2 GUIDEWIRE | DQX | Substantially Equivalent | Boston Scientific - Precision Vascular | accessdata.fda.gov |
| December 13, 2005 | K052776 | TIGHTROPE ACROMIOCLAVICULAR (AC) DEVICE, TITANIUM, STAINLESS STEEL , MODELS AR-2257, AR-TBD | HTN | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| October 15, 2004 | K042568 | EXCELSIOR 1018 AND SL-10 MICROCATHETERS | DQY | Substantially Equivalent | Boston Scientific Corp | accessdata.fda.gov |
| December 4, 2002 | K023700 | PVS 1600 SYNCHRO 0.010 NEURO GUIDE WIRE | DQX | Substantially Equivalent | Precision Vascular Systems, Inc. | accessdata.fda.gov |
| June 13, 2002 | K021593 | MODIFICATION TO ENVOY AND VISTA BRITE TIP | DQY | Substantially Equivalent | Cordis Corp. | accessdata.fda.gov |
| May 17, 2002 | K021256 | Z3 GUIDE CATHETER | DQY | Substantially Equivalent | Medtronic Vascular | accessdata.fda.gov |
| March 18, 2002 | K020069 | MEDTRONIC MIDA REX LEGEND SYSTEM, MIDAS REX LEGEND PNEUMATIC HIGH SPEED SYSTEM OR LEGEND SYSTEM | HBB | Substantially Equivalent | Medtronic Midas Rex | 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 |
| December 6, 2001 | K013789 | EXCELSIOR SL-10 MICROCATHETER, MODELS 168581, 168381, 168181, 168189 | DQY | Substantially Equivalent | Boston Scientific, Target | accessdata.fda.gov |
| March 26, 2001 | K010013 | LIGASURE LAPAROSCOPIC SEALER DIVIDER MODEL LS1100 | GEI | Substantially Equivalent | Valleylab, Inc. | accessdata.fda.gov |
| March 8, 2001 | K002907 | PVS 1300 NEURO GUIDE WIRE | DQX | Substantially Equivalent | Precision Vascular Systems, Inc. | accessdata.fda.gov |
| May 7, 1997 | K963962 | VISTA BRITE TIP CATHETERS | DQY | Substantially Equivalent | Cordis Corp. | accessdata.fda.gov |
| February 1, 1996 | K955836 | VALLEYLAB COATED ELECTRODES | GEI | Substantially Equivalent | Valleylab, Inc. | accessdata.fda.gov |
| November 9, 1995 | K954175 | DUO BALLOON SYSTEM (DBS) 1[10 AND 12 MM SIZES] | GCJ | Substantially Equivalent | Origin Medsystems, Inc. | accessdata.fda.gov |
| May 3, 1995 | K951589 | MANUAL SURGICAL INSRUMENT | GEI | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc | 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 |
| 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 |
| April 20, 1990 | K900486 | APPOSE UNITY STERILE DISPOSABLE SKIN STAPLER | GDT | Substantially Equivalent | Davis & Geck, Inc. | accessdata.fda.gov |
| September 21, 1982 | K822572 | POLYHESIVE PATIENT RETURN ELECTRODE | GEI | Substantially Equivalent | Valleylab, Inc. | 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 |
|---|---|---|---|---|---|---|
| December 13, 2021 | P210014 | SLENDER Sirolimus-Eluting Coronary Stent Integrated Delivery System and DIRECT Sirolimus-Eluting Coronary Stent Rapid Ex | NIQ | 2 | April 6, 2023 | accessdata.fda.gov |
| February 22, 2019 | P170030 | ORSIRO Sirolimus Eluting Coronary Stent System | NIQ | 63 | September 24, 2026 | accessdata.fda.gov |
| October 2, 2015 | P150003 | SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM | NIQ | 109 | August 21, 2026 | accessdata.fda.gov |
| November 22, 2011 | P110010 | PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM | NIQ | 207 | January 14, 2025 | accessdata.fda.gov |
| June 26, 2002 | P010031 | CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC RESYNCHICNIZATION | NIK | 902 | October 5, 2026 | accessdata.fda.gov |
| December 9, 1993 | P920015 | MEDTRONIC(R) TRANSVENE LEAD SYSTEM | NVY | 294 | August 19, 2026 | accessdata.fda.gov |
| November 28, 1986 | P860019 | SCIMED PTCA DILATATION CATHETER | LOX | 247 | March 31, 2011 | accessdata.fda.gov |
Compare with other makers
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
- All makers of Fastener, Fixation, Nondegradable, Soft Tissue
- All makers of Suture, Nonabsorbable, Synthetic, Polyethylene
- All makers of Bit, Drill
- All makers of Catheters, Transluminal Coronary Angioplasty, Percutaneous
- All makers of Catheter, Percutaneous
Updated March 21, 2025. 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.