Data / Medical devices / Slovakia / Mdtglobal, A.S.
Mdtglobal, A.S.: FDA-registered device maker in Bratislava Bratislavsky, Slovakia, 63 510(k) clearances and 1 PMA approval
Mdtglobal, A.S. is registered with the FDA (registration 3024021261) in Bratislava Bratislavsky, Slovakia. It lists 50 device types. The FDA files 63 510(k) clearances and 1 PMA approval under its listings, the newest dated August 13, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3024021261
- Address
- Lomonosovova 2, Bratislava Bratislavsky, Slovakia, 811 09
- Owner or operator
- MDTGlobal, a.s. (10085911)
- Roles
- Exporter to the US
- First device listed
- September 6, 2022
- Registered through
- 2026
- Brand names listed
- 0112760, 0112770, 0112780, 0279-351-100, 030458, 031200-10, 0375-544-000, 0375-545-000 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 |
|---|---|---|---|---|---|---|
| August 13, 2025 | K243653 | KARL STORZ HOPKINS Telescopes for Urology | FAJ | Substantially Equivalent | Karl Storz SE & CO. KG | accessdata.fda.gov |
| November 21, 2023 | K233333 | KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit | OWN | Substantially Equivalent | Karl Storz SE & CO. KG | accessdata.fda.gov |
| September 14, 2023 | K223885 | HOPKINS Telescopes | HIH | Substantially Equivalent | Karl Storz Endoscopy America, Inc. | accessdata.fda.gov |
| March 17, 2023 | K221893 | KARL STORZ Bipolar Resectoscopes with HF Cable | FJL | Substantially Equivalent | Karl Storz Endoscopy America, Inc. | accessdata.fda.gov |
| December 29, 2022 | K221690 | OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5), OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5R), LIGHT GUIDE ADAPTER (MAJ-1413) | FAJ | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| April 28, 2021 | K203277 | Electrosurgical Generator ESG-410, Foot Switches, PK Cutting Forceps | GEI | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| October 29, 2020 | K202646 | Visera Elite II Video System Center | FET | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| August 19, 2020 | K193563 | Medline ReNewal Reprocessed Harmonic ACE+7 Shears | NLQ | Substantially Equivalent | Surgical Instrument Service and Savings Inc.(Dba Medline Ren | accessdata.fda.gov |
| August 17, 2020 | K201399 | HOPKINS ICG/NIR 10mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 5mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 4mm Ridgid Endoscope 0°, 30°, 45°, VITOM II ICG/NIR Telescope, Power LED Rubina Light Source, Foot Switch, Fiber Optic Light Cable, Image S CCU, Image S 4U Rubina Camera Head | OWN | Substantially Equivalent | Karl Storz-Endoscopy-America, Inc. | accessdata.fda.gov |
| July 9, 2019 | K190969 | ENDOSCOPE REPROCESSOR OER-Elite | FEB | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| December 12, 2018 | K182812 | Medline Cautery Electrode (SILICONE) | GEI | Substantially Equivalent | Medline Industries, Inc. | accessdata.fda.gov |
| March 9, 2018 | K173796 | 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) | FTL | Substantially Equivalent | Sofradim Production | accessdata.fda.gov |
| March 2, 2018 | K173281 | LigaSure Exact Dissector, Nano-coated | GEI | Substantially Equivalent | Covidien | accessdata.fda.gov |
| November 17, 2017 | K171158 | Single Use Electrosurgical knife | KNS | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| October 17, 2017 | K172817 | 4K CAMERA HEAD OLYMPUS CH-S400-XZ-EB, 4K AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S400-XZ-EA | FET | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| October 13, 2017 | K171916 | Single Use Hot Biopsy Forceps FD-231 | KGE | Substantially Equivalent | Olympus Medical Systems Corp. | 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 2, 2017 | K161554 | ENDOFLATOR 40, ENDOFLATOR 50 | HIF | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| November 14, 2016 | K162941 | Ligasure Blunt Tip, Sealer/Divider, Nano-coated | GEI | Substantially Equivalent | Covidien | 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 |
| November 24, 2015 | K151191 | OES ELITE Telescopes, Protective Tube | FBP | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| September 14, 2015 | K143644 | Premium Surgiclip¿; Endo Clip¿; AcuClip¿ | FZP | Substantially Equivalent | Covidien | accessdata.fda.gov |
| July 28, 2015 | K151105 | Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith and Nephew Suture Anchors - TAG Bioraptor Suture Anchor 7209317, 7209318, Smith and Nephew Suture Anchors - Bioraptor 2.3 PK Suture Anchor, Smith and Nephew Suture Anchors - Osteoraptor Suture Anchor, Smith and Nephew Suture Anchors - Twinfix Ultra HA Suture Anchor, Smith and Nephew Suture Anchors - OSTEORAPTOR Curved Suture Anchors, Smith and Nephew Suture Anchors - Ultra Fast-Fix Meniscal Repair System, Ultra Fa | MAI | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| July 2, 2015 | K151548 | VersaOne Bladed Trocar, VersaOne Bladeless Trocar | GCJ | Substantially Equivalent | Covidien | accessdata.fda.gov |
| April 29, 2015 | K150633 | ULTRA Telescopes | GCJ | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| March 13, 2015 | K143386 | Progrip Laparoscopic Self-Fixating Mesh | FTL | Substantially Equivalent | Sofradim Production | accessdata.fda.gov |
| November 13, 2014 | K142428 | Shock Pulse-SE Lithotripsy System CYBERWAND II | FEO | Substantially Equivalent | Cybersonics, 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 |
| August 22, 2013 | K131969 | SYMBOTEX(TM) COMPOSITE MESH | FTL | Substantially Equivalent | Sofradim Production | accessdata.fda.gov |
| August 22, 2013 | K131581 | MYOSURE TISSUE REMOVAL DEVICE (1 PACK AND 3 PACK) | HIH | Substantially Equivalent | Hologic, 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 |
| October 23, 2012 | K123109 | ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE | GDW | Substantially Equivalent | Covidien | 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 |
| April 20, 2012 | K111425 | OLYMPUS LTF-S190-10, OLUMPUS OTV-S190, OLYMPUS CLV-S190 | HET | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| January 20, 2012 | K113294 | SMITH & NEPHEW HEALICOIL PK SUTURE ANCHOR | MBI | Substantially Equivalent | Smith & Nephew, 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 |
| November 10, 2010 | K103052 | V-LOC(TM) NONABSORBABLE WOUND CLOSURE DEVICE | GAT | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| July 1, 2010 | K100275 | WORKING ELEMENT, RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATON, HF-RESECTION ELECTRODE LOOPS AND BANDS | FAS | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| May 10, 2010 | K100257 | VLOC9ABSORBABLE WOUND CLOSURE DEVICE | GAM | Substantially Equivalent | Surgical Devices, A Division of Tyco Healthcare | 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 |
| January 28, 2010 | K092508 | FAST-FIX 360 MENISCAL REPAIR SYSTEM, STRIAGHT, CURVED, REVERSE CURVED,FAST FIX 360 AB MENISCAL REPAIR SYSTEM, STRAIGHT, | GAT | Substantially Equivalent | Smith & Nephew, 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 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 |
| 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 |
| January 30, 2009 | K083635 | SMITH & NEPHEW BIOSURE PK INTERFERENCE SCREW | MBI | Substantially Equivalent | Smith & Nephew Endoscopy, Inc. | accessdata.fda.gov |
| December 10, 2008 | K083306 | MODIFICATION TO ARTHROCARE ARTHROWANDS | GEI | Substantially Equivalent | Arthrocare Corp. | accessdata.fda.gov |
| May 28, 2008 | K081050 | PARIETEX PROGRIP MESH | FTL | Substantially Equivalent | Sofradim Production | accessdata.fda.gov |
| April 23, 2008 | K080358 | PLLA, HA SCREW | HWC | Substantially Equivalent | Smith & Nephew Inc., Endoscopy Div. | 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 |
| October 13, 2005 | K051645 | EVIS EXERA 160A SYSTEM | NWB | Substantially Equivalent | Olympus Medical Systems Corporation | accessdata.fda.gov |
| June 15, 2005 | K051326 | SMITH & NEPHEW 25 FLUID MANAGEMENT SYSTEM | HRX | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| December 21, 2004 | K041810 | SERFAS ENERGY SYSTEM | GEI | Substantially Equivalent | Stryker Endoscopy | accessdata.fda.gov |
| May 15, 2001 | K011151 | EVIS EXERA GASTROINTESTINAL VIDEOSCOPE GIF-Q160Z | FDS | Substantially Equivalent | The Olympus Optical Co. | accessdata.fda.gov |
| March 26, 2001 | K010013 | LIGASURE LAPAROSCOPIC SEALER DIVIDER MODEL LS1100 | GEI | Substantially Equivalent | Valleylab, Inc. | 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 |
| August 29, 1994 | K931763 | HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESS | FAS | Substantially Equivalent | Olympus Corp. | accessdata.fda.gov |
| August 24, 1992 | K922916 | BARD MARLEX MESH DART | FTL | Substantially Equivalent | C.R. Bard, Inc. | 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 |
| August 16, 1982 | K822162 | MYRINGOTOMY KNIFE (VARIOUS TYPES) | JYP | Substantially Equivalent | Kelleher Corp. | accessdata.fda.gov |
| March 2, 1982 | K820362 | REUTER BOBBIN VENTILA. TUBE-TITANIUM | ETD | Substantially Equivalent | Richard'S Medical Equip., 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 |
|---|---|---|---|---|---|---|
| September 28, 2001 | P010013 | NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM | MNB | 86 | December 17, 2025 | accessdata.fda.gov |
Compare with other makers
- All makers of Urethroscope
- All makers of Telescope, Rigid, Endoscopic
- All makers of Hysteroscope (And Accessories)
- All makers of Fastener, Fixation, Nondegradable, Soft Tissue
- All makers of Suture, Nonabsorbable, Synthetic, Polyethylene
- All makers of Laparoscope, General & Plastic Surgery
Updated December 17, 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.