Data / Medical devices / Turkey / Voma Ecza Deposu Medikal Urunler San. Tic. A.S.
Voma Ecza Deposu Medikal Urunler San. Tic. A.S.: FDA-registered device maker in Izmir, Turkey, 132 510(k) clearances and 1 PMA approval
Voma Ecza Deposu Medikal Urunler San. Tic. A.S. is registered with the FDA (registration 3017210488) in Izmir, Turkey. It lists 67 device types. The FDA files 132 510(k) clearances and 1 PMA approval under its listings, the newest dated October 16, 2025. Registered through 2027. 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
- 3017210488
- Address
- Fatih Mah. 1191 SK. 26/2 A Blok Gaziemir, Izmir, Turkey, 35410
- Owner or operator
- VOMA ECZA DEPOSU MEDIKAL URUNLER SAN. TIC. A.S. (10076888)
- Roles
- Exporter to the US
- First device listed
- August 4, 2020
- Registered through
- 2027
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. Newest 100 of 132.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 16, 2025 | K252612 | INDIGO® Aspiration System Lightning Flash Aspiration Tubing; INDIGO® Aspiration System Lightning Bolt Aspiration Tubing | QEW | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| June 25, 2025 | K251627 | BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (white); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid blue) | MBI | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| February 6, 2025 | K250066 | Resolution Clip (M00522600); Resolution Clip (M00522601); Resolution Clip (M00522602); Resolution Clip (M00522610); Resolution Clip (M00522611); Resolution Clip (M00522612) | PKL | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| January 17, 2025 | K243315 | ProGrip Self-Gripping Polypropylene Mesh | FTL | Substantially Equivalent | Sofradim Production | accessdata.fda.gov |
| January 18, 2024 | K232373 | Progrip Self-Gripping Polypropylene Mesh | FTL | Substantially Equivalent | Sofradim Production | accessdata.fda.gov |
| October 26, 2023 | K230320 | NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube | ETN | Substantially Equivalent | Medtronic Xomed, Inc. | accessdata.fda.gov |
| March 23, 2023 | K223488 | ClosureFast Endovenous Radiofrequency Ablation Catheter | GEI | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| March 9, 2023 | K221919 | DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets | HRX | Substantially Equivalent | Hemodia Sas | accessdata.fda.gov |
| February 17, 2023 | K222971 | ULTRABUTTON QUAD Adjustable Fixation Device; ULTRABUTTON BB Adjustable Fixation Device; ULTRABUTTON TIB SMALL Adjustable Fixation Device; ULTRABUTTON TIB MEDIUM Adjustable Fixation Device; ULTRABUTTON TIB LARGE Adjustable Fixation Device | MBI | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| February 2, 2023 | K221515 | StoneSmart Connect Console, LithoVue Elite Single Use Digital Flexible Ureteroscope Standard w/Pressure Monitoring, LithoVue Elite Single Use Digital Flexible Ureteroscope Reverse w/Pressure Monitoring | FGB | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| December 2, 2022 | K223218 | Parietene Macroporous Mesh | FTL | Substantially Equivalent | Sofradim Production | accessdata.fda.gov |
| September 30, 2022 | K221003 | Autosuture EEA Stapler / circular stapler with DST Series Technology / EEA Autosuture Circular Stapler with DST Series Technology / DST Series EEA Stapler / DST EEA | GDW | Substantially Equivalent | Covidien | accessdata.fda.gov |
| June 27, 2022 | K213818 | VersaOne Optical Trocar with Fixation Balloon Cannula, VersaOne Universal Fixation Balloon Cannula | GCJ | Substantially Equivalent | Covidien | 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 |
| May 5, 2022 | K221013 | GIA Auto Suture Stapler with DST Series Technology | GDW | Substantially Equivalent | Covidien | accessdata.fda.gov |
| March 21, 2022 | K213246 | NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long | ETN | Substantially Equivalent | Medtronic Xomed, Inc. | accessdata.fda.gov |
| February 4, 2022 | K212724 | BD Vacutainer UltraTouch Push Button Blood Collection Set | JKA | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| June 24, 2021 | K210423 | Werewolf+ Coblation System, Werewolf+ Controller, Werewolf Fastseal 6.0 Hemostasis Wand | GEI | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| March 23, 2021 | K202917 | LigaSure Exact Dissector, Nano-coated | GEI | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| February 16, 2021 | K210114 | Rebar Micro Catheter | KRA | Substantially Equivalent | Micro Therapeuatics, Inc. D/B/A Ev3 Neurovascular | accessdata.fda.gov |
| February 9, 2021 | K210083 | Indigo System Aspiration Catheter 7, Indigo Aspiration System Separator 7, Lightning 7 | QEW | Substantially Equivalent | Penumbra, Inc. | accessdata.fda.gov |
| February 1, 2021 | K203393 | FAST-FIX FLEX | GAT | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| September 29, 2020 | K193131 | BD Quincke Spinal NRFit Needle, BD Whitacre Spinal NRFit Needle, BD Spinal Introducer NRFit Needle | BSP | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| September 25, 2020 | K202522 | Synchro SELECT Guidewire | MOF | Substantially Equivalent | Stryker Neurovascular | accessdata.fda.gov |
| September 14, 2020 | K202318 | Marathon Flow Directed Micro Catheter | KRA | Substantially Equivalent | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | accessdata.fda.gov |
| July 17, 2020 | K200818 | 3DMax MID Anatomical Mesh | FTL | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| March 24, 2020 | K193579 | PlasmaBlade X 3.0S LIGHT | GEI | Substantially Equivalent | Medtronic Navigation | accessdata.fda.gov |
| December 6, 2019 | K192443 | Dextile Anatomical Mesh | FTL | Substantially Equivalent | Sofradim Production | accessdata.fda.gov |
| May 1, 2019 | K190843 | Synchro2 Support Guidewire | MOF | Substantially Equivalent | Stryker | accessdata.fda.gov |
| March 1, 2019 | K181730 | BD Vacutainer Eclipse UltraFill Blood Collection Needle | FMI | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| January 7, 2019 | K183470 | Precision Ideal Eyes Arthroscopes | HRX | Substantially Equivalent | Stryker | accessdata.fda.gov |
| August 2, 2018 | K181257 | PlasmaBlade X 3.0S, PlasmaBlade X 4.0 | GEI | Substantially Equivalent | Medtronic Advanced Energy | accessdata.fda.gov |
| April 23, 2018 | K180499 | Reprocessed LigaSure Maryland Jaw Sealer/Divider | NUJ | Substantially Equivalent | Stryker Sustainability Solutions | 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 5, 2018 | K173741 | Reprocessed ArthoCare Ablation Wand | NUJ | Substantially Equivalent | Renovo, Inc. | accessdata.fda.gov |
| September 14, 2017 | K171953 | Bard Mission Disposable Core Biopsy Instrument | KNW | Substantially Equivalent | Bard Peripheral Vascular, Inc. | accessdata.fda.gov |
| June 23, 2017 | K171324 | Medline ReNewal Reprocessed ArthroCare ArthroWands and Smith & Nephew Dyonics | NUJ | Substantially Equivalent | Surgical Instrument Service and Savings, 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 |
| November 14, 2016 | K162941 | Ligasure Blunt Tip, Sealer/Divider, Nano-coated | GEI | Substantially Equivalent | Covidien | accessdata.fda.gov |
| October 31, 2016 | K160450 | Pleurx Pleural Catheter System | DWM | Substantially Equivalent | Care Fusion | 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 |
| May 3, 2016 | K160050 | SERFAS 90-S Electrosurgical Probe | GEI | Substantially Equivalent | Stryker Corporation | accessdata.fda.gov |
| April 26, 2016 | K160176 | Signia Stapler | GDW | Substantially Equivalent | Covidien | accessdata.fda.gov |
| December 2, 2015 | K152566 | PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to Twinfix Ti Quick-T, Twinfix FT PK, Twinfix Ultra Ti, Twinfix Ultra PK, Twinfix Ultra HA Suture Anchors, FOOTPRINT Ultra OK Suture Anchors, BIORAPTOR 2.9 Suture Anchor, BIORAPTOR 2.3 PK Suture Anchor, OSTEORAPTOR Suture Anchor, BIORAPTOR Knotless Suture Anchor, HEALICOIL PK Suture Anchor (formerly Next Generation Fully Threaded Suture Anchor), Bioraptor Curved 2.3 PK Suture Anchors | MBI | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| December 1, 2015 | K152121 | NuVent EM Sinus Dilation System | LRC | Substantially Equivalent | Medtronic Xomed, Inc. | accessdata.fda.gov |
| September 14, 2015 | K143644 | Premium Surgiclip¿; Endo Clip¿; AcuClip¿ | FZP | Substantially Equivalent | Covidien | accessdata.fda.gov |
| September 10, 2015 | K150840 | Ligaclip 10mm M/L Endoscopic Rotating Multiple Clip Applier | FZP | Substantially Equivalent | Ethicon Endo-Surgery, LLC | accessdata.fda.gov |
| July 14, 2015 | K150844 | Shiley Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula, Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Reusable Inner Cannula | JOH | 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 |
| March 25, 2015 | K141833 | STYLET, 23CM, SKULL-MOUNT PATIENT TRACKER, NON-INVASIVE PATIENT TRACKER, TRACER POINTER, TOUCH-N-GO POINTER, NAVIGATION | HAW | Substantially Equivalent | Medtronic Navigation, Inc. | 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 21, 2014 | K141820 | JAGWIRE HIGH PERFORMANCE GUIDWIRE | OCY | Substantially Equivalent | Boston Scientific Corp | accessdata.fda.gov |
| October 10, 2014 | K142014 | SOFIA DISTAL ACCESS CATHETER | DQY | Substantially Equivalent | MicroVention, Inc. | accessdata.fda.gov |
| May 7, 2014 | K140941 | PROGRIP SELF-GRIPPING POLYPROPYLENE MESH, PARIETENE FLAT SHEET MESH | FTL | Substantially Equivalent | Sofradim Production | accessdata.fda.gov |
| February 21, 2014 | K133948 | BARD(R) MONOPTY(R) DISPOSABLE CORE BIOPSY INSTRUMENT, BARD(R) MAX-CORE(R) DISPOSABLE CORE INSTRUMENT | KNW | Substantially Equivalent | Bard Peripheral Vascular, 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 3, 2013 | K132974 | AQUAMANTYS 2.3 BIPOLAR SEALER, EVS 4.0 EPIDURAL VEIN SEALER, MINI EVS 3.4 EPIDURAL VEIN SEALER, SBS 5.0 SHEATHED BIPOLAR | GEI | Substantially Equivalent | Medtronic Advanced Energy, LLC | accessdata.fda.gov |
| August 22, 2013 | K131969 | SYMBOTEX(TM) COMPOSITE MESH | FTL | Substantially Equivalent | Sofradim Production | accessdata.fda.gov |
| August 7, 2013 | K130608 | QUADCUT | HAW | Substantially Equivalent | Medtronic Navigation, Inc. | 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 |
| January 23, 2013 | K123579 | FOOTPRINT ULTRA PK4.5MM AND 5.5MM SUTURE ANCHOR, SL | MBI | Substantially Equivalent | Smith & Nephew, Inc. | 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 |
| October 9, 2012 | K122531 | SHILEY NEONATAL TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY T | JOH | Substantially Equivalent | Covidien | accessdata.fda.gov |
| June 27, 2012 | K112686 | NEXT GEN EMG ENDOTRACHEAL TUBE | ETN | Substantially Equivalent | Medtronic Xomed, Inc. | accessdata.fda.gov |
| May 3, 2012 | K121194 | ENDO CLIP III 5MM CLIP APPLIER | FZP | Substantially Equivalent | Covidien | 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 |
| August 4, 2011 | K111372 | TAL PALLINDROME (TM) SYMMETRIC TIP DUAL LUMEN CATHETER, MAHURKAR (R) MAXID (TM) DUAL LUMEN CATHETER, PALINDROME (TM)... | MSD | Unknown | Covidien | accessdata.fda.gov |
| April 20, 2011 | K110833 | CRE BALLOON DILATATION CATHETER | FDT | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| March 25, 2011 | K110699 | LIGAMAX 5 | FZP | Substantially Equivalent | Ethicon Endo-Sugery, LLC | accessdata.fda.gov |
| March 23, 2011 | K101928 | VENTRALEX ST HERNIA PATCH | FTL | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| March 23, 2011 | K101920 | VENTRIO ST HERNIA PATCH | FTL | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| April 26, 2010 | K100548 | VERSAPORT BLADELESS LOW PROFILE TROCAR MODEL NB3SHFLP, NB5SHFLP, NB5STFLP | GCJ | Substantially Equivalent | Covidien Lp, Formerly Registered AS Tyco Healthcar | accessdata.fda.gov |
| April 13, 2010 | K093695 | PEAK PLASMABLADE 3.OS TISSUE DISSECTION DEVICE | GEI | Substantially Equivalent | Peak Surgical, Inc. | 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 |
| 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 |
| January 21, 2010 | K093972 | BD MICROTAINER MAP MICROTUBE FOR AUTOMATED PROCESS, MODEL 363706 | JKA | Substantially Equivalent | Becton, Dickinson & CO | 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 |
| October 23, 2009 | K093183 | BIS QUATRO SENSOR | GXY | Substantially Equivalent | Aspect Medical Systems, Inc. | accessdata.fda.gov |
| May 14, 2009 | K090470 | AUTOSUTURE PROTACK; TACKER SYSTEM; ABSORBATACK FIXATION DEVICES | OCW | Substantially Equivalent | Covidien | 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 |
| December 4, 2008 | K083343 | HEADWAY 17 MICROCATHETER | DQY | Substantially Equivalent | MicroVention, Inc. | accessdata.fda.gov |
| October 17, 2008 | K081475 | ELECTRIC DRILL SYSTEM [XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONSOLE (IPC)] | HBE | Substantially Equivalent | Medtronic Xomed, Inc. | accessdata.fda.gov |
| September 5, 2008 | K081277 | XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONS0LE (IPC) | ERL | Substantially Equivalent | Medtronic Xomed, Inc. | accessdata.fda.gov |
| May 28, 2008 | K081050 | PARIETEX PROGRIP MESH | FTL | Substantially Equivalent | Sofradim Production | accessdata.fda.gov |
| May 23, 2008 | K081169 | AUTOSUTURE VERSAPORT PLUS BLADLESS TROCAR; BLADELESS TROCAR | GCJ | Substantially Equivalent | Covidien Lp, Formerly Registered AS United States | 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 23, 2006 | K061754 | BARD COMPOSITE L/P MESH | FTL | Substantially Equivalent | Davol Inc., Sub. C. R. Bard, Inc. | accessdata.fda.gov |
| October 5, 2006 | K062779 | DEFOGGING HEATED ENDOSCOPE LENS PROTECTOR (DHELP); DEFOGGING ENDOSCOPE LENS PROTECTOR (DELP) | GCJ | Substantially Equivalent | New Wave Surgical Corporation | 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 1, 2006 | K061373 | VNUS CLOSUREFAST CATHETER, MODELS CF7-7-60 AND CF7-7-100 | GEI | Substantially Equivalent | Vnus Medical Technologies, 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 |
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 |
|---|---|---|---|---|---|---|
| November 22, 2011 | P110010 | PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM | NIQ | 207 | January 14, 2025 | accessdata.fda.gov |
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Updated October 16, 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.