Data / Medical devices / Canada / Dylan Lucas International Inc
Dylan Lucas International Inc: FDA-registered device maker in Vaughan Ontario, Canada, 77 510(k) clearances and 1 PMA approval
Dylan Lucas International Inc is registered with the FDA (registration 3011689956) in Vaughan Ontario, Canada. It lists 99 device types. The FDA files 77 510(k) clearances and 1 PMA approval under its listings, the newest dated June 18, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011689956
- Address
- 101 Innovation Drive Unit 4, Vaughan Ontario, Canada, L4H 0S3
- Owner or operator
- Dylan Lucas International Inc (10054202)
- Roles
- Exporter to the US
- First device listed
- February 22, 2017
- Registered through
- 2026
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 18, 2026 | K253110 | Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe | FMF | Substantially Equivalent | Sol-Millennium Medical, Inc. | accessdata.fda.gov |
| November 1, 2024 | K242320 | BD Vacutainer® One Use Holder | JKA | Substantially Equivalent | Becton, Dickinson and Company | 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 |
| March 10, 2023 | K222478 | BD Vacutainer® Luer-Lok Access Device, BD Vacutainer® Blood Transfer Device | JKA | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| September 26, 2021 | K201592 | Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove | KGO | Substantially Equivalent | Cardinal Health200, LLC | accessdata.fda.gov |
| December 21, 2020 | K201996 | Monocryl Plus Antibacterial Suture | GAM | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| December 18, 2020 | K201075 | BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter, BD Insyte Autoguard BC Pro Shielded IV Catheter | FOZ | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| June 27, 2019 | K183183 | VICRYL Polyglactin 910 Sterile Synthetic Absorbable Surgical Suture, PDS II Polydioxanone Sterile Synthetic Absorbable Surgical Suture, PDS Plus Antibacterial Polydioxanone Sterile Synthetic Absorbable Surgical Suture | GAM | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| June 28, 2018 | K180829 | PROLENE Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh, PROLENE (Polypropylene) Hernia System, Non-absorbable Synthetic Surgical Mesh | FTL | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| May 1, 2018 | K173035 | Gordon Large-Bore Curved Drainage Catheter, Nephrostomy Pigtail Drainage Catheter, Percutaneous Nephrostomy Set, Pigtail Drainage Catheter Needle Set, Multipurpose Drainage Catheters and Sets | FGE | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| February 27, 2017 | K163591 | BD PosiFlush Heparin Lock Flush Syringe | NZW | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| June 30, 2016 | K160235 | ViaValve Safety I.V. Catheter | FOZ | Substantially Equivalent | Smiths Medical Asd, Inc. | accessdata.fda.gov |
| July 27, 2015 | K151698 | BD Angiocath IV Catheter, BD Insyte IV Catheter | FOZ | Substantially Equivalent | Becton Dickinson Infusion Therapy Systems, Inc. | accessdata.fda.gov |
| March 4, 2015 | K142990 | Insta-Gard Surgical and Procedure Face Mask | FXX | Substantially Equivalent | Cardinal Health200, LLC | accessdata.fda.gov |
| June 12, 2014 | K133280 | TERUMO SURFLO I.V. CATHETER | FOZ | Substantially Equivalent | Terumo (Philippines) Corporation | accessdata.fda.gov |
| December 6, 2013 | K133356 | PROLENE POLYPROPYLENE NONABSORBABLE SUTURE | GAW | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| May 30, 2013 | K130869 | TAKE 1 ADVANCE | ELW | Substantially Equivalent | Sybron Dental Specialties | accessdata.fda.gov |
| November 8, 2012 | K121607 | TERUMO(R) NEEDLE | FMI | Substantially Equivalent | Terumo (Philippines) Corporation | accessdata.fda.gov |
| August 28, 2012 | K122249 | TERUMO SURGUARD3 SAFETY NEEDLE & HYPODERMIC SYRINGE WITH SAFETY NEEDLE | FMI | Substantially Equivalent | Terumo (Philippines) Corporation | accessdata.fda.gov |
| May 13, 2011 | K110771 | BD SINGLE USE, HYPODERMIC SYRINGE | FMF | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| May 5, 2011 | K111185 | RELYX LUTING PLUS AUTOMIX | EMA | Substantially Equivalent | 3M Espe Dental Products | accessdata.fda.gov |
| January 20, 2011 | K103351 | DMC COMPOSITE 2 | EBF | Substantially Equivalent | Kerr Corporation | accessdata.fda.gov |
| December 20, 2010 | K102875 | CAMINO 110-4B OLM INTRACRANIAL PRESSURE MNITORING KIT; CAMINO 110-4G POST CRANIOTOMY SUBDURAL PRESSURE MONITORING KIT; C | GWM | Substantially Equivalent | Integra LifeSciences Corporation | accessdata.fda.gov |
| September 15, 2010 | K100029 | MEPILEX BORDER AG DRESSING | FRO | Substantially Equivalent | Molnlycke Health Care | accessdata.fda.gov |
| December 18, 2007 | K070060 | WELCH ALLYN FLEXIPORT DISPOSABLE BLOOD PRESSURE CUFF (ONE-PIECE); REUSABLE BLOOD PRESSURE CUFF (ONE-PIECE) | DXQ | Substantially Equivalent | Welch Allyn, Inc. | accessdata.fda.gov |
| June 5, 2007 | K071249 | ULTRAPRO* HERNIA SYSTEM, MODELS UHSL, UHSM, UHSOV | FTL | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| January 29, 2007 | K062925 | COAGUCHEK XS SYSTEM | GJS | Substantially Equivalent | Roche Diagnostics Corp. | accessdata.fda.gov |
| August 3, 2006 | K061492 | MONOJECT MAGELLAN INSULIN AND TUBERCULIN SAFETY SYRINGE | FMF | Substantially Equivalent | Tyco Healthcare | accessdata.fda.gov |
| February 18, 2005 | K042683 | WELL LEAD ENDOTRACHEAL TUBE | BTR | Substantially Equivalent | Well Lead Medical Instruments | accessdata.fda.gov |
| December 21, 2004 | K042825 | ACCUDRAIN EXTERNAL CSF DRAINAGE SYSTEM | JXG | Substantially Equivalent | Integra LifeSciences Corporation | accessdata.fda.gov |
| December 1, 2004 | K041913 | POWDERFREE COLORED AND FLAVORED CHLOREPRENE PATIENT EXAMINATION GLOVES TESTED FOR CHEMO USE | LZA | Substantially Equivalent | Pt. Medisafe Technologies | accessdata.fda.gov |
| June 28, 2004 | K040511 | SCD EXPRESS PORTABLE COMPRESSION SYSTEM | JOW | Substantially Equivalent | Tyco Healthcare/Kendall | accessdata.fda.gov |
| October 22, 2003 | K032420 | MODIFIED COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SYNTHETIC ABSORBABLE SUTURE | GAM | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| March 26, 2003 | K024240 | BD VACUTAINER PLUS PLASTIC URINE C&S PRESERVAYIVE TUBES AND KITS | JSM | Substantially Equivalent | Bd | accessdata.fda.gov |
| December 18, 2002 | K023271 | TERUMO SYRINGE WITH/WITHOUT NEEDLE | FMF | Substantially Equivalent | Terumo Medical Corp. | accessdata.fda.gov |
| September 13, 2002 | K022269 | COATED VICRYL* (POLYGLACTIN 910) SUTURE | GAM | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| July 19, 2002 | K021475 | BD SINGLE LUMEN NEEDLE, SYRINGE AND BLOOD COLLECTION SET | FMI | Substantially Equivalent | Bd | accessdata.fda.gov |
| March 1, 2001 | K010188 | BD ECLIPSE HYPODERMIC NEEDLE | FMI | Substantially Equivalent | Bd Medical Systems | accessdata.fda.gov |
| December 5, 2000 | K002768 | ACAPELLA | BWF | Substantially Equivalent | Dhd Healthcare Corp. | accessdata.fda.gov |
| July 17, 2000 | K001730 | GC FUJICEM | EMA | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| April 5, 2000 | K000629 | FLEXTIME | ELW | Substantially Equivalent | Heraeus Kulzer, Inc. | accessdata.fda.gov |
| November 24, 1999 | K992257 | NEW MULTIPLES REAGENT STRIPS | JIR | Substantially Equivalent | Bayer Corp. | accessdata.fda.gov |
| October 1, 1999 | K992734 | BECTON DICKINSON SYRINGE | MEG | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| September 8, 1999 | K992897 | IMPREGUM PENTA | ELW | Substantially Equivalent | Espe Dental AG | accessdata.fda.gov |
| September 8, 1999 | K992895 | IMPREGUM F | ELW | Substantially Equivalent | Espe Dental AG | accessdata.fda.gov |
| August 20, 1999 | K990236 | MODIFICATION OF JELCO*,JELCO*-W AND JELCO* PLUS I.V. CATHETERS, CATHLON* I.V. CATHETERS, OPTIVA* I.V. CATHETERS, PROTECT | FOZ | Substantially Equivalent | Johnson & Johnson Medical, Div. of Ethicon, Inc. | accessdata.fda.gov |
| March 8, 1999 | K990498 | OPTIBOND SOLO PLUS | KLE | Substantially Equivalent | Sybron Dental Specialties, Inc. | accessdata.fda.gov |
| October 28, 1998 | K982541 | VACUTAINER BRAND ECLIPSE BLOOD COLLECTION NEEDLE, MODELS# 368607 & 368608 | FMI | Substantially Equivalent | Becton Dickinson Vacutainer Systems | accessdata.fda.gov |
| July 31, 1998 | K981596 | ULTRAPAK E | MVL | Substantially Equivalent | Ultradent Products, Inc. | accessdata.fda.gov |
| March 3, 1998 | K980414 | VACUTAINER BRAND SAFETY-LOK BLOOD COLLECTION SET MODEL MULTIPLE, VACUTAINER BRAND BLOOD COLLECTION SET | JKA | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| May 19, 1997 | K970658 | LUMBAR DRAINAGE ACCESSORY KIT | JXG | Substantially Equivalent | Integra Neurocare, LLC | accessdata.fda.gov |
| April 11, 1997 | K970123 | DENTSPLY CAVITRON SPS SCALER SYSTEM | ELC | Substantially Equivalent | Dentsply Intl. | 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 |
| June 5, 1996 | K961113 | CNS INTERCHANGEABLE BIT CRANIAL DRILL | HBG | Substantially Equivalent | Clinical Neuro Systems, LLC | accessdata.fda.gov |
| March 28, 1996 | K960653 | MONOCRYL (POLIGLECAPRONE 25) SUTURE, DYED (MODIFIED) | GAN | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| November 28, 1995 | K954592 | VACUTAINER BRAND PST PLASMA SEPARATION TUBE | JKA | Substantially Equivalent | Becton Dickinson Vacutainer Systems | accessdata.fda.gov |
| October 7, 1995 | K951254 | SAFETYGLIDE NEEDLE | FMI | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| July 31, 1995 | K952861 | ANGIOCATH & INSYTE AUTOGUARD CATHETERS | FOZ | Substantially Equivalent | Becton Dickinson Vascular Access, 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 |
| December 2, 1994 | K945197 | THE SHARPS COLLECTION AND DISPOSAL SYSTEM | MMK | Substantially Equivalent | Devon Industries, Inc. | accessdata.fda.gov |
| November 17, 1994 | K943642 | HERCULITE XR & XRV | EBF | Substantially Equivalent | Sybron Dental Specialties, Inc. | accessdata.fda.gov |
| November 10, 1994 | K944566 | VACUTAINER BRAND PLUS SODIUM HEPARIN TUBE | JKA | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| May 26, 1994 | K941562 | 1ML LUER-LOK SYRINGE | FMF | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| September 28, 1993 | K932860 | MAYFIELD ADULT DISPOSABLE SKULL PIN | HBL | Substantially Equivalent | Ohio Medical Instrument Co., Inc. | accessdata.fda.gov |
| June 18, 1993 | K925126 | INTERLINK(TM) INJECTION SITE | FPA | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| February 12, 1993 | K923789 | MAYFIELD ADULT DISPOSABLE SKULL PIN | HBL | Substantially Equivalent | Ohio Medical Instrument Co., Inc. | accessdata.fda.gov |
| December 10, 1992 | K924600 | INTEGRAL DRAINAGE/VENTRICULAR/LUMBAR DRAINAGE SETS | JXG | Substantially Equivalent | Cordis Corp. | accessdata.fda.gov |
| April 29, 1992 | K921806 | VACUTAINER(R) BRAND SST(R) AND CAT TUBES | JKA | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| August 9, 1990 | K901449 | VACUTAINER PLUS WITH HEMOGARD CLOSURE | JKA | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| March 28, 1990 | K900436 | PROTEMP II | EBG | Substantially Equivalent | Espe GmbH (Us) | accessdata.fda.gov |
| October 9, 1987 | K872743 | BAXA TUBING SETS (FOR PHARMACY PUMP) | FMF | Substantially Equivalent | Baxa Corp., Sub. of Cook Group, Inc. | accessdata.fda.gov |
| September 19, 1986 | K863092 | DENTAL COMPOSITE RESTORATIVE | EBF | Substantially Equivalent | Dentsply Intl. | accessdata.fda.gov |
| March 25, 1985 | K844846 | ESPE KETAC-CEM RADIOPAQUE | EMA | Substantially Equivalent | Espe GmbH (Us) | accessdata.fda.gov |
| July 31, 1984 | K841909 | VAGINAL SPECULUM - DISPOSABLE | HIB | Substantially Equivalent | Galenica Enterprises, Inc. | accessdata.fda.gov |
| September 19, 1979 | K791665 | SCOTTS SURGICAL RETRACTOR AND ELASTIC | GAD | Substantially Equivalent | Lone Star Medical Products, Inc. | accessdata.fda.gov |
| April 4, 1979 | K790366 | URINE CULTURE KIT | JTW | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | 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 30, 1999 | P990004 | SURGIFOAM ABSORBABLE GELATIN SPONGE, USP | LMF | 79 | September 18, 2026 | accessdata.fda.gov |
Compare with other makers
- All makers of Needle, Hypodermic, Single Lumen
- All makers of Cement, Stomal Appliance, Ostomy
- All makers of Spirometer, Therapeutic (Incentive)
- All makers of Needle, Aspiration And Injection, Disposable
- All makers of Tubes, Vials, Systems, Serum Separators, Blood Collection
- All makers of Holder, Head, Neurosurgical (Skull Clamp)
Updated September 18, 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.