Data / Medical devices / United States / Zapalign LLC
Zapalign LLC: FDA-registered device maker in Fort Lauderdale, FL, United States, 213 510(k) clearances
Zapalign LLC is registered with the FDA (registration 3043226252) in Fort Lauderdale, FL, United States. It lists 174 device types. The FDA files 213 510(k) clearances under its listings, the newest dated March 11, 2026. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3043226252
- Address
- 2281 Griffin Rd, Fort Lauderdale, FL, United States, 33312
- Owner or operator
- Zapalign LLC (10095225)
- Roles
- Manufacturer for export, Repackager or relabeler
- First device listed
- February 8, 2026
- Registered through
- 2026
- Brand names listed
- ABSORBER, CARBON-DIOXIDE, ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION, AGENT, TOOTH BONDING, RESIN, ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE, Attachment, breathing, positive end expiratory pressure, BUR, SURGICAL, GENERAL & PLASTIC SURGERY, Bandage, liquid, CATHETERS, SUCTION, TRACHEOBRONCHIAL 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. Newest 100 of 213.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 11, 2026 | K260783 | Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One | EBF | Substantially Equivalent | Kulzer, LLC | accessdata.fda.gov |
| February 28, 2025 | K242339 | Intravascular Extension Sets and Accessories | FPA | Substantially Equivalent | Baxter Healthcare Corporation | accessdata.fda.gov |
| November 1, 2024 | K242320 | BD Vacutainer® One Use Holder | JKA | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| April 27, 2023 | K230547 | PlumePen Elite Surgical Smoke Evacuation Pencils, PlumePen Pro Surgical Smoke Evacuation Pencil, PlumePen Ultra Surgical Smoke Evacuation Pencils, PenAdapt Electrosurgical Pencil Adapter, SnapEvac Electrosurgical Pencil Adapter | GEI | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| June 24, 2022 | K220942 | 3M Attest Steam Chemical Integrators (1243A, 1243B, 1243RE, 1243RES) | JOJ | Substantially Equivalent | 3M Company | accessdata.fda.gov |
| June 13, 2022 | K221695 | 3M Filtek Supreme Flowable Restorative | EBF | Substantially Equivalent | 3M Company Espe Dental Products | accessdata.fda.gov |
| November 20, 2019 | K191865 | SmartLite Pro Modular LED Curing Light | EBZ | Substantially Equivalent | Dentsply Sirona | accessdata.fda.gov |
| October 31, 2019 | K192961 | ADH19 | KLE | Substantially Equivalent | 3M Deutschland GmbH | accessdata.fda.gov |
| May 29, 2019 | K191122 | 3M RelyX Pediatric Resin Modified Glass Ionomer Cement | EMA | Substantially Equivalent | 3M Espe Dental Products | accessdata.fda.gov |
| May 28, 2019 | K180739 | Clearlink System Solution Set | FPA | Substantially Equivalent | Baxter Healthcare Corporation | accessdata.fda.gov |
| March 20, 2019 | K183399 | BD Nexiva Closed IV Catheter System | FOZ | Substantially Equivalent | Becton Dickinson Infusion Therapy Systems, Inc. | accessdata.fda.gov |
| January 2, 2019 | K183476 | 3M Filtek Universal Restorative | EBF | Substantially Equivalent | 3M Espe Dental Products | accessdata.fda.gov |
| August 31, 2018 | K173477 | ChemoCLAVE Cytotoxic Medication Preparation and Delivery System | ONB | Substantially Equivalent | Icu Medical, Inc. | accessdata.fda.gov |
| April 23, 2018 | K173519 | 3M Attest Super Rapid Readout Steam Challenge Pack, 3M Attest Super Rapid 5 Steam-Plus Chaallenge Pack, 3M Attest Auto-reader, 3M Attest Auto-reader | FRC | Substantially Equivalent | 3M Company | accessdata.fda.gov |
| January 22, 2018 | K173584 | 3M Attest Super Rapid Readout Biological Indicator, 3M Attest Auto-reader, 3M Attest Auto-reader | FRC | Substantially Equivalent | 3M Company | accessdata.fda.gov |
| September 21, 2017 | K161719 | Salter Labs Bubble Humidifier | BTT | Substantially Equivalent | Salter Labs | accessdata.fda.gov |
| December 19, 2016 | K162081 | BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse Hypodermic Needle, BD 1ml Luer-lok Insulin Syringe | FMF | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| November 28, 2016 | K163207 | Filtek One Bulk Fill Restorative | EBF | Substantially Equivalent | 3M Company | accessdata.fda.gov |
| April 13, 2016 | K153174 | Ketac Universal Aplicap | EMA | Substantially Equivalent | 3M Deutschland GmbH | accessdata.fda.gov |
| March 10, 2016 | K151421 | Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample Lines | CCK | Substantially Equivalent | Salter Labs | accessdata.fda.gov |
| February 9, 2016 | K152476 | Exofin High Viscosity Tissue Adhesive | MPN | Substantially Equivalent | Chemence Medical Products, Inc. | accessdata.fda.gov |
| December 28, 2015 | K153158 | Solution Administration Sets with 0.2 Micron Filter | FPA | Substantially Equivalent | Baxter Healthcare Corporation | accessdata.fda.gov |
| December 1, 2015 | K152060 | 3M Attest Rapid Readout Biological Indicator 1295 | FRC | Substantially Equivalent | 3M Company | accessdata.fda.gov |
| November 23, 2015 | K143704 | Advanced Air System | EFB | Substantially Equivalent | W&H Dentalwerk Buermoos GmbH | accessdata.fda.gov |
| October 21, 2015 | K152770 | ProBP 2400 Digital Blood Pressure Device | DXN | Substantially Equivalent | Microlife Intellectual Property GmbH | 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 |
| 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 7, 2015 | K150933 | iBond Universal & iBond Ceramic Primer | KLE | Substantially Equivalent | Heraeus Kulzer, LLC, Mitsui Chemicals Group | accessdata.fda.gov |
| May 8, 2015 | K150333 | MedSource Sharps Dart | MMK | Substantially Equivalent | Medsource International, LLC | accessdata.fda.gov |
| April 3, 2015 | K143053 | KIMGUARD ONE-STEP Sterilization Wrap | FRG | Substantially Equivalent | Kimberly-Clark Health Care | accessdata.fda.gov |
| March 24, 2015 | K143287 | Fluidshield* Surgical Mask with Expanded Chamber | FXX | Substantially Equivalent | Halyard Health, Inc. | accessdata.fda.gov |
| September 3, 2014 | K141495 | TRUWAVE DISPOSABLE PRESSURE TRANSDUCER | DXO | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| August 18, 2014 | K142011 | SOLUTION SET/EXTENSION SET | FPA | Substantially Equivalent | Baxter Healthcare Corporation | accessdata.fda.gov |
| July 11, 2014 | K141582 | CP150 ELECTROCARDIOGRAPH WITH SPIROMETRY OPTION | DPS | Substantially Equivalent | Welch Allyn | accessdata.fda.gov |
| July 11, 2014 | K141558 | QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE | GAM | Substantially Equivalent | Surgical Specialties Corp | accessdata.fda.gov |
| May 8, 2014 | K141081 | FILTEK BULK FILL POSTERIOR RESTROATIVE | EBF | Substantially Equivalent | 3M Espe Dental Products | accessdata.fda.gov |
| March 11, 2014 | K132322 | NEWTRON P5 XS B.LED | ELC | Substantially Equivalent | Satelec - Acteon Group | accessdata.fda.gov |
| February 12, 2014 | K130040 | MEPITEL AG | FRO | Substantially Equivalent | Molnlycke Health Care | accessdata.fda.gov |
| August 23, 2013 | K132268 | QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN | NEW | Substantially Equivalent | Surgical Specialties Corporation Dba Angiotech | accessdata.fda.gov |
| May 30, 2013 | K131404 | FLASH AR PENTA / FLASH AR PENTA QUICK | ELW | Substantially Equivalent | 3M Deutschland GmbH | accessdata.fda.gov |
| May 17, 2013 | K130647 | XANTASIL DYNAMIX FAST SET CARTRIDGE -2 X 380ML; XANTASIL FAST SET CARTRIDGE -6 X 50ML | ELW | Substantially Equivalent | Heraeus Kulzer, LLC | accessdata.fda.gov |
| May 16, 2013 | K131224 | SHARPOINT POLYPROPYLENE SURGICAL SUTURE, LOOK POLYPROPYLENE SURGICAL SUTURE, QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE | GAW | Substantially Equivalent | Surgical Specialties Corp. Dba Angiotech | accessdata.fda.gov |
| January 8, 2013 | K123868 | INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECONDARY MEDICATION SETS, SOLUTION SETS, CONTINU-FLO SOLUTION SET | FPA | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| December 20, 2012 | K122075 | DISPOSABLE GAS SAMPLING LINE WITH AND WITHOUT IN-LINE FILTER | CCK | Substantially Equivalent | Intersurgical, Inc. | accessdata.fda.gov |
| July 27, 2012 | K121897 | PROTEXIS LATEX BASIC STERILE POWDER-FREE SURGICAL GLOVES | KGO | Substantially Equivalent | Cardinal Health, Inc. | accessdata.fda.gov |
| June 12, 2012 | K120322 | CONMED SUREFIT DUAL DISPERSIVE ELECTRODE | GEI | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| March 23, 2012 | K120743 | SPECULUM, VAGINAL, NONMETAL | HIB | Substantially Equivalent | Welch Allyn, Inc. | accessdata.fda.gov |
| March 19, 2012 | K120453 | FILTEK BULK FILL FLOWABLE RESTORATIVE | EBF | Substantially Equivalent | 3M Espe Dental Products | accessdata.fda.gov |
| February 13, 2012 | K113406 | AQUASIL ULTRA SMART WETTING IMPRESSION MATERIAL | ELW | Substantially Equivalent | Dentsply International, Inc. | accessdata.fda.gov |
| October 20, 2011 | K111402 | KC200, SURGICAL MASK, KC200, PROCEDURE MASK, KC300, SURGICALMASK, FLUIDSHIELD, KC300, PROCEDURE MASK, FLUIDSHIELD MODEL | FXX | Substantially Equivalent | Kimberly-Clark | accessdata.fda.gov |
| October 18, 2011 | K112893 | CLEARLINK LUER ACTIVATED VALVE, CLEARLINK SYSTEM NON-DEHP CATHETER EXTENSION SETS | FPA | Substantially Equivalent | Baxter Healthcare Corporation | accessdata.fda.gov |
| June 3, 2011 | K110508 | SUGLUE-10 | EMA | Substantially Equivalent | 3M Espe AG | accessdata.fda.gov |
| May 19, 2011 | K110302 | ADHESIVE EXL-759 | KLE | Substantially Equivalent | 3M Espe AG | accessdata.fda.gov |
| May 13, 2011 | K110771 | BD SINGLE USE, HYPODERMIC SYRINGE | FMF | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| October 21, 2010 | K101145 | SURGILANCE SAFETY LANCETS, MODELS SLN100, SLN200, SLN240, SLN300, SLB200, SLB250 | FMK | Substantially Equivalent | Medipurpose Pte. , Ltd. | accessdata.fda.gov |
| September 15, 2010 | K100029 | MEPILEX BORDER AG DRESSING | FRO | Substantially Equivalent | Molnlycke Health Care | accessdata.fda.gov |
| August 4, 2010 | K101747 | BRAUN THERMOSCAN PRO 4000 SERIES AND BRAUN THERMOSCAN IRT 4000 SERIES MODEL 6021791-PRO 4000 SERIES, 6022790-IRT 4000 SE | FLL | Substantially Equivalent | Kaz USA, Inc (A Subsidiaryof Kaz Inc) | accessdata.fda.gov |
| July 28, 2010 | K101276 | DERMA+FLEX QS HIGH VISCOSITY TISSUE ADHESIVE MODEL: QS70404 | MPN | Substantially Equivalent | Chemence Medical Products, Inc. | accessdata.fda.gov |
| June 2, 2010 | K100756 | MALTA | EMA | Substantially Equivalent | 3M Espe AG Dental Products | accessdata.fda.gov |
| May 12, 2010 | K100235 | FILTEK SUPREME ULTRA FLOWABLE RESTORATIVE | EBF | Substantially Equivalent | 3M Company | accessdata.fda.gov |
| April 16, 2010 | K100241 | CONTIPLEX D CONTINUOUS NERVE BLOCK SET, MODEL 331687, 331686, 331685, 331680 | BSP | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| April 8, 2010 | K094007 | UNICEM | EMA | Substantially Equivalent | 3M Espe AG Dental Products | accessdata.fda.gov |
| March 12, 2010 | K093556 | VCARE DX | LKF | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| February 19, 2010 | K093721 | COSP2 | MVL | Substantially Equivalent | 3M Espe AG Dental Products | 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 |
| October 9, 2009 | K091758 | BD SPINAL NEEDLE 27G | BSP | Substantially Equivalent | Becton Dickson & Co. | accessdata.fda.gov |
| August 20, 2009 | K090710 | MERCURY CPAP | BYE | Substantially Equivalent | Mercury Medical | accessdata.fda.gov |
| August 7, 2009 | K091856 | CONMED ECG MONITORING ELECTRODES , MODEL 1700 ( INCLUDING 2500), 1750, 2700, 2710, 1800, SERIES | DRX | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| July 9, 2009 | K091700 | AIRCAST VENAFLOW ELITE SYSTEM | JOW | Substantially Equivalent | Djo, LLC | accessdata.fda.gov |
| April 6, 2009 | K082806 | SPINNING SPIROS, MODEL CH-2000 | FPA | Substantially Equivalent | Icu Medical, Inc. | accessdata.fda.gov |
| March 23, 2009 | K090634 | PHASEAL PROTECTOR P14, P21, P28 AND P50 | LHI | Substantially Equivalent | Carmel Pharma Ab. | accessdata.fda.gov |
| February 23, 2009 | K083641 | BIVONA TRACHEOSTOMY TUBES | JOH | Substantially Equivalent | Smiths Medical Asd, Inc. | accessdata.fda.gov |
| December 11, 2008 | K081825 | BD PROBETEC NEISSERIA GONORRHOEAE (GC) Q AMPLIFIED DNA ASSAY | LSL | Substantially Equivalent | Becton, Dickinson & CO | accessdata.fda.gov |
| October 27, 2008 | K080339 | MEDSOURCE ENDOTRACHEAL TUBE (WITH AND WITHOUT CUFF) | BTR | Substantially Equivalent | Medsource International, LLC | accessdata.fda.gov |
| October 16, 2008 | K082258 | CROSSTEX ISOLITE AND ISOFLUID EARLOOP FACE MASKS AND ISOFLUID FOGFREE FACE MASKS WITH AND WITHOUT SPLASH VISOR | FXX | Substantially Equivalent | Crosstex International | accessdata.fda.gov |
| October 1, 2008 | K082238 | NEOMED POLYURETHANE FEEDING TUBE | FPD | Substantially Equivalent | Neomed, Inc. | accessdata.fda.gov |
| August 28, 2008 | K081361 | CHEMOCLAVE CYTOTOXIC MEDICATION PREPARATION AND DELIVERY SYSTEM, MODEL, CH-XXXX | FPA | Substantially Equivalent | Icu Medical, Inc. | accessdata.fda.gov |
| August 26, 2008 | K081903 | XIOS PLUS WALL-MODULE | MUH | Substantially Equivalent | Sirona Dental Systems GmbH | accessdata.fda.gov |
| July 29, 2008 | K080939 | SURGICAL HANDPIECES, MIKRO SAW HANDPIECES | KMW | Substantially Equivalent | W&H Dentalwerk Buermoos GmbH | accessdata.fda.gov |
| July 21, 2008 | K081229 | SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH SAF-HOLDER DEVICE, WITH 21G, 23G, 25G SAF-T WING | JKA | Substantially Equivalent | Smiths Medical Asd, Inc. | accessdata.fda.gov |
| July 17, 2008 | K081446 | BD SPINAL NEEDLE, MODELS: 405081, 405235, 405236, 405237 | BSP | Substantially Equivalent | Becton, Dickinson & CO | accessdata.fda.gov |
| June 25, 2008 | K081634 | CONMED GOLDVAC INTEGRATED SMOKE EVACUATION PENCIL | GEI | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| January 17, 2008 | K073395 | GILB-2, GLASS IONOMER PROTECTIVE COATING | EMA | Substantially Equivalent | 3M Espe Dental Products | accessdata.fda.gov |
| October 5, 2007 | K071907 | VCARE RETRACTOR/ELEVATOR | LKF | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| September 25, 2007 | K072542 | MAXPLUS TRU-SWAB POSITIVE DISPLACEMENT CONNECTOR | FPA | Substantially Equivalent | Medegen Medical Manufacturing System | accessdata.fda.gov |
| August 2, 2007 | K071785 | HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE, HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE WITH SYRINGE | FMI | Substantially Equivalent | Smiths Medical Asd, Inc. | accessdata.fda.gov |
| July 13, 2007 | K071354 | MEPILEX AG DRESSING | FRO | Substantially Equivalent | Monlycke Health Care | accessdata.fda.gov |
| May 18, 2007 | K070964 | KLEENSPEC SINGLE USE VAGINAL SPECULUM AND 790 SERIES CORDLESS ILLUMINATION SYSTEM | HIB | Substantially Equivalent | Welch Allyn, Inc. | accessdata.fda.gov |
| October 25, 2006 | K062292 | UNICEM | EMA | Substantially Equivalent | 3M Espe Dental Products | accessdata.fda.gov |
| October 24, 2006 | K061878 | ELECTRODE COATED BALL, MODEL AB302C; NEEDLE, MODEL AN301C; BLADE, MODEL AE301HC | GEI | Substantially Equivalent | E Surgical, LLC | accessdata.fda.gov |
| July 26, 2006 | K061285 | SMARTSITE NEEDLE FREE VALVE ADMINISTRATION SETS | FPA | Substantially Equivalent | Cardinal Health, Alaris Products | accessdata.fda.gov |
| April 24, 2006 | K060865 | BAIR PAWS TEMPERATURE MANAGEMENT SYSTEM MODEL 850 | DWJ | Substantially Equivalent | Arizant Healthcare, Inc. | accessdata.fda.gov |
| January 10, 2006 | K053106 | TEGO, MODEL D1000 | FPA | Substantially Equivalent | Icu Medical, Inc. | accessdata.fda.gov |
| October 21, 2005 | K052104 | ULTRACLEAN HANDCONTROLLED SUCTION COAGULATOR, MODEL 130182, 130183, 130184, 130185; ULTRACLEAN FOOTCONTROLLED SUCTION | GEI | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| October 6, 2005 | K052549 | LEADCARE II BLOOD LEAD TESTING SYSTEM | DOF | Substantially Equivalent | Esa Biosciences, Inc. | accessdata.fda.gov |
| May 17, 2005 | K050322 | MICROTEK EQUIPMENT DRAPES | KKX | Substantially Equivalent | Microtek Medical, Inc. | accessdata.fda.gov |
| May 12, 2005 | K050600 | MINILOC SAFETY INFUSION SET | FPA | Substantially Equivalent | Specialized Health Products, Intl. | accessdata.fda.gov |
| February 22, 2005 | K050159 | MODIFICATION TO: 3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3000 | DQD | Substantially Equivalent | 3M Company | accessdata.fda.gov |
| January 13, 2005 | K043286 | ANEROID SPHYGMOMANOMETER, MODEL BK2002 | DXQ | Substantially Equivalent | Wenzhou Bokang Instrument Co.,Ltd | accessdata.fda.gov |
| December 15, 2004 | K043131 | TORPICALGIN | ELW | Substantially Equivalent | Zhermack S.P.A. | accessdata.fda.gov |
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Updated March 11, 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.