| DenTek Ultimate Dental Guard (K180933) | Medtech Products, Inc. | 2018-09-17 |
| AMSure Sterile Water, and Sterile Normal Saline for Wound Flush (K181423) | Amsino International, Inc. | 2018-09-07 |
| Natrelle 133S Tissue Expander (K182054) | Allergan | 2018-08-29 |
| Tenex Health TX System with the TXP MicroTip (K181367) | Tenex Health, Inc. | 2018-08-28 |
| Simple Science Antimicrobial Facial and Eyelid Cleanser (K181074) | Simple Science, LLC | 2018-08-17 |
| Ultraxx Nephrostomy Balloon Catheter Set (K181713) | Cook Incorporated | 2018-08-17 |
| BIAFINE (K173549) | Valeant Pharmaceuticals | 2018-08-13 |
| Titan Ag 200 (K173844) | Specialty Fibres and Materials, Ltd. | 2018-08-09 |
| Surgical Silver Post Operative Dressing (K180634) | Advanced Medical Solutions, Ltd. | 2018-08-07 |
| PHMB Foam Wound Dressing (K181197) | Advanced Medical Solutions, Ltd. | 2018-08-03 |
| Voutia™ (K173808) | Jeffrey Ward Cash, Dds | 2018-07-27 |
| AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening Fiber (K173675) | Convatec Limited | 2018-07-20 |
| Medline Burn and Wound Dressing (K173911) | Medline Industries, Inc. | 2018-07-19 |
| G•U•M HYDRAL Dry Mouth Oral Gel, G•U•M HYDRAL Dry Mouth Oral Rinse, G•U•M HYDRAL Dry Mouth Oral Spray (K181134) | Sunstar Americas, Inc. | 2018-07-13 |
| Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector (K173627) | Surgical Instrument Service and Savings, Inc. | 2018-07-12 |
| Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USP (K173276) | Medline Industries, Inc. | 2018-07-02 |
| FaSet Fixation System (K180729) | Huvexel Co. , Ltd. | 2018-06-28 |
| gel-e Flex (K180152) | Gel-E, Inc. | 2018-06-22 |
| Atlas Percussion Adjusting Instrument (K172536) | Spinalight, Inc. | 2018-06-20 |
| SURECELL Gelling Fiber Wound Dressing (K173005) | Jiangsu Newvalue Medical Producst Co.,Ltd | 2018-05-25 |
| ALGS6 Ag Alginate Wound Dressing (K172570) | Foshan United Medical Technologies, Ltd. | 2018-05-11 |
| Cytal Wound Particulate (K180776) | Acell, Inc. | 2018-05-11 |
| Smartcord, Smartcord X (K171577) | Eastdent Co., Ltd. | 2018-05-03 |
| LUOFUCON Extra Silver Alginate Dressing, LUOFUCON Extra Antibacterial Alginate Dressing (K172554) | Huizhou Foryou Medical Devices Co., Ltd. | 2018-05-01 |
| HYALURONIC ACID TOPICAL WOUND CREAM (K172747) | Virchow Biotech Pvt, Ltd. | 2018-04-27 |
| Oniko nail brace (K162525) | Begum Saglik Hizmetleri Tibbi Malzemeler Danismanlik Lsti | 2018-04-25 |
| Coventry Topical Anesthetic Mist Spray HAZMAT FREE, Coventry Topical Anesthetic Stream Spray HAZMAT FREE (K172598) | Itw Contamination Control Electronics | 2018-04-19 |
| Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC) (K180305) | Aquilabs Us, LLC | 2018-04-13 |
| StatGuard Hemostatic Patch, StatGuard Hemostatic Dressing (K172155) | Statguard, LLC | 2018-04-12 |
| Algidex Ag Silver Alginate Wound Dressing (K173072) | Deroyal Industries, Inc. | 2018-04-04 |
| K-D Balance (K173669) | King-Devick Technologies, Inc. | 2018-04-02 |
| Microcyn Antimicrobial Hydrogel (K173896) | Sonoma Pharmaceuticals, Inc. | 2018-04-02 |
| Dr’s Finder NEO (K171867) | Good Doctors Co., Ltd. | 2018-03-30 |
| Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw Dissectors (multiple lengths), Sonicision Battery Charger, Sonicision Battery Insertion Guide (K180149) | Covidien, LLC | 2018-03-26 |
| Test of Variables of Attention (T.O.V.A.) (K173915) | The Tova Company | 2018-03-22 |
| Moisyn Dry Mouth Oral Rinse, Moisyn Dry Mouth Oral Mist, Moisyn Free Dry Mouth Oral Rinse, Moisyn Free Dry Mouth Oral Mist (K173237) | Syendgen, Inc. | 2018-03-19 |
| TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges (K171542) | Dr. Harold Katz, LLC (Dba Therabreath | 2018-03-16 |
| XCelliStem Wound Powder (K172593) | Stemsys | 2018-03-16 |
| Phoenix Wound Matrix (K173544) | Nanofiber Solutions, Inc. | 2018-03-02 |
| ologen Collagen Matrix (K173223) | Aeon Astron Europe B.V. | 2018-03-02 |
| Spectra Optia Apheresis System (K172590) | Terumobct, Inc. | 2018-03-02 |
| Ultraxx Nephrostomy Balloon Catheter (K171601) | Cook Incorporated | 2018-02-23 |
| Axiostat Chitosan Hemostatic Dressing (K172324) | Advamedica, Inc. | 2018-02-23 |
| Catasyn Advanced Technology Wound Hydrogel (K172338) | Synedgen, Inc. | 2018-02-21 |
| ChlorCid, ChlorCid V, ChlorCid Surf (K173163) | Ultradent Products, Inc. | 2018-02-09 |
| SUNTOUCH Dental Dressing (K173196) | Huizhou Foryou Medical Devices Co., Ltd. | 2018-01-24 |
| Bruxor (K172452) | Sleep Specialties, LLC | 2018-01-11 |
| Instalief (K172358) | Privi Medical Pte, Ltd. | 2018-01-10 |
| Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, and Clear Renal Sheath (K172929) | Boston Scientific Corporation | 2018-01-10 |
| Facet Screw Fixation System (K173198) | U&I Corporation | 2018-01-03 |
| gel-e Bandage (K172010) | Gel-E, Inc. (Formerly Remedium Technologies, Inc.) | 2017-12-07 |
| Alevicyn SG Antimicrobial Gel (K171935) | Sonoma Pharmaceuticals, Inc. | 2017-12-01 |
| 3M Tegaderm Antimicrobial Transparent Dressing, 3M Tegaderm Antimicrobial I.V. Advanced Securement Dressing (K170754) | 3M Company, 3M Healthcare | 2017-11-21 |
| Microcyn Antimicrobial Skin and Wound Cleanser (K172622) | Sonoma Pharmaceuticals | 2017-11-21 |
| SleepRight ProRx Custom Dental Guard (K172223) | Splintek, Inc. | 2017-11-17 |
| Endoform Silver Dermal Template (K172318) | Aroa Biosurgery | 2017-11-17 |
| Microcyn Plus Antimicrobial Wound Care Solution (K172851) | Sonoma Pharmaceuticals, Inc. | 2017-11-15 |
| Geistlich Wound Matrix (K171842) | Geistlich Pharma AG | 2017-11-03 |
| SANGRAY (K172087) | Hitachi , Ltd. | 2017-10-27 |
| Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray) (K172028) | Gebauer Company | 2017-10-27 |
| GingiDent Gingival Retraction Paste (K162662) | Pac-Dent International, Inc. | 2017-10-20 |
| Amplatz Renal Dilator Set, Catheter for Use with Amplatz Renal Dilator Set, Amplatz Dilator, Amplatz Renal Introducer, Amplatz Radiopaque TFE Sheath, Clear Amplatz Sheath with Radiopaque Stripe (K172527) | Cook Incorporated | 2017-10-19 |
| CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray (K172203) | Nuance Medical, LLC | 2017-10-18 |
| HylaGuard Moisturizing Cream (K171879) | Founders Science Group, LLC | 2017-10-16 |
| MicroMatrix (K172399) | Acell, Inc. | 2017-10-06 |
| Ultrasonic Generator (K172691) | Olympus Medical Systems Corp. | 2017-10-04 |
| CUSA Excel+ Ultrasonic Surgical Aspirator System (K172595) | Integra LifeSciences Corporation | 2017-09-28 |
| Urbanek Device (K170985) | Tmj Services, LLC | 2017-09-25 |
| Anexa Wound Flush, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 120 mL cup, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 100mL bottle, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 250mL bottle, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 500mL bottle (K172486) | Anexa Biomedical, Inc. | 2017-09-21 |
| Hexagen Derm (K171191) | Global Health Solutions, LLC | 2017-08-25 |
| SilverSeal (K171041) | Alliqua Biomedical, Inc. | 2017-08-22 |
| NEOCERA Advanced Barrier Cream (K170911) | Exeltis USA Dermatology, LLC | 2017-08-22 |
| Sorbact Wound Dressing-Ribbon Gauze (K171225) | Abigo Medical AB | 2017-08-21 |
| ARK Methotrexate Assay (K163359) | Ark Diagnostics, Inc. | 2017-08-18 |
| NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10cm), NovoSorb BTM Wound Dressing (10cm x 20cm), NovoSorb BTM Wound Dressing (20cm x 40cm) (K172140) | Polynovo Biomaterials Pty, Ltd. | 2017-08-11 |
| Styptin, Hemogin-L, Hemodettes, and GingiGEL Aluminum Chloride Impregnated Retraction Cord/Materials (K162948) | Kerr Corporation | 2017-08-08 |
| Hydrocleanse Antimicrobial Skin and Wound Care Solution (K171727) | Sonoma Pharmaceuticals | 2017-07-26 |
| PHMB Antimicrobial Foam Wound Dressing (K163062) | Advanced Medical Solutions, Ltd. | 2017-07-25 |
| CoMatryx Collagen Wound Dressing 1 gram pouch, CoMatryx Collagen Wound Dressing 1 gram vial, CoMatryx Collagen Wound Dressing 10 gram bottle (K171645) | Strukmyer Medical | 2017-07-25 |
| BD ChloraShield IV Dressing with CHG Antimicrobial (K170407) | Avery Dennison Belgie Bvba | 2017-07-17 |
| 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing (K171908) | 3M Company | 2017-07-11 |
| Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector (K170955) | Surgical Instrument Service and Savings Inc.(Dba Medline Ren | 2017-07-03 |
| SupraSDRM Biodegradable Matrix Wound Dressing (K170213) | Polymedics Innovations, GmbH | 2017-06-28 |
| Aqua Care & Accu-Rinse, Sterile Water & Sterile Normal Saline (K170270) | Ls Scientific Inc. D.B.A. Kse Scientific | 2017-06-23 |
| Cerdak Basic (K153138) | Bu Polysciences Equipment & Trading, LLC | 2017-06-23 |
| Hydris™ Oral Rinse (K163029) | Biopharm Consult, LLC | 2017-06-19 |
| Endoform Topical Matrix (K171231) | Aroa Biosurgery | 2017-06-14 |
| KeraStat(R) Gel (K162759) | Keranetics, LLC | 2017-06-02 |
| Prontosan Wound Gel (K163430) | B.Braun Medical, Inc. | 2017-05-23 |
| Test of Variables of Attention (T.O.V.A.) Version 9.0 (K170082) | The Tova Company | 2017-05-17 |
| 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing (K153410) | 3M Company | 2017-05-15 |
| ABCcolla Collagen Matrix (K162348) | Acro Biomedical Co., Ltd. | 2017-05-10 |
| Lubricity (K163476) | You First Services, Incorporated | 2017-05-10 |
| Restrata Wound Matrix (K170300) | Acera Surgical, Inc. | 2017-04-26 |
| Ross Ru Wound Dressing Gel (K162017) | Biotd S.A. | 2017-04-20 |
| Ortho System (K161884) | 3Shape A/S | 2017-04-19 |
| Lacriflow CL (K170247) | Kaneka Pharma America, LLC | 2017-04-18 |
| Soft Plug Extended Duration 180 Canalicular Plug (K162361) | Oasis Medical, Inc. | 2017-04-17 |
| Atellica CH Phencyclidine (Pcp) (K163220) | Siemens Healthcare Diagnostics, Inc. | 2017-04-06 |
| Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology (K170456) | Stryker Sustainability Solutions | 2017-04-05 |