| LED Light Therapy Device (K180900) | Uvbiotek, LLC | 2018-07-10 |
| Fractional CO2 Surgical Laser System (K173359) | Ami, Inc. | 2018-07-05 |
| 400um Perforator and Accessory Vein Ablation Kit (K181044) | AngioDynamics, Inc. | 2018-07-05 |
| ULTRAPRO Mesh and ULTRAPRO ADVANCED (K180910) | ETHICON, Inc. | 2018-07-02 |
| Beurer IPL 5500 device/ IPL 5000/ IPL PureSkin Pro (K181121) | Home Well Trading, Ltd. | 2018-06-28 |
| PROLENE Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh, PROLENE (Polypropylene) Hernia System, Non-absorbable Synthetic Surgical Mesh (K180829) | ETHICON, Inc. | 2018-06-28 |
| ArtiClip LAA Exclusion System (K181474) | AtriCure, Inc. | 2018-06-28 |
| Beacon Advanced CO2 Laser System (K180993) | Omniguide, Inc. | 2018-06-28 |
| SafePath Suturing System (K180701) | Safepath Medical, Inc. | 2018-06-25 |
| FIJI SUN FLUORESCENT TANNING UNIT (K151721) | Kdb Inc. (Dba) Sperti Sunlamp | 2018-06-22 |
| UV Lamps for Sunlamp Products (K180581) | Feilo Sylvania Germany GmbH | 2018-06-22 |
| LigaSure Maryland Jaw Thoracic Sealer/Divider One-step Sealing, Nano-coated (K181085) | Covidien | 2018-06-21 |
| PICOPLUS Laser System (K173700) | Lutronic Corporation | 2018-06-19 |
| Neutrogena Light Therapy Aging Mask+ (K180856) | Johnson & Johnson Consumer, Inc. | 2018-06-19 |
| Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy Platform (K181389) | Covidien | 2018-06-19 |
| Neutrogena Light Therapy Acne Mask+ (K180847) | Johnson & Johnson Consumer, Inc. | 2018-06-19 |
| Medline Prevention CoolZone Gown (K172954) | Medline Industries, Inc. | 2018-06-15 |
| InMode Diolaze System (K180719) | Inmode MD , Ltd. | 2018-06-14 |
| Harmony XL Multi-Application Platform (K181298) | Alma Lasers, Inc. | 2018-06-13 |
| Pollogen Legend System (K173503) | Pollogen, Ltd. | 2018-06-11 |
| VT Dressing Kits (K172725) | Carilex Medical, Inc. | 2018-06-08 |
| ELEVARE, PERFECTIO 4 (K172909) | Omm Imports D/B/A Zero Gravity | 2018-06-07 |
| Paxman Scalp Cooler (K173032) | Paxman Coolers Limited | 2018-06-07 |
| TYRX Neuro Absorbable Antibacterial Envelope (medium); TYRX Neuro Absorbable Antibacterial Envelope (large) (K180122) | Medtronic, Inc. | 2018-06-07 |
| EchoMark, EchoMark LP (K180621) | Sonavex, Inc. | 2018-06-06 |
| truSculpt RF Device; truSculpt; truSculpt 3D (K180709) | Cutera, Inc. | 2018-06-06 |
| SuperBall Meniscal Repair System (K180191) | Arcuro Medical , Ltd. | 2018-06-05 |
| Vbeam Prima Laser System (K180593) | Syneron-Candela | 2018-06-05 |
| reVive Light Therapy LED Cleansing System (K180447) | Led Technologies, Inc. | 2018-06-04 |
| SmartClip Soft Tissue Marker (K180640) | Elucent Medical, Inc. | 2018-06-04 |
| Prevena Plus Incision Management System, Prevena Plus Duo Incision Management System (K180855) | Kci USA, Inc. | 2018-06-01 |
| InMode System with Fractora3D/3D-90 Applicators (K180189) | Inmode MD , Ltd. | 2018-06-01 |
| SOMAVAC Device (K180606) | Somavac Medical Solutions, Inc. | 2018-05-31 |
| Automatic Tissue Processing Unit (K172717) | Bsl Co. | 2018-05-25 |
| ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating 37 cm Shaft Length; ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating 45 cm Shaft Length (K180403) | Ethicon Endo-Surgery, LLC | 2018-05-23 |
| DiLumen Endolumenal Interventional Scissors (DiLumen Is) (K173405) | Lumendi, LLC | 2018-05-22 |
| Irrigation Tubing Bipolar Cord Set (K180908) | New Deantronics Taiwan , Ltd. | 2018-05-18 |
| Smoklean (K173108) | Sejong Medical Co., Ltd. | 2018-05-18 |
| XSTAT 30, 1-Pack (K180051) | Revmedx, Inc. | 2018-05-18 |
| JOULE SYSTEM (K180508) | Sciton, Inc | 2018-05-18 |
| Esophageal Stent System (K172813) | Micro-Tech (Nanjing) Co., Ltd. | 2018-05-18 |
| VESTEX Apparel (K180217) | Vestagen Protective Technologies, Inc. | 2018-05-18 |
| reVive Light Therapy LED Ultrasonic Wrinkle System (K180445) | Led Technologies, Inc. | 2018-05-15 |
| ICEfx Cryoablation System (K181153) | Galil Medical, Inc. | 2018-05-15 |
| Light based hair removal device (K180383) | Shenzhen Gsd Tech Co., Ltd. | 2018-05-11 |
| Rondek PGA Suture (Beige or Violet) (K180625) | Rk Manufacturing Corporation | 2018-05-10 |
| Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound Therapy System (Invia Motion - Endure, Invia Motion – 120 days, Invia Motion – 60 days, Invia Motion – 30 days, Invia Motion – 15 days, Invia Motion – 7 days), Invia Liberty Negative Pressure Wound Therapy System, Invia Gauze Dressing Kits with FitPad (K172145) | Medela AG | 2018-05-09 |
| Empower H100, Cyber Ho 100, Litho 100 (K180922) | Quanta System Spa | 2018-05-08 |
| Hemospray Endoscopic Hemostat (DEN170015) | Wilson-Cook Medical, Inc. | 2018-05-07 |
| Endopath Electrosurgery Probe Plus II (K180031) | Ethicon Endo-Surgery, LLC | 2018-05-07 |
| Ulthera System (K180623) | Ulthera, Inc. | 2018-05-04 |
| StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDO (K173874) | Origami Surgical, LLC | 2018-05-04 |
| VivaScope System (K180162) | Caliber Imaging & Diagnostics, Inc. | 2018-05-03 |
| SAPPHIRE, ELEVARE SAPPHIRE (K172555) | Omm Imports, Inc. D/B/A Zero Gravity | 2018-05-01 |
| AMBIENT Super MULTIVAC 50 Wand with Integrated Finger Switches (K180848) | ArthroCare Corporation | 2018-05-01 |
| VitaMESH Macroporous PP Surgical Mesh (K172636) | Proxy Biomedical , Ltd. | 2018-04-30 |
| Finessis Intense Polyisoprene Surgical Glove (K173304) | Lucenxia Prescience AG | 2018-04-30 |
| ESG-300, APU-300, Pressure Reducer, MAPC Probes (K180200) | Olympus Winter & Ibe GmbH | 2018-04-26 |
| Phasix ST Mesh (K173143) | C.R. Bard, Inc. | 2018-04-25 |
| TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large) (K180030) | Medtronic, Inc. | 2018-04-24 |
| Reprocessed LigaSure Maryland Jaw Sealer/Divider (K180499) | Stryker Sustainability Solutions | 2018-04-23 |
| Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy (K173258) | Pt. Medisafe Technologies | 2018-04-20 |
| Etherea MX (K171443) | Vydence Medical Industria E Comercio Ltda | 2018-04-20 |
| ProFlex Laser Fibers (K180140) | Innovaquartz, LLC | 2018-04-20 |
| PICO Single Use Negative Pressure Wound Therapy System (K180618) | Smith & Nephew Medical Limited | 2018-04-20 |
| Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/Divider (K180451) | Stryker Sustainability Solutions | 2018-04-20 |
| Solar Storm, Solar Wave, Sunco, and ESB (Avalon, Galaxy, Grande, Oasis, Elite and Leisure Select) (K180576) | Lpi, Inc. | 2018-04-19 |
| Diode laser hair removal device (K180353) | Zhengzhou PZ Laser Slim Technology Co., Ltd. | 2018-04-17 |
| THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (K172610) | Olympus Medical Systems Corp. | 2018-04-17 |
| Voyant Open Fusion Device (K180699) | Applied Medical Resources Corporation | 2018-04-13 |
| Aurora Evacuator (K180372) | Rebound Therapeutics | 2018-04-09 |
| Medline Cautery Electrode (PTFE) (K173889) | Medline Industries, Inc. | 2018-04-09 |
| Finessis Zero Flexylon Powder Free Sterile White Surgical Glove Tested for use with Chemotherapy Drugs (K173386) | Lucenxia Prescience AG | 2018-04-09 |
| Viveve RF System, Secure (K180584) | Viveve, Inc. | 2018-04-06 |
| PICO Single Use Negative Pressure Wound Therapy System (K180614) | Smith & Nephew Medical Limited | 2018-04-06 |
| PTFE SURGICAL SUTURE (K180630) | Omnia Spa | 2018-04-06 |
| Bipolar Micro-Coagulation Forceps (K172368) | Gunter Bissinger Medizintechnik GmbH | 2018-04-05 |
| GORE ENFORM Biomaterial (K173333) | W. L. Gore & Associates, Inc. | 2018-04-05 |
| Master-Frank N95 Particulate Respirator (K172963) | Master & Frank Enterprise Co., Ltd. | 2018-04-04 |
| AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO (K180597) | Lumenis, Ltd. | 2018-04-03 |
| dpl IIa Panel (K180320) | Led Technologies, Inc. | 2018-04-03 |
| NovoStitch Pro Meniscal Repair System (K180531) | Ceterix Orthopaedics, Inc. | 2018-03-29 |
| NES Reprocessed RF Stylet (RFS) (K173214) | Northeast Scientific, Inc. (Nes) | 2018-03-27 |
| C-PTFETM Surgical Suture (K173922) | Cp Medical, Inc. | 2018-03-26 |
| Tumark Vision (K180443) | Somatex Medical Technologies GmbH | 2018-03-22 |
| Freezpoint (K180211) | Bovie Medical Corp. | 2018-03-21 |
| Home Use IPL Beauty Device (K180016) | Shenzhen Mismon Technology Co., Ltd. | 2018-03-20 |
| ReConnex Pre-Sutured Tendon (K170957) | Allosource | 2018-03-20 |
| Reprocessed DePuy Mitek Ablation Wand (K173740) | Renovo, Inc. | 2018-03-19 |
| Empower H35 (K180426) | Quanta System Spa | 2018-03-16 |
| miraDry System (K180396) | Miramar Labs, Inc. | 2018-03-15 |
| Ellipse Ydun (K180406) | Ellipse A/S | 2018-03-15 |
| ELEMENT-TL (K180224) | Elemenic Co., Ltd. | 2018-03-15 |
| Empower H65 (K180423) | Quanta System Spa | 2018-03-15 |
| star RF Electrode, VIVA RF Electrode (K172012) | Starmed Co., Ltd. | 2018-03-14 |
| Biodesign Diaphragmatic Hernia Graft (K171817) | Cook Biotech Incorporated | 2018-03-13 |
| REXMONO, PDREX (K173779) | Sm Eng Co., Ltd. | 2018-03-12 |
| UltraCor Twirl Breast Tissue Marker (K180061) | Bard Peripheral Vascular, Inc. | 2018-03-09 |
| PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management System (K173426) | Kci USA, Inc. | 2018-03-09 |
| 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) (K173796) | Sofradim Production | 2018-03-09 |