| Device Electrosurgical Generator ESG-150 (K182587) | Olympus Winter & Ibe GmbH | 2018-11-29 |
| AEON Endoscopic Stapler (K182380) | Lexington Medical, Inc. | 2018-11-28 |
| Codman Electrosurgical Irrigator, Codman Electrosurgical Irrigator Interconnecting Cable (K182801) | Integra LifeSciences Corporation | 2018-11-27 |
| AdVance XP Male Sling (K182169) | Boston Scientific Corporation | 2018-11-27 |
| HEMOSTATIX MODEL P8400 DISPOSABLE HANDLE, HEMOSTATIX MODEL P8400 DISPOSABLE BLADES (K183009) | Hemostatix Medical Technologies, LLC | 2018-11-26 |
| Valleylab Smoke Evacuation Rocker Switch Pencil , Valleylab Telescoping Smoke Evacuation Rocker Switch Pencil (K182772) | Covidien | 2018-11-19 |
| CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro Envelope (large) ; CanGaroo Neuro Envelope (extra large) (K182255) | Aziyo Biologics, Inc. | 2018-11-15 |
| Amsel Endo Occluder (K180650) | Amsel Medical Corporation | 2018-11-15 |
| Voyant Maryland Fusion Device (K182653) | Applied Medical Resources Corp. | 2018-11-14 |
| New Era (K182604) | Step UP Skin Laser, LLC | 2018-11-14 |
| Miracu (K172602) | Feeltech Co., Ltd. | 2018-11-14 |
| BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider (K182451) | Covidien, LLC | 2018-11-06 |
| Cellene CO2 Laser System (K182270) | Bio-Med USA, Inc. | 2018-11-02 |
| Invia White Foam NPWT (K180415) | Medela AG | 2018-11-02 |
| Fluobeam 800 Clinic Imaging Device used with Fluocase 800 Control System (DEN170092) | Fluoptics | 2018-11-02 |
| Parathyroid Detection (Model PTeye) System (DEN170056) | Aibiomed, Corp. | 2018-11-02 |
| HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN) (K180180) | M.I.Tech Co., Ltd. | 2018-11-02 |
| DynaMesh-POSTERIOR (K182087) | Feg Textiltechnik Forschungs- Und Entwicklungsgesellschaft | 2018-10-31 |
| XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP Spectro (K182088) | Fotona D.O.O. | 2018-10-31 |
| Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider (K182588) | Surgical Instrument Service and Savings Inc.(Dba Medline Ren | 2018-10-31 |
| Tumark for Eviva, Tumark for Brevera (K182082) | Somatex Medical Technologies GmbH | 2018-10-31 |
| Frozen C (K182392) | B.M. Tech. Worldwide Co., Ltd. | 2018-10-30 |
| LIGACLIP 12mm L Endoscopic Rotating Multiple Clip Applier (K181488) | Ethicon Endo-Surgery, LLC | 2018-10-30 |
| ClearLink Controlled Phototherapy Equipment (K182215) | Daavlin Distributing Company | 2018-10-29 |
| TempSure System (K182365) | Cynosure, Inc. | 2018-10-24 |
| Certus 140 2.45GHz Ablation System (K173756) | Neuwave Medical, Inc. | 2018-10-24 |
| AVELLE Negative Pressure Wound Therapy System (K180205) | Convatec Limited | 2018-10-19 |
| Swift System (K181941) | Emblation , Ltd. | 2018-10-18 |
| Youlaser CO2 (K182669) | Quanta System Spa | 2018-10-17 |
| NeuroBlate System (K182036) | Monteris Medical, | 2018-10-15 |
| Percuvance Percutaneous Surgical System (K181852) | Teleflexmedical, Inc. | 2018-10-12 |
| SCARLET SRF (K180872) | VIOL Co., Ltd. | 2018-10-11 |
| DemeTECH PTFE Nonabsorbable Surgical Suture (K181578) | Demetech Corporation | 2018-10-11 |
| Voyant Electrosurgical Generator (K182244) | Applied Medical Resources Corp. | 2018-10-11 |
| Ergoline Prestige 1600 Hybrid Performance (K180555) | Jk Holding GmbH | 2018-10-11 |
| Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures; Force Fiber OrthoTape suture; Bondek suture and Bondek Plus suture; Monodek suture; Polyglytone*6211 suture (K181774) | Teleflex Medical Incorporated | 2018-10-10 |
| SHINY RPL System (K181868) | Ids, Ltd. | 2018-10-05 |
| Deka Smartxide2 Trio (K181867) | El.En Electronic Engineering Spa | 2018-10-02 |
| Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable Suture (K181652) | ETHICON, Inc. | 2018-09-28 |
| InMode RF System (K182325) | Inmode MD , Ltd. | 2018-09-26 |
| 5cm Tag Applicator, 7cm Tag Applicator, 10 cm Tag Applicator, 5 cm Tag Applicator (10 pack), 7cm Tag Applicator (10 pack), 10cm Tag Applicator (10 pack), LOCalizer Surgical Probe, LOCalizer Surgical Probe (5 pack) (K181692) | Health Beacons, Inc. | 2018-09-25 |
| Agile Esophageal Stent System (K180144) | Boston Scientific Corporation | 2018-09-21 |
| Cellulize (K180338) | Ward Photonics, LLC | 2018-09-21 |
| AEROmini Tracheobronchial Stent System (K181200) | Merit Medical Systems, Inc. | 2018-09-21 |
| NICO Myriad (K182340) | Nico Corporation | 2018-09-20 |
| Beurer IPL 8500 device/ IPL VelvetSkin Pro (K181734) | Home Well Trading, Ltd. | 2018-09-19 |
| Magnetic Surgical System (K180894) | Levita Magnetics International Corp | 2018-09-19 |
| Caprolon (K181320) | Resorba Medical GmbH | 2018-09-18 |
| Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed (K181653) | Ethicon Endo-Surgery, LLC | 2018-09-18 |
| Endoscopic Linear Cutting Staplers and Loading Units for Single Use (K181620) | Ezisurg (Suzhou) Medical Co., Ltd. | 2018-09-18 |
| Venacure 1470 Pro (K181632) | Quanta System Spa | 2018-09-17 |
| LightScalpel (K173827) | Lightscalpel, LLC | 2018-09-14 |
| A-FIT (K173676) | Hironic Co., Ltd. | 2018-09-14 |
| POLY REJUV (K180875) | Medtek Skincare, LLC | 2018-09-14 |
| IPL Salon Hair Reduction System (K181568) | Medical Device Branch of Zhangzhou Easepal Industrial Co.,Lt | 2018-09-11 |
| ProSun sunlamp products, Luxura sunlamp products (K181455) | Prosun International, LLC | 2018-09-10 |
| Human Tecar HCR 1002 (K181211) | Unibell S.R.L | 2018-09-10 |
| Exceed Microneedling Device (K180778) | Mt. Derm GmbH | 2018-09-07 |
| IPL Hair Removal Device Joy Version (K173813) | Shen Zhen Cosbeauty Co., Ltd. | 2018-09-07 |
| Ultravision™ Visual Field Clearing System (K182053) | Alesi Surgical, Ltd. | 2018-09-07 |
| Sebacia Microparticles (K181518) | Sebacia, Inc. | 2018-09-06 |
| Iridex TruFocus LIO Premiere (K181662) | Iridex Corporation | 2018-09-05 |
| ECHOLASER X4 (K181510) | El.En Electronic Engineering Spa | 2018-09-04 |
| EUSRA RF Electrode (K181249) | Starmed Co., Ltd. | 2018-09-04 |
| DEKA Motus AY (K181486) | El.En Electronic Engineering Spa | 2018-08-30 |
| LYFT (K180888) | Uplevity, Inc. | 2018-08-30 |
| ZELTIQ CoolSculpting System (K181740) | Zeltiq Aesthetics, Inc. | 2018-08-29 |
| DemeTECH DemeDIOX absorbable surgical suture (K181582) | Demetech Corporation | 2018-08-27 |
| PICO 7 Single Use Negative Pressure Wound Therapy System (K180698) | Smith & Nephew Medical Limited | 2018-08-21 |
| GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement (K181940) | W. L. Gore & Associates, Inc. | 2018-08-17 |
| PleuraFlow System with FlowGlide Extra Drainage Length (K182067) | Clearflow, Inc. | 2018-08-14 |
| VT - 100, VT - 200 (K173407) | Carilex Medical, Inc. | 2018-08-09 |
| Powder Free White, Green Sterilized Polychloroprene Copolymer Surgical Gloves - Tested for Use with Chemotherapy Drugs (K180221) | Smart Glove Corporation Sdn. Bhd. | 2018-08-08 |
| Polydioxanone Surgical Scaffold (K181094) | Lntegra Lifesciences | 2018-08-02 |
| DYNACORD Suture (K181182) | Medos International SARL | 2018-08-02 |
| Cianna Medical SAVI Scout Reflector and SAVI Scout System (K181007) | Cianna Medical, Inc. | 2018-08-02 |
| PlasmaBlade X 3.0S, PlasmaBlade X 4.0 (K181257) | Medtronic Advanced Energy | 2018-08-02 |
| MMD Tip (K181480) | Strata Skin Sciences, Inc. | 2018-08-01 |
| NovoStitch Pro Meniscal Repair System, CTX-A004 (size 0) (K181772) | Ceterix Orthopaedics, Inc. | 2018-08-01 |
| MolecuLight i:X (DEN180008) | MolecuLight, Inc. | 2018-07-31 |
| 3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield (K180874) | 3M Healthcare | 2018-07-31 |
| Picocare Family (K181272) | Wontech Co., Ltd. | 2018-07-31 |
| Laser Ureteral Catheter (K181431) | Cook Incorporated | 2018-07-30 |
| 308nm Excimer System (K172273) | Chongqing Peninsula Medical Technology Co., Ltd. | 2018-07-30 |
| IceSphere 1.5 CX Cryoablation Needle (K181741) | Galil Medical , Ltd. | 2018-07-30 |
| PROLENE (Polypropylene) 3D Patch (K181268) | ETHICON, Inc. | 2018-07-26 |
| Avologi ENEO (K181659) | Premier North America, Inc. | 2018-07-26 |
| TWBM Pump (K180115) | Taiwan Biomaterial Co., Ltd. | 2018-07-24 |
| RF-Relief (K181095) | El Global Trade, Ltd. | 2018-07-24 |
| DV-300 Aspirator (K181398) | Ding Hwa Co., Ltd. | 2018-07-23 |
| GME LinScan Lite 808 Laser System (K180518) | Gme German Medical Engineering GmbH | 2018-07-23 |
| Disposable Electrosurgical Pencils (K170369) | Cathay Manfacturing Corp. | 2018-07-19 |
| ePTFE-Coated Auricular Implant (K172389) | Implantech Associates, Inc. | 2018-07-18 |
| Diode Laser System (K181019) | Guangzhou Huafei Tongda Technology Co., Ltd. | 2018-07-16 |
| Surgical gown (AE1001, AE2001, AE3001); Surgical Gown (AG1001, AG2001, AG3001) (K172987) | Gmax Industries, Inc. | 2018-07-13 |
| Sterile Latex Surgical Gloves, Powder Free (K171550) | Sanrea Healthcare Products Pvt, Ltd. | 2018-07-13 |
| PINXEL-RF system (K180654) | Rohrer Aesthetics, LLC | 2018-07-13 |
| THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type X, THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type X, THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type X (K180575) | Olympus Medical Systems Corp. | 2018-07-12 |
| Dental Diode Laser System (K180967) | Lazon Medical Laser Co., Ltd. | 2018-07-11 |
| Syneron CO2RE System (K181523) | Syneron-Candela Corp | 2018-07-11 |