| SIROLaser Blue (K180044) | Dentsply Sirona | 2018-03-08 |
| AnastoClip GC Closure System (K173323) | LeMaitre Vascular, Inc. | 2018-03-08 |
| LMT-3000 (K172818) | Lameditech Co. , Ltd. | 2018-03-07 |
| Dornier Medilas H Solvo 35 Laser (K180350) | Dornier Medtech America | 2018-03-07 |
| Aesculap Optilene Nonabsorbable Suture (K180321) | Aesculap, Inc. | 2018-03-07 |
| Reprocessed ArthoCare Ablation Wand (K173741) | Renovo, Inc. | 2018-03-05 |
| LigaSure Exact Dissector, Nano-coated (K173281) | Covidien | 2018-03-02 |
| V.A.C.VIA 7 Day Therapy System Kit, V.A.C.VIA Therapy Starter Kit, V.A.C.VIA Negative Pressure Wound Therapy Unit (K173447) | Kci USA, Inc. | 2018-03-02 |
| Omega VL (K162366) | Ov World Co., Ltd. | 2018-03-02 |
| SkinPen Precision System (DEN160029) | Bellus Medical, LLC | 2018-03-01 |
| Technoweb Surgical Mask (K172500) | Yts Global, Inc. | 2018-03-01 |
| InMode VLaze (K173677) | Inmode MD , Ltd. | 2018-02-23 |
| Sutter CURIS RF Generator (K171869) | Sutter Medizintechnik GmbH | 2018-02-23 |
| LightForce LTS Model 1000, 1500, 2500, and 4000 (K173067) | Litecure, LLC | 2018-02-22 |
| Reprocessed ArthroCare ENT Coblator (K172647) | Renovo, Inc. | 2018-02-21 |
| DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto) (K180193) | El.En Electronic Engineering Spa | 2018-02-21 |
| Tri-Staple 2.0 Reinforced Reload (K173270) | Covidien | 2018-02-20 |
| Magseed Magnetic Marker Systtem (K173587) | Endomagnetics Ltd., | 2018-02-16 |
| EEA Circular Stapler with Tri-Staple Technology (K172361) | Covidien | 2018-02-16 |
| Gazelle Polypropylene Suture and Delivery Device (K173644) | Dura Tap, LLC | 2018-02-15 |
| BOWA Neutral Electrodes (K173877) | Bowa-Electronics GmbH & Co. KG | 2018-02-15 |
| SURGICAL ISOLATION GOWN (K171535) | Jingzhou Haixin Green Cross Medical Products Co., Ltd. | 2018-02-15 |
| AtriCure cryoICE cryo-ablation probe (CRYO3), AtriCure cryoICE cryoFORM cryo-ablation probe (CRYOF) (K180137) | AtriCure, Inc. | 2018-02-15 |
| Surgical Laser fibers (K180158) | Quanta System Spa | 2018-02-14 |
| Sunrise 6200, Sunrise 7200 (K173565) | Jk-Holding GmbH | 2018-02-14 |
| Siberian Fit (K172439) | Vydence | 2018-02-14 |
| Voyant 5mm Fusion Device (K172624) | Applied Medical Resources Corporation | 2018-02-13 |
| Disposable Endoscopic Surgical Instrument, Reusable Endoscopic Surgical Instrument (K171825) | Hunan Handlike Minimally Invasive Surgery Co., Ltd. | 2018-02-13 |
| Home Use Hair Removal Device/T1, T2, T3 (K172883) | Shenzhen Mareal Tech Co., Ltd. | 2018-02-12 |
| Gazelle PTFE and Suture Delivery Device (K173335) | Dura Tap, LLC | 2018-02-08 |
| PicoSure Workstation (K173199) | Cynosure, Inc. | 2018-02-07 |
| Gammex PI Breach Detect Powder Free Surgical Glove (K171375) | Ansell Healthcare Products, LLC | 2018-02-06 |
| PICO 7 Single Use Negative Pressure Wound Therapy System (K172005) | Smith & Nephew Medical Limited | 2018-02-02 |
| SMAXEL CO2 Surgical Laser System (K180036) | Ids, Ltd. | 2018-02-02 |
| Duatene bilayer mesh (K172395) | Sofradim Production | 2018-02-01 |
| MERISTEEL (K172146) | M/s. Meril Endo Surgery Private Limited. | 2018-02-01 |
| AEON Endoscopic Stapler (K173443) | Lexington Medical, Inc. | 2018-02-01 |
| AtriClip FLEX-V (K180010) | AtriCure, Inc. | 2018-01-31 |
| Rex Medical Aspiration Pump (K173389) | Rex Medical, L.P. | 2018-01-30 |
| Luma Light System (K173436) | Luma Therapeutics | 2018-01-30 |
| JOULE SYSTEM (K173285) | Sciton, Inc | 2018-01-29 |
| Stryker 90-S Max SERFAS Energy Probe (K171391) | Stryker | 2018-01-26 |
| Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties)) (K173062) | V&Q Manufacturing Corporation | 2018-01-25 |
| C2 CryoBalloon Ablation System (K163684) | C2 Therapeutics, Inc. | 2018-01-23 |
| Lumilisse IPL Hair Remover (K172791) | Conair Corporation | 2018-01-18 |
| ThermiX Temperature Control Radiofrequency System, Accessories - RF Electrodes (K173582) | Thermigen, L.L.C | 2018-01-17 |
| reVive Perioral (K172662) | Led Technologies, Inc. | 2018-01-09 |
| Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms [SopranoXL, SopranoXLi, SopranoICE and Soprano ICE Platinum] with Duo and Trio Diode Laser Modules., Soprano Duo and Trio Diode Laser Modules (K172193) | Alma Lasers, Inc. | 2018-01-09 |
| Thermage CPT System and Accessories (K173759) | Solta Medical | 2018-01-08 |
| Pristeen (Latex Surgeon’s Gloves Powder Free, Polymer coated with protein content labeling claim of 50 ug/dm2 or less per glove of extractable protein (K172942) | Beta Healthcare Products Pvt., Ltd. | 2018-01-08 |
| dermaPACE System (DEN160037) | Sanuwave, Inc. | 2017-12-28 |
| easyEndoTM Linear Cutting Stapler and Loading Units for Single Use, easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use (K172960) | Ezisurg Medical Co., Ltd. | 2017-12-21 |
| AQUABEAM System (DEN170024) | Procept Biorobotics, Corporation | 2017-12-21 |
| Operio (K173349) | Toul Meditech AB | 2017-12-20 |
| ContainOR (DEN170075) | Advanced Surgical Concepts, Ltd. | 2017-12-19 |
| Polyform Synthetic Mesh (K171271) | Boston Scientific Corporation | 2017-12-15 |
| Holycon Synthetic Absorbable Sutures (K173043) | Nantong Holycon Medical Devices Co., Ltd. | 2017-12-14 |
| 2940 nm Er:Yag Laser Handpiece (K173002) | Quanta System Spa | 2017-12-13 |
| LipiVage (K172714) | Genesis Biosystems, Inc. | 2017-12-08 |
| RoyalGuard Surgical Gown, i600, Breathable (K172445) | Gri Medical & Electrical Technology Co., Ltd. | 2017-12-08 |
| InMode PLUS System (K172302) | Inmode MD , Ltd. | 2017-12-08 |
| Q-Switched Nd:YAG Laser System (K172908) | Ami, Inc. | 2017-12-07 |
| Vivaer ARC Stylus (K172529) | Aerin Medical, Inc. | 2017-12-05 |
| Disposable Circular Stapler (K172561) | Changzhou Kangdi Medical Stapler Co., Ltd. | 2017-12-05 |
| LightWalker Laser System Family (K172819) | Fotona D.O.O. | 2017-12-01 |
| CuRAS Nd:YAG Laser (K173038) | Ilooda Co,., Ltd. | 2017-12-01 |
| CryOmega Flexx (K172769) | Cryoconcepts LP | 2017-11-30 |
| Disposable Linear Stapler, Disposable Linear Cutter (K172538) | Changzhou Kangdi Medical Stapler Co., Ltd. | 2017-11-30 |
| DESCRIBE PFD Patch (K172689) | Merz North America, Inc. | 2017-11-29 |
| Epic Pro 940 (K172771) | Biolase, Inc. | 2017-11-29 |
| Vevazz LED (K172111) | Vevazz, LLC | 2017-11-22 |
| LAP-iX (K173112) | Sejong Medical Co., Ltd. | 2017-11-21 |
| Visual-ICE MRI Cryoblation Console, Visual-ICE MRI Junction Box Assembly, Visual-ICE MRI Mobile Connection Panel (K173037) | Galil Medical, Inc. | 2017-11-21 |
| ENSEAL X1 Tissue Sealer, Straight Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Straight Jaw, 37 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 25 cm Shaft Length,ENSEAL X1 Tissue Sealer, Curved Jaw, 37 cm Shaft Length,ENSEAL X1 Tissue Sealer, Curved Jaw, 45 cm Shaft Length (K172580) | Ethicon Endo-Surgery, LLC | 2017-11-20 |
| Rapid Family (K173169) | Sharplight Technologies, Ltd. | 2017-11-20 |
| DEKA SMARTXIDE ULTRASPEED (K172363) | El.En Electronic Engineering Spa | 2017-11-17 |
| DEKA SMARTXIDE TOUCH (K172362) | El.En Electronic Engineering Spa | 2017-11-17 |
| NeuroBlate System (K173305) | Monteris Medical, | 2017-11-17 |
| AEON Endoscopic Stapler (K171589) | Lexington Medical, Inc. | 2017-11-17 |
| Reprocessed LigaSure Blunt Tip Laparoscopic Sealer/Divider (K172856) | Stryker Sustainability Solutions | 2017-11-16 |
| Bipolar applicator CELON ProCurve V (K172535) | Olympus Winter & Ibe GmbH | 2017-11-16 |
| gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler (K172712) | Gri Medical & Electronic Technology Co., Ltd. | 2017-11-06 |
| PALLAS 308/311 Solid-State UV Laser System (K172639) | Laseroptek Co., Ltd. | 2017-11-03 |
| Compound W Nitro-Freeze (K172373) | Medtech Products, Inc. | 2017-11-02 |
| Valleylab FX8 Electrosurgical Platform (K172757) | Covidien, LLC | 2017-11-02 |
| Surgical Stainless Steel Suture, Stainless Steel Suture (K170767) | ETHICON, Inc. | 2017-11-01 |
| CoolSculpting System (K172144) | Zeltiq Aesthetics | 2017-11-01 |
| Cianna Medical SAVI Scout Reflector and SAVI Scout System (K171767) | Cianna Medical, Inc. | 2017-10-31 |
| Crystal Vision (K163659) | I.C Medical, Inc. | 2017-10-30 |
| Cutera enlighten III Laser System (K172077) | Cutera, Inc. | 2017-10-27 |
| Rhapsody H-30 Holmium Laser System (K172325) | Cook Incorporated | 2017-10-26 |
| CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large) (K173242) | Aziyo Biologics, Inc. | 2017-10-25 |
| Colorado Therapeutics Xenograft Implant (K172937) | Colorado Therapeutics, LLC | 2017-10-25 |
| CleanCision Wound Retraction and Protection System (K172132) | Prescient Surgical, Inc. | 2017-10-25 |
| AtriClip LAA Exclusion System with Preloaded PRO·V Clip (K173031) | AtriCure, Inc. | 2017-10-25 |
| gi-4000 Electrosurgical Generator (K172805) | United States Endoscopy Group, Inc. | 2017-10-23 |
| Monosyn Quick Synthetic Absorbable Surgical Suture (K171001) | Aesculap, Inc. | 2017-10-23 |
| FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture (K172149) | M/s. Meril Endo Surgery Private Limited. | 2017-10-20 |
| Finessis Zero Flexylon Powder Free Sterile White Surgical Glove (K171987) | Lucenxia Prescience AG | 2017-10-20 |
| Ultimate Contour, Ultimate Contour Mini (K171052) | CAO Group, Inc. | 2017-10-20 |