| ACUVUE OASYS (senofilcon A) with Photochromic Additive (K180299) | Johnson & Johnson Vision Care, Inc. | 2018-04-10 |
| Precision Flow® HVNI (DEN170001) | Vapotherm, Inc. | 2018-04-10 |
| Digital Automatic Wrist Blood Pressure Monitor MD4300 (K171379) | Grandway Technology (Shenzhen) Limited | 2018-04-10 |
| AXIS 5.5 Lumbar Pedicle Screw System (K180301) | Axis Orthopaedics | 2018-04-10 |
| DTI-1 SLA IMPLANT SYSTEM (K170776) | Dti Implant Sistemleri Sanayi Ticaret Anonim Sirketi | 2018-04-10 |
| BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube (K173384) | Smiths Medical Ads, Inc. | 2018-04-10 |
| Mercury® Spinal System (K172967) | Spinal Elements, Inc. | 2018-04-10 |
| Eviva Stereotactic Guided Breast Biopsy System (K180233) | Hologic, Inc. | 2018-04-10 |
| Hysteroscopy System (K172151) | Chongquin Jinshan Science & Technology (Group) Co., Ltd. | 2018-04-09 |
| Aurora Evacuator (K180372) | Rebound Therapeutics | 2018-04-09 |
| OT EQUATOR (K171409) | Rhein'83 Srl | 2018-04-09 |
| ClotTriever Thrombectomy System (K180329) | Inari Medical, Inc. | 2018-04-09 |
| Silicone Personal Lubricant, ALL-IN-ONE (K180083) | United Consortium | 2018-04-09 |
| Disposable Endoscopic Trocar (K180208) | Fengh Medical Co., Ltd. | 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 |
| NAVIO™ Surgical System (NAVIO system) (K180271) | Blue Belt Technologies, Inc. | 2018-04-06 |
| 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 |
| FIBERGRAFT BG Matrix Bone Graft Substitute (K180080) | Prosidyan, Inc. | 2018-04-06 |
| Anchored Beacon(R) transponder, Anchored transponder, Beacon Care Package - Lung (K170570) | Varian Medical Systems, Inc. | 2018-04-06 |
| PTFE SURGICAL SUTURE (K180630) | Omnia Spa | 2018-04-06 |
| A. L. P. S. Clavicle Plating System (K173767) | Biomet, Inc. | 2018-04-06 |
| DiaSpect Tm, DiaSpect Tm Cuvettes (K172173) | Ekf-Diagnostic GmbH | 2018-04-06 |
| Medicant Mucosal Atomizer (K172956) | Medica Holdings, LLC | 2018-04-06 |
| NovoGro (K173525) | Osteonovus, Inc. | 2018-04-06 |
| Clench Compression Staple (K173775) | F & A Foundation, LLC D.B.A. Reign Medical | 2018-04-06 |
| 8mm Monopolar Curved Scissors (K180033) | Intuitive Surgical, Inc. | 2018-04-06 |
| Patriot Spinal Fixation System (K180324) | Valorus Spine | 2018-04-06 |
| SIC invent Dental Implant Systems (K173207) | Sic Invent AG | 2018-04-05 |
| Bipolar Micro-Coagulation Forceps (K172368) | Gunter Bissinger Medizintechnik GmbH | 2018-04-05 |
| Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters (K180694) | Spectranetics, Inc. | 2018-04-05 |
| Medacta Shoulder System Short Humeral Diaphysis (K180089) | Medacta International S.A. | 2018-04-05 |
| VAMP Venous/Arterial Blood Management Protection System (K173586) | Edwards Lifesciences, LLC | 2018-04-05 |
| PENTAX Medical EPK-3000 Video Imaging System (K172156) | Pentax Medical | 2018-04-05 |
| DR 800 with MUSICA Dynamic (K180589) | Agfa Healthcare N.V. | 2018-04-05 |
| Neodent Instrument Kits (K171713) | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2018-04-05 |
| Wedge Microcatheter (K172014) | MicroVention, Inc. | 2018-04-05 |
| Axis Anterior Cervical Plate System (K173867) | Axis Orthopaedics | 2018-04-05 |
| Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module (K180378) | Optomed OY | 2018-04-05 |
| AssureTech Panel Dip Tests, AssureTech Quick Cup Tests (K180349) | Assure Tech. (Hangzhou) Co, Ltd. | 2018-04-05 |
| SENTIO MMG Gen 2 (K173526) | Medos International SARL | 2018-04-05 |
| K2M Patient Specific Rods (K180376) | K2m, Inc. | 2018-04-05 |
| TheraCal DC (K180344) | Bisco, Inc. | 2018-04-05 |
| Corin Optimized Positioning System (OPS™) Plan (K171847) | Corin U.S.A. Limited | 2018-04-05 |
| syngo.via MI Workflows (K173897) | Siemens Medical Solutions USA, Inc. | 2018-04-05 |
| PowerLook Density Assessment Software (K180125) | Icad, Inc. | 2018-04-05 |
| uWS-MI (K172998) | Shanghai United Imaging Healthcare Co., Ltd. | 2018-04-05 |
| GORE ENFORM Biomaterial (K173333) | W. L. Gore & Associates, Inc. | 2018-04-05 |
| Nano Varnish, Plaquit, Lightpaint on Surface (K162408) | Dreve Dentamid GmbH | 2018-04-05 |
| Liofilchem MIC Test Strip (MTS), Azithromycin 0.016 - 256 µg/mL (K180339) | Liofilchem s.r.l. | 2018-04-04 |
| TrapLiner catheter (K180088) | Vascular Solutions, Inc. | 2018-04-04 |
| Master-Frank N95 Particulate Respirator (K172963) | Master & Frank Enterprise Co., Ltd. | 2018-04-04 |
| leva Pelvic Floor Trainer (K180637) | Renovia, Inc. | 2018-04-04 |
| ICONIX XBraid TT with Needles, NanoTack TT Suture Anchor (K173074) | Stryker | 2018-04-04 |
| The Pump by Babyation (K173699) | Babyation, LLC | 2018-04-04 |
| GammaPod (K180571) | Xcision Medical Systems, LLC | 2018-04-04 |
| SIMPLANT 18 (K172239) | Dentsply Sirona | 2018-04-04 |
| SciMoCa (K180595) | Radialogica, LLC | 2018-04-04 |
| SYSTEM 1E Liquid Chemical Sterilant Processing System (K180342) | Steris Corporations | 2018-04-04 |
| Algidex Ag Silver Alginate Wound Dressing (K173072) | Deroyal Industries, Inc. | 2018-04-04 |
| Ingenia 1.5T, Ingenia 1 5T S, Ingenia 1.5T CX, Ingenia 3.0T CX R5.4 (K173079) | Philips Medical Systems Nederland B.V. | 2018-04-04 |
| Pulse Oximeter (K172141) | Shanghai Berry Electronic Tech Co., Ltd. | 2018-04-04 |
| Scenium VE20 Software (K173597) | Siemens Medical Solutions USA, Inc. | 2018-04-04 |
| MobileX Portable X-ray System (K180561) | Denterprise International, Inc. | 2018-04-04 |
| PRECICE STRYDE System (K180503) | Nuvasive Specialized Orthopedics, Inc. | 2018-04-03 |
| DSM Biomedical Calcium Phosphate Cement (K173362) | Kensey Nash Corporation Dba Dsm Biomedical | 2018-04-03 |
| AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO (K180597) | Lumenis, Ltd. | 2018-04-03 |
| Curetis Unyvero LRT Application (DEN170047) | Curetis GmbH | 2018-04-03 |
| High-Flo Silver Polyethylene Catheter (K172635) | Cook Incorporated | 2018-04-03 |
| LigaPASS (K173506) | Medicrea International SA | 2018-04-03 |
| Infinity-Lock Button System (K180243) | Xiros, Ltd. | 2018-04-03 |
| OxyAqua (olifilcon D) spherical silicone hydrogel soft contact lens, OxyAqua (olifilcon D) multifocal silicone hydrogel soft contact lens, OxyAqua (olifilcon D) toric silicone hydrogel soft contact lens (K173958) | Visco Vision, Inc. | 2018-04-03 |
| Unite Connect for Clinical Systems (K180566) | Ascom Sweden AB | 2018-04-03 |
| Genesys Spine Binary Lumbar Plate System (K173885) | Genesys Spine | 2018-04-03 |
| Surefire Spark Infusion System (K180677) | Surefire Medical, Inc. | 2018-04-03 |
| dpl IIa Panel (K180320) | Led Technologies, Inc. | 2018-04-03 |
| Kisses Plus Implant System (K172630) | Achimhai Medical Corporation | 2018-04-03 |
| Varian Head Frame (K180586) | Varian Medical Systems, Inc. | 2018-04-02 |
| Instrument basket, for EndoEYE (K171692) | Olympus Winter & Ibe GmbH | 2018-04-02 |
| GC Fuji Direct (K172382) | GC America, Inc. | 2018-04-02 |
| Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax (K173639) | Siemens Medi Cal Solutions, Inc. | 2018-04-02 |
| CREO® Stabilization System (K180210) | Globus Medical, Inc. | 2018-04-02 |
| K-D Balance (K173669) | King-Devick Technologies, Inc. | 2018-04-02 |
| Microcyn Antimicrobial Hydrogel (K173896) | Sonoma Pharmaceuticals, Inc. | 2018-04-02 |
| SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Deinition AS/AS+, SOMATOM Confidence (K173630) | Siemens Medical Solutions USA, Inc. | 2018-03-30 |
| SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System (K180194) | Paragonix Technologies, Inc. | 2018-03-30 |
| MAGNETOM Vida with Compressed Sensing GRASP-VIBE (K173617) | Siemens Medical Solutions USA, Inc. | 2018-03-30 |
| G-scan Brio (K180592) | Esaote, S.p.A. | 2018-03-30 |
| syngo.CT Coronary Analysis; syngo.CT Vascular Analysis (K173637) | Siemens Medical Solutions USA, Inc. | 2018-03-30 |
| Bleep DreamPort (K172335) | Snapcpap | 2018-03-30 |
| Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon (K173789) | Elekta Instrument AB | 2018-03-30 |
| OLYMPUS URF-V2/V2R (K172246) | Olympus Medical Systems Corp. | 2018-03-30 |
| Merit Pursue Microcatheter (K173548) | Merit Medical Systems, Inc. | 2018-03-30 |
| gammaCore Sapphire (K180538) | Electrocore, LLC | 2018-03-30 |
| AMSure® Enteral Feeding Syringe with ENFit Tip (K171857) | Amsino International, Inc. | 2018-03-30 |
| RADspeed fit (K173517) | Shimadzu Corporation | 2018-03-30 |
| Performer Guiding Sheath (K171988) | Cook Incorporated | 2018-03-30 |
| Straumann Variobase for Crown AS (K173379) | Institut Straumann AG | 2018-03-30 |
| Dimesol Tubing Sets for Hemodialysis (K171952) | Dimesol, Inc. | 2018-03-30 |