| Harmony (K182376) | Topcon Medical Systems, Inc. | 2018-09-28 |
| Adaptive Biotechnologies clonoSEQ Assay (DEN170080) | Adaptive Biotechnologies Corporation | 2018-09-28 |
| Prime&Bond active Universal Adhesive (K181476) | Dentsply Sirona | 2018-09-28 |
| FibriCheck (K173872) | Qompium NV | 2018-09-28 |
| TSP Crosser Transseptal Access System (K181088) | Transseptal Solutions , Ltd. | 2018-09-28 |
| MICRORAPTOR Knotless Suture Anchor (K181746) | Smith and Nephew, Inc. | 2018-09-28 |
| Seidmon Antegrade AQ Stent Set (K180216) | Cook Incorporated | 2018-09-28 |
| Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid Inlay (K182039) | Arthrex, Inc. | 2018-09-28 |
| Alphenix, INFX-8000F/B, V8.0 (K182415) | Canon Medical Systems Corporation | 2018-09-28 |
| Libertas Hip Replacement System (K180973) | Maxx Orthopedics, Inc. | 2018-09-28 |
| E-CUBE 12 (K181277) | Alpinion Medical Systems Co., Ltd. | 2018-09-28 |
| Truliant Porous Femoral Components (K181794) | Exactech, Inc. | 2018-09-28 |
| RightEye Vision System (K181771) | Righteye, LLC | 2018-09-28 |
| Endoscope Sterilization Tray (K180964) | Intuitive Surgical, Inc. | 2018-09-28 |
| BioCode Gastrointestinal Pathogen Panel (GPP) (K180041) | Applied BioCode, Inc. | 2018-09-28 |
| ORISE Gel (K180068) | Boston Scientific | 2018-09-28 |
| Kawasumi Laboratories Blood Drawing Kit (BDK) System (K172957) | Kawasumi Laboratories, Inc. | 2018-09-28 |
| Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable Suture (K181652) | ETHICON, Inc. | 2018-09-28 |
| ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA) (K181742) | Stryker GmbH | 2018-09-27 |
| Acculoc Total Knee System (K182370) | Rootloc Co., Ltd. | 2018-09-27 |
| CoLink View Plating System (K182402) | In2bones USA, LLC | 2018-09-27 |
| DualX (K181397) | Innovasive, Inc. | 2018-09-27 |
| PureSet Tray (K181075) | Nobel Biocare AB | 2018-09-27 |
| CarboClear® Pedicle Screw System (K182377) | CarboFix Orthopedics , Ltd. | 2018-09-27 |
| Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30µg) MEV30 (K181975) | Oxoid Limited (Part of Thermo Fisher Scientific) | 2018-09-27 |
| Disposable Standard Clamp (K181608) | Standard Bariatrics | 2018-09-27 |
| EmboCube Embolization Gelatin (K181021) | Biosphere Medical, S.A. | 2018-09-27 |
| CRP Vario (K173833) | SENTINEL CH. SpA | 2018-09-27 |
| BeautiBond Universal (K180803) | Shofu Dental Corporation | 2018-09-26 |
| The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology (K181563) | Access Scientific, LLC | 2018-09-26 |
| Powder Free Nitrile Examination Glove (Blue) with Low Dermatitis claim and with tested for Use with Chemotherapy Drugs Claims (K181066) | Eco Medi Glove Sdn. Bhd. | 2018-09-26 |
| Magic Torque DLVR Guidewire (K182315) | Boston Scientific Corporation | 2018-09-26 |
| Stat Profile Prime Plus Analyzer System (K180340) | Nova Biomedical Corporation | 2018-09-26 |
| InMode RF System (K182325) | Inmode MD , Ltd. | 2018-09-26 |
| NxStage Connected Health System (K181991) | Nxstage Medical, Inc. | 2018-09-26 |
| Fixated Asfora BULLET CAGE® (FABC) (K181591) | Medical Designs, LLC | 2018-09-26 |
| HardyDisk AST Eravacycline 20µg (ERV20) (K182357) | Hardy Diagnostics | 2018-09-26 |
| Everyway Wireless TENS & EMS Unit (K181707) | Everyway Medical Instruments Co.,Ltd | 2018-09-26 |
| CPX 4 Breast Tissue Expander with Smooth Surface (K182335) | Mentor Worldwide, LLC | 2018-09-25 |
| IBM iConnect Access (K182290) | Merge Healthcare Incorporated | 2018-09-25 |
| PeDIA (K181424) | Pedia, LLC | 2018-09-25 |
| AST Model MA012 and MS019 Rehab Wheelchair (K181795) | Sichuan Ast Medical Equipment Co., Ltd. | 2018-09-25 |
| 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 |
| OsseoScrew System (K181980) | Alphatec Spine, Inc. | 2018-09-25 |
| Synapse 3D Optional Tools (K181773) | Fujifilm Corporation | 2018-09-25 |
| 5 FR Dual Lumen Piper PICC (K181904) | Piper Access, LLC | 2018-09-25 |
| skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent Kit) (K173127) | Skyla Corporation H.S.P.B | 2018-09-25 |
| Probe Covers for Thermometers (K180714) | K-Jump Health Co., Ltd. | 2018-09-24 |
| AMADEO M-DR mini, AMADEO M-AX mini (K182317) | Oehm Und Rehbein GmbH | 2018-09-24 |
| Comprehensive Reverse Shoulder System (K181611) | Biomet Manufacturing Corp | 2018-09-24 |
| iNtuition-T1 Mapping and T2/T2* Mapping (K180916) | Terarecon,Inc. | 2018-09-24 |
| REDAPT Porous Acetabular Shell (K181366) | Smith & Nephew, Inc. | 2018-09-24 |
| Agile Esophageal Stent System (K180144) | Boston Scientific Corporation | 2018-09-21 |
| Spineology Navigation Instruments (K182345) | Spineology, Inc. | 2018-09-21 |
| VeriSuite (K181789) | Medcom GmbH | 2018-09-21 |
| BD Phoenix Automated Microbiology System - BD Phoenix CPO detect - GN (K181665) | Becton, Dickinson and Company | 2018-09-21 |
| InVivo Web Viewer (K181926) | Anatomage, Inc. | 2018-09-21 |
| DePuy Corail AMT Hip Prosthesis (K173960) | Depuy France S.A.S. | 2018-09-21 |
| NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR PRIMER AND PROBE SET (DEN070001) | Centers for Disease Control and Prevention | 2018-09-21 |
| BB-613 Watch Oximeter (K181006) | Bio-Beat Technologies , Ltd. | 2018-09-21 |
| TEVADAPTOR Closed Drug Reconstitution and Transfer System (K180489) | Teva Medical Ltd., Migada Plant | 2018-09-21 |
| PSM 3-Way Silicone Foley Catheter (K181616) | Pathway, LLC | 2018-09-21 |
| Arthrex FiberTak Suture Anchor (K181769) | Arthrex, Inc. | 2018-09-21 |
| Cellulize (K180338) | Ward Photonics, LLC | 2018-09-21 |
| SOLOASSIST II (K171947) | Aktormed GmbH | 2018-09-21 |
| Tranquil-L Interbody System (K181702) | Nexus Spine, LLC | 2018-09-21 |
| AquaShield System CO2 ; AquaShield System CO2 - PENTAX ; AquaShield System CO2 - Fujifilm (K182258) | United States Endoscopy Group, Inc. | 2018-09-21 |
| Volpara Imaging Software (K182310) | Volpara Health Technologies Limited | 2018-09-21 |
| Malecot Nephrostomy Catheter/Stent Set (K180029) | Cook Incorporated | 2018-09-21 |
| Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored) (K182043) | Hebei Titans Hongsen Medical Technology Co., Ltd. | 2018-09-21 |
| Pocket Colposcope System (K181034) | Hadleigh Health Technologies, LLC | 2018-09-21 |
| OpenSight (K172418) | Novarad Corporation | 2018-09-21 |
| AEROmini Tracheobronchial Stent System (K181200) | Merit Medical Systems, Inc. | 2018-09-21 |
| EndoTool SubQ (K180366) | Al Pacheco and Associates | 2018-09-20 |
| LOGIQ P9; LOGIQ P7 (K181783) | GE Healthcare | 2018-09-20 |
| Medline Patient Cables and Lead Wires (K181726) | Medline Industries, Inc. | 2018-09-20 |
| Chiral Surgical Pedicle Screw System (K181995) | Chiral Surgical | 2018-09-20 |
| MicroPort Orthopedics Total Hip Systems MR Labeling (K173898) | Microport Orthopedics Inc. (Mpo) | 2018-09-20 |
| OralTox Oral fluid Drug Test (K181305) | Premier Biotech, Inc. | 2018-09-20 |
| Katalyst Mark 1 Muscle Stimulation System Model 2 (K181199) | Katalyst, Inc. | 2018-09-20 |
| Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set (K181205) | Centers for Disease Control and Prevention | 2018-09-20 |
| Aequalis Flex Revive Shoulder System (K181420) | Tornier, Inc. | 2018-09-20 |
| NICO Myriad (K182340) | Nico Corporation | 2018-09-20 |
| Beurer IPL 8500 device/ IPL VelvetSkin Pro (K181734) | Home Well Trading, Ltd. | 2018-09-19 |
| Scope Antifogging System (K182080) | Xodus Medical, Inc. | 2018-09-19 |
| Bard Vertus Foley Catheter (K180781) | C.R. Bard, Inc. | 2018-09-19 |
| FORTIFY Corpectomy Spacers (K173982) | Globus Medical, Inc. | 2018-09-19 |
| CSM Submerged3-L Implant System (K173141) | Csm Implant | 2018-09-19 |
| T2 STRATOSPHERE™ Expandable Corpectomy System (K181328) | Medtronic Sofamor Danek USA, Inc. | 2018-09-19 |
| IHM Technology Bandage (K180893) | Protege Biomedical | 2018-09-19 |
| Ortoma Treatment Solution - OTS (K181449) | Ortoma AB | 2018-09-19 |
| Magnetic Surgical System (K180894) | Levita Magnetics International Corp | 2018-09-19 |
| Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit (K180981) | Stimwave Technologies Incorporated | 2018-09-19 |
| Oh'Care Lite Smart Blood Glucose Monitoring System (K182286) | Osang Healthcare Co. , Ltd. | 2018-09-19 |
| TirboLOX-C Cervical IBFD (K181229) | Captiva Spine, Inc. | 2018-09-19 |
| Vexillum (olifilcon B) with Tangible Polymers Silicone Hydrogel Soft Contact Lens; Daily Breeze (olifilcon B) Silicone Hydrogel Soft Contact Lens (K181349) | Visco Vision, Inc. | 2018-09-19 |
| Elecsys FT4 III (K181233) | Roche Diagnostics | 2018-09-18 |
| The CVC WAND Safety Introducer with Valved Peelable Sheath (K182243) | Access Scientific, LLC | 2018-09-18 |
| MAC VU360 Resting ECG Analysis System (K173830) | Ge Medical Systems Information Technologies, Inc. | 2018-09-18 |
| Caprolon (K181320) | Resorba Medical GmbH | 2018-09-18 |