| Spectra Cashmere (K191208) | Uzinmedicare Co. | 2019-10-11 |
| Razor, Everest, U&C Liquid (K191902) | U&C International Co., Ltd. | 2019-10-11 |
| BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20 (K192515) | Shenzhen Bioeasy Biotechnology Co., Ltd. | 2019-10-11 |
| SMR Finned Short Stems (K191963) | Lima Corporate S.P.A. | 2019-10-10 |
| Paper Sterilization Pouch and Roll(Sterilization Pouch Flat, Sterilization Pouch Gusseted, Sterilization Roll Flat and Sterilization Roll Gusseted) (K182184) | Mdk (Shanghai) Medical Packing Co., Ltd. | 2019-10-10 |
| DigiFix Sterile Kit (K192465) | Virak Orthopedics, LLC | 2019-10-10 |
| Legacy SMARTBase Abutments (K191458) | Implant Direct Sybron Manufacturing, LLC | 2019-10-10 |
| Belun Ring (K191417) | Belun Technology Company Limited | 2019-10-10 |
| Palladium High Flow Therapy System (K191010) | Vapotherm, Inc. | 2019-10-10 |
| Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303) (K182136) | Shenzhen Osto Technology Co., Ltd. | 2019-10-10 |
| KTA Adipose Treatment Kit (K190386) | Stemics S.A.S | 2019-10-10 |
| VERA (K192474) | Reflexion Health, Inc. | 2019-10-10 |
| ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System (K192210) | Fiab Spa | 2019-10-10 |
| Instylla Delivery Kit (K191659) | Instylla, Inc. | 2019-10-10 |
| Spine Wave Navigated Instruments (K192526) | Spine Wave, Inc. | 2019-10-10 |
| Cranial PSI Accessory – Anatomical Model Original, Cranial PSI Accessory – Anatomical Model Modified, Cranial PSI Accessory – Plastic Drawing Guide, Cranial PSI Accessory – Cranial Implant Trial (K190523) | Ossdsign AB | 2019-10-10 |
| Mercy babyTAPE (K191174) | Children'S Mercy Hospital | 2019-10-10 |
| SURGICAL MICROSCOPE SYSTEM ORBEYE with IR (K190772) | Olympus Medical Systems Corp. | 2019-10-10 |
| OraQuick Ebola Rapid Antigen Test (DEN190025) | OraSure Technologies, Inc. | 2019-10-10 |
| Waterlase Laser System Family (K190319) | Biolase, Inc. | 2019-10-10 |
| Halyard ONE-STEP* Sterilization Wrap (K192147) | Owens & Minor (O&M) Halyard, Inc. | 2019-10-10 |
| Visalys Restorative Primer (K191523) | Kettenbach GmbH & Co. KG | 2019-10-09 |
| SolidAIRity III Airway Stabilization System (K190630) | Securisyn Medical, LLC | 2019-10-09 |
| Parcus Synd-EZ Ti (K191783) | Parcus Medical, LLC | 2019-10-09 |
| The Cellfina System (K192185) | Ulthera, Inc. | 2019-10-09 |
| Nipro Syringe (K191359) | Nipro Medical Corporation | 2019-10-09 |
| CORNICE Cervical Spacer System (K192208) | Legend Spine Technologies | 2019-10-09 |
| pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire (K191687) | Phenox Limited | 2019-10-09 |
| Arcadia Balloon Catheter (K191596) | Merit Medical Systems, Inc. | 2019-10-09 |
| AnyRidge Octa 1 Implant System (K182448) | Megagen Implant Co., Ltd. | 2019-10-09 |
| Pediatric Nailing PlatformFemur (K190321) | OrthoPediatrics Corp. | 2019-10-09 |
| DynaCAD (K192200) | Invivo Corporation | 2019-10-09 |
| Advanced Intelligent Volumetric Ultrasound System, Model AiVUS 1000 (K190314) | Mednovel Technology, Ltd. | 2019-10-09 |
| Bodycad Unicompartmental Knee System (K191150) | Bodycad Laboratories, Inc. | 2019-10-08 |
| KATANA Cleaner, KATANA Cleaner (Trial) (K191133) | Kuraray Noritake Dental, Inc. | 2019-10-08 |
| Barrier Sleeves (K191448) | Ivoclar Vivadent, AG | 2019-10-08 |
| Advanced Intermezzo Implant System (K191127) | Megagen Implant Co., Ltd. | 2019-10-08 |
| TSolution One Total Knee Application (K191369) | THINK Surgical, Inc. | 2019-10-08 |
| Single-Use Non-Stick Bipolar forceps Bayonet, Single-Use Non-Stick Bipolar Irrigating forceps, Single Use Non-Stick Bipolar Suction forceps (K182773) | Faulhaber Pinzetten Ohg | 2019-10-08 |
| ScopeSeal Duodenoscope Protective Device (K183171) | Gi Scientific, LLC | 2019-10-08 |
| 32mm Glenosphere and Humeral Cup (K192206) | Fx Shoulder USA, Inc. | 2019-10-08 |
| Attune Revision LPS Inserts (K191779) | Depuy(Ireland) | 2019-10-08 |
| Premia Spine XL Instruments (K191854) | Premia Spine, Ltd. | 2019-10-08 |
| Dexcom G6 Pro Continuous Glucose Monitoring System (K191833) | Dexcom, Inc. | 2019-10-07 |
| NIO-I (K190538) | Waismed, Ltd. | 2019-10-07 |
| Cepheid Xpert Respiratory Control Panel (K190086) | Microbiologics, Inc. | 2019-10-07 |
| Interlude Rolled Tampons in Plastic Applicator (K191431) | Albaad Fem | 2019-10-07 |
| PROFEMUR TL2 Stems (K191632) | Microport Orthopedics, Inc. | 2019-10-07 |
| AFX Femoral Implant with Inserter (K192428) | Cayenne Medical | 2019-10-05 |
| Bausch + Lomb PreVue Inserter for enVista Preloaded (K192005) | Bausch & Lomb, Inc. | 2019-10-04 |
| Steerable Introducer 12F (K192422) | Freudenberg Medical, LLC | 2019-10-04 |
| DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12 (K190298) | Beckman Coulter Biomedical GmbH | 2019-10-04 |
| Urethrotech UCD (K190060) | Urethrotech | 2019-10-04 |
| Ceramill A-Temp (K191843) | Amann Girrbach AG | 2019-10-04 |
| Powder-free Nitrile Patient Examination Glove, Green Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs (K183441) | Semperit Investments Asia Pte , Ltd. | 2019-10-04 |
| Delta Xtend Revers Shoulder System (K192448) | Depuy(Ireland) | 2019-10-04 |
| CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™ (ROI Assembly) (K191713) | Omega Medical Imaging, LLC | 2019-10-04 |
| Tokuyama Rebase III (K190940) | Tokuyama Dental Corporation | 2019-10-04 |
| Vivio System (K183710) | Avicena, LLC | 2019-10-04 |
| Safergel Sterile Ultrasound Gel (K190591) | Safersonic Us, Inc. | 2019-10-04 |
| LZI Methadone II Enzyme Immunoassay (K192433) | Lin-Zhi International, Inc. | 2019-10-04 |
| Sutter Arrowtip Monopolar Electrodes (K192128) | Sutter Medizintechnik GmbH | 2019-10-04 |
| Hypodermic Safety Needle, Hypodermic Safety Needle with Syringe (K190183) | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | 2019-10-04 |
| ProFound AI Software V2.1 (K191994) | Icad, Inc. | 2019-10-04 |
| Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe (K190208) | Diversatek Healthcare | 2019-10-03 |
| XACT Robotic System (K191332) | Xact Robotics, Ltd. | 2019-10-03 |
| Millenium HX (K192398) | Mar Cor Purification, Inc. | 2019-10-03 |
| Propex IQ Apex Locator (K191806) | Dentsply Sirona | 2019-10-03 |
| Arthrex Mini Comprehensive Fixation System – 2.0mm & 2.4mm Module (K191344) | Arthrex, Inc. | 2019-10-03 |
| Asthma Monitor AM3 (K183479) | Eresearch Technology | 2019-10-03 |
| Yumizen C1200 CRP (K191993) | HORIBA ABX SAS | 2019-10-03 |
| Ablation Confirmation (K192427) | Neuwave Medical, Inc. | 2019-10-03 |
| Vintage Art Universal (K191794) | Shofu Dental Corporation | 2019-10-03 |
| EVS 4343A, EVS 4343AG, EVS 3643A, EVS 3643AG (K192400) | DRTECH Corporation | 2019-10-03 |
| Mobius3D (K192424) | Varian Medical Systems, Inc. | 2019-10-03 |
| Retractable Safety Syringe, Retractable Safety Insulin Syringe, Retractable Safety Tuberculin Syringe, Retractable Safety Allergy Syringe (K191490) | Jiangsu Caina Medical Co.,Ltd | 2019-10-03 |
| Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel (K191099) | Atlas Medical | 2019-10-03 |
| ALFA GATE Dental Implants System (K182143) | Alfa Gate Mazen, Ltd. | 2019-10-03 |
| SAHARA Stabilization System (K190179) | K2m, Inc. | 2019-10-03 |
| CD Horizon™ Astute™ Spinal System (K191066) | Medtronic Sofamor Danek USA, Inc. | 2019-10-03 |
| Ultraverse 014 and 018 PTA Balloon Dilatation Catheters (K192318) | Bard Peripheral Vascular, Inc. | 2019-10-03 |
| Neocis Planning Software Application (NPSA) for 3rd Party PCs (K191363) | Neocis, Inc. | 2019-10-02 |
| NG-Test CARBA 5 (K191889) | Ng Biotech | 2019-10-02 |
| Aimanfun Lumea Comfort (K190820) | Kam Yuen Plastic Products , Ltd. | 2019-10-02 |
| LIAISON Vitamin B12 (K192064) | DiaSorin, Inc. | 2019-10-02 |
| Momentum™ Posterior Spinal Fixation System (K191932) | Ulrich Medical USA | 2019-10-02 |
| OxySoft (olifilcon C) silicone hydrogel soft contact lens (K191397) | Visco Vision, Inc. | 2019-10-02 |
| RTapp (K191610) | Segana, LLC | 2019-10-01 |
| Intellijoint® Navigation System (K191507) | Intellijoint Surgical, Inc. | 2019-10-01 |
| Signa Voyager, Signa Voyager Quantum (K192426) | Ge Healthcare (Tianjin) Company Limited | 2019-10-01 |
| DIAMOND-5A/6A/8A (K192453) | DRGEM Corporation | 2019-10-01 |
| ExactVu High Resolution Micro-Ultrasound System (K192303) | Exact Imaging, Inc. | 2019-10-01 |
| Cardioblate CryoFlex Surgical Ablation System (K191526) | Medtronic, Inc. | 2019-10-01 |
| Aveta System (K191958) | Meditrina, Inc. | 2019-10-01 |
| BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System (K192416) | Zimmer GmbH | 2019-10-01 |
| Applied Biosystems Bacillus anthracis Detection Kit (K183462) | Mriglobal | 2019-10-01 |
| SmileAlign Orthodontic Aligner System (K191774) | 3D Global Biotech, Inc. | 2019-09-30 |
| UF(II) Anatomic abutment (K190048) | Dio Corporation | 2019-09-30 |
| APTUS Wrist Spanning Plates 2.5 (K191848) | Medartis AG | 2019-09-30 |
| Hair Boom 69, Hair Boom Air, Ulike Hair UpUp (K192425) | Wontech Co., Ltd. | 2019-09-30 |