| Rodo Abutment System (K193274) | Rodo Medical, Inc. | 2020-02-27 |
| Disposable Sclerotherapy Needle (K190032) | Hangzhou AGS MedTech Co., Ltd. | 2020-02-27 |
| Pitkar Locked Plating System (K192619) | S.H.Pitkar Orthotools Pvt. , Ltd. | 2020-02-27 |
| CEREBASE DA Guide Sheath, 95cm, CEREBASE DA Guide Sheath, 90cm, CEREBASE DA Guide Sheath, 80cm, CEREBASE DA Guide Sheath, 70cm (K192804) | Medos International SARL | 2020-02-27 |
| Luna Dental Implant System- Healing Abutment (K200189) | Shinhung Mst Co., Ltd. | 2020-02-26 |
| DePuy Synthes Hammertoe Continuous Compression Implant (K191463) | Synthes (USA) Products, LLC | 2020-02-26 |
| VSP System (K192192) | 3D Systems | 2020-02-26 |
| ARK Fentanyl II Assay (K200197) | Ark Diagnostics, Inc. | 2020-02-26 |
| NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR System (K193506) | Nu Vasive, Incorporated | 2020-02-26 |
| Allcem Veneer APS (K191389) | Dentscare Ltda | 2020-02-25 |
| SonicEye Dual-Array Ultrasound System (K192253) | Sonivate Medical, Inc. | 2020-02-25 |
| iTind System (DEN190020) | Medi-Tate , Ltd. | 2020-02-25 |
| uCT 530, uCT 550 (K200016) | Shanghai United Imaging Healthcare Co., Ltd. | 2020-02-25 |
| Surgical laser fibers (K200234) | Quanta System Spa | 2020-02-25 |
| Heater-Cooler System 3T (K191402) | Livanova Deutschland, GmbH | 2020-02-25 |
| Trigon HA Stand-Alone Wedge Fixation System (K193414) | Nvision Biomedical Technologies, Inc. | 2020-02-25 |
| PneumoLiner (K192898) | Advanced Surgical Concepts | 2020-02-25 |
| Ez3D-i /E3 (K200178) | Ewoosoft Co., Ltd. | 2020-02-25 |
| VITROS BRAHMS PCT Reagent Pack and Calibrators (K200236) | Ortho Clinical Diagnostics | 2020-02-25 |
| DELTA XTEND(TM) Reverse Shoulder System (K192855) | Depuy(Ireland) | 2020-02-24 |
| Aquadex FlexFlow System 2.0 (K192756) | Chf Solutions, Inc. | 2020-02-24 |
| Alliance Augmented Glenoid (K193180) | Zimmer, Inc. | 2020-02-24 |
| Titanium Interference Screws (K193451) | Biomet, Inc. | 2020-02-24 |
| 3D Predict (K200214) | 3D Smile USA, Inc. | 2020-02-24 |
| NEXXT MATRIXX System (K193412) | Nexxt Spine, LLC | 2020-02-24 |
| NaturaLyte Dry Bicarbonate Concentrate (Rx-10 Bag), NaturaLyte Dry Bicarbonate Concentrate (Rx-12 Bag), NaturaLyte Dry Bicarbonate Concentrate (Carton) (K191474) | Fresenius Medical Care Renal Therapies Group, LLC | 2020-02-24 |
| Pylant Monitor (K191858) | Kal-Med, LLC | 2020-02-24 |
| T2 Alpha Tibia Nailing System, IMN Screws System (K193308) | Stryker Trauma GmbH | 2020-02-23 |
| Omnia Medical TiBrid Cervical Cage, Omnia Medical TiBrid Lateral Cage, Omnia Medical TiBrid ALIF Cage, Omnia Medical TiBrid PLIF Cage, Omnia Medical TiBrid TLIF Cage (K190363) | Omnia Medical, LLC | 2020-02-21 |
| Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i (K192832) | Canon Medical Systems Corporation | 2020-02-21 |
| AR_N SLA Type Implant System (K190641) | Biotem Co., Ltd. | 2020-02-21 |
| Novalung System (K191407) | Fresenius Medical Care Renal Therapies Group, LLC | 2020-02-21 |
| LightForce Orthodontic System (LFO System) (K200148) | Lightforce Orthodontics | 2020-02-21 |
| PatCom Single-Use Introducer (K192691) | H&A Mui Enterprises, Inc. | 2020-02-21 |
| Coolief Radiofrequency Generator (CRG) System (K192491) | Avanos Medical, Inc. | 2020-02-21 |
| Glenoid Baseplate with Screw (K192799) | Fx Shoulder USA, Inc. | 2020-02-21 |
| ULTepap Expiratory Positive Airway Pressure (EPAP) Device (K191728) | Bryggs Medical, LLC | 2020-02-21 |
| OASIS MRI System (K192851) | Hitachi Healthcare Americas | 2020-02-21 |
| Unity Subcutaneous Infusion System for Remodulin (K191313) | DEKA Research & Development | 2020-02-21 |
| SmoothSkin Pure (K200184) | Cyden Limited | 2020-02-21 |
| Biatain Silicone Ag (K191536) | Coloplast A/S | 2020-02-21 |
| TGS Guidewire and updated Scopis Software (K193118) | Stryker Ent | 2020-02-21 |
| Applied Biosystems™ 3500 Dx Genetic Analyzer and Applied Biosystems™ 3500xL Dx Genetic Analyzer (K191030) | Life Technologies Corporation | 2020-02-21 |
| Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 60 (K192600) | Quanta System Spa | 2020-02-21 |
| Beamscan MR (K191646) | Ptw-Freiburg Physikalisch-Technische-Werkstaetten | 2020-02-21 |
| Tina-quant C-Reactive Protein IV (K192072) | Roche Diagnostics Operations (Rdo) | 2020-02-21 |
| Cardiac Monitor 1500 (K191697) | Zynex Medical, Inc. | 2020-02-21 |
| UCLA CCM Abutment (K192263) | Dio Corporation | 2020-02-21 |
| 3MP Monochrome Digital Mammography LCD Monitor MS-S300 (K200161) | Jvckenwood Corporation | 2020-02-21 |
| Upper Arm Blood Pressure Monitor (K191894) | Shenzhen Zhengkang Technology Co., Ltd. | 2020-02-21 |
| DORO LUCENT® iXI and iMRI Headrest System (K191740) | Pro Med Instruments GmbH | 2020-02-21 |
| AmplideX Fragile X Dx & Carrier Screen Kit (DEN190023) | Asuragen, Inc. | 2020-02-21 |
| Video Laparoscope, Video Processor, Light Source (K192918) | Fujifilm Corporation | 2020-02-20 |
| Largo PEEK Interbody System (K193255) | Flospine, LLC | 2020-02-20 |
| X-MIND Trium (K191719) | De Gotzen S.R.L. | 2020-02-20 |
| Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter (K192922) | Gentuity, LLC | 2020-02-20 |
| Exactech® Equinoxe® Reverse Shoulder Glenospheres (K193098) | Exactech, Inc. | 2020-02-20 |
| ApneaTrak (K192624) | Cadwell Industries, Inc. | 2020-02-20 |
| Potenza (K192545) | Jeisys Medical Incorporated | 2020-02-20 |
| Tinnitus Sound Generator Module (K193303) | GN Hearing A/S | 2020-02-20 |
| Flowart (K190806) | Asset Medikal Tasarim As. | 2020-02-20 |
| Wingman 14, Wingman 14C, Wingman 18, Wingman 35 (K193596) | Reflow Medical | 2020-02-20 |
| SDS2.2 dental implant (K190406) | Sds Swiss Dental Solutions AG | 2020-02-20 |
| Gemini 810+980 Soft Tissue Laser (K192617) | Azena Medical, LLC | 2020-02-20 |
| WIN Flexible Nail System (K193533) | Biomet, Inc. | 2020-02-20 |
| HydroPICC (PICC-142) (K193015) | Access Vascular, Inc. | 2020-02-20 |
| speX Support Catheter (K193012) | Reflow Medical | 2020-02-19 |
| Wego-Stainless Steel (K193209) | Foosin Medical Supplies Inc., Ltd. | 2020-02-19 |
| densitas densityai (K192973) | Densitas, Inc. | 2020-02-19 |
| D R Burton OxyPAP (K192000) | D R Burton Healthcare, LLC | 2020-02-19 |
| Sentinel Cerebral Protection System (K192460) | Boston Scientific Corporation | 2020-02-19 |
| ClearCam System (K200228) | Clearcam, LLC | 2020-02-19 |
| DFV Desensitizing Varnish-Strawberry Flavor, DFV Desensitizing Varnish-Bubblegum (Tutti-Fruity) Flavor, DFV Desensitizing Varnish-Spearmint Flavor, DFV Desensitizing Varnish-Chocolate Flavor, DFV Desensitizing Varnish-Marshmallow Flavor (K192381) | Scientific Pharmaceuticals | 2020-02-18 |
| Mixing and Delivery System (K192674) | Bone Solutions, Inc. | 2020-02-18 |
| Vita Flex CR System with LLI (K192894) | Carestream Health, Inc. | 2020-02-18 |
| Collaboration Live (K200179) | Philips Health Care | 2020-02-18 |
| Ashvins (K200132) | Medicalcommunications GmbH | 2020-02-18 |
| CareStart Flu A&B Plus (K191514) | Access Bio, Inc. | 2020-02-18 |
| InPen Dose Calculator (K190487) | Companion Medical, Inc. | 2020-02-18 |
| MOJAVE Expandable Interbody System (K193203) | K2m, Inc. | 2020-02-18 |
| APTUS® Forearm Shaft Plates and APTUS® Wrist 2.5 System (K193554) | Medartis AG | 2020-02-16 |
| Swan-Ganz Catheters (K193466) | Edwards Lifesciences, LLC | 2020-02-16 |
| CapsoCam Plus (SV-3) Capsule Endoscopy System (K192662) | CapsoVision, Inc. | 2020-02-14 |
| Affinity (K193152) | Hermes Medical Solutions AB | 2020-02-14 |
| Biograph Vision, Biograph mCT Family of PET/CTs (K193248) | Siemens Medical Solutions USA, Inc. | 2020-02-14 |
| Vitrea Software Package (K192923) | Canon Medical Systems Corporation | 2020-02-14 |
| OneTouch Verio Reflect Blood Glucose Monitoring System (K193475) | Lifescan Europe GmbH | 2020-02-14 |
| VITEK 2 AST- Gram Negative Polymyxin B (<=0.25 – >=16 ug/mL) (K193567) | bioMerieux, Inc. | 2020-02-14 |
| CardIQ Flow (K192277) | GE Medical Systems SCS | 2020-02-14 |
| i-STAT CHEM8+ cartridge with the i-STAT 1 System (K191360) | Abbott Point of Care, Inc. | 2020-02-14 |
| Orion LifeSpan MEG (K191785) | Compumedics Limited | 2020-02-14 |
| EMBA Hourglass Peripheral Embolization Device (PED) (K200083) | Embolic Acceleration, LLC | 2020-02-14 |
| Maximus System (K192143) | Hill-Rom Services Pte, Ltd. | 2020-02-14 |
| Dunamis PunchTac Suture Anchors (K193245) | Dunamis, LLC | 2020-02-14 |
| Real Intelligence Cori (K193120) | Blue Belt Technologies, Inc. | 2020-02-14 |
| T-TAS 01 Total Thrombus-formation Analysis System Instrument, PL Chip for T-TAS 01, PL Chip Reservoir Set for T-TAS 01, BAPA tube for T-TAS 01 (K191364) | Fujimori Kogyo, Co., Ltd. | 2020-02-14 |
| The Graft Bone Substitute (K191737) | Purgo Biologics, Inc. | 2020-02-14 |
| Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids) (K191346) | Blackrock Microsystems | 2020-02-14 |
| ASCEND Image Viewer (K192372) | Ascend Hit | 2020-02-14 |
| Venner PneuX™ ETT (Endotracheal Tube) 6 mm, Venner PneuX™ ETT (Endotracheal Tube) 7 mm, Venner PneuX™ ETT (Endotracheal Tube) 8 mm, Venner PneuX™ ETT (Endotracheal Tube) 9 mm (K192120) | Venner Medical (Singapore) Pte, Ltd. | 2020-02-14 |