| Shaders ZR (K190569) | Digital Age Dental Lab | 2019-07-29 |
| CoLink® Mini Plating System (K191535) | In2bones USA, LLC | 2019-07-29 |
| Helioseal F Plus (K190339) | Ivoclar Vivadent, AG | 2019-07-29 |
| Sample Imaging for Senographe Pristina (K190809) | GE Healthcare | 2019-07-29 |
| Non-invasive blood pressure measurement systems (K190886) | Joytech Healthcare Co. , Ltd. | 2019-07-29 |
| Quantisal II Oral Fluid Collection Device (K183048) | Immunalysis Corporation | 2019-07-29 |
| ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgM Test System (K191240) | Zeus Scientific, Inc. | 2019-07-29 |
| BiomarC Fiducial Marker (K191797) | Carbon Medical Technologies | 2019-07-29 |
| Bonus Therapeutics Mixing and Delivery System (K190996) | Bonus Therapeutics , Ltd. | 2019-07-28 |
| Megadyne Foot Switch (K191328) | Megadyne Medical Products, Inc. | 2019-07-26 |
| ScanX Barrier Envelopes (K190949) | Air Techniques, Inc. | 2019-07-26 |
| Arthrex Eclipse Shoulder Prosthesis System (K183194) | Arthrex, Inc. | 2019-07-26 |
| Medtronic Total Hip Arthroplasty System (K183129) | Medtronic Advanced Energy | 2019-07-26 |
| RapidVit™ Oocyte, RapidWarm™ Oocyte (K183486) | Vitrolife Sweden AB | 2019-07-26 |
| ACR LAB Urine Analysis Test System (K182384) | Healthy.Io, Ltd. | 2019-07-26 |
| ActivOrtho Continuous Compression Screw System (K191817) | Activortho, Inc. | 2019-07-26 |
| Hair Growth System (K190685) | Xuzhou Kernel Medical Equipment Co., Ltd. | 2019-07-26 |
| Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe (K191396) | HORIBA ABX SAS | 2019-07-26 |
| Infrared Ear/Forehead Thermometer (K190873) | Joytech Healthcare Co. , Ltd. | 2019-07-26 |
| da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30 (K191736) | Intuitive Surgical | 2019-07-26 |
| The ZIP Accessory Shuttle for PleuraFlow System (K191733) | Clearflow, Inc. | 2019-07-26 |
| Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition (K191777) | Ge Medical Systems, LLC | 2019-07-26 |
| STATCLAVE G4 Chamber Autoclave (K190062) | Scican , Ltd. | 2019-07-26 |
| ASAHI Neurovascular Guide Wire CHIKAI X 014 soft (K191714) | Asahi Intecc Co., Ltd. | 2019-07-26 |
| AI-Rad Companion (Pulmonary) (K183271) | Siemens Medical Solutions USA, Inc. | 2019-07-26 |
| PowderFree White Blue Sterilized Nitrile Copolymer Examination Gloves Tested for use with chemotherapy drugs (K183280) | Smart Glove Corporation Sdn. Bhd. | 2019-07-26 |
| KLS Martin Individual Patient Solutions (IPS) Planning System (K182889) | KLS-Martin L.P. | 2019-07-26 |
| Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask, Veraseal 3 Full Face Non-Vented Mask, Veraseal 3 Full Face AAV Non-Vented (K190533) | Sleepnet Corporation | 2019-07-26 |
| JOURNEY II Unicompartmental Knee System (K191211) | Smith & Nephew, Inc. | 2019-07-25 |
| RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL Implant (K190774) | Medos International SARL | 2019-07-25 |
| Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar Cage (K183249) | Stryker Spine | 2019-07-25 |
| Remedy Femoral Component 84mm, Remedy Stemmed Knee Spacer (K183017) | Osteoremedies, LLC | 2019-07-25 |
| Maxima Electric System (K180845) | Handpiece Headquarters - Hpr, Inc. | 2019-07-25 |
| Silicone PHMB Foam Wound Dressing (K190819) | Advanced Medical Solutions, Ltd. | 2019-07-25 |
| Galilei G6 Lens Professional (K182659) | Sis Ag, Surgical Instrument Systems | 2019-07-25 |
| Passio Pump Drainage System (K190292) | Bearpac Medical | 2019-07-25 |
| PrisMax System Version 2 (K190910) | Baxter Healthcare Corp | 2019-07-25 |
| The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD™ Technology-3 Fr, 4 Fr, and 5 Fr Model (K183066) | Access Scientific, LLC | 2019-07-25 |
| Stonetome Stone Removal Device (K191789) | Boston Scientific Corporation | 2019-07-25 |
| Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires (K191173) | Abbott Vascular | 2019-07-25 |
| Discovery XR656 HD with VolumeRad (K191699) | Ge Hualun Medical Systems Co. , Ltd. | 2019-07-24 |
| TempSure (K190678) | Cynosure, Inc. | 2019-07-24 |
| 4CIS® Chiron Spinal Fixation System (K190471) | Solco Biomedical Co., Ltd. | 2019-07-24 |
| Coolrail Linear Pen (K190587) | AtriCure, Inc. | 2019-07-24 |
| ExcelsiusGPS Spine 1.1 Interbody Module (K191100) | Globus Medical, Inc. | 2019-07-24 |
| Cobas Influenza A/B Nucleic Acid Test for Use on the Cobas Liat System (K191729) | Roche Molecular Systems, Inc. | 2019-07-24 |
| Canon OCT-A1 (K182942) | Canon, Inc. | 2019-07-24 |
| MaxiTears Contacts PF (K182984) | Omnivision AG | 2019-07-24 |
| ProLift Expandable System (K190488) | Life Spine, Inc. | 2019-07-23 |
| Hammertoe Truss System (HTS) (K190926) | 4Web, Inc. | 2019-07-23 |
| DePuy Synthes Craniomaxillofacial Sternal Devices - MR Conditional (K190963) | Synthes (USA) Products, LLC | 2019-07-23 |
| Vantage Orian 1.5T, MRT-1550, V4.5 (K191662) | Canon Medical Systems Corporation | 2019-07-23 |
| Roadrunner PC Wire Guide, Olcott Torque Device (K182985) | Cook Incorporated | 2019-07-22 |
| Powder-Free Vinyl Patient Examination Gloves, Yellow Color (K191092) | Anhui Intco Medical Products Co., Ltd. | 2019-07-22 |
| Digital Automatic Blood Pressure Monitor MD36 Series (K191593) | Grandway Technology (Shenzhen) Limited | 2019-07-22 |
| CottonDay Tampon (K182817) | Taebong Co., Ltd. | 2019-07-22 |
| Revival Modular Hip Stem (K191374) | Corin U.S.A. Limited | 2019-07-22 |
| BAROnova Access Sheath Kit (K191078) | Baronova, Inc. | 2019-07-22 |
| Corin Optimized Position System Functional Hip Analysis (OPS FHA) (K190834) | Corin USA | 2019-07-22 |
| Plexus SCD110 Sequential Compression Device Sleeve (K190975) | Midway Medical, LLC | 2019-07-22 |
| CerusEndo Microcatheter (K182487) | Cerus Endovascular, Inc. | 2019-07-20 |
| CARTO 3 EP Navigation System, Version 7.1 and Accessories (K191660) | Biosense Webster, Inc. | 2019-07-20 |
| Tech Dots - Adhesive and conductive gel (K190050) | Spes Medica Srl | 2019-07-19 |
| AeroDVx System (K183349) | Sun Scientific, Inc. | 2019-07-19 |
| SpaceOAR Vue Hydrogel (K182971) | Augmenix, Inc. | 2019-07-19 |
| Surdial DX Hemodialysis System (K182940) | Nipro Medical Corporation | 2019-07-19 |
| NvisionVLE Low-profile Optical Probe (K191117) | Ninepoint Medical, Inc. | 2019-07-19 |
| Mariner MIS Pedicle Screw System; SeaSpine Navigation System (K191648) | SeaSpine Orthopedics Corporation | 2019-07-19 |
| syngo.via MI Workflows VB40A, Scenium (K191309) | Siemens Medical Soultions USA, Inc. | 2019-07-19 |
| Stat Profile Prime ES Comp Plus Analyzer System (K191365) | Nova Biomedical Corporation | 2019-07-19 |
| STERIZONE(R) VP4 Sterilizer (K190260) | Tso3, Inc. | 2019-07-19 |
| Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0 (K191467) | Canon Medical Systems Corporation | 2019-07-19 |
| EUROPA Pedicle Screw System (K191757) | MiRus, LLC | 2019-07-19 |
| Infyna Chic (K191633) | Hollister Incorporated | 2019-07-19 |
| Anspach Helix Dissection Tools (K183545) | The Anspach Effort, Inc. | 2019-07-19 |
| KIDScore D3 (K182798) | Vitrolife A/S | 2019-07-19 |
| Exceed Microneedling device (K182407) | Mt. Derm GmbH | 2019-07-19 |
| Trilogy Evo (K181166) | Respironics, Inc. | 2019-07-18 |
| Peralta Stone Removal Catheter (K190492) | Calcula Technologies, Inc. | 2019-07-18 |
| Silverlon Wound Contact, Burn Contact Dressings (K190343) | Argentum Medical, LLC | 2019-07-18 |
| Qraypen (K183121) | AIOBIO Co., Ltd. | 2019-07-18 |
| Trilogy Evo Universal (K181170) | Respironics, Inc. | 2019-07-18 |
| FAVO S-TLIF (K190680) | Silony Medical GmbH | 2019-07-18 |
| AcuSnare Polypectomy Snare - Duckbill (K191048) | Wilson-Cook Medical, Inc. | 2019-07-18 |
| BionicGym Powered Muscle Stimulator (K182794) | Medical Currents, Ltd. | 2019-07-18 |
| Huvitz Imaging System (K191615) | Huvitz Co., Ltd. | 2019-07-18 |
| Immucise (K190427) | Terumo Corporation | 2019-07-18 |
| Ziacom Dental Implant Systems (K182908) | Ziacom Medical, S.L. | 2019-07-18 |
| SPAR-K Instruments (for use with Gemini SL Total Knee System) (K191755) | Waldemar Link GmbH & Co. KG | 2019-07-18 |
| DreaMed Advisor Pro (K191370) | DreaMed Diabetes, Ltd. | 2019-07-18 |
| MONTAGE-QS Settable, Resorbable Hemostatic Bone (K191140) | Orthocon, Inc. | 2019-07-18 |
| AOS ES Retrograde Femoral Nail (K191598) | Advanced Orthopaedic Solutions, Inc. | 2019-07-18 |
| MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System, SYMPHONY OCT System, SUMMIT Fixation System (K190895) | Medos International SARL | 2019-07-18 |
| Latitud Hip Replacement System (K183532) | Meril Healthcare Pvt. , Ltd. | 2019-07-18 |
| ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000 Manifold Kit, BT2000 Manifold Kit, AngioToiuch Hand Controller Kit (K191060) | Acist Medical Systems, Inc. | 2019-07-18 |
| Powersculp laser lipolysis system (K191068) | Wuhan Lotuxs Technology Co., Ltd. | 2019-07-17 |
| Fungitell STAT (K191167) | Associates of Cape Cod, Inc. | 2019-07-17 |
| Silent Nite sl (K183270) | Prismatik Dentalcraft, Inc. | 2019-07-17 |
| Xtreme-Loop (K191053) | Xiros, Ltd. | 2019-07-17 |
| Pegasus System (K191345) | A.M. Surgical, Inc. | 2019-07-17 |