| Erchonia EVRL (K191257) | Erchonia Corporation | 2019-08-08 |
| binx health io CT/NG Assay (K191352) | Binx Health, Inc. | 2019-08-08 |
| Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Atrial Pacing Lead, Streamline 6494 Unipolar Temporary Myocardial Pacing Wire, Streamline 6495 Unipolar Temporary Myocardial Pacing Lead (K190716) | Medtronic | 2019-08-08 |
| ARx Spinal System (K191575) | Life Spine, Inc. | 2019-08-08 |
| iTotal Identity Cruciate Retaining Knee Replacement System (K190562) | Conformis, Inc. | 2019-08-08 |
| Transit-Pellets (K181760) | Medifactia AB | 2019-08-08 |
| CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan Compression Staple System (K190385) | In2bones USA, LLC | 2019-08-08 |
| REFRESH RELIEVA For CONTACTS (K190674) | Allergan, Inc. | 2019-08-08 |
| Conformity Stem (K183312) | United Orthopedic Corporation | 2019-08-08 |
| Non-invasive Hemodynamic Blood Pressure Monitor (K190893) | Vita-Course Technologies Co., Ltd. | 2019-08-07 |
| RenovoCath (K191606) | Renovorx, Inc. | 2019-08-07 |
| Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement) (K191840) | Shockwave Medical, Inc. | 2019-08-07 |
| 7D Surgical System (K183276) | 7D Surgical, Inc. | 2019-08-07 |
| Accurate Multi Panel Drug Urine Test Cup (K191841) | Healstone Biotech, Inc. | 2019-08-07 |
| Elevation Spine Saber-C System (K190885) | Elevation Spine | 2019-08-07 |
| BonAlive Granules (K191274) | Bonalive Biomaterials, Ltd. | 2019-08-07 |
| ILLUMISITE Platform (K191394) | Covidien, LLC | 2019-08-07 |
| Navigated Pedicle Access Kit (K191012) | Izi Medical Products, LLC | 2019-08-07 |
| 15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer Set (K191871) | Boston Scientific Corporation | 2019-08-07 |
| Revolution Centrifugal Blood Pump (K190650) | Sorin Group Italia S.R.L. | 2019-08-07 |
| Wagner SL Revision Stem Lateral and Wagner Cone Prosthesis System (K191781) | Zimmer GmbH | 2019-08-06 |
| OrthoPediatrics PediFoot Deformity Corrections System (K190992) | OrthoPediatrics Corp. | 2019-08-06 |
| M3290B Patient Information Center iX (K183387) | Philips Medical Systems | 2019-08-06 |
| exoplan 2.3 (K183458) | Exocad GmbH | 2019-08-06 |
| Normandy VBR System (K191423) | Zavation Medical Products, LLC | 2019-08-06 |
| Percutaneous Introducer Needle (K191295) | Progressive Medical, Inc. | 2019-08-06 |
| The AIO Solution (K191158) | Orfit Industries NV | 2019-08-06 |
| Endoskeleton TCS Interbody Fusion Device (K191565) | Titan Spine, Inc. | 2019-08-06 |
| EmboCube Embolization Gelatin (K183120) | Biosphere Medical, S.A. | 2019-08-06 |
| BiMobile Dual Mobility System - E-Dur Inserts (K190535) | Waldemar Link GmbH & Co. KG | 2019-08-06 |
| CREO Stabilization System, Navigation Instruments, ExcelsiusGPS Instruments (K191835) | Globus Medical, Inc. | 2019-08-06 |
| ENFit Oral / Enteral Syringe (K190502) | Jiangsu Caina Medical Co.,Ltd | 2019-08-06 |
| Beddr 200 System (K190399) | Hancock Medical, Inc. | 2019-08-05 |
| Crossing Support Catheter (K183305) | Tractus Vascular, LLC | 2019-08-05 |
| TDS Standard Solution (K191496) | Mesa Laboratories, Inc. | 2019-08-05 |
| VITEK 2 AST-Gram Negative Eravacycline (<=0.12 - >=4µg/mL) (K191766) | bioMerieux, Inc. | 2019-08-05 |
| EEG Electrode Template (K191225) | Rhythmlink International, LLC | 2019-08-05 |
| LunaGuard Nighttime Dental Protector (K191033) | Mckeon Products | 2019-08-05 |
| aBSI (K191262) | Exini Diagnostics AB | 2019-08-05 |
| UPJ Occlusion Balloon Catheter (K183323) | Cook Incorporated | 2019-08-05 |
| Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant System EV (K191222) | Prismatik Dentalcraft, Inc. | 2019-08-05 |
| FLUOROspeed (K191877) | Shimadzu Corporation | 2019-08-05 |
| Med-link Wrist Digital Blood Pressure Monitor, Med-link Upper Arm Digital Blood Pressure Monitor (K181154) | Shenzhen Med-Link Electronics Tech Co., Ltd. | 2019-08-02 |
| Single Use Cytology Brush BC-205D (K190293) | Olympus Medical Systems Corp. | 2019-08-02 |
| Primelase Excellence (K191321) | High Technology Products S.L.U | 2019-08-02 |
| HAMILTON-T1, HAMILTON-C1 (K181216) | Hamilton Medical AG | 2019-08-02 |
| Rezum System (K191505) | Nxthera (A Boston Scientific Company) | 2019-08-02 |
| JAZZ PF (K191217) | Implanet, S.A. | 2019-08-02 |
| PowerFlow Implantable Apheresis IV Port (K191143) | C.R. Bard, Inc. | 2019-08-02 |
| DynoSense Vital Sign Measuring System (K190090) | Dynosense Corp. | 2019-08-02 |
| Elaris Pedicle Screw System (K183091) | Spinewelding AG | 2019-08-02 |
| DiLumen Endolumenal Interventional Knife (“DiLumen IK™”) (K183112) | Lumendi, LLC | 2019-08-02 |
| Intertape Polymer Inc., Type 1 Bismuth Process Indicator Steam Sterilization Tape (K191741) | Intertape Polymer, Inc. | 2019-08-02 |
| 046 Zenith Flex (K190338) | Inneuroco, Inc. | 2019-08-02 |
| MobileDiagnost wDR 2.2 (K191813) | Sedecal., Sa. | 2019-08-02 |
| ADVIA Centaur Erythropoietin (EPO) assay (K183088) | Axis-Shield Diagnostics Limited | 2019-08-02 |
| Epicardial Access System (K191546) | Baylis Medical Company, Inc. | 2019-08-02 |
| APA Oxy Blade (K191602) | Venner Medical (Singapore) Pte, Ltd. | 2019-08-02 |
| AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILM (K191559) | United States Endoscopy Group, Inc. | 2019-08-01 |
| MREplus+ Software (K183193) | Resoundant, Inc. | 2019-08-01 |
| Leksell Vantage Stereotactic System (K190887) | Elekta Instrument AB | 2019-08-01 |
| ImagingRing System on Rails (K191267) | Medphoton GmbH | 2019-08-01 |
| Single Use Reloadable Clip Applicator, Clip, Long Clip, Short Clip, Super Short Clip (K183590) | Olympus Medical Systems Corp. | 2019-08-01 |
| MINAMO (K190176) | Asahi Intecc Co., Ltd. | 2019-08-01 |
| LOQTEQ VA Calcaneus Plate 3.5 (K182818) | Aap Implantate AG | 2019-08-01 |
| Mini TENS Therapy Device (K182871) | Shenzhen Jumper Medical Equipment Co., Ltd. | 2019-08-01 |
| MAGLUMI 2000 25-OH Vitamin D (K191499) | Shenzhen New Industries Biomedical Engineering Co., Ltd. | 2019-08-01 |
| SurgTech GENOLL Total Knee System (K191192) | Surgtech, Inc. | 2019-08-01 |
| JO Premium Jelly Original Personal Lubricant (K191214) | United Consortium | 2019-08-01 |
| Steerable Introducer (K191190) | Freudenberg Medical, LLC | 2019-08-01 |
| Biotronik Stylets (K191469) | Biotronik, Inc. | 2019-08-01 |
| HardyDisk AST Imipenem/relebactam 10/25µg (IMR10/25) (K191931) | Hardy Diagnostics | 2019-07-31 |
| Fluobeam LX (K190891) | Fluoptics | 2019-07-31 |
| EyeBOX (K191183) | Oculogica, Inc. | 2019-07-31 |
| GORE BIO-A Tissue Reinforcement (K191773) | W. L. Gore & Associates, Inc. | 2019-07-31 |
| DemeTECH DemeFORCE Nonabsorbable Surgical Suture (K190777) | Demetech Corporation | 2019-07-31 |
| Mobius3D (K191761) | Varian Medical Systems, Inc. | 2019-07-31 |
| AOCup Lens Case with AODisc (K191795) | Alcon Laboratories, Inc. | 2019-07-31 |
| Noveos Immunoanalyzer System, Noveos Specific IgE (slgE), Capture Reagent D002, Dermatophagoides farinae (K191510) | Hycor Biomedical | 2019-07-31 |
| Diode Laser Therapy Systems (K191611) | Wingderm Electro-Optics , Ltd. | 2019-07-31 |
| StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1 (K190672) | Medtronic Navigation, Inc. | 2019-07-31 |
| P200TxE (K190732) | Optos Plc. | 2019-07-31 |
| Inion BioRestore (K191764) | Inion OY | 2019-07-31 |
| Hamilton-G5 (K180295) | Hamiton Medical AG | 2019-07-30 |
| Transcutaneous Electrical Nerve Stimulator (K183288) | Shenzhen Kentro Medical Electronics Co., Ltd. | 2019-07-30 |
| Marinr Steerable Intracardiac Electrode Catheter, StableMapr Steerable Intracardiac Electrode Catheter, Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter (K183547) | Medtronic | 2019-07-30 |
| Endotracheal Tube (K190274) | Tianjin Medis Medical Device Co., Ltd. | 2019-07-30 |
| Renuvion/J-Plasma Precise Handpiece (K191484) | Apyx Medical Corporation(Formerly Bovie Medical Corporation) | 2019-07-30 |
| Powder Free Blue Nitrile Examination Gloves - Tested for Use with Chemotherapy Drugs (K182089) | Platinum Glove Industries Sdn. Bhd. | 2019-07-30 |
| Addivation Medical Cervical Interbody System (K190291) | Addivation Medical, LLC | 2019-07-30 |
| Atellica CH Amylase_2 (AMY_2) (K191454) | Siemens Healthcare Diagnostics, Inc. | 2019-07-30 |
| Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter (K190132) | Medtronic | 2019-07-30 |
| Blood Transfer Accessory (BTA) (K181743) | Nsp Tech Pte, Ltd. | 2019-07-30 |
| Blood Collection Accessory (BUCA) (K181754) | Nsp Tech Pte, Ltd. | 2019-07-30 |
| AXS Vecta Aspiration System (K191768) | Stryker Neurovascular | 2019-07-30 |
| ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG/IgM Test System (K190907) | Zeus Scientific, Inc. | 2019-07-29 |
| ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG Test System (K191398) | Zeus Scientific, Inc. | 2019-07-29 |
| Bone Screw Line Addition (K191289) | Vilex IN Tennessee, Inc. | 2019-07-29 |
| Access CT (K191136) | Philips Healthcare (Suzhou) Co., Ltd. | 2019-07-29 |
| Hair Boom 69 (K191154) | Wontech | 2019-07-29 |