| ADVIA Centaur Zika test, ADVIA Centaur Zika Ab (100 tests), ADVIA Centaur Zika IgM (50 tests), ADVIA Centaur Zika Ab Quality Control, ADVIA Centaur Zika IgM Quality Control (K191578) | Siemens Healthcare Diagnostics, Inc. | 2019-07-17 |
| The POD (K182820) | Advanced Facialdontics, LLC | 2019-07-17 |
| ORTHOLOC™ SPS Shoulder Plating System (K191711) | Tornier, Inc. | 2019-07-17 |
| Biotex (K180992) | Purgo Biologics, Inc. | 2019-07-16 |
| OptiFix AT Absorbable Fixation System with Articulating Technology – 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology – 15 Fasteners (K191287) | Davol Inc., Subsidiary of C.R. Bard | 2019-07-16 |
| Orthophos S (K191616) | Dentsply Sirona | 2019-07-16 |
| Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set (K183051) | Cook Incorporated | 2019-07-16 |
| ALARA Neuro Access Kit (K190163) | SurGenTec, LLC | 2019-07-16 |
| Microlife Digital Infrared Ear Thermometer (K183663) | Microlife Intellectual Property GmbH | 2019-07-16 |
| Impress Angiographic Catheter (K191608) | Merit Medical Systems, Inc. | 2019-07-16 |
| iBreastExam (K190575) | Ue Lifesciences, Inc. | 2019-07-16 |
| FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L and EC-740T/L (K183572) | Fujifilm Corporation | 2019-07-16 |
| Sage 2-in-1 Personal Lubricant and Moisturizer (K190150) | Fairhaven Health, LLC | 2019-07-16 |
| EMPOWR Partial Knee (K191325) | Encore Medical L.P. | 2019-07-16 |
| A.B. DENTAL DEVICES Dental Implants System (K182455) | A.B. Dental Device , Ltd. | 2019-07-15 |
| MicroPort CoCr Femoral Heads (K190123) | Microport Orthopedics, Inc. | 2019-07-15 |
| UNiD Patient-matched PLIF cage (K182158) | Medicrea International SA | 2019-07-15 |
| Rael Tampon (K182814) | Rael, Inc. | 2019-07-15 |
| 087 Balloon Guide Catheter System (K190749) | Q'Apel | 2019-07-15 |
| Lyra (K191372) | Interacoustics A/S | 2019-07-15 |
| Optilite IgM Kit (K191635) | The Binding Site Group , Ltd. | 2019-07-15 |
| Modus Nav (K183325) | Synaptive Medical, Inc. | 2019-07-14 |
| DROWZLE (K173974) | Resonea, Inc. | 2019-07-14 |
| Valleylab FT10 Electrosurgical Platform (K191601) | Covidien | 2019-07-12 |
| StitchKit (K191317) | Origami Surgical | 2019-07-12 |
| PerioLase Nd:YAG Pulsed Dental Laser System (K182930) | Millennium Dental Technologies, Inc. | 2019-07-12 |
| SureForm 45 Curved Tip, SureForm 45 Gray Reload (K190999) | Intuitive Surgical, Inc. | 2019-07-12 |
| Remington Medical, Inc. Automatic Cutting Needle (NAC) (K191315) | Remington Medical, Inc. | 2019-07-12 |
| Novidia Bulk Fill Flow Composite (K182714) | Nobio , Ltd. | 2019-07-12 |
| VERITON CT whole body SPECT/CT system (K190457) | Spectrum Dynamics Medical, Ltd. | 2019-07-12 |
| Ambu aScope 4 RhinoLaryngo Intervention (K190972) | Ambu A/S | 2019-07-12 |
| Radial Medical Compression System (K190976) | Radial Medical, Inc. | 2019-07-12 |
| iNtuition-Structural Heart Module (K191585) | Terarecon,Inc. | 2019-07-12 |
| Wearable Device, Wearable Package (K191272) | Current Health , Ltd. | 2019-07-12 |
| Stryker CrossFlow Integrated Arthroscopy Pump (K191259) | Stryker Corp. | 2019-07-12 |
| Osstem Abutment System (K182091) | Osstem Implant Co., Ltd. | 2019-07-12 |
| AMSafe(R) Pre-Filled Normal Saline Flush Syringe (K183473) | Amsino International, Inc. | 2019-07-12 |
| MAGNETOM Aera and MAGNETOM Skyra with Software syngo MR E11E with Ischemic Heart Disease (IHD) Workflow (K191050) | Siemens Medical Solutions USA, Inc. | 2019-07-12 |
| AeroForm Tissue Expander, Smooth (K191138) | Airxpanders, Inc. | 2019-07-11 |
| ID NOW Influenza A & B 2 (K191534) | Abbott Diagnostics Scarborough, Inc. | 2019-07-11 |
| ScopeFlow Pure(TM) (K181418) | Partnership Medical Limited | 2019-07-11 |
| Nalu Lead Blank (50cm) (K190960) | Boston Scientific Neuromodulation | 2019-07-11 |
| Stryker PEEK Customized Cranial Implant Kit (K190229) | Stryker | 2019-07-11 |
| Nuvis Battery Arthroscope (K191594) | Integrated Endoscopy, Inc. | 2019-07-11 |
| GC FujiCEM 2 (Improved) (K182854) | GC America, Inc. | 2019-07-11 |
| EndoStream(TM) (K181457) | Partnership Medical Limited | 2019-07-11 |
| Unifi Workspace v1.0.0 (K190694) | Hologic, Inc. | 2019-07-11 |
| Senhance Surgical System (K191482) | Transenterix, Inc. | 2019-07-11 |
| Voyant System (K191579) | Viseon, Inc. | 2019-07-11 |
| Zygomatic Implants (K190718) | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2019-07-11 |
| Scepter Mini Occlusion Balloon Catheter (K182829) | MicroVention, Inc. | 2019-07-10 |
| Full Digital Colour Doppler Ultrasonic Diagnostic System (K183041) | Wuhan Zoncare Bio-medical Electronics Co., Ltd. | 2019-07-10 |
| Conometric Abutments (K183079) | Dentsply Sirona, Inc. | 2019-07-10 |
| PressOn Electrode Headset (K190801) | Rhythmlink International, LLC | 2019-07-10 |
| VeriSplint (K190107) | Whip Mix Corporation | 2019-07-10 |
| DeepCT (K182875) | Deep01 Limited | 2019-07-10 |
| Velofix TLIF Cage (K183243) | U&I Corporation | 2019-07-10 |
| MariGen Wound Extra (K190528) | Kerecis Limited | 2019-07-10 |
| Identify (K190137) | Varian Medical Systems, Inc. | 2019-07-10 |
| Vave Personal Ultrasound System (K191541) | Vave Health, Inc. | 2019-07-10 |
| CentriMag Acute Circulatory Support System (K191557) | Thoratec Corporation (Now Part of Abbott) | 2019-07-10 |
| Calprest, EasyCal (K191589) | Eurospital S.P.A. | 2019-07-10 |
| Scooter (K182471) | Tianjin Kepler Vehicle Industry Co. , Ltd. | 2019-07-10 |
| Salvo™ Spine System (K191045) | Spine Wave, Inc. | 2019-07-10 |
| Nexxt Matrixx System (K191408) | Nexxt Spine, LLC | 2019-07-10 |
| CalprestNG, EasyCal (K191592) | Eurospital S.P.A. | 2019-07-10 |
| physIQ Heart Rhythm and Respiratory Module (K183322) | Physiq, Inc. | 2019-07-10 |
| Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1) (K190011) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2019-07-10 |
| Microlife Upper Arm Automatic Digital Blood Pressure Monitor (K190818) | Microlife Intellectual Property GmbH | 2019-07-10 |
| SpeediCath Flex Coude Pro (K190620) | Coloplast | 2019-07-10 |
| LifeSPARC Pump, LifeSPARC Controller (K183623) | Cardiacassist, Inc. | 2019-07-09 |
| ENDOSCOPE REPROCESSOR OER-Elite (K190969) | Olympus Medical Systems Corp. | 2019-07-09 |
| Heat Sealing Sterilization Pouch Flat, Heat Sealing Sterilization Pouch Gusseted, Heat Sealing Sterilization Pouch Roll Flat, Heat Sealing Sterilization Pouch Roll Gusseted (K181957) | Tianchang Jiarui Packaging Material Co., Ltd. | 2019-07-09 |
| SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8F (K180994) | Interrad Medical, Inc. | 2019-07-09 |
| Gem FlowCoupler System (K191252) | Baxter/ Synovis Micro Companies Alliance, Inc. | 2019-07-09 |
| EpiLaze Multi-wavelength Laser (K191162) | Rohrer Aesthetics, LLC | 2019-07-09 |
| Shear Stress Therapeutics SST 3000 (K182163) | Shear Stress Therapeutics, LLC | 2019-07-09 |
| GLISSANT Intimate Lubricant (K183050) | Vjuvenate, LLC | 2019-07-08 |
| Tuttnauer Horizontal Models:4472,5596,6690,66120,69120 and 69180 autoclaves (K181456) | Tuttnauer , Ltd. | 2019-07-08 |
| Surgikor Dental Implant System (K182615) | Surgikor, LLC | 2019-07-08 |
| ProVate Vaginal Support (K190277) | Contipi Medical , Ltd. | 2019-07-08 |
| Materialise Glenoid Positioning System (K190286) | Materialise NV | 2019-07-08 |
| nView system 1 (K190064) | Nview Medical, Inc. | 2019-07-08 |
| Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) (K190485) | Kawasumi Laboratories, Inc. | 2019-07-08 |
| Bard Power-Injectable Implantable Ports (PowerPorts®) (K181446) | C.R. Bard, Inc. | 2019-07-08 |
| Microwave Ablation System (K183153) | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | 2019-07-08 |
| BRAVOS Afterloader System, Transfer Guide Tubes, Length Assessment Device (K191580) | Varian Medical Systems, Inc. | 2019-07-08 |
| RayCare 2.3 (K191384) | RaySearch Laboratories AB (PUBL) | 2019-07-08 |
| PRAMA White Implant Systems (K180365) | Sweden & Martina S.P.A. | 2019-07-08 |
| OrthoPediatrics Cannulated Screw System (K190324) | OrthoPediatrics Corp. | 2019-07-05 |
| Aesculap® SterilContainer(TM) S2 System (K182414) | Aesculap, Inc. | 2019-07-05 |
| syngo.MR Applications (K182904) | Siemens Medical Solutions USA, Inc. | 2019-07-05 |
| Zimmer Guide Wire Devices (K191238) | Zimmer, Inc. | 2019-07-05 |
| Harrier-SA Lumbar Interbody System (K191367) | Choice Spine, LLC | 2019-07-05 |
| Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs: Fortilink®-TS IBF System, Fortilink®-L I BF System, Fortilink®-C IBF System (K190498) | Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. | 2019-07-05 |
| AngioVac C20, AngioVac C180 (K190594) | AngioDynamics, Inc. | 2019-07-05 |
| BIOMONITOR III, Remote Assistant III (K190548) | Biotronik, Inc. | 2019-07-05 |
| Miethke Shunt System GAV 2.0 and SA 2.0 Valves (K190174) | Aesculap, Inc. | 2019-07-05 |
| Arthrex NanoScope System (K190645) | Arthrex, Inc. | 2019-07-05 |
| Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE (K182901) | Canon Medical Systems Corporation | 2019-07-05 |