| Asimov-MKS Imaging System (K192761) | Onlume, Inc. | 2020-01-17 |
| Merit ONE Snare System (K193507) | Merit Medical Systems, Inc. | 2020-01-17 |
| Study Watch with Irregular Pulse Monitor (K192415) | Verily Life Sciences, LLC | 2020-01-17 |
| Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Orange) (K192635) | Wrp Asia Pacific Sdn. Bhd. | 2020-01-17 |
| LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module (K193007) | Lina Medical Aps | 2020-01-17 |
| Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen Catheter (K192302) | Covidien, LLC | 2020-01-17 |
| SureLead Cable System (K181089) | Authentic Medical | 2020-01-17 |
| CareSens S Fit BT Blood Glucose Monitoring System (K193590) | I-Sens, Inc. | 2020-01-17 |
| Altera gas Sampling Lines (K192563) | Meditera Tibbi Malzeme San VE Tic AS | 2020-01-17 |
| AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QX (K193509) | Acutus Medical, Inc. | 2020-01-17 |
| MAGLUMI 2000 HCG/ß-HCG (K192547) | Shenzhen New Industries Biomedical Engineering Co., Ltd. | 2020-01-17 |
| CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System, CoLink View Plating System, CoLink Afx Plating System (K193543) | In2bones USA, LLC | 2020-01-17 |
| SoundBite Console, SoundBite Active Wire 18 (K192211) | Soundbite Medical Solution, Inc. | 2020-01-17 |
| CustomizedBone Service (K193547) | Fin-Ceramica Faenza S.P.A. | 2020-01-17 |
| RxSight Insertion Device (K192926) | Rxsight, Inc. | 2020-01-17 |
| Dental Pain Eraser (K193570) | Synapse Dental | 2020-01-17 |
| C015 (K192182) | Micronica Srl | 2020-01-17 |
| PicoLazer Laser System (K192583) | Rohrer Aesthetics, LLC | 2020-01-17 |
| AMD Ritmed AssureWear VersaGown (K190306) | Amd Medicom, Inc. | 2020-01-17 |
| Black Diamond Navigation Instruments (K192495) | Osseus Fusion Systems | 2020-01-17 |
| Auto Positioning (K192956) | Ge Hangwei Medical Systems Co., Ltd. | 2020-01-16 |
| Viveve 2.0 System (K193611) | Viveve Medical, Inc. | 2020-01-16 |
| MobiliT Cup (K191831) | Corin U.S.A. Limited | 2020-01-16 |
| SherpaPak Lung Preservation System , SherpaPak Liver Transport System (K192869) | Pragonix Technologies | 2020-01-16 |
| Resectr Tissue Resection Device (K191538) | Boston Scientific Corporation | 2020-01-16 |
| GlideScope BFlex 3.8 Single-Use Bronchoscope (K193488) | Verathon Medical (Canada) Ulc | 2020-01-16 |
| Stellar M22 for Intense Pulsed Light (IPL) and Laser System (K193500) | Lumenis, Ltd. | 2020-01-16 |
| AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate Hip (K192750) | Parcus Medical, LLC | 2020-01-16 |
| Maxxi Snore Sensor (K191095) | Neurovirtual USA, Inc. | 2020-01-16 |
| ALLthread Titanium Suture Anchor (K192942) | Biomet, Inc. | 2020-01-16 |
| Electric Breast Pump (K191802) | Ningbo Huiyoo Baby Products Co., Ltd. | 2020-01-16 |
| INNOVO (K192357) | Atlantic Therapeutics, Ltd. | 2020-01-16 |
| ADVIA Centaur Total IgE (tIgE) (K193493) | Siemens Healthcare Diagnostics, Inc. | 2020-01-15 |
| NEX-D2 Posterior Fixation System (K190981) | Next Orthosurgical | 2020-01-15 |
| KDR AU-DDR System Advanced U-Arm with Dynamic Digital Radiography, KDR AU System Advanced U-Arm with Static Digital Radiography (K193225) | Konica Minolta Healthcare Americas, Inc. | 2020-01-15 |
| UNO 30 (K190028) | Genadyne Biotechnologies | 2020-01-15 |
| VitalScan ANS (K191266) | Medeia, Inc. | 2020-01-15 |
| All’InCath 035M PTA Balloon Dilatation Catheter (K191275) | Nexstep Medical | 2020-01-15 |
| INTRAcel RF Microneedle System (K183284) | Jeisys Medical, Inc. | 2020-01-15 |
| Wattson Temporary Pacing Guidewire (K192454) | Vascular Solutions | 2020-01-15 |
| Arthrex SwiveLock Suture Anchor (K193503) | Arthrex, Inc. | 2020-01-15 |
| ADAS 3D (K191125) | Galgo Medical S.L | 2020-01-15 |
| Livento Press, Soprano 10, Soprano (K192251) | Cendres+Metaux SA | 2020-01-15 |
| ClenchGuard (K181005) | Boyd Research, Inc. | 2020-01-15 |
| Eko Analysis Software (K192004) | Eko Devices, Inc. | 2020-01-15 |
| Icare ic200 (K190316) | Icare Finland OY | 2020-01-14 |
| SABLE Expandable Spacer (K192115) | Globus Medical, Inc. | 2020-01-14 |
| Dental Pain Eraser (K192429) | Synapse Dental | 2020-01-14 |
| MiiS Horus Eye Anterior Camera (K193188) | Medimaging Integrated Solution, Inc (Miis) | 2020-01-14 |
| Streamline TL Spinal Fixation System (K192800) | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | 2020-01-14 |
| G210 InviCell Plus with SignipHy pH monitoring (K191020) | CooperSurgical, Inc. | 2020-01-14 |
| XTRAC Momentum Excimer Laser System (K193478) | Strata Skin Sciences, Inc. | 2020-01-14 |
| Oragene®•Dx (K192920) | DNA Genotek, Inc. | 2020-01-14 |
| nva, nvp, and nvt (K193645) | Nvision Biomedical Technologies, Inc. | 2020-01-13 |
| Route 92 Medical Sheath System (K191717) | Route 92 Medical, Inc. | 2020-01-13 |
| Erchonia Emerald (K192544) | Erchonia Corporation | 2020-01-13 |
| Midwest Rhino XE and Air Motor M (K192409) | Dentsply Sirona | 2020-01-13 |
| TENS and EMS Stimulator, TENS Stimulator (K183074) | Astek Technology , Ltd. | 2020-01-11 |
| CD Horizon™ Fenestrated Screw Set (K193011) | Medtronic Sofamor Danek USA, Inc. | 2020-01-10 |
| Univers Revers Modular Glenoid System (Augemented baseplates) (K193372) | Arthrex, Inc. | 2020-01-10 |
| CorticaLINK Spinal Fusion Platform (K193465) | Spine Smith Holdings, LLC | 2020-01-10 |
| FlowMet (K192966) | Laser Associated Sciences, Inc. | 2020-01-10 |
| Cybird LED Curing Light (K191221) | Dxm Co., Ltd. | 2020-01-10 |
| Trach- Vac Endotracheal Tube (SFTVPU) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuff, Trach- Vac Endotracheal Tube (SFTVVC) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuff (K190878) | Salter Labs, Inc. | 2020-01-10 |
| KardioScreen (K191692) | Imedrix Inc. (Formerly Piitech Inc.) | 2020-01-10 |
| OsteoRemedies Hip Spacer System (K192995) | Osteoremedies, LLC | 2020-01-10 |
| Nihon Kohden NKV-550 Series Ventilator System (K192307) | Nihon Kohden Orangemed, Inc. | 2020-01-10 |
| Medline Green Ambidextrous Power-Free Nitrile Examination Gloves with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs) (K192315) | Medline Industries, Inc. | 2020-01-10 |
| MotoBAND CP Implant System (K193452) | Crossroads Extemity Systems, LLC | 2020-01-10 |
| IP Converter (K191678) | Sony Electronics, Inc. | 2020-01-10 |
| ER-REBOA PLUS Catheter (K193440) | Prytime Medical Devices, Inc. | 2020-01-09 |
| HyaloGYN Vaginal Moisturizing Suppositories (K191052) | Fidia Farmaceutici S.P.A. | 2020-01-09 |
| TrellOss™-L MPF (K192687) | Nexxt Spine, LLC | 2020-01-09 |
| Longeviti ClearFit Cranial Implant (K191210) | Longeviti Neuro Solutions, LLC | 2020-01-09 |
| AMIStem-C (K193433) | Medacta International S.A. | 2020-01-09 |
| LED Curing Light (K192009) | Ezgo Group, Inc. | 2020-01-09 |
| Tyber Medical Trauma Screws (K192975) | Tyber Medical, LLC | 2020-01-09 |
| Altapore (K192363) | Baxter Healthcare Corporation | 2020-01-09 |
| Clear Aligner (K192767) | Royal Dental Lab | 2020-01-08 |
| Genesys Spine 3DP Cervical Interbody System (K191489) | Genesys Spine | 2020-01-08 |
| EASYGRIP FLO-41 Precision MIS Delivery System (K193137) | Baxter Healthcare Corportation | 2020-01-08 |
| Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint, Susceptibility System with Lefamulin in the dilution range of 0.008-16ug/mL (K193024) | Thermo Fisher Scientific | 2020-01-08 |
| Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion Device (K191581) | Titan Spine, Inc. | 2020-01-08 |
| Tyber Medical Trauma Screw (K192974) | Tyber Medical, LLC | 2020-01-08 |
| ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch, Extension cable f. ERBECRYO 2 footswitch; Flexible Cryoprobe; ERBECRYO 2 Cart, VIO-Cart, Wire basket; Connecting hoses, switching valves, adapter (K190651) | Erbe Elektromedizin GmbH | 2020-01-07 |
| Avenger Radial Head System (K192754) | In2bones USA, LLC | 2020-01-07 |
| CRF Radiofrequency Ablation System (K192715) | Cambridge Interventional, LLC | 2020-01-07 |
| BioCardia 8F Morph DNA Deflectable Guide Catheter (K192774) | Biocardia | 2020-01-07 |
| VV330 Continuous ECG Platform, VivaLNK Adhesive Patch (K191870) | VivaLNK, Inc. | 2020-01-07 |
| Disposable Powder Free Nitrile Examination Glove, Pink/Black Color (K190942) | Ever Growth (Vietnam) Co. , Ltd. | 2020-01-07 |
| R2P Destination Slender Guiding Sheath (K193125) | Terumo Medical Corporation | 2020-01-06 |
| EVOL ha - D Lateral Interbody Fusion System (K192497) | Cutting Edge Spine, LLC | 2020-01-06 |
| Multi-unit Abutments (K191123) | Medentika GmbH | 2020-01-06 |
| ViewPoint 6 (K192917) | Ge Medical Systems Ultrasound And | 2020-01-06 |
| SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubricated High Speed Handpiece, SD500 Pro LubeFree High Speed Handpiece, Pro Lubricated High Speed Handpiece (K192412) | Dentalez, Inc. | 2020-01-06 |
| TK Sterile Piston Syringe without Needle (K191642) | Anhui Tiankang Medical Technology Co., Ltd. | 2020-01-06 |
| RS85 Diagnostic Ultrasound System (K192903) | Samsung Medison Co., Ltd. | 2020-01-06 |
| Quadra-P (K192827) | Medacta International S.A. | 2020-01-06 |
| MRIaudio PREM System with MRIview (K193102) | Mriaudio, Inc. | 2020-01-06 |
| TriMed ASET Foot Plating System (K192696) | TriMed, Inc. | 2020-01-05 |