| syngo Ultrasound Apps Suite (sUSAS) (K201062) | Siemens Medical Solutions USA, Inc. | 2020-05-18 |
| V.A.C. DERMATAC Drape (K200390) | Kci USA, Inc. | 2020-05-18 |
| UF(II) Bar holder abutment (K193404) | Dio Corporation | 2020-05-18 |
| VarseoSmile Temp (K193553) | Bego Bremer Goldschlagerei Wilh. Herbst GmbH & Co. KG | 2020-05-18 |
| 3D GraftRasp System (K200431) | Surgentec | 2020-05-18 |
| Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System) (K200866) | Hologic, Inc. | 2020-05-17 |
| SonarMed AirWave Airway Monitoring System (K193058) | Sonarmed, Inc. | 2020-05-15 |
| IPL Treatment Systems (K200746) | Shanghai Apolo Medical Technology Co., Ltd. | 2020-05-15 |
| BP-BT Kiosk (K200287) | Ld Technology, LLC | 2020-05-15 |
| Pristina Serena Bright (K193334) | GE Healthcare | 2020-05-15 |
| PuriLens Plus Preservative Free Saline (K200747) | The Lifestyle Company, Inc. | 2020-05-15 |
| AquaPulse Auxiliary Water Connector (K200479) | Ga Health Company Limited | 2020-05-15 |
| Medtronic Commander Flex (K191745) | Medtronic Care Management Services | 2020-05-15 |
| Biocore9 Humeral Resurfacing System (K193122) | Biocore9, LLC | 2020-05-15 |
| VFS1 Bipolar Electrosurgical Generator (K200169) | FHC, Inc. | 2020-05-14 |
| Skeletal Dynamics Midshaft Humerus Plating System (K200701) | Skeletal Dynamics, Inc. | 2020-05-14 |
| Reliance Endoscope Processing System (K200989) | STERIS Corporation | 2020-05-14 |
| Support Catheter (K200317) | Qxmedical, LLC | 2020-05-14 |
| PAL Single-Use Cannulas (K192694) | Microaire Surgical Instruments | 2020-05-14 |
| Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing, Silicone Ag Foam Dressing with Border (K191819) | Winner Medical Co., Ltd. | 2020-05-14 |
| Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty) Dilatation Catheter (K200700) | Creagh Medical, Ltd. | 2020-05-14 |
| Syngo.CT CaScoring (K201034) | Siemens Medical Solutions USA, Inc. | 2020-05-14 |
| XV Lung Ventilation Analysis Software (K193293) | 4Dx Limited | 2020-05-14 |
| Single Use Endoscope Valves Set (K192048) | Anrei Medical (Hangzhou) Co., Ltd. | 2020-05-14 |
| Lumipulse G CA19-9-N (K200997) | Fujirebio Diagnostics,Inc. | 2020-05-14 |
| VITA Ambria (K193436) | Vita Zahnfabrik GmbH H Rauter & CO | 2020-05-14 |
| KeYi Total Hip System (K191826) | Beijing Keyi Medical Device Technology Co., Ltd. | 2020-05-14 |
| Distal Humerus Plating System (K200367) | Skeletal Dynamics, Inc. | 2020-05-14 |
| PercuNav Image Fusion and Interventional Navigation (K201053) | Philips Ultrasound, Inc. | 2020-05-14 |
| PHMB Foam Dressing Non-Adhesive, PHMB Foam Dressing Adhesive, Silicone PHMB Foam Dressing, Silicone PHMB Foam Dressing with Border (K192463) | Winner Medical Co., Ltd. | 2020-05-14 |
| S.I.N. Dental Implant System (K193096) | S.I.N. - Sistema DE Implante Nacional S.A. | 2020-05-14 |
| Medtronic Model 5392 External Pulse Generator (EPG) (K201011) | Medtronic, Inc. | 2020-05-13 |
| 308nm Excimer System (K192642) | Chongqing Peninsula Medical Technology Co., Ltd. | 2020-05-13 |
| EVOL Spinal Interbody System (K200991) | Cutting Edge Spine, LLC | 2020-05-13 |
| Purzir Dental Zirconia (K193055) | 3DBiocad | 2020-05-13 |
| Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite, Triathlon Cruciate Retaining Femoral Component - beaded with Peri-Apatite (K200782) | Howmedica Osteonics Corp. | 2020-05-13 |
| Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled (K200205) | Stryker Sustainability Solutions | 2020-05-13 |
| InCore MPJ System (K200124) | Nextremity Solutions, Inc. | 2020-05-13 |
| Dr-Ho's Foot Pad Electrode (Models: DHFRE-I, CP-I, CP-II, CP-III) (K190118) | Guangzhou Xinbo Electronic Co., Ltd. | 2020-05-13 |
| HealthVCF (K192901) | Zebra Medical Vision, Ltd. | 2020-05-12 |
| Dymaxeon Spine System (K192930) | Back 2 Basics Direct, LLC | 2020-05-12 |
| AUDERE Lumbar Spacer System (K193457) | Met One Technologies | 2020-05-12 |
| Cure™ Lumbar Plate System (K201136) | Meditech Spine, LLC | 2020-05-12 |
| EZ-Inject Single use Needle (K192222) | Poonglim Pharmatech, Inc. | 2020-05-12 |
| Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W) (K201043) | Iray Technology Taicang , Ltd. | 2020-05-12 |
| Disposable ECG Cable (K200026) | Shenzhen Changke Connect Electronics Co., Ltd. | 2020-05-12 |
| PuraDERM Gel (K193085) | 3-D Matrix, Inc. | 2020-05-11 |
| Resorbable Mesh Pouch (Ballast MT, OsteoBallast MT) (K200290) | SeaSpine Orthopedics Corporation | 2020-05-11 |
| Critical Alert CommonPath Enterprise (K193043) | Critical Alert | 2020-05-11 |
| Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11 (K200841) | Ethicon Endo-Surgery, LLC | 2020-05-11 |
| Thunderbeat Open Fine Jaw Type X Hand Instrument (K192103) | Olympus Medical Systems Corp. | 2020-05-11 |
| NP Screen (DEN190031) | Advance Sentry Corporation | 2020-05-11 |
| Arcad SmileStudio and Aligner System (K192244) | Arcadlab | 2020-05-11 |
| Biograph mMR with syngo MR E11P-AP01 system software (K200213) | Siemens Medical Solutions USA, Inc. | 2020-05-11 |
| ArtiSential Laparoscopic Instrument-Electrodes (K200501) | Livsmed, Inc. | 2020-05-11 |
| Dermalux Tri-Wave MD (K200659) | Aesthetic Technology, Ltd. | 2020-05-09 |
| Neocis Guidance System (NGS) with Fiducial Array Splint (FAS) (K200348) | Neocis, Inc. | 2020-05-08 |
| Precice® Screws (K193617) | Nuvasive Specialized Orthopedics, Inc. | 2020-05-08 |
| ALTAPORE SHAPE (K200640) | Baxter Healthcare Corporation | 2020-05-08 |
| Sonosite PX Ultrasound System (K200964) | FUJIFILM Sonosite, Inc. | 2020-05-08 |
| PRECICE Bone Transport System (K193016) | Nuvasive Specialized Orthopedics, Inc. | 2020-05-08 |
| Ventricular Catheter (K200950) | Aesculap, Inc. | 2020-05-08 |
| Treace Medical Concepts (TMC) Plating System (K200961) | Treace Medical Concepts, Inc. | 2020-05-08 |
| Custom Legacy and Custom InterActive Titanium Abutments (K192218) | Implant Direct Sybron Manufacturing, LLC | 2020-05-08 |
| Mazor X (K200935) | Mazor Robotics , Ltd. | 2020-05-08 |
| Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate (K192209) | Fresenius Medical Care Renal Therapies Group, LLC | 2020-05-08 |
| EZER, Portable X-ray System (K193535) | Livermoretech, Inc. | 2020-05-07 |
| Catalyst+, Catalyst+ HD (K200435) | C-Rad Positioning AB | 2020-05-07 |
| Patient Monitor (K192972) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2020-05-07 |
| LiteSaber Wire Torque Assist Device (K200120) | Vesatek, LLC | 2020-05-07 |
| HET Bipolar Electrocautery Forceps, HET Bipolar Electrocautery Monitor (K200146) | Covidien, LLC | 2020-05-07 |
| LOSPA II Knee System (EXULT Knee Replacement System) (K200395) | Corentec Co., Ltd. | 2020-05-07 |
| AMF Revision TT Cones (K200653) | Lima Corporate S.P.A. | 2020-05-07 |
| ZAGA Zygomatic System (K192651) | Southern Implants (Pty), Ltd. | 2020-05-07 |
| Chemfort CSTD (K192866) | Simplivia Healthcare , Ltd. | 2020-05-07 |
| Actreen Hi-Lite Intermittent Urinary Catheters (K192577) | B.Braun Medical, Inc. | 2020-05-07 |
| ETEST Plazomicin (PLZ) (0.016-256 µg/mL) (K200512) | Biomérieux SA | 2020-05-07 |
| Icare HOME Tonometer (K200966) | Icare Finland OY | 2020-05-07 |
| Nuvo Nano Portable Oxygen Concentrator (K192693) | Nidek Medical Products, Inc. | 2020-05-07 |
| HS70A Diagnostic Ultrasound System (K200699) | Samsung Medison Co., Ltd. | 2020-05-07 |
| RFID Localization System (K193189) | Health Beacons, Inc. | 2020-05-06 |
| CharmFil (K193496) | Dentkist, Inc. | 2020-05-06 |
| LIAISON® Folate (K192586) | DiaSorin, Inc. | 2020-05-06 |
| MEDRON Vessel Dilator - 6F x 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F - 17.5F HDPE Dilator (K192283) | Medron, LLC | 2020-05-06 |
| Aerodentis System (K192069) | Dror Orthodesign | 2020-05-06 |
| Accuvue+ (K201058) | Radmedix, LLC | 2020-05-06 |
| XO Cross Support Catheter (K193420) | Transit Scientific | 2020-05-06 |
| Syntec Non-Sterile Steinmann Pins System (K200933) | Syntec Scientific Corporation | 2020-05-05 |
| AVIEW LCS (K193220) | Coreline Soft Co., Ltd. | 2020-05-05 |
| Lascod Impression Materials (K201184) | Lascod Spa | 2020-05-05 |
| uMR 780 (K193176) | Shanghai United Imaging Healthcare Co., Ltd. | 2020-05-05 |
| ZeeroMED View (K200546) | O3 Enterprise Srl | 2020-05-05 |
| Balteum™ Lumbar Plate System (K200846) | Huvexel Co. , Ltd. | 2020-05-05 |
| InMode System with vTone Applicator (K200293) | InMode , Ltd. | 2020-05-05 |
| AA temp temporary restoration 3D printing photoreactive resin (K191590) | Enlighten Materials Co., Ltd. | 2020-05-05 |
| Healix Compression Screw System (K200914) | Nvision Biomedical Technologies, Inc. | 2020-05-05 |
| Ziostation2 (K200315) | Ziosoft, Inc. | 2020-05-05 |
| Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1 (K193516) | Gynesonics, Inc. | 2020-05-04 |
| Hamilton-G5 (K193228) | Hamilton Medical AG | 2020-05-04 |
| Anscare SIMO Negative Pressure Wound Therapy (NPWT) System (K193185) | Benq Materials Corporation | 2020-05-04 |