| Acapella Choice Blue Vibratory PEP Device (K181660) | Smiths Medical | 2019-10-24 |
| Latex Surgeon’s Gloves Powder Free with protein content labeling claim of 50µg/dm2 or less per glove of extractable protein (K190632) | Lenora Glove Pvt , Ltd. | 2019-10-24 |
| RESONATE Anterior Cervical Plate System (K192314) | Globus Medical, Inc. | 2019-10-23 |
| Intraosseous infusion device (K191258) | Einstein Works, LLC | 2019-10-23 |
| Alliance Glenoid (K191814) | Zimmer, Inc. | 2019-10-23 |
| Powder-Free Nitrile Examination Glove (White Colored, Blue Colored, and Black Colored) Tested for Use with Chemotherapy Drugs (K183562) | Encompass Industries Sdn. Bhd. | 2019-10-23 |
| Diana ChemoClave Transfer Set (K190157) | Icu Medical | 2019-10-23 |
| Patient-Specific Airway Stent (K182743) | New Cos, Inc. | 2019-10-23 |
| stentfix OTSC System Set (K183309) | Ovesco Endoscopy AG | 2019-10-22 |
| FORTICO Anterior Cervical Fixation System (K191584) | Camber Spine Technologies, LLC | 2019-10-22 |
| Europa Pedicle Screw System (K192268) | MiRus, LLC | 2019-10-22 |
| LipiFlow Thermal Pulsation System (K192623) | Tearscience, Inc. | 2019-10-22 |
| ClearEdge Balance System (K183661) | Quadrant Biosciences | 2019-10-22 |
| Exactech Alteon Modular Dual Mobility (MDM) System (K190890) | Exactech, Inc. | 2019-10-22 |
| DORO QR3 XTom Headholder System (K191979) | Pro Med Instruments GmbH | 2019-10-22 |
| ACUSON NX3 Diagnostic Ultrasound System / ACUSON NX3 Elite Diagnostic Ultrasound System (K192835) | Siemens Medical Solutions USA, Inc. | 2019-10-22 |
| Lumpipulse G CA19-9-N (K191973) | Fujirebio Dianostics, Inc. | 2019-10-22 |
| RCT800 (K192737) | Ray Co., Ltd. | 2019-10-22 |
| TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non Sterile (K190539) | Monumedical, LLC | 2019-10-22 |
| Madison Total Knee System (K192084) | Implanet, S.A. | 2019-10-22 |
| VICRYL Mesh (K191373) | ETHICON, Inc. | 2019-10-22 |
| Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device (K192001) | Sterilucent, Inc. | 2019-10-22 |
| Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter (K191073) | Vein 360, LLC | 2019-10-22 |
| Omnipod Insulin Management System, Omnipod DASH Insulin Management System (K192659) | Insulet Corporation | 2019-10-21 |
| Fusion Silastic System (K190136) | Fusion Orthopedics, LLC | 2019-10-21 |
| BD Insulin Syringe (K190054) | Becton, Dickinson and Company | 2019-10-21 |
| Sterilucent VH2O2 Chemical Indicators (K191999) | Sterilucent, Inc. | 2019-10-21 |
| CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Envelope (extra extra large) (SubQ) (K192616) | Aziyo Biologics, Inc. | 2019-10-21 |
| FORE-SIGHT ELITE Tissue Oximeter Module (K190270) | Cas Medical Systems, Inc. | 2019-10-21 |
| BD MAX Vaginal Panel (K191957) | Geneohm Sciences Canada, Inc. (Bd Diagnostics) | 2019-10-21 |
| Servo Guard (K182862) | Maquet Critical Care AB | 2019-10-21 |
| PENTAX Medical ED-3490TK Video Duodenoscope (K192280) | Pentax Medical | 2019-10-21 |
| EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One (K190124) | E.M.S Electro Medical Systems S.A | 2019-10-20 |
| Altapore Shape (K191513) | Baxter Healthcare Corporation | 2019-10-19 |
| NuVasive® Reline® 4.5-5.0 System (K190636) | Nu Vasive, Incorporated | 2019-10-19 |
| Arthrex SwiveLock Anchor (K192532) | Arthrex, Inc. | 2019-10-19 |
| Pulse Oximeter (K191430) | Shenzhen Yimi Life-Technology Co., Ltd. | 2019-10-18 |
| RTHawk, HeartVista Cardiac Package (K183274) | Heartvista, Inc. | 2019-10-18 |
| Care Orchestrator Essence (K183226) | Respironics, Inc. | 2019-10-18 |
| BIAFINE Topical Cream (K190342) | Bausch Health Americas Incorporated | 2019-10-18 |
| Bashir S-B Endovascular Catheter, Ref. No. 7101 (K192598) | Thrombolex, Inc. | 2019-10-18 |
| Infrared Forehead Thermometer (Model IR-FT) (K191668) | Comper Chuangxiang (Beijing) Technology Co., Ltd. | 2019-10-18 |
| LIPOcel (K181896) | Jeisys Medical, Inc. | 2019-10-18 |
| Saalio (K191436) | Saalmann Medical GmbH & Co. KG | 2019-10-18 |
| SomnaPatch (K183625) | Respironics, Inc. | 2019-10-18 |
| QT Scanner 2000 Model A (K190646) | Qt Ultrasound, LLC | 2019-10-18 |
| Infrared Thermometer, Breeze model (K191283) | Suzhou Melodicare Medical Technology Co., Ltd. | 2019-10-18 |
| SYMPHONY Navigation Ready Instruments, Universal Navigation Adaptor Set (K191943) | Medos International SARL | 2019-10-18 |
| Quantum Blood and Fluid Warming System (K192325) | Life Warmer, Inc. | 2019-10-18 |
| Tetragraph Neuromuscular Transmission Monitor (K190795) | Senzime AB | 2019-10-18 |
| Synapse 3D Blood Flow Analysis (K191544) | Fujifilm Corporation | 2019-10-18 |
| ATEC IOM Accessory Instruments (K191723) | Alphatec Spine, Inc. | 2019-10-18 |
| Confirm Rx Insertable Cardiac Monitor (K192593) | Abbott | 2019-10-18 |
| NuVasive Modulus XLIF Interbody System (K192760) | Nu Vasive, Incorporated | 2019-10-18 |
| Evolve Breast Pump (K190465) | Hygeia II Medical Group, Inc. | 2019-10-18 |
| Arthrex SwiveLock Anchors (K192441) | Arthrex, Inc. | 2019-10-17 |
| WavelinQ Plus EndoAVF System (K192239) | C.R. Bard, Inc. | 2019-10-17 |
| SmartCeph (K190162) | Ortho2, LLC | 2019-10-17 |
| EasyMark Tissue Marker (K183503) | Inrad, Inc. | 2019-10-17 |
| Freestyle Flex (K191653) | Medela AG | 2019-10-17 |
| DyeVert™ Plus Contrast Reduction System, DyeTect™ Contrast Monitoring System, DyeVert™ Plus EZ Contrast Reduction System (K190102) | Osprey Medical, Inc. | 2019-10-17 |
| BcSs-PICNI-2000 Sensor (K182073) | Braincare Desenvolvimento E Inovacao Tecnologica S.A. | 2019-10-17 |
| Matrix HA PEEK Cervical Implant System (K192316) | Sapphire Medical Group | 2019-10-17 |
| MT One Diamond (K191942) | M&T S.R.L. | 2019-10-17 |
| On Call Express II Blood Glucose Monitoring System (K192175) | ACON Laboratories, Inc. | 2019-10-17 |
| Merge PACS (K192455) | Merge Healthcare Incorporated | 2019-10-17 |
| Reach and CQ'ENCE Circular Staplers (K192566) | Reach Surgical, Inc. | 2019-10-17 |
| Carnation Ambulatory Monitor (K192556) | Bardy Diagnostics, Inc. | 2019-10-17 |
| Voxel Dosimetry™ v1.0 (K191216) | Hermes Medical Solutions AB | 2019-10-17 |
| DigiX FDX (K192541) | Allengers Medical Systems Limited | 2019-10-16 |
| Focus 35C Detector, Trimax 35C Detector (K192512) | Iray Technology Taicang , Ltd. | 2019-10-16 |
| Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Imipenem-Relebactam in the dilution range of 0.03/4-256/4 ug/mL (K192250) | Thermo Fisher Scientific | 2019-10-16 |
| Arthrex Minimally Invasive Ankle Fusion Plate (K190953) | Arthrex, Inc. | 2019-10-16 |
| Pitkar External Fixation System (K190486) | S.H.Pitkar Orthotools Pvt. , Ltd. | 2019-10-16 |
| Ventripoint Medical System Plus (VMS+) 3.0 (K191493) | Ventripoint Diagnostics , Ltd. | 2019-10-16 |
| SECURE Screw (K191771) | A.M. Surgical, Inc. | 2019-10-16 |
| Vial Adapter Ø20 mm (K190149) | Avenir Performance Europeenne Medical (Apem) | 2019-10-15 |
| Medtronic Transportation / Sterilization Cassettes (K190840) | Medtronic Sofamor Danek USA, Inc. | 2019-10-15 |
| Arthrex Mini Comprehensive Fixation System – 1.4mm & 1.6mm Module (K191326) | Arthrex, Inc. | 2019-10-15 |
| NuFACE Mini Device (K191672) | Carol Cole Company Dba Nuface | 2019-10-15 |
| Infared Thermometer (K191251) | Shenzhen Calibeur Industries Co., Ltd. | 2019-10-15 |
| TotalShield II Surgical Helmet System (K192194) | Zimmer Surgical, Inc. | 2019-10-15 |
| DualX Lumbar Intervertebral Body Fusion Device (K192434) | Amplify Surgical, Inc. | 2019-10-15 |
| Echelon Endopath Staple Line Reinforcement (K190937) | Ethicon Endo-Surgery, LLC | 2019-10-14 |
| K-Pack II Needle - 27G x 1/2” Extra Thin Wall, K-Pack II Needle - 27G x 1/2” Ultra Thin Wall, K-Pack II Needle - 30G x 1/2” Extra Thin Wall, K-Pack II Needle - 30G x 1/2” Ultra Thin Wall (K192057) | Terumo Europe N.V. | 2019-10-11 |
| Nexus Universal Self-Cure (K191548) | Kerr Corporation | 2019-10-11 |
| Protego Antimicrobial Wound Dressing (K183681) | Global Health Solutions (Dba Turn Therapeutics) | 2019-10-11 |
| Nano FortiCore, FortiCore (K191822) | Nanovis, LLC | 2019-10-11 |
| PMT Facet Screw (K183589) | Providence Medical Technology, Inc. | 2019-10-11 |
| Reusable SpO2 Sensor (K191420) | Shenzhen Changke Connect Electronics Co., Ltd. | 2019-10-11 |
| NXPRO Neuromuscular Electrical Stimulation Device (K191181) | Neux Technologies, Inc. | 2019-10-11 |
| McLean-Ring Enteral Feeding Tube Set (K190084) | Cook Incorporated | 2019-10-11 |
| CarboClear VBR System (K192214) | CarboFix Orthopedics , Ltd. | 2019-10-11 |
| Apyx Plasma/RF Handpiece (K191542) | Bovie Medical Corporation Dba Apyx Medical Corporation | 2019-10-11 |
| MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External CSF Drainage System (K191684) | Integra LifeSciences Corporation | 2019-10-11 |
| Wet Water Based Personal Lubricant (additionally, branded as WET Platinum Houston, Elite Water-Based Hybrid) (K191480) | Trigg Laboratories, Inc. D/B/A Wet International | 2019-10-11 |
| AEON Laparoscopic Instruments (K192235) | Lexington Medical, Inc. | 2019-10-11 |
| F&P Vitera Mask Full Face A Model (Small, Medium, Large), F&P Vitera Mask Full Face Sleep Lab Model (Small, Medium, Large) (K190713) | Fisher & Paykel Healthcare, Ltd. | 2019-10-11 |
| Electronic Pulse Stimulator (K183674) | Shenzhen Leading Perfection Technology Co., Ltd. | 2019-10-11 |
| Zimmer Natural Nail System Cephalomedullary Nails (K192312) | Zimmer GmbH | 2019-10-11 |