| EthanZir Zirconia (K191304) | Besorah Dental Solutions NZ Limited | 2019-11-04 |
| Idys ALIF ZP 3DTi (K192168) | Clariance, Sas | 2019-11-04 |
| Scan Abutments and Comfort Caps (K191634) | Dentium Co., Ltd. | 2019-11-04 |
| NuVasive AttraX Putty (K191974) | Nu Vasive, Incorporated | 2019-11-03 |
| Allcem, Allcem Core (K183465) | Dentscare Ltda | 2019-11-02 |
| Parcus Knotless AP Suture Anchors (K192824) | Parcus Medical, LLC | 2019-11-02 |
| DePuy Corail AMT Hip Prosthesis (K190344) | Depuy(Ireland) | 2019-11-01 |
| Stealth Autoguide System, Midas Rex Legend Depth Stop System (K191597) | Medtronic Navigation, Inc. | 2019-11-01 |
| BC-5 (K191693) | Reveallux, Corp | 2019-11-01 |
| Combo Electrotherapy Device (K192087) | Shenzhen Roundwhale Technology Co. , Ltd. | 2019-11-01 |
| ZMAXX Dental Zirconia Blanks (K191631) | Zmaxx Bioceramics, LLC | 2019-11-01 |
| MIMOSA Imager (K190334) | Mimosa Diagnostics, Inc. | 2019-11-01 |
| STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R) (K181993) | Sturdy Industrial Co., Ltd. | 2019-11-01 |
| XIHPOS™ ZFUZE™ Interbody Fusion System (K190544) | Difusion Technologies | 2019-11-01 |
| Luminelle DTx Hysteroscopy System, Luminelle Dx 360 Rotatable Disposable Sheath (Diagnostic) (K192278) | Uvision360, Inc. | 2019-11-01 |
| CAPI 3 Immunotyping, Capillarys 3 Tera (K192095) | Sebia | 2019-11-01 |
| NextDent Denture 3D+ (K191497) | Vertex-Dental B.V. | 2019-11-01 |
| MDT2 BLE Self-Monitoring Blood Glucose System (K190189) | Eps Bio Technology Corp. | 2019-11-01 |
| COPAL exchange G Hip and Knee Spacers (K191016) | Heraeus Medical GmbH | 2019-11-01 |
| BD Acute Central Line (K190855) | Bard Access Systems, Inc. (Bard Has Joined Bd) | 2019-11-01 |
| FDR SE Lite (K192440) | Fujifilm Corporation | 2019-11-01 |
| Delta Multihole TT Pro Acetabular System (K191622) | Lima Corporate S.P.A. | 2019-11-01 |
| LEGION System (K191650) | Alcon Research, LLC | 2019-11-01 |
| VPro5 (K183018) | Propel Orthodontics, LLC | 2019-11-01 |
| WV1 Endoscope (K190190) | 270surgical , Ltd. | 2019-11-01 |
| Sight OLO (K190898) | Sight Diagnostics , Ltd. | 2019-11-01 |
| Perfect PFE (K191312) | Tenscare, Ltd. | 2019-11-01 |
| Foryou NPWT Dressing Kit (K190119) | 4l Health Co., Ltd. | 2019-11-01 |
| Small VBR™ (K192117) | Ulrich GmbH & Co. KG | 2019-11-01 |
| Ultrasonic Surgical System (K190281) | Medisonic Technology CO | 2019-10-31 |
| ADH19 (K192961) | 3M Deutschland GmbH | 2019-10-31 |
| OR3O Dual Mobility System (K191002) | Smith & Nephew, Inc. | 2019-10-31 |
| Belimed Steam Sterilizer MST-H TOP 5000 (K191896) | Belimed AG | 2019-10-31 |
| Apyx Helium Plasma Generator (APYX-200H/P, APYX-JS3/RS3) (K192867) | Bovie Medical Corporation Dba Apyx Medical Corporation | 2019-10-31 |
| VisionX 2.4 (K192743) | Durr Dental SE | 2019-10-31 |
| 087 Balloon Guide Catheter System (K192525) | Q'Apel Medical, LLC | 2019-10-31 |
| Vitek Densichek (K192110) | bioMerieux, Inc. | 2019-10-31 |
| ePM Series Patient monitors (K191769) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2019-10-31 |
| MTS Ampicillin-Sulbactam 0.016/0.008 - 256/128 µg/mL (K192345) | Liofilchem s.r.l. | 2019-10-31 |
| mediCAD Web (K183412) | Medicad Hectec GmbH | 2019-10-31 |
| Claritag (K190747) | Dgi Technologies | 2019-10-31 |
| StimRouter Neuromodulation System (K190047) | Bioness, Inc. | 2019-10-31 |
| Reprocessed Reflexion Spiral Bi-Directional Variable Radius Electrophysiology Catheter (K191170) | Innovative Health, LLC | 2019-10-30 |
| EZE SIT Valvulotome (K190267) | Lemaitre Vascular | 2019-10-30 |
| Okami Medical LOBO Vascular Occlusion System (K192083) | Okami Medical | 2019-10-30 |
| IB3D ALIF (K191134) | Medicrea International SA | 2019-10-30 |
| Arthrex Low Profile Screws (K190921) | Arthrex, Inc. | 2019-10-30 |
| Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”) (K191264) | Ujenzi Charitable Trust | 2019-10-30 |
| Treace Medical Concepts (TMC) Plating System (K192504) | Treace Medical Concepts, Inc. | 2019-10-30 |
| Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri (K192775) | Stereotaxis, Inc. | 2019-10-30 |
| Aristotle 24 Guidewire, 200cm, Soft Profile ; Aristotle 24 Guidewire, 200cm, Standard Profile ; Aristotle 24 Guidewire, 200cm, Support Profile (K192783) | Scientia Vascular, LLC | 2019-10-30 |
| Atellica IM Total hCG (ThCG) (K192790) | Siemens Healthcare Diagnostics, Inc. | 2019-10-30 |
| ROSA ONE Spine application (K192173) | Medtech S.A | 2019-10-29 |
| G21 SpaceFlex Hip (K192041) | G21, S.R.L. | 2019-10-29 |
| NexGen Anterior Cervical Plate System (K192494) | Precision Spine | 2019-10-29 |
| BRILLIANT COMPONEER (K191385) | Coltene/Whaledent AG | 2019-10-29 |
| Compression Therapy Device Model LGT-2200SP (K191862) | Guangzhou Longest Science & Technology Co., Ltd. | 2019-10-29 |
| W Zirconia Implants (K192053) | Tav Medical , Ltd. | 2019-10-29 |
| PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit (K192369) | Ixensor Co, Ltd. | 2019-10-29 |
| MATRx Plus (K191925) | Zephyr Sleep Technologies | 2019-10-29 |
| Zimmer Biomet Universal Navigation System (K192133) | Zimmer Biomet Spine, Inc. | 2019-10-29 |
| Black Diamond Pedicle Screw System (K192121) | Osseus Fusion Systems | 2019-10-29 |
| EmFace Device (K191855) | Inmode MD , Ltd. | 2019-10-29 |
| Game Ready GRPro 2.1 System (K192114) | Cool Systems, Inc. (Dba Game Ready) | 2019-10-29 |
| 3d Cage (K180347) | Fims Co., Ltd. | 2019-10-28 |
| KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSun (K191881) | Kbl GmbH | 2019-10-28 |
| Straumann PUREloc abutments (K192029) | Institut Straumann AG | 2019-10-28 |
| primeMidline Catheters (K192802) | Pfm Medical, Inc. | 2019-10-28 |
| 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 (K192673) | 3M Company | 2019-10-28 |
| LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set (K192046) | DiaSorin, Inc. | 2019-10-28 |
| HS AMICA devices family (K182605) | H.S Hospital Service S.P.A | 2019-10-28 |
| EarlyVue VS30 (K190624) | Philips Medizin Systeme Boeblingen GmbH | 2019-10-27 |
| MiniCap Extended Life PD Transfer Sets (K192705) | Baxter Healthcare | 2019-10-25 |
| Instruments for LINK MEGASYSTEM-C Family (K190181) | LinkBio Corp. | 2019-10-25 |
| F5 Corpus VS (K191874) | Permobil AB | 2019-10-25 |
| IntellaMap Orion High Resolution Mapping Catheter (K192360) | Boston Scientific Corporation | 2019-10-25 |
| REDAPT Blade Augments (K190847) | Smith & Nephew, Inc. | 2019-10-25 |
| Maverick RNP Assay and Maverick Diagnostic System (K191085) | Genalyte, Inc. | 2019-10-25 |
| C-CAT Anaesthesia Catheter kit (K191470) | Cimpax Aps | 2019-10-25 |
| gel-e Flex+ gel OTC (K192667) | Gel-E, Inc. | 2019-10-25 |
| ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction Device (K191807) | ALPCO | 2019-10-25 |
| Cytal Wound Matrix 3-Layer (K192725) | Acell, Inc. | 2019-10-25 |
| Reusable Monopolar Active Cord (K192518) | Us Endoscopy | 2019-10-25 |
| Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems (K191007) | Supersonic Imagine | 2019-10-25 |
| FILTRAY 2G Disposable Water Filters (K191563) | Aqua-Tools | 2019-10-25 |
| IOB Warming Blankets (K190221) | Iob Medical, Inc. | 2019-10-25 |
| Dexcom G6 Glucose Program Continuous Glucose Monitoring (GCM) System (K192787) | Dexcom, Inc. | 2019-10-25 |
| Genesys Spine Binary® Lumbar Plate System (K192678) | Genesys Spine | 2019-10-24 |
| Agnes (K192728) | Agnes Medical Co., Ltd. | 2019-10-24 |
| Padlock Clip defect closure system, Padlock Pro-Select defect closure device (K192722) | STERIS Corporation | 2019-10-24 |
| ALTA Anterior Cervical Corpectomy System (K190426) | Astura Medical, LLC | 2019-10-24 |
| MU2net (K191944) | Dosisoft | 2019-10-24 |
| Tear Pool Dissolvable Punctum Plugs (K190210) | Alphamed, Inc. | 2019-10-24 |
| Revolution Maxima, Revolution Ace (K192686) | Ge Hangwei Medical Systems Co., Ltd. | 2019-10-24 |
| MediExpand TL Expandable VBR System (K190349) | Cmf Medicon Surgical, Inc. | 2019-10-24 |
| ADI Cervical Interbody Fusion Device (K191812) | Additive Device, Inc. (Adi) D/B/A Restor3D | 2019-10-24 |
| Cronus HP PTA Balloon Catheter (K190037) | Nipro Medical Corporation | 2019-10-24 |
| Zimmer Biomet Universal Navigation System (K190556) | Zimmer Biomet Spine, Inc. | 2019-10-24 |
| Trident II Acetabular System (K191358) | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | 2019-10-24 |
| Upgrade Kit MR GUI PRO, MrJ 3300 Plus (K192690) | Asg Superconductors S.P.A. | 2019-10-24 |