| Dornier Ureteral Stent (K190312) | Dornier Medtech America, Inc. | 2019-11-15 |
| HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High (K192842) | Eurotrol B.V. | 2019-11-15 |
| Pentax Medical Video Duodenoscope ED34-i10T2 (K192245) | Pentax of America, Inc. | 2019-11-15 |
| SmartSPACE Shoulder System (K191247) | Techmah Medical, LLC | 2019-11-15 |
| Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical Instruments (K191921) | Cochlear Americas | 2019-11-15 |
| IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit (K192289) | Irras USA, Ltd. | 2019-11-15 |
| EM SA Implant System (K191201) | Hiossen, Inc. | 2019-11-15 |
| Ophthalmic Yag Laser System YC-200 (K192045) | Nidek Co., Ltd. | 2019-11-15 |
| Soltus 500 (K192936) | Sedecal., Sa. | 2019-11-15 |
| E-100 Electrosurgical Generator, SynchroSeal (K191280) | Intuitive Surgical, Inc. | 2019-11-14 |
| HeraBEAT™ US (K191110) | Heramed, Ltd. | 2019-11-14 |
| Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes (K192908) | Wilson-Cook Medical, Inc. | 2019-11-14 |
| Brainlab Compatible K2M Navigation Instruments (K192911) | K2m, Inc. | 2019-11-14 |
| LongBow Ti (K190721) | Life Spine, Inc. | 2019-11-14 |
| Allwin Intra Uterine Insemination Catheters (INSEMINA and INSEMINA Open Tip Intra Uterine Insemination Catheter, CURVED and CURVED Open Tip Intra Uterine Insemination Catheter, TRACKABLE and TRACKABLE Open Tip Intra Uterine Insemination Catheter, FLEXI and FLEXI Open Tip Intra Uterine Insemination Catheter, STUMPY Intra Uterine Insemination Catheter) (K190522) | Allwin Medical Devices, Inc. | 2019-11-14 |
| Reprocessed ViewFlex™ Xtra ICE Catheter (K190478) | Sterilmed, Inc. | 2019-11-14 |
| EBA One Nailing System (K183666) | Citieffe S.R.L. | 2019-11-14 |
| ST Internal Implant System (K192347) | Megagen Implant Co., Ltd. | 2019-11-14 |
| MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32ug/mL) (K192355) | Beckman Coulter, Inc. | 2019-11-14 |
| Piper GO-IO Intraosseous Infusion System (K191976) | Piper Access, LLC | 2019-11-13 |
| NuVasive CoRoent Small Interlock System (K192582) | Nu Vasive, Incorporated | 2019-11-13 |
| GMA 2.0 Pedicle Screw System (K192915) | Grafton Medical Alliance | 2019-11-13 |
| EchoGo Core (K191171) | Ultromics, Ltd. | 2019-11-13 |
| Infrared Thermometer Model MD-H30 (K191570) | Guangzhou Berrcom Medical Device Co., Ltd. | 2019-11-13 |
| Nox Sleep System (K192469) | Nox Medical | 2019-11-13 |
| AEON-C Stand Alone System (K191477) | Huvexel Co. , Ltd. | 2019-11-13 |
| AMICUS Separator System (K192150) | Fresenius Kabi AG | 2019-11-13 |
| LaseMD LEO Laser System (K192331) | Lutronic Global | 2019-11-12 |
| AC3 Series Intra-Aortic Balloon Pump (IABP) (K192238) | Arrow International, Teleflex | 2019-11-12 |
| xTAG Gastrointestinal Pathogen Panel (GPP) (K191161) | Luminex Molecular Diagnostics, Inc. | 2019-11-12 |
| PENTAX Medical Video Upper GI Scopes (EG Family) (K190799) | Pentax of America, Inc. | 2019-11-12 |
| Clear21 (K192202) | World Class Technology Corporation | 2019-11-12 |
| IDENTIFY (K192968) | Varian Medical Systems, Inc. | 2019-11-12 |
| FDR D-EVO III flat panel detector system (K192932) | Fujifilm Corporation | 2019-11-12 |
| ARIX Wrist System (K191972) | Jeil Medical Corporation | 2019-11-12 |
| DESS Dental Smart Solutions (K191986) | Terrats Medical SL | 2019-11-10 |
| LATERA Absorbable Nasal Implant System (K192661) | Entellus Medical, Inc. (Aka Stryker Ent) | 2019-11-10 |
| Neodent Implant System (K190958) | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2019-11-09 |
| Omics Core (K190661) | Nanthealth, Inc. | 2019-11-09 |
| Visalys CemCore, Visalys Cem Core Try In Paste (K191527) | Kettenbach GmbH & Co. KG | 2019-11-08 |
| OEC Elite (K192819) | Ge Oec Medical Systems, Inc. | 2019-11-08 |
| BA Pit & Fissure Sealant (K190998) | Apex Dental Materials, Inc. | 2019-11-08 |
| Dragonfly OpStar™ Imaging Catheter, AptiVue™ Software version E.5.1 (K192019) | ABBOTT MEDICAL | 2019-11-08 |
| APTUS Wrist Arthrodesis Plates (K192297) | Medartis AG | 2019-11-08 |
| PFC SIGMA Knee System (K182301) | DePuy Orthopaedics, Inc. | 2019-11-08 |
| VK100 Percutaneous Vertebral Augmentation System (K192403) | Bonwrx, Ltd. | 2019-11-08 |
| CONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT USB Blood Glucose Monitoring System, CONTOUR® NEXT ONE Blood Glucose Monitoring System, CONTOUR® NEXT EZ Blood Glucose Monitoring System, CONTOUR® NEXT LINK Wireless Blood Glucose Monitoring System (K191286) | Ascensia Diabetes Care | 2019-11-08 |
| Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (White) (K192232) | Hartalega NGC Sdn. Bhd. | 2019-11-08 |
| CRP Vario (K192118) | SENTINEL CH. SpA | 2019-11-08 |
| HIVOX Spopad EMS SP-911, SP-921 (K192264) | Hivox Biotek, Inc. | 2019-11-08 |
| Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves (K191230) | O&M Halyard, Inc. | 2019-11-08 |
| IPL Home Use Hair Removal Device Model(s): D-1128, D-1103, D-1119, D-1129, D-1130 (K192432) | Shenzhen Bosidin Technology Co., Ltd. | 2019-11-08 |
| PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family (K191282) | Pentax of America, Inc. | 2019-11-08 |
| CERENOVUS Large Bore Catheter (K191237) | Codman & Shurtleff, Inc. | 2019-11-08 |
| Oryx Cervical Plate System (K192049) | Innovasis, Inc. | 2019-11-08 |
| QuantX Breast MRI Biopsy Guidance Plugin (K191959) | Qlarity Imaging | 2019-11-08 |
| StoneBite and StoneBite scan (K190571) | Dreve Dentamid GmbH | 2019-11-07 |
| BioGenesis Fertility Lubricant (K190872) | Good Clean Love, Inc. | 2019-11-07 |
| DePuy Synthes 2.4mm LCP Straight Wrist Plate, Sterile (K192327) | Synthes (USA) Products, LLC | 2019-11-07 |
| Salem Sump Dual Lumen Stomach Tube with ENFit Connection (K190923) | Cardinalhealth | 2019-11-07 |
| SandShark Injectable Anchor (SIA) System (K191466) | Stimwave Technologies, Inc. | 2019-11-07 |
| Progenikine Concentrating System 25 mL System (K191564) | Emcyte Corporation | 2019-11-07 |
| EleVation Breast Biopsy Driver, EleVation Breast Biopsy Probe - 10G, EleVation Breast Biopsy Probe - 14G (K192948) | Bard Peripheral Vascular, Inc. | 2019-11-07 |
| PRECICE Plating System (K192181) | Nuvasive Specialized Orthopedics, Inc. | 2019-11-07 |
| DIGITAL RADIOGRAPHY CXDI-702C Wireless, DIGITAL RADIOGRAPHY CXDI-402C Wireless (K192632) | Canon, Inc. | 2019-11-07 |
| Portux CAD/CAM Disc (K192153) | New Stetic, SA | 2019-11-07 |
| B. anthracis Real-time PCR Assay (K192871) | Centers for Disease Control and Prevention | 2019-11-07 |
| DemeDIOX Barbed Absorbable Surgical Suture (K191361) | Demetech Corporation | 2019-11-07 |
| MEDIP PRO (K191026) | Medical IP Co., Ltd. | 2019-11-07 |
| Laparoscope Lens Shield Device (LENS) (K192891) | Medeon Biodesign, Inc. | 2019-11-07 |
| Thermo Scientific Sensititre ARIS HiQ System (K191918) | Thermo Fisher Scientific | 2019-11-06 |
| Hydrofera Blue READY - Border (K190268) | Hydrofera, LLC | 2019-11-06 |
| Vivid Aligners (K190003) | Orthodent Laboratory, Inc. | 2019-11-06 |
| Thermo Scientific Sensititre ARIS HiQ System (K191914) | Thermo Fisher Scientific | 2019-11-06 |
| Silicone Foley Catheter (K182463) | Biosensors International Pte, Ltd. | 2019-11-06 |
| BIO-RAY A-1 Anchor Screw System (K182929) | Microware Precision Co., Ltd. | 2019-11-06 |
| Conformis Hip System (K192198) | Conformis, Inc. | 2019-11-06 |
| Arthrex Nano SwiveLock Suture Anchor (K191651) | Arthrex, Inc. | 2019-11-06 |
| Sensititre 18-24 Hour MIC or Breakpoint Susceptibility System with Lefamulin in the dilution range of 0.008-16ug/ml (K192729) | Thermo Fisher Scientific | 2019-11-06 |
| GSP Neonatal Total Galactose kit (K190335) | Perkinelmer, Inc. | 2019-11-06 |
| SOMATOM X.cite (K191891) | Siemens Medical Solutions USA, Inc. | 2019-11-06 |
| A1AT Genotyping Test (K192858) | Progenika Biopharma S.A., A Grifols Company | 2019-11-05 |
| ADI TiDAL Osteotomy Wedge (K191047) | Additive Device, Inc. (Adi) D/B/A Restor3D | 2019-11-05 |
| Zimmer Biomet 12/14 CoCr Femoral Head and Freedom Head (K183457) | Zimmer, Inc. | 2019-11-05 |
| Fitmore Hip Stem (K192236) | Zimmer GmbH | 2019-11-05 |
| Suglue 3 (K192992) | 3M Deutschland GmbH | 2019-11-05 |
| Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) (K191292) | Anhui Powerguard Technology Co., Ltd. | 2019-11-05 |
| MucoPEG (K190144) | Sunbio, Inc. | 2019-11-05 |
| Cleerly Labs (K190868) | Cleerly, Inc. | 2019-11-05 |
| 7D Surgical System (K192140) | 7D Surgical, Inc. | 2019-11-05 |
| KOALA (K192109) | Ib Lab GmbH | 2019-11-05 |
| iASSIST Knee System (K192080) | Orthosoft Inc (D/B/A Zimmer Cas) | 2019-11-05 |
| TAP Blood Collection Device (K190225) | Seventh Sense Biosystems, Inc. | 2019-11-05 |
| MTS225 and MTS300 Multiple Tray Sterilization Systems (K190541) | Pmbs, LLC | 2019-11-05 |
| WellDoc BlueStar (K190013) | Welldoc, Inc. | 2019-11-04 |
| Mei Ceramic Bracket (K190608) | Orthosun Co., Ltd. | 2019-11-04 |
| Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen (K192125) | AtriCure, Inc. | 2019-11-04 |
| DRX-Evolution/Plus with Dual Energy (K190330) | Carestream Health, Inc. | 2019-11-04 |
| xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) (K191160) | Luminex Molecular Diagnostics, Inc. | 2019-11-04 |
| LARS AC Band Device (K190143) | Corin USA | 2019-11-04 |