| BACT/ALERT MP Reagent System (K190405) | bioMerieux, Inc. | 2019-05-15 |
| Liba3 System (K182532) | National Cardiac, Inc. | 2019-05-15 |
| VeriClear Digital Early Result Pregnancy Test (K182328) | True Diagnostics, Inc. | 2019-05-15 |
| Recovery Pump, 737R (RPX) (K190493) | Mego Afek AC , Ltd. | 2019-05-15 |
| Flexible Overtube (K182520) | Sumitomo Bakelite Co., Ltd. | 2019-05-15 |
| FLIX-EMS (K181419) | Casgarum Investment, S.L. | 2019-05-14 |
| ORTHOLOC™ 2 Lapidus with Rotation System (K190670) | Wrightmedicaltechnologyinc | 2019-05-14 |
| BAROnova Insufflation System, BAROnova Accessory Kit (K190985) | Baronova, Inc. | 2019-05-14 |
| SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) (K190069) | Arrowhead De, LLC | 2019-05-14 |
| ImmunoCAP Allergen e229, Allergen Component rCan f 4 Dog, ImmunoCAP Allergen e230, Allergen Component rCan f 6 Dog, ImmunoCAP Allergen e231, Allergen Component rFel d 7 Cat (K190315) | Phadia AB | 2019-05-14 |
| Celerity HP Incubator (K190297) | STERIS Corporation | 2019-05-14 |
| JUSHA-M550G/ JUSHA-M550/M550G/M550 LCD Monitor (K190848) | Nanjing Jusha Display Technology Co., Ltd. | 2019-05-14 |
| D'Vill Introducer (K190974) | NuMED, Inc. | 2019-05-14 |
| ControlRad Trace Model 8 (K183109) | Controlrad, Inc. | 2019-05-13 |
| MVP Cervical Plate System (K190170) | GS Medical Co., Ltd. | 2019-05-13 |
| Simplexa VZV Direct, Simplexa VZV Positive Control Pack (K190219) | Diasorin Molecular, LLC | 2019-05-13 |
| SurgicalAR (K190764) | Medivis, Inc. | 2019-05-13 |
| PIVO (K190604) | Velano Vascular | 2019-05-13 |
| MR8 Drill System, Midas Rex MR8 ClearView Tools (K183515) | Medtronic Powered Surgical Solutions | 2019-05-12 |
| SPEAC System (K182180) | Brain Sentinel, Inc. | 2019-05-11 |
| Hysteroscope System (K181545) | Shanghai AnQing Medical Instrument Co., Ltd. | 2019-05-10 |
| 6400 Ultrasound System (MyLabX6, MyLabX7) (K190989) | Esaote, S.p.A. | 2019-05-10 |
| Ergoline Inspiration 550 Hybrid Technology / Sound, Ergoline Inspiration 550 Hybrid Technology / AC / Sound, Ergoline Planet Fitness 42/4 Hybrid Light Technology / Sound (K190173) | Jk-Holding GmbH | 2019-05-10 |
| Triangle System (K183319) | AliveCor, Inc. | 2019-05-10 |
| GenePOC Carba (K190275) | Genepoc, Inc. | 2019-05-10 |
| ExactVu High Resolution Micro-Ultrasound System (K190995) | Exact Imaging, Inc. | 2019-05-10 |
| Powder Free Nitrile Examination Gloves (Cobalt Blue, Black, Blue and Violet Blue) (K182612) | Zibo Yahao Supplies Co., Ltd. | 2019-05-10 |
| Vanguard Complete Knee System (K183583) | Zimmer, Inc. | 2019-05-10 |
| SteriStay (K190027) | Toul Meditech AB | 2019-05-10 |
| Wallace Dual Lumen Oocyte Recovery System (K182959) | CooperSurgical, Inc. | 2019-05-10 |
| L10 LED Light Source with AIM, L11 LED Light Source with AIM (K191046) | Stryker | 2019-05-10 |
| Therm-X (K190854) | Zenith Technical Innovations | 2019-05-10 |
| Unscented Menstrual Tampon (K190218) | Qingdao Youjia Hygiene Technology Co., Ltd. | 2019-05-09 |
| TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay Cartridge (K183160) | Haemonetics Corporation | 2019-05-09 |
| Delta Dual Mobility System (K181491) | Lima Corporate S.P.A. | 2019-05-09 |
| V-PRO 60 a Low Tempurature Strilization Systems, V-PRO s2 Low Temperature Sterilization Systems (K190917) | STERIS Corporation | 2019-05-09 |
| DePuy Synthes Sterilization Container System (K181933) | Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. | 2019-05-09 |
| CYGNUS™ Anterior Cervical Plate System (K190666) | MiRus, LLC | 2019-05-09 |
| TOF-Cuff monitor (K181894) | Rgb Medical Devices SA | 2019-05-09 |
| Wingman 14C Crossing Catheter (K190393) | Reflow Medical, Inc. | 2019-05-09 |
| Encore System (K183310) | Siesta Medical, Inc. | 2019-05-09 |
| Rowheels Revolution 1.0 (K190699) | Rowheels, Inc. | 2019-05-09 |
| ATEC IOM Accessory Instruments (K182617) | Alphatec Spine, Inc. | 2019-05-09 |
| Magic Clear Aligners (K190948) | Voodoo Manufacturing, Inc. | 2019-05-09 |
| UNiD Patient specific 3D printed TLIF cage (K190092) | Medicrea International SA | 2019-05-08 |
| Gynescope System (K190187) | Illumigyn , Ltd. | 2019-05-08 |
| Reprocessed ViewFlex Xtra ICE Catheter (K182238) | Stryker Sustainability Solutions | 2019-05-08 |
| KeYi Spinal Fixation System (K190567) | Beijing Keyi Medical Device Technology Co., Ltd. | 2019-05-08 |
| Electrosurgical accessory (K183126) | New Deantronics Taiwan , Ltd. | 2019-05-08 |
| GlucoLeader Enhance Blood Glucose Monitoring System (K182428) | Hmd Biomedical, Inc. | 2019-05-08 |
| COLOSSEUM Mesh (K190147) | Globus Medical, Inc. | 2019-05-08 |
| SomnoDent Avant (K183443) | Somnomed, Inc. | 2019-05-08 |
| Cepheid Xpert CT/NG Control Panel (K190223) | Microbiologics, Inc. | 2019-05-08 |
| Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter (K183461) | Teleflexmedical, Inc. | 2019-05-08 |
| cobas u 601 urinalysis test system (K183432) | Roche Diagnostics | 2019-05-07 |
| Ethyl Chloride Medium Jet Stream, Ethyl Chloride Fine Pinpoint spray, Ethyl Chloride Mist, Ethyl Chloride Accustream 360* Medium Spray, Ethyl Chloride Accustream 360* Fine Spray (K190161) | Gebauer Company | 2019-05-07 |
| Stryker ChestShield Sterilization Tray System (K183701) | Paragon Medical | 2019-05-07 |
| FUJIFILM Endoscope Model EC-760S-V/L (K190649) | Fujifilm Corporation | 2019-05-07 |
| OssBuilder System (K181854) | Osstem Implant Co., Ltd. | 2019-05-07 |
| Scope ProTech (K191011) | Meditech Endoscopy, Ltd. | 2019-05-07 |
| Moore Park Mask (K183512) | Resmed, Ltd. | 2019-05-07 |
| Neodent Instruments Kits (K182865) | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2019-05-07 |
| SteriCap Mini Needle (K183016) | Ocujet, LLC | 2019-05-07 |
| Showa(R) Medical Exam Glove (Green) powder-free, disposable nitrile glove (K190159) | Showa Best Glove, Inc. | 2019-05-06 |
| MD-6000P Bladder Scanner (K182460) | MEDA Co., Ltd. | 2019-05-06 |
| Medline Electrocautery Pencil (K190643) | Medline Industries, Inc. | 2019-05-06 |
| Capstone Control™ Spinal System (K190165) | Medtronic Sofamor Danek USA, Inc. | 2019-05-06 |
| BioCardia 8.5 F Avance Steerable lntroducer (K190941) | Biocardia, Inc. | 2019-05-06 |
| Biograph Vision (K190900) | Siemens Medical Solutions USA, Inc. | 2019-05-06 |
| HealthPNX (K190362) | Zebra Medical Vision, Ltd. | 2019-05-06 |
| Unity Subcutaneous Delivery System for Remodulin (K190182) | DEKA Research & Development | 2019-05-06 |
| Wireless Intelligent Thermometer (K182437) | Shenzhen Jumper Medical Equipment Co., Ltd. | 2019-05-05 |
| Medline Quick-Clear Wand (K183577) | Medline Industries, Inc. | 2019-05-04 |
| N Latex FLC kappa, N Latex FLC lambda (K190879) | Siemens Healthcare Diagnostics Products GmbH | 2019-05-03 |
| Arthrex DynaNite® PIP (Hammertoe) Implant (K190287) | Arthrex, Inc. | 2019-05-03 |
| Flexible Sensor-Ureterorenoscopes BOA Vision EF, Flexible Sensor-Ureterorenoscopes COBRA Vision EF (K183188) | Richard Wolf Medical Instruments Corporation | 2019-05-03 |
| Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator (K190504) | Relievant Medsystems | 2019-05-03 |
| NeoLSD MSMS Kit (K190266) | Perkinelmer, Inc. | 2019-05-03 |
| CLEARFIL MAJESTY IC (K182430) | Kuraray Noritake Dental, Inc. | 2019-05-03 |
| armor LC (K182118) | Mavrik Dental Systems, Ltd. | 2019-05-03 |
| HALF DOME Posterior Lumbar Interbody System (K182877) | Astura Medical, LLC | 2019-05-03 |
| Aptis Medical Distal Radio Ulnar Joint Implant (K190599) | Aptis Medical, LLC | 2019-05-03 |
| RELIEVA ULTIRRA Sinus Balloon Catheter (K190525) | Acclarent, Inc. | 2019-05-03 |
| MatrixRIB Fixation System (K190409) | DePuy Synthes | 2019-05-03 |
| AuraGen 123 Suction Lipoplasty System (A123) (K190278) | Auragen Aesthetics, LLC | 2019-05-03 |
| Manual Wheelchair W54 (K180309) | Jiangsu Jumao Medical Equipment Co., Ltd. | 2019-05-03 |
| Leaf Photocoagulator (K190083) | Norlase Aps | 2019-05-03 |
| TruDi NAV Wire (K190532) | Acclarent, Inc. | 2019-05-03 |
| FilmArray Pneumonia/Pneumoniaplus Control (K190222) | Maine Molecular Quality Controls, Inc. | 2019-05-03 |
| alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL (K182474) | Biosystems S.A. | 2019-05-02 |
| HYDRASHIFT 2/4 daratumumab (K190851) | Sebia | 2019-05-02 |
| PASS LP Spinal System (K190376) | Medicrea International SA | 2019-05-02 |
| SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface (K190560) | Nonin Medical, Inc. | 2019-05-02 |
| TRIO Handpiece (K183199) | Omniguide, Inc. | 2019-05-02 |
| Cocoon Convective Warming System (K181671) | Care Essentials Pty, Ltd. | 2019-05-02 |
| K-Shield Advantage Port Access Infusion Set (PAIS) (K190233) | Kawasumi Laboratories, Inc. | 2019-05-02 |
| Ponto 4 (K190540) | Oticon Medical AB | 2019-05-02 |
| Boomerang™ Anterior Cervical Plate System (K190227) | Choicespine, LP | 2019-05-01 |
| HS Fiber (K190817) | Riverpoint Medical | 2019-05-01 |
| CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO (K183394) | GE Healthcare Finland Oy | 2019-05-01 |