| ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL) (K190154) | Biomerieux S.A. | 2019-05-01 |
| PowerX Lipo System (K190555) | Solta Medical | 2019-05-01 |
| Synchro2 Support Guidewire (K190843) | Stryker | 2019-05-01 |
| Vitreq disposable laser probes, light fibers and Chandelier (K182646) | VitreQ BV | 2019-05-01 |
| TruWave Disposable Pressure Transducer (K183413) | Edwards Lifeciences, LLC | 2019-05-01 |
| Brush Biopsy Set ; Deflectable Brush Biopsy Set (K182231) | Cook Incorporated | 2019-05-01 |
| VASERlipo System (K190551) | Solta Medical | 2019-05-01 |
| NS 120P-TRS Airway Pressure Gauge (K180510) | Instrumentation Industries, Inc. | 2019-05-01 |
| Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector) (K190114) | Convatec Limited | 2019-04-30 |
| Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip Oral/Enteral Syringes with ENFit connector (1 mL to 6 mL) (K183540) | Neomed, Inc. | 2019-04-30 |
| SambaScrew 3D SI Fusion System (K183342) | Orthofix, Inc. | 2019-04-30 |
| Medtronic Model 5392 External Pulse Generator (EPG) (K190825) | Medtronic, Inc. | 2019-04-30 |
| Additive Cap (K190305) | International Medical Industries, Inc. | 2019-04-30 |
| TOTIM Patient Cushion Immobilization System (K190894) | Essebi Medical Srl | 2019-04-30 |
| Eclipse 2L (K183045) | Balt USA, LLC | 2019-04-30 |
| BD Intelliport System (K182092) | Becton, Dickinson and Company | 2019-04-30 |
| MRCAT Pelvis (K182888) | Philips Medical Systems MR Finland | 2019-04-30 |
| XmaruView V1 (Xmaru Chiroview, Xmaru Podview) (K190866) | Rayence Co., Ltd. | 2019-04-30 |
| HardyCHROM CRE (K190553) | Hardy Diagnostics | 2019-04-29 |
| Compex HD (K182017) | Addent, Inc. | 2019-04-29 |
| Magnetic Surgical System (K190006) | Levita Magnetics International Corp | 2019-04-29 |
| YelloPort Elite Port Access System (K190592) | Surgical Innovations Limited | 2019-04-29 |
| MyDay (K190965) | CooperVision, Inc. | 2019-04-29 |
| Element Pediatric Wheelchair (K182840) | Leggero, LLC | 2019-04-29 |
| Aspiron(TM) Aspiration Catheter (K190619) | Meril Life Sciences Private Limited | 2019-04-29 |
| VALO Grand Corded (K190627) | Ultradent Products, Inc. | 2019-04-29 |
| SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone System (K190655) | SeaSpine Orthopedics Corporation | 2019-04-29 |
| InterSpace Knee Extra-Large Size, InterSpace Knee ATS (K181732) | Tecres S.P.A. | 2019-04-27 |
| JO Actively Trying Personal Lubricant (K182585) | United Consortium | 2019-04-26 |
| AltiVate Reverse Humeral Stem, 48mm (K190290) | Encore Medical L.P. | 2019-04-26 |
| Philips IntelliVue XDS Software (K182637) | Philips Medizin Systeme Boeblingen GmbH | 2019-04-26 |
| VITROS XT Chemistry Products TBIL-ALKP Slides (K190807) | Ortho-Clinical Diagnostics, Inc. | 2019-04-26 |
| CyclaPlex Correction System (K183094) | Cycla Orthopedics, Ltd. | 2019-04-26 |
| Cardinal HealthTM Poly-Coated Open-Back Protective Gown (K182830) | Cardinal Health200, LLC | 2019-04-26 |
| Portable Electro-Stimulation Therapy Device (K182108) | Guangzhou Longest Science & Technology Co., Ltd. | 2019-04-26 |
| Penumbra System 3D Revascularization Device (K190464) | Penumbra, Inc. | 2019-04-26 |
| Multi-Sideport Catheter Infusion Set (K182071) | Cook Incorporated | 2019-04-25 |
| PANAVIA SA Cement Universal (K183537) | Kuraray Noritake Dental, Inc. | 2019-04-25 |
| Cediflo Enteral Feeding Tubes & Cediflo Junior Enteral Feeding Tubes (K181787) | Cedic S.R.L. | 2019-04-25 |
| Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System (K190771) | Cepheid | 2019-04-25 |
| exCellerator Cervical Collection Device (K182049) | Excell Company, LLC | 2019-04-25 |
| Synapse Enterprise Viewer Version 1.0 (K183248) | Fujifilm Corporation | 2019-04-25 |
| MasteRad MX30 (K190601) | Medicatech USA | 2019-04-25 |
| Smile Makers Personal Lubricant (K182100) | Lfbeauty (Thailand) Limited | 2019-04-25 |
| Ranfac Cartilage Biopsy Needle (K183146) | Ranfac Corporation | 2019-04-25 |
| Brainlab Elements Image Fusion Angio (K190042) | Brainlab AG | 2019-04-25 |
| A&D Medical Blood Pressure Monitors (K173065) | A&D Company, Ltd. | 2019-04-24 |
| Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse), Medline Level 4 Surgical Gown (Aurora) (K182172) | Medline Industries, Inc. | 2019-04-24 |
| Halley resin (K190043) | Dentsply Sirona | 2019-04-24 |
| Occlusion Balloon Catheter (K183679) | Qxmedical, LLC | 2019-04-24 |
| hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS (K190496) | Cefla S.C. | 2019-04-24 |
| Comaneci, Comaneci Petit, Comaneci 17 (DEN170064) | Rapid-Medical , Ltd. | 2019-04-24 |
| V-Laser (K183156) | Wontech Co., Ltd. | 2019-04-24 |
| RAYSCAN a-Expert3D (K190812) | Ray Co., Ltd. | 2019-04-24 |
| Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags (K190113) | Corinth Medtech, Inc. | 2019-04-24 |
| AXS Vecta Aspiration System (K190212) | Stryker Neurovascular | 2019-04-24 |
| IntelliCartTM System (K190789) | Dornoch Medical Systems | 2019-04-24 |
| Parcus ATLAS (K190375) | Parcus Medical, LLC | 2019-04-24 |
| Reprocessed Supreme Diagnostic Electrophysiology Catheter (K182386) | Innovative Health, LLC | 2019-04-23 |
| AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor (K181472) | Advanced Sterilization Products (Asp) | 2019-04-23 |
| Elcam Stopcocks and Manifolds (K190489) | Elcam Medical Acal | 2019-04-23 |
| Bander Ureteral Diversion Stent Set, Dretler Ureteroscopy Stent Set (K181971) | Cook Incorporated | 2019-04-23 |
| NanoBone SBX PUTTY, NanoBone QD (K190110) | Artoss GmbH | 2019-04-23 |
| Flexible HD Cysto-Urethroscope System (K182723) | KARL STORZ Endoscopy-America, Inc. | 2019-04-23 |
| SB Knife/Short type, SB Knife/Standard type, SB Knife/Jr type, SB Knife/Jr type - Long (K190621) | Sumitomo Bakelite Co., Ltd. | 2019-04-23 |
| EverCrossTM 0.035 OTW PTA Dilatation Catheter (K190753) | Medtronic, Inc. (Formerly D.B.A. Ev3, Inc. Covidien, LLC.) | 2019-04-23 |
| LC GLOSSFILL XR (K182778) | S&C Polymer Silicon- Und Composite Spezialitaeten GmbH | 2019-04-22 |
| FluChip-8G Influenza A+B Assay (K182513) | Indevr, Inc. | 2019-04-22 |
| CryoLab (K190407) | Cryoconcepts LP | 2019-04-22 |
| exGraft, exGraft Carbon (K183613) | Peca Labs | 2019-04-22 |
| Comprehensive Nano Stemless Shoulder (K182516) | Biomet Manufacturing Corp | 2019-04-22 |
| FUSION Plus Curing Light (K180065) | Dentlight, Inc. | 2019-04-19 |
| CapsoCam Plus (SV-3) (K183192) | CapsoVision, Inc. | 2019-04-19 |
| ASSURE® Anterior Cervical Plate System (K183056) | Globus Medical, Inc. | 2019-04-19 |
| SPY Portable Handheld Imaging (SPY-PHI) System (K190729) | Novadaq Technologies Ulc. (Now A Part of Stryker) | 2019-04-19 |
| ATLAS Plating System (K190415) | MiRus, LLC | 2019-04-19 |
| Cepheid Xpert C. difficile/Epi Control Panel (K190463) | Microbiologics, Inc. | 2019-04-19 |
| OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor (K181571) | Mark Abramson, D.D.S., Inc. | 2019-04-19 |
| PREVENA 125 and PREVENA PLUS 125 Therapy Units (DEN180013) | Kci USA, Inc. | 2019-04-19 |
| Ez3D-i/E3 (K190791) | Ewoosoft Co., Ltd. | 2019-04-19 |
| Monarch eTNS System (DEN180041) | Neurosigma, Inc. | 2019-04-19 |
| Relieva Tract Balloon Dilation System (K183090) | Acclarent, Inc. | 2019-04-19 |
| Hi-Torque Vektor, .014, 195cm, Str, Hi-Torque Vektor, .014, 195cm, J, Hi-Torque Vektor, .014, 300cm, Str, Hi-Torque Vektor, .014, 300cm, J (K182457) | Brivant Limited (Lake Region Medical) | 2019-04-18 |
| Orthodontic Appliance (K181747) | Shandong Huge Dental Material Corporation | 2019-04-18 |
| Lung Vision System (K183593) | Bodyvision Medical , Ltd. | 2019-04-18 |
| NeoForm Annuloplasty Ring (K190506) | Genesee Biomedical, Inc. | 2019-04-18 |
| Guide Sheath (K190644) | Surmodics,Inc. | 2019-04-18 |
| Disposable Standard Clamp (K190788) | Standard Bariatrics | 2019-04-18 |
| Psychemedics Microplate EIA for Fentanyl in Hair (K182103) | Psychemedics Corporation | 2019-04-18 |
| CryoTouch (K183601) | Cryoconcepts LP | 2019-04-18 |
| MicroScan Dried Gram Negative MIC/Combo Panels with Eravacycline (ERV) (0.016-32 ug/mL) (K190109) | Beckman Coulter, Inc. | 2019-04-18 |
| CancelleX Porous Titanium Lumbar Interbody Device (K190364) | Xenco Medical, LLC | 2019-04-18 |
| Straumann BLX Variobase Abutment (K190082) | Institut Straumann AG | 2019-04-17 |
| JO H2O Jelly Original Personal Lubricant (K183584) | United Consortium | 2019-04-17 |
| QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents (K190088) | Inova Diagnostics, Inc. | 2019-04-17 |
| Arthrex 2.5 mm Tenodesis Screw (K183395) | Arthrex, Inc. | 2019-04-17 |
| 0.071” ID MantaRay Reperfusion Catheter, 0.055” ID MantaRay Reperfusion Catheter, 0.045” ID MantaRay Reperfusion Catheter, 0.035” ID MantaRay Reperfusion Catheter (K183043) | Imperative Care, Inc. | 2019-04-17 |
| Phoenix (K183152) | Us Bionics, Inc. (Dba Suitx) | 2019-04-17 |
| JETi 88 Peripheral Thrombectomy System (K183403) | Walk Vascular, LLC | 2019-04-17 |
| HEM-6410T-ZL Wrist Blood Pressure Monitor (K190693) | Omron Healthcare, Inc. | 2019-04-17 |