| K190154 — ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL) | Biomerieux S.A. May 1, 2019 |
| K190227 — Boomerang Anterior Cervical Plate System | Choicespine, LP May 1, 2019 |
| K182646 — Vitreq disposable laser probes, light fibers and Chandelier | VitreQ BV May 1, 2019 |
| K190551 — VASERlipo System | Solta Medical May 1, 2019 |
| K183394 — CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO | GE Healthcare Finland Oy May 1, 2019 |
| K190555 — PowerX Lipo System | Solta Medical May 1, 2019 |
| K183413 — TruWave Disposable Pressure Transducer | Edwards Lifeciences, LLC May 1, 2019 |
| K182231 — Brush Biopsy Set ; Deflectable Brush Biopsy Set | Cook Incorporated May 1, 2019 |
| K190894 — TOTIM Patient Cushion Immobilization System | Essebi Medical Srl Apr 30, 2019 |
| K190114 — Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector) | Convatec Limited Apr 30, 2019 |
| K190305 — Additive Cap | International Medical Industries, Inc. Apr 30, 2019 |
| K182888 — MRCAT Pelvis | Philips Medical Systems MR Finland Apr 30, 2019 |
| K183342 — SambaScrew 3D SI Fusion System | Orthofix, Inc. Apr 30, 2019 |
| K183045 — Eclipse 2L | Balt USA, LLC Apr 30, 2019 |
| K190866 — XmaruView V1 (Xmaru Chiroview, Xmaru Podview) | Rayence Co., Ltd. Apr 30, 2019 |
| K183540 — 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) | Neomed, Inc. Apr 30, 2019 |
| K182092 — BD Intelliport System | Becton, Dickinson And Company Apr 30, 2019 |
| K190825 — Medtronic Model 5392 External Pulse Generator (EPG) | Medtronic, Inc. Apr 30, 2019 |
| K190627 — VALO Grand Corded | Ultradent Products, Inc. Apr 29, 2019 |
| K182840 — Element Pediatric Wheelchair | Leggero, LLC Apr 29, 2019 |
| K190965 — MyDay | CooperVision, Inc. Apr 29, 2019 |
| K190655 — SeaSpine® Shoreline ACS- Anterior Cervical Standalone System | SeaSpine Orthopedics Corporation Apr 29, 2019 |
| K190592 — YelloPort Elite Port Access System | Surgical Innovations Limited Apr 29, 2019 |
| K190619 — Aspiron(TM) Aspiration Catheter | Meril Life Sciences Private Limited Apr 29, 2019 |
| K190006 — Magnetic Surgical System | Levita Magnetics International Corp Apr 29, 2019 |
| K190553 — HardyCHROM CRE | Hardy Diagnostics Apr 29, 2019 |
| K182017 — Compex HD | Addent, Inc. Apr 29, 2019 |
| K181732 — InterSpace Knee Extra-Large Size, InterSpace Knee ATS | Tecres S.P.A. Apr 27, 2019 |
| K190807 — VITROS XT Chemistry Products TBIL-ALKP Slides | Ortho-Clinical Diagnostics, Inc. Apr 26, 2019 |
| K190290 — AltiVate Reverse Humeral Stem, 48mm | Encore Medical L.P. Apr 26, 2019 |
| K182108 — Portable Electro-Stimulation Therapy Device | Guangzhou Longest Science & Technology Co., Ltd. Apr 26, 2019 |
| K182585 — JO Actively Trying Personal Lubricant | United Consortium Apr 26, 2019 |
| K183094 — CyclaPlex Correction System | Cycla Orthopedics, Ltd. Apr 26, 2019 |
| K190464 — Penumbra System 3D Revascularization Device | Penumbra, Inc. Apr 26, 2019 |
| K182637 — Philips IntelliVue XDS Software | Philips Medizin Systeme Boeblingen GmbH Apr 26, 2019 |
| K182830 — Cardinal HealthTM Poly-Coated Open-Back Protective Gown | Cardinal Health200, LLC Apr 26, 2019 |
| K183146 — Ranfac Cartilage Biopsy Needle | Ranfac Corporation Apr 25, 2019 |
| K183248 — Synapse Enterprise Viewer Version 1.0 | Fujifilm Corporation Apr 25, 2019 |
| K190601 — MasteRad MX30 | Medicatech USA Apr 25, 2019 |
| K183537 — PANAVIA SA Cement Universal | Kuraray Noritake Dental, Inc. Apr 25, 2019 |
| K181787 — Cediflo Enteral Feeding Tubes & Cediflo Junior Enteral Feeding Tubes | Cedic S.R.L. Apr 25, 2019 |
| K182049 — exCellerator Cervical Collection Device | Excell Company, LLC Apr 25, 2019 |
| K182071 — Multi-Sideport Catheter Infusion Set | Cook Incorporated Apr 25, 2019 |
| K190042 — Brainlab Elements Image Fusion Angio | Brainlab AG Apr 25, 2019 |
| K182100 — Smile Makers Personal Lubricant | Lfbeauty (Thailand) Limited Apr 25, 2019 |
| K190771 — Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System | Cepheid Apr 25, 2019 |
| K190212 — AXS Vecta Aspiration System | Stryker Neurovascular Apr 24, 2019 |
| K190812 — RAYSCAN a-Expert3D | Ray Co., Ltd. Apr 24, 2019 |
| K182172 — Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse), Medline Level 4 Surgical Gown (Aurora) | Medline Industries, Inc. Apr 24, 2019 |
| DEN170064 — Comaneci, Comaneci Petit, Comaneci 17 | Rapid-Medical , Ltd. Apr 24, 2019 |