| K192312 — Zimmer Natural Nail System Cephalomedullary Nails | Zimmer GmbH Oct 11, 2019 |
| K192057 — K-Pack II Needle - 27G x 1/2 Extra Thin Wall, K-Pack II Needle - 27G x 1/2 Ultra Thin Wall, K-Pack II Needle - 30G x 1/2 Extra Thin Wall, K-Pack II Needle - 30G x 1/2 Ultra Thin Wall | Terumo Europe N.V. Oct 11, 2019 |
| K183589 — PMT Facet Screw | Providence Medical Technology, Inc. Oct 11, 2019 |
| K191458 — Legacy SMARTBase Abutments | Implant Direct Sybron Manufacturing, LLC Oct 10, 2019 |
| K182136 — Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303) | Shenzhen Osto Technology Co., Ltd. Oct 10, 2019 |
| K191010 — Palladium High Flow Therapy System | Vapotherm, Inc. Oct 10, 2019 |
| K192526 — Spine Wave Navigated Instruments | Spine Wave, Inc. Oct 10, 2019 |
| K192147 — Halyard ONE-STEP* Sterilization Wrap | Owens & Minor (O&M) Halyard, Inc. Oct 10, 2019 |
| K191417 — Belun Ring | Belun Technology Company Limited Oct 10, 2019 |
| DEN190025 — OraQuick Ebola Rapid Antigen Test | OraSure Technologies, Inc. Oct 10, 2019 |
| K190386 — KTA Adipose Treatment Kit | Stemics S.A.S Oct 10, 2019 |
| K192465 — DigiFix Sterile Kit | Virak Orthopedics, LLC Oct 10, 2019 |
| K192210 — ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System | Fiab Spa Oct 10, 2019 |
| K190319 — Waterlase Laser System Family | Biolase, Inc. Oct 10, 2019 |
| K182184 — Paper Sterilization Pouch and Roll(Sterilization Pouch Flat, Sterilization Pouch Gusseted, Sterilization Roll Flat and Sterilization Roll Gusseted) | Mdk (Shanghai) Medical Packing Co., Ltd. Oct 10, 2019 |
| K191174 — Mercy babyTAPE | Children'S Mercy Hospital Oct 10, 2019 |
| K191659 — Instylla Delivery Kit | Instylla, Inc. Oct 10, 2019 |
| K192474 — VERA | Reflexion Health, Inc. Oct 10, 2019 |
| K190772 — SURGICAL MICROSCOPE SYSTEM ORBEYE with IR | Olympus Medical Systems Corp. Oct 10, 2019 |
| K190523 — Cranial PSI Accessory Anatomical Model Original, Cranial PSI Accessory Anatomical Model Modified, Cranial PSI Accessory Plastic Drawing Guide, Cranial PSI Accessory Cranial Implant Trial | Ossdsign AB Oct 10, 2019 |
| K191963 — SMR Finned Short Stems | Lima Corporate S.P.A. Oct 10, 2019 |
| K190630 — SolidAIRity III Airway Stabilization System | Securisyn Medical, LLC Oct 9, 2019 |
| K191523 — Visalys Restorative Primer | Kettenbach GmbH & Co. KG Oct 9, 2019 |
| K190314 — Advanced Intelligent Volumetric Ultrasound System, Model AiVUS 1000 | Mednovel Technology, Ltd. Oct 9, 2019 |
| K182448 — AnyRidge Octa 1 Implant System | Megagen Implant Co., Ltd. Oct 9, 2019 |
| K192200 — DynaCAD | Invivo Corporation Oct 9, 2019 |
| K191359 — Nipro Syringe | Nipro Medical Corporation Oct 9, 2019 |
| K191687 — pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire | Phenox Limited Oct 9, 2019 |
| K192208 — CORNICE Cervical Spacer System | Legend Spine Technologies Oct 9, 2019 |
| K191596 — Arcadia Balloon Catheter | Merit Medical Systems, Inc. Oct 9, 2019 |
| K190321 — Pediatric Nailing PlatformFemur | OrthoPediatrics Corp. Oct 9, 2019 |
| K191783 — Parcus Synd-EZ Ti | Parcus Medical, LLC Oct 9, 2019 |
| K192185 — The Cellfina System | Ulthera, Inc. Oct 9, 2019 |
| K183171 — ScopeSeal Duodenoscope Protective Device | Gi Scientific, LLC Oct 8, 2019 |
| K192206 — 32mm Glenosphere and Humeral Cup | Fx Shoulder USA, Inc. Oct 8, 2019 |
| K191369 — TSolution One Total Knee Application | THINK Surgical, Inc. Oct 8, 2019 |
| K191133 — KATANA Cleaner, KATANA Cleaner (Trial) | Kuraray Noritake Dental, Inc. Oct 8, 2019 |
| K191150 — Bodycad Unicompartmental Knee System | Bodycad Laboratories, Inc. Oct 8, 2019 |
| K191854 — Premia Spine XL Instruments | Premia Spine, Ltd. Oct 8, 2019 |
| K191127 — Advanced Intermezzo Implant System | Megagen Implant Co., Ltd. Oct 8, 2019 |
| K191779 — Attune Revision LPS Inserts | Depuy(Ireland) Oct 8, 2019 |
| K182773 — Single-Use Non-Stick Bipolar forceps Bayonet, Single-Use Non-Stick Bipolar Irrigating forceps, Single Use Non-Stick Bipolar Suction forceps | Faulhaber Pinzetten Ohg Oct 8, 2019 |
| K191448 — Barrier Sleeves | Ivoclar Vivadent, AG Oct 8, 2019 |
| K190086 — Cepheid Xpert Respiratory Control Panel | Microbiologics, Inc. Oct 7, 2019 |
| K190538 — NIO-I | Waismed, Ltd. Oct 7, 2019 |
| K191833 — Dexcom G6 Pro Continuous Glucose Monitoring System | Dexcom, Inc. Oct 7, 2019 |
| K191431 — Interlude Rolled Tampons in Plastic Applicator | Albaad Fem Oct 7, 2019 |
| K191632 — PROFEMUR TL2 Stems | Microport Orthopedics, Inc. Oct 7, 2019 |
| K192428 — AFX Femoral Implant with Inserter | Cayenne Medical Oct 5, 2019 |
| K190940 — Tokuyama Rebase III | Tokuyama Dental Corporation Oct 4, 2019 |