| K193615 — NorthStar OCT Spinal System | SeaSpine Orthopedics Corporation Mar 25, 2020 |
| K193614 — FINE Osteotomy around the knee | Bodycad Laboratories, Inc. Mar 25, 2020 |
| K192284 — DiaFil Flow | DiaDent Group International Mar 25, 2020 |
| K193328 — IPL + Diode Laser Machine | Beijing Globalipl Development Co., Ltd. Mar 25, 2020 |
| K200241 — TempSure System | Cynosure, LLC Mar 25, 2020 |
| K192534 — CrossBay Endometrial Tissue Sampler (ETS) | Crossbay Medical Mar 25, 2020 |
| K192008 — LaserShot M, NaviLase | Vitrolife GmbH Mar 25, 2020 |
| K192967 — Medacta Shoulder System | Medacta International S.A. Mar 25, 2020 |
| K193593 — NuVasive 3DP Interfixated ALIF System | Nu Vasive, Incorporated Mar 25, 2020 |
| K193667 — Shapiro MD model laser 272 | Conversion Labs, Pr, LLC Mar 25, 2020 |
| K193311 — Aluna | Knox Medical Diagnostics, Inc. Mar 25, 2020 |
| K193078 — MIS CONNECT Conical Connection System | Dentsply Sirona Mar 25, 2020 |
| K193661 — LightWalker Laser System Family | Fotona D.O.O. Mar 25, 2020 |
| K192144 — STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device | ETHICON, Inc. Mar 25, 2020 |
| K193145 — Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch | Megadyne Medical Products, Inc. Mar 24, 2020 |
| K193579 — PlasmaBlade X 3.0S LIGHT | Medtronic Navigation Mar 24, 2020 |
| K200224 — SEA-LINK Anterior Cervical Plate System | Indius Medical Technologies Pvt. , Ltd. Mar 24, 2020 |
| K193335 — Sherlock | Open Implants, LLC Mar 24, 2020 |
| K200209 — Persona Personalized Knee System | Zimmer, Inc. Mar 24, 2020 |
| K200337 — FloPatch (FP120) | Flosonics Medical (R/A 1929803 Ontario Corp.) Mar 24, 2020 |
| K193100 — RESPONSE Spine System, RESPONSE 4.5/5.0 Spine System, RESPONSE 5.5/6.0 Spine System | OrthoPediatrics Corp. Mar 24, 2020 |
| K191788 — CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium, DIVERGENCE-L Anterior/Oblique Lumbar Fusion System | Medtronic Sofamor Danek USA, Inc. Mar 23, 2020 |
| K200436 — Aptima Combo 2 Assay (Panther) - 250 test kit, Aptima Combo 2 Assay (Tigris) - 250 test kit, Aptima Trichomonas Vaginalis (Panther) - 250 test kit, Aptima Trichomonas Vaginalis (Tigris) - 250 test kit | Hologic, Inc. Mar 23, 2020 |
| K200543 — NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) System | Nexxt Spine, LLC Mar 23, 2020 |
| K200043 — Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws; Field Orthopaedics Bony Trauma Extremity System (BTES) Screw Range | Field Orthopaedics Pty, Ltd. Mar 23, 2020 |
| K191716 — Somryst | Pear Therapeutics, Inc. Mar 23, 2020 |
| K200485 — RadiForce RX1270, RadiForce RX1270-AR | Eizo Corporation Mar 23, 2020 |
| K193479 — Sternal Cable System | A & E Medical Corporation Mar 23, 2020 |
| K193453 — TruDi Probe | Acclarent, Inc. Mar 23, 2020 |
| K191909 — HepaShield Bacterial Viral Breathing System Filter | Flexicare Medical Limited. Mar 23, 2020 |
| K191763 — MyDay (Stenfilcon A) ASPHERE, MyDay (Stenfilcon A) TORIC, MyDay (Stenfilcon A) MULTIFOCAL, MyDay (Stenfilcon A) MULTIFOCAL TORIC | CooperVision, Inc. Mar 23, 2020 |
| K200493 — Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgical Togas, Zippered with Peel Away Face Shield, Stryker T7 Surgical Togas, Pullover | Stryker Corporation Mar 21, 2020 |
| K200180 — MTS Omadacycline 0.002 - 32 ug/mL | Liofilchem S.R.L. Mar 20, 2020 |
| K191657 — Bioland Blood Glucose Monitoring System | Bioland Technology, Ltd. Mar 20, 2020 |
| K193121 — GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for use with Chemotherapy Drugs Claims | Eco Medi Glove Sdn. Bhd. Mar 20, 2020 |
| K193560 — Materialise Shoulder Guide and Models, Materialise SurgiCase Shoulder Planner, Materialise Shoulder Planner, SurgiCase Shoulder Planner, SurgiCase Planner | Materialise NV Mar 20, 2020 |
| K193183 — ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter | Acist Medical Systems, Inc. Mar 20, 2020 |
| K200036 — AI-ECG Tracker | Shenzhen Carewell Electronics Co., Ltd. Mar 20, 2020 |
| K191838 — Clearform Aligners | Motor City Lab Works Mar 20, 2020 |
| K192897 — icotec Cervical Cage | Icotec AG Mar 20, 2020 |
| K193327 — Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus Full Coverage Gown, Open Back, Cardinal Health ChemoPlus Full Coverage Sleeve | Cardinal Health200, LLC Mar 20, 2020 |
| K191735 — CPT Hip System | Zimmer, Inc. Mar 20, 2020 |
| K193281 — Hepatic VCAR | GE Medical Systems SCS Mar 20, 2020 |
| K193659 — iTero Element 5D | Align Technology, Inc. Mar 20, 2020 |
| K193581 — Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Lilac, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Orchid, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Oyster | Sri Trang Gloves (Thailand) Public Company Limited Mar 20, 2020 |
| K191612 — Encision AEM Monopolar Laparoscopic Instruments and Accessories | Encision Incorporated Mar 20, 2020 |
| K193211 — Nano FortiFix® System | Nanovis Spine, LLC Mar 20, 2020 |
| K192510 — DIAFIL & DIAFIL Capsule | DiaDent Group International Mar 20, 2020 |
| K193609 — Q Switched Nd: YAG Laser machine | Beijing Lead Beauty S & T Co., Ltd. Mar 20, 2020 |
| K193366 — T2 ICF | Stryker GmbH Mar 20, 2020 |