| K200688 — hyperion X5, NewTom GO, X-RADiUS COMPACT | Cefla S.C. Apr 9, 2020 |
| K200539 — Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl | Sri Trang Gloves (Thailand) Public Company Limited Apr 9, 2020 |
| K200517 — Standard Trocar | Standard Bariatrics Apr 9, 2020 |
| K193104 — Unified Arrhythmia Diagnostic System PocketECG IV | Medicalgorithmics S.A. Apr 9, 2020 |
| K200634 — Arrow FiberOptix Intra-Aortic Balloon Catheter Kit | Arrow International, Inc. Apr 9, 2020 |
| K191935 — Nautilus Smart ECMO Module | Mc3 Incorporated Apr 9, 2020 |
| K200630 — Medtronic External Drainage and Monitoring System, Medtronic External Drainage and Monitoring System, Becker Replacement Drainage Bags | Medtronic, Inc. Apr 9, 2020 |
| K193640 — ClearCalc | Radformation, Inc. Apr 9, 2020 |
| K192138 — Rejuvapen NXT | Refine USA, LLC Apr 9, 2020 |
| K191574 — OxSAT 100 | S.L.P. , Ltd. Apr 9, 2020 |
| K191867 — ATLAS Plating System | MiRus, LLC Apr 9, 2020 |
| K200001 — MX7/ MX7T/ Vaus7/ Zeus Diagnostic Ultrasound System, ME7/ Anesus ME7/ Anesus ME7T Diagnostic Ultrasound System, MX8/ MX8T/ Vaus8/ ME8 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Apr 9, 2020 |
| K200492 — i-STAT CG4+ Cartridge with the i-STAT 1 System | Abbott Point Of Care, Inc. Apr 9, 2020 |
| K200052 — CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer System | Orthofix, Inc. Apr 9, 2020 |
| K193329 — PreXion3D Explorer EX | Prexion Corporation Apr 9, 2020 |
| K193571 — Go2Wire Guide Wire | Merit Medical System, Inc. Apr 8, 2020 |
| K200411 — Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Apr 8, 2020 |
| K192636 — TYRX Neuro Absorbable Antibacterial Envelope (Medium), TYRX Neuro Absorbable Antibacterial Envelope (Large) | Medtronic, Inc. Apr 8, 2020 |
| K200598 — Voyant Maryland Fusion Device | Applied Medical Resources Corp. Apr 8, 2020 |
| K200632 — TCAT TKA Instrument Tray Set | THINK Surgical, Inc. Apr 8, 2020 |
| K192108 — Panthera Dental Milled Bars | Panthera Dental, Inc. Apr 8, 2020 |
| K200144 — HI-TORQUE Steelcore Bare Guide Wire | Abbott Vascular Apr 8, 2020 |
| K200477 — Flex Body Speeder | Quality Electrodynamics, LLC Apr 8, 2020 |
| K200282 — Orfit Aerial Couchtop | Orfit Industries NV Apr 8, 2020 |
| K193300 — AIMI-Triage CXR PTX | Radlogics, Inc. Apr 8, 2020 |
| K191885 — Standard Bougie | Standard Bariatrics Apr 8, 2020 |
| K191084 — The Optimotion Blue Total Knee System | Optimotion Implants, LLC Apr 7, 2020 |
| K200339 — HS40 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. Apr 7, 2020 |
| K193654 — BlueStar Rx | Welldoc, Inc. Apr 7, 2020 |
| K200266 — BD Centro Vena Acute Central Line (7 French Dual Lumen) | Bard Access Systems, Inc. (Bard Has Joined Bd) Apr 7, 2020 |
| K192013 — VERTICALE® Cervical System | Silony Medical GmbH Apr 7, 2020 |
| K193218 — Innovision Audio | Innovere Medical, Inc. Apr 7, 2020 |
| K193250 — Irrigation Tubing with CO2 or Air | Keymed (Medical And Industrial Equipment) , Ltd. Apr 6, 2020 |
| K200204 — Stat Profile Prime Plus Analyzer System | Nova Biomedical Corporation Apr 6, 2020 |
| K200776 — Eko CORE | Eko Devices, Inc. Apr 6, 2020 |
| K193494 — Origin Anterior Cervical Plate System | Orthopaedic & Spine Development Apr 6, 2020 |
| K200576 — ClearMask Transparent Surgical Face Mask | Clearmask, LLC Apr 6, 2020 |
| K192401 — Straumann Screw-Retained Abutments | Straumann USA, LLC Apr 6, 2020 |
| K200199 — ADVIA Centaur CA 125II | Siemens Healthcare Diagnostics, Inc. Apr 6, 2020 |
| K200308 — MTS Lefamulin 0.016- 256 µg/mL | Liofilchem S. R. 1. Apr 6, 2020 |
| K191970 — Diode Laser Hair Removal System | Beijing Sano Laser S&T Development Co.,Ltd Apr 6, 2020 |
| K200025 — Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit | Gold Standard Diagnostics Apr 6, 2020 |
| K200312 — Tryptik Ti | Spineart Apr 6, 2020 |
| K192558 — Q3 Distal Access Catheter, Q4 Distal Access Catheter, Q5 Distal Access Catheter, Q6Distal Access Catheter | Mivi Neurovascular Apr 6, 2020 |
| K192500 — Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometer | Honsun (Nantong) Co., Ltd. Apr 6, 2020 |
| K200023 — Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit | Gold Standard Diagnostics Apr 6, 2020 |
| K193217 — SensiCare PI and SensiCare PI Micro Surgical Gloves | Medline Industries, Inc. Apr 6, 2020 |
| K200019 — Nitrile Powder Free Examination Gloved Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue), Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black) | Hartalega NGC Sdn. Bhd. Apr 6, 2020 |
| K200361 — Akros Scruture Anchor LisFranc Repair Kit | Akros Medical Apr 6, 2020 |
| K191422 — Neural Navigator | Soterix Medical, Inc. Apr 6, 2020 |