| K200269 — Sapphire II PRO | Orbusneich Medical Trading, Inc. Mar 4, 2020 |
| K200028 — Coronet Soft Tissue Fixation System | Conextions Medical Mar 4, 2020 |
| K200275 — OVision Imaging System | Ophthalmic Labs, Inc. Mar 3, 2020 |
| K193358 — MicroScan Dried Gram-Negative MIC/Combo Panels with Levofloxacin (Lvx) (0.008-16ug/mL) | Beckman Coulter, Inc. Mar 3, 2020 |
| K192032 — Fixone Biocomposite Small Anchor | Aju Pharm Co., Ltd. Mar 3, 2020 |
| K193064 — Atlantis suprastructures | Dentsply Sirona, Inc. Mar 3, 2020 |
| K193378 — CarboClear Lumbar Cage System | CarboFix Orthopedics , Ltd. Mar 2, 2020 |
| K183425 — CARDIOVIT AT-102 G2 | Schiller AG Mar 2, 2020 |
| K192506 — Vantage Galan 3T, MRT-3020, V6.0 | Canon Medical Systems Corporation Mar 2, 2020 |
| K193532 — LIAISON Anti-HAV Assay | DiaSorin, Inc. Mar 2, 2020 |
| K193356 — BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider | Covidien, LLC Mar 2, 2020 |
| K193256 — Anjon Bremer Halo System | Anjon Holdings, LLC Mar 2, 2020 |
| K192637 — High Strength Suture | Yunyi (Beijing) Medical Device Co., Ltd. Mar 2, 2020 |
| K191872 — Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution | Menicon Co, Ltd. Mar 2, 2020 |
| K190304 — Kingon P2 Oxygen Concentrator | Qingdao Kingon Medical Science And Technology Co. Feb 29, 2020 |
| K183680 — i-STAT CHEM8+ cartridge with the i-STAT 1 System | Abbott Point Of Care, Inc. Feb 28, 2020 |
| K192820 — SensiCare Neoprene Synthetic Polychloroprene Surgical Glove (Tested for Use with Chemotherapy Drugs) | Medline Industries, Inc. Feb 28, 2020 |
| K193243 — Alta Multipurpose Device | Qfix Feb 28, 2020 |
| K192346 — scaffolene CL100 Bioresorbable Collagen Matrix | Freudenberg Technology Innovation SE & Co. KG Feb 28, 2020 |
| K200225 — Arctic Sun Stat Temperature Management System | Medivance, Inc. Feb 28, 2020 |
| K192496 — Magnetom Sola, Magnetom Altea and Magnetom Sola Fit | Siemens Medical Solutions USA, Inc. Feb 28, 2020 |
| K193483 — Basal-IQ Technology | Tandem Diabetes Care, Inc. Feb 28, 2020 |
| K200221 — CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem and Ovoid Applicators (Henschke), HDR CT Compatible Split Ring Applicator, Segmented Vaginal Applicator, HDR Miami Applicator HDR Brachytherapy Applicator, 2/3 Endometrial Applicator Sets, CT HDR Ring & Tandem Applicator with Rectal Retractor | Mick Radio-Nuclear Instruments, Inc. Feb 28, 2020 |
| K193416 — Cellvizio I.V.E. with Confocal Miniprobes | Mauna Kea Technologies Feb 28, 2020 |
| K192962 — icobrain-ctp | Icometrix NV Feb 28, 2020 |
| K192447 — Superelastic Staple | Neosteo Feb 28, 2020 |
| K191246 — Paragon Adult Maxi PMP Oxygenator (Model: XCMOP405PMP) | Chalice Medical , Ltd. Feb 28, 2020 |
| K192660 — Zimmer M/L Taper Hip Prosthesis | Zimmer, Inc. Feb 28, 2020 |
| K192247 — Steripath Gen2 Blood Collection System | Magnolia Medical Technologies, Inc. Feb 28, 2020 |
| K200284 — R-Sensor, R-Sensor | Remedi Co., Ltd. Feb 28, 2020 |
| K191555 — HARMONIC HD 1000i Shears, 20 cm length, HARMONIC HD 1000i Shears, 36 cm length | Ethicon Endo-Surgery, LLC Feb 28, 2020 |
| K191556 — Red Dot | Behold.Ai Technologies Limited Feb 28, 2020 |
| K191928 — AccuContour | Xiamen Manteia Technology , Ltd. Feb 28, 2020 |
| K192570 — Atlas Spine Expandable Cervical Standalone Interbody System | Atlas Spine, Inc. Feb 28, 2020 |
| K200381 — Daytona® Small Stature Spinal System | SeaSpine Orthopedics Corporation Feb 28, 2020 |
| K193550 — Therm-X | Zenith Technical Innovations Feb 28, 2020 |
| K193029 — CONQUEST FN | Smith & Nephew, Inc. Feb 28, 2020 |
| K192683 — Biolox delta Ceramic Heads, Biolox delta Option Ceramic Heads | Biomet UK, Ltd. Feb 27, 2020 |
| K200206 — AXS Vecta 71 Intermediate Catheter, AXS Vecta 74 Intermediate Catheter | Stryker Neurovascular Feb 27, 2020 |
| K190032 — Disposable Sclerotherapy Needle | Hangzhou AGS MedTech Co., Ltd. Feb 27, 2020 |
| K190682 — Explorer Mini | Permobil AB Feb 27, 2020 |
| K193274 — Rodo Abutment System | Rodo Medical, Inc. Feb 27, 2020 |
| K190919 — ST Internal Implant System | T-Plus Implant Tech. Co., Ltd. Feb 27, 2020 |
| K191946 — Penumbra System Penumbra JET 7X | Penumbra, Inc. Feb 27, 2020 |
| K191462 — Proov Test | Mfb Fertility, Inc. Feb 27, 2020 |
| K192804 — CEREBASE DA Guide Sheath, 95cm, CEREBASE DA Guide Sheath, 90cm, CEREBASE DA Guide Sheath, 80cm, CEREBASE DA Guide Sheath, 70cm | Medos International SARL Feb 27, 2020 |
| K193313 — Elecsys Anti-TSHR | Roche Diagnostics Feb 27, 2020 |
| K192305 — Colibri Endoscopy System | 3Nt Medical , Ltd. Feb 27, 2020 |
| K193242 — Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and Accessories, Masimo Radius-7 Pulse CO-Oximeter and Accessories | Masimo Corporation Feb 27, 2020 |
| K192876 — INTELLIO Tablet Application | Smith & Nephew Feb 27, 2020 |