| K210281 — Fist Assist Devices Model FA-1 | Fist Assist Devices, LLC Jun 17, 2021 |
| K203200 — Disposable Medical Surgical Face Mask | Guangdong Haiou Medical Apparatus Co., Ltd. Jun 16, 2021 |
| K210694 — Silent Nite Sleep Appliance with the Glidewell Hinge | Prismatik Dentalcraft, Inc. Jun 16, 2021 |
| K211044 — Sublime Radial Access 018 RX Dilatation Catheter | Creagh Medical Ltd. (A Wholly Owned Subsidiary Of Surmodics, Jun 16, 2021 |
| K193604 — Aptiva Celiac Disease IgA Reagent | Inova Diagnostics, Inc. Jun 16, 2021 |
| K210034 — EnsoSleep | Ensodata, Inc. Jun 16, 2021 |
| K210920 — iBOT Personal Mobility Device (iBOT PMD) | Mobius Mobility Jun 16, 2021 |
| K202718 — Qmenta Care Platform Family | Mint Labs, Inc., D/B/A. Qmenta Jun 16, 2021 |
| K211310 — AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile (Blue, Black, Orange) | Megine Industries Sdn Bhd Jun 16, 2021 |
| K211336 — Disposable Vinyl Examination Glove | Inner Mongolia Cureguard Medical Materials Co., Ltd. Jun 16, 2021 |
| K203244 — CellChek 20 rc | Konan Medical, Inc. Jun 15, 2021 |
| K211520 — Amerishield Surgical Mask | Premiumestore, LLC Jun 15, 2021 |
| K210595 — SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar Spacers | Camber Spine Technologies, LLC Jun 15, 2021 |
| K210518 — Surgical Face Mask | Shandong Haidike Medical Products Co., Ltd. Jun 14, 2021 |
| K201397 — Ultrasonic Mesh Nebulizer | Shenzhen Ivankaca Technology Co., Ltd. Jun 14, 2021 |
| K211136 — VITEK 2 AST-Gram Negative Imipenem/Relebactam (<0.25/4 - >16/4 ug/ML) | bioMerieux, Inc. Jun 14, 2021 |
| K210814 — Coconu Water Based Personal Lubricant | Coconu, LLC Jun 14, 2021 |
| K202813 — URO-TOUCH 9 French Probe | Northgate Technologies, Inc. Jun 14, 2021 |
| K203400 — Corrugated tube with mouthpiece accessory | Trudell Medical International Jun 14, 2021 |
| K211518 — 2.4mm X 130cm Phoenix Deflecting Atherectomy System, 1.5mm X 149cm Phoenix Atherectomy System | Volcano Atheromed, Inc. Jun 14, 2021 |
| K211101 — E-Temp | Envisiontec GmbH Jun 14, 2021 |
| K203850 — CATS®-D Tonometer Prism | Cats Tonometer, LLC Jun 14, 2021 |
| K200466 — Manual Wheelchair (Model W28) | Jiangsu Jumao X-Care Medical Equipment Co., Ltd. Jun 14, 2021 |
| K210401 — Microflex Nitrile Patient Examination Gloves Blue Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex Nitrile Patient Examination Gloves Green Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex Nitrile Patient Examination Gloves Black Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Ansell Healthcare Products, LLC Jun 13, 2021 |
| K210484 — LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System | Medtronic, Inc. Jun 11, 2021 |
| K202766 — EOS Air Cleaner | Guangzhou Ajax Medical Equipment Co., Ltd. Jun 11, 2021 |
| K210021 — Axon Therapy | Neuralace Medical, Inc. Jun 11, 2021 |
| K210500 — Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD | Elekta Limited Jun 11, 2021 |
| K203818 — Replens Long-Lasting Vaginal Moisturizer | Church & Dwight Co., Inc. Jun 11, 2021 |
| K203732 — Surgical Face Mask | Zhuhai Gaoge Medical Technology Co., Ltd. Jun 11, 2021 |
| K210504 — PANAVIA Veneer LC | Kuraray Noritake Dental, Inc. Jun 11, 2021 |
| K203030 — POWDER FREE NITRILE SURGICAL GLOVE, STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS | Wrp Asia Pacific Sdn. Bhd. Jun 11, 2021 |
| K210756 — Neck Care Therapy, Model: AST-905A, AST-905D, AST-905H | Shenzhen Osto Technology Company Limited Jun 11, 2021 |
| K203215 — Radius T wearable thermometer | Masimo Corporation Jun 11, 2021 |
| K202714 — Medical Face Mask | Chongqing Chaoke Industry Development Co., Ltd. Jun 11, 2021 |
| K203569 — Gold Tapered Weight Eyelid Implants, Platinum Tapered Weight Eyelid Implants | Fci (France Chirurgie Instrumentation) Sas Jun 11, 2021 |
| K211590 — Fiducial Marker | Carbon Medical Technologies, Inc. Jun 10, 2021 |
| K210972 — H2O Warming Personal Lubricant, H2O Anal Warming Personal Lubricant, JO 2 To Tango for You, JO 2 To Tango Couples Pleasure Kit, #LubeLife Sensations Warming, #LubeLife Sensations Pleasure Kit for Two | CC Wellness, LLC Jun 10, 2021 |
| K210416 — M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Jun 10, 2021 |
| K210015 — Surgical Face Mask | Sample King Manufacturing, Ltd. Jun 10, 2021 |
| K203756 — Disposable Surgical Mask | Lucky Textile Industrial(Wuxi) Co., Ltd. Jun 10, 2021 |
| K211459 — syngo.via MI WorkFlows, Scenium, syngo MBF | Siemens Medical Solutions USA, Inc. Jun 10, 2021 |
| K203629 — IDx-DR | Digital Diagnostics, Inc. Jun 10, 2021 |
| K210767 — Surgical Masks, Model:FE-1 | Hunan Triplex Precision Medical Devices Co., Ltd. Jun 10, 2021 |
| K210335 — Blood Administration Set | Baxter Healthcare Corporation Jun 10, 2021 |
| K210699 — Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S, Imagyn I9 Easi, Nuewa I9, Nuewa I9S, Nuewa I9T, Nuewa I9 Exp, Nuewa I9 Easi, Anesus I9, Anesus I9 Easi, Eagus I9 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Jun 10, 2021 |
| K211469 — Callaly Tampliner | Calla Lily Personal Care, Ltd. Jun 10, 2021 |
| K203779 — Symmetric Total Knee System | Signal Medical Corporation Jun 10, 2021 |
| K210986 — H2O Cooling Personal Lubricant, H2O Anal Cooling Personal Lubricant, #LubeLife Sensations Cooling, #LubeLife Sensations Pleasure Kit for Two, JO 2 To Tango for Me, JO 2 To Tango Couples Pleasure Kit | CC Wellness, LLC Jun 10, 2021 |
| K211061 — BASHIR Endovascular Catheter (Ref. 7201), BASHIR Plus 10 Endovascular Catheter (Ref. 7210), BASHIR Plus 20 Endovascular Catheter (Ref. 7220), BASHIR Plus 30 Endovascular Catheter (Ref. 7230), BASHIR Plus 40 Endovascular Catheter (Ref. 7240) | Thrombolex, Inc. Jun 10, 2021 |