| LABYRINTH (K211306) | Zavation Medical Products, LLC | 2021-06-24 |
| Omnilux CLEAR (K210948) | Globalmed Technologies | 2021-06-24 |
| Powder Free Black Nitrile Examination Glove (K201428) | Vietglove Corporation | 2021-06-24 |
| TMJ Relax (K202523) | Moonwalker Innovations, Inc. | 2021-06-24 |
| NovoFine (K210258) | Novo Nordisk, Inc. | 2021-06-23 |
| Straumann CARES M-Series CAD/CAM System (K203456) | Institut Straumann AG | 2021-06-23 |
| CervAlign® Anterior Cervical Plate System (K211408) | Pioneer Surgical Technology, Inc. | 2021-06-23 |
| da Vinci SP Surgical System (SP1098) (K211595) | Intuitive Surgical, Inc. | 2021-06-23 |
| Synthetic Vinyl Examination Gloves (K211045) | Jiangsu Huayuan Medical Technology Co., Ltd. | 2021-06-23 |
| CD Horizon Spinal System (K211596) | Medtronic | 2021-06-23 |
| Valkyrie Thoracic Fixation System (K211695) | Jm Longyear Manufacturing, LLC D/B/A Able Medical Devices | 2021-06-23 |
| Reprocessed PentaRay Nav eco High-Density Mapping Catheter (K201806) | Sterilmed Inc. (Johnson and Johnson) | 2021-06-23 |
| S.I.N. Dental Implant System (K203725) | S.I.N. - Sistema DE Implante Nacional S.A. | 2021-06-23 |
| Mariner Deformity System (K211606) | SeaSpine Orthopedics Corporation | 2021-06-23 |
| M Series Phototherapy Equipment (K210881) | Daavlin Distributing Co. | 2021-06-22 |
| Disposable Surgical Mask (K210840) | Safeway Industry Healthcare. | 2021-06-22 |
| MolecuLight I:X (K210882) | MolecuLight, Inc. | 2021-06-22 |
| AnyOne Onestage Implant System (K210161) | Megagen Implant Co., Ltd. | 2021-06-22 |
| MICROMATE (K203720) | Isys Medizintechnik GmbH | 2021-06-22 |
| Air Pressure Therapy System (K201935) | Xiamen Weiyou Intelligent Technology Co., Ltd. | 2021-06-22 |
| SenoBright HD (K211215) | GE Healthcare | 2021-06-22 |
| ICOONE Laser Med (also referred to as ICOONE Medical laser) (K211272) | I-Tech Industries Srl | 2021-06-22 |
| Fotona XPulse Pro Laser Platform (K202991) | Fotona D.O.O. | 2021-06-22 |
| LF900 (K203019) | Daesung Maref Co., Ltd. | 2021-06-22 |
| VisionPort System (K211250) | New View Surgical, Inc. | 2021-06-21 |
| Powder Free Blue Nitrile Examination Glove (K210375) | Duramitt Sdn Bhd | 2021-06-21 |
| Posterior Spinal Fixation System (K201737) | Shanghai Reach Medical Instrument Co, Ltd. | 2021-06-21 |
| LINK Embrace Shoulder System- Anatomical Configuration (K210899) | Waldemar Link GmbH & Co. KG | 2021-06-21 |
| Orthodontic Facemask (K202855) | Ita.O Italian Orthodontic System S.R.L. | 2021-06-21 |
| 7D Registration Frame, 7D Flex Iliac Pin Connector, 7D Pin Guide Block, 7D 3.2 mm Steinmann Pin, 7D Iliac Crest Pin Chuck & Key (K210457) | 7D Surgical, Inc. | 2021-06-21 |
| Straumann BLX Implant System (K210855) | Institut Straumann AG | 2021-06-21 |
| Steri-Dot Process Indicator (K210866) | Propper Manufacturing Co., Inc. | 2021-06-21 |
| Biodegradable Powder Free Neoprene Examination Glove, Low Dermatitis Potential Claim, Green (K202085) | Shen Wei USA, Inc. | 2021-06-21 |
| 2430MCA with Xmaru W (K202902) | Rayence Co., Ltd. | 2021-06-21 |
| coDiagnostiX (K193301) | Dental Wings GmbH | 2021-06-21 |
| iBed Wireless with iBed Mobile (K202964) | Stryker Corporation | 2021-06-18 |
| Intravascular Extension Set (K210430) | Baxter Healthcare Corporation | 2021-06-18 |
| Transcutaneous Electrical Nerve Stimulator (K202893) | Wuxi Jiajian Medical Instrument Co., Ltd. | 2021-06-18 |
| Port Access System (K210495) | Surgical Innovations Limited | 2021-06-18 |
| Kontact Dental Implant System (K210220) | Biotech Dental, Sas | 2021-06-18 |
| Sonata Transcervical Fibroid Ablation System 2.2 (K211535) | Gynesonics, Inc. | 2021-06-17 |
| Infrared Thermometer (K202440) | Shenzhen Sonida Digital Technology Co., Ltd. | 2021-06-17 |
| Restor3d Utility Wedge (K201314) | Restor3D, Inc. | 2021-06-17 |
| Su2ura Approximation Device (K201744) | Anchora Medical, Ltd. | 2021-06-17 |
| Precise Position (K203514) | Philips Healthcare (Suzhou) Co., Ltd. | 2021-06-17 |
| Fist Assist Devices Model FA-1 (K210281) | Fist Assist Devices, LLC | 2021-06-17 |
| Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) (K202806) | Osteonic Co., Ltd. | 2021-06-17 |
| NaviNetics D1 Stereotactic System (K210700) | Navinetics, Inc. | 2021-06-17 |
| aScope 4 Broncho Regular Sampler Set 5.0/2.2, aScope 4 Broncho Large Sampler Set 5.8/2.8 (K210883) | Ambu A/S | 2021-06-17 |
| MIS Lance+ Conical Connection Dental Implant System (K210886) | Dentsply Sirona | 2021-06-17 |
| Migraine Tens Digital Pain Reliever (K210364) | Shenzhen Dongdixin Technology Co., Ltd. | 2021-06-17 |
| EnsoSleep (K210034) | Ensodata, Inc. | 2021-06-16 |
| Sublime Radial Access 018 RX Dilatation Catheter (K211044) | Creagh Medical Ltd. (A Wholly Owned Subsidiary of Surmodics, | 2021-06-16 |
| Aptiva Celiac Disease IgA Reagent (K193604) | Inova Diagnostics, Inc. | 2021-06-16 |
| AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile (Blue, Black, Orange) (K211310) | Megine Industries Sdn Bhd | 2021-06-16 |
| iBOT Personal Mobility Device (iBOT PMD) (K210920) | Mobius Mobility | 2021-06-16 |
| Silent Nite Sleep Appliance with the Glidewell Hinge (K210694) | Prismatik Dentalcraft, Inc. | 2021-06-16 |
| Disposable Medical Surgical Face Mask (K203200) | Guangdong Haiou Medical Apparatus Co., Ltd. | 2021-06-16 |
| Qmenta Care Platform Family (K202718) | Mint Labs, Inc., D/B/A. Qmenta | 2021-06-16 |
| Disposable Vinyl Examination Glove (K211336) | Inner Mongolia Cureguard Medical Materials Co., Ltd. | 2021-06-16 |
| CellChek 20 rc (K203244) | Konan Medical, Inc. | 2021-06-15 |
| SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar Spacers (K210595) | Camber Spine Technologies, LLC | 2021-06-15 |
| Amerishield Surgical Mask (K211520) | Premiumestore, LLC | 2021-06-15 |
| CATS®-D Tonometer Prism (K203850) | Cats Tonometer, LLC | 2021-06-14 |
| URO-TOUCH 9 French Probe (K202813) | Northgate Technologies, Inc. | 2021-06-14 |
| 2.4mm X 130cm Phoenix Deflecting Atherectomy System, 1.5mm X 149cm Phoenix Atherectomy System (K211518) | Volcano Atheromed, Inc. | 2021-06-14 |
| Corrugated tube with mouthpiece accessory (K203400) | Trudell Medical International | 2021-06-14 |
| E-Temp (K211101) | Envisiontec GmbH | 2021-06-14 |
| Surgical Face Mask (K210518) | Shandong Haidike Medical Products Co., Ltd. | 2021-06-14 |
| VITEK 2 AST-Gram Negative Imipenem/Relebactam (<0.25/4 - >16/4 ug/ML) (K211136) | bioMerieux, Inc. | 2021-06-14 |
| Manual Wheelchair (Model W28) (K200466) | Jiangsu Jumao X-Care Medical Equipment Co., Ltd. | 2021-06-14 |
| Coconu Water Based Personal Lubricant (K210814) | Coconu, LLC | 2021-06-14 |
| Ultrasonic Mesh Nebulizer (K201397) | Shenzhen Ivankaca Technology Co., Ltd. | 2021-06-14 |
| 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 (K210401) | Ansell Healthcare Products, LLC | 2021-06-13 |
| EOS Air Cleaner (K202766) | Guangzhou Ajax Medical Equipment Co., Ltd. | 2021-06-11 |
| Axon Therapy (K210021) | Neuralace Medical, Inc. | 2021-06-11 |
| Surgical Face Mask (K203732) | Zhuhai Gaoge Medical Technology Co., Ltd. | 2021-06-11 |
| Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD (K210500) | Elekta Limited | 2021-06-11 |
| Gold Tapered Weight Eyelid Implants, Platinum Tapered Weight Eyelid Implants (K203569) | Fci (France Chirurgie Instrumentation) Sas | 2021-06-11 |
| POWDER FREE NITRILE SURGICAL GLOVE, STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS (K203030) | Wrp Asia Pacific Sdn. Bhd. | 2021-06-11 |
| LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System (K210484) | Medtronic, Inc. | 2021-06-11 |
| Radius T wearable thermometer (K203215) | Masimo Corporation | 2021-06-11 |
| PANAVIA Veneer LC (K210504) | Kuraray Noritake Dental, Inc. | 2021-06-11 |
| Neck Care Therapy, Model: AST-905A, AST-905D, AST-905H (K210756) | Shenzhen Osto Technology Company Limited | 2021-06-11 |
| Replens Long-Lasting Vaginal Moisturizer (K203818) | Church & Dwight Co., Inc. | 2021-06-11 |
| Medical Face Mask (K202714) | Chongqing Chaoke Industry Development Co., Ltd. | 2021-06-11 |
| 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 (K210699) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2021-06-10 |
| Callaly Tampliner (K211469) | Calla Lily Personal Care, Ltd. | 2021-06-10 |
| Disposable Surgical Mask (K203756) | Lucky Textile Industrial(Wuxi) Co., Ltd. | 2021-06-10 |
| syngo.via MI WorkFlows, Scenium, syngo MBF (K211459) | Siemens Medical Solutions USA, Inc. | 2021-06-10 |
| M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System (K210416) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2021-06-10 |
| Disposable Vinyl Examination Gloves (K210522) | Shandong Shengshixincheng Medical Science & Technology Co., | 2021-06-10 |
| Surgical Masks, Model:FE-1 (K210767) | Hunan Triplex Precision Medical Devices Co., Ltd. | 2021-06-10 |
| Blood Administration Set (K210335) | Baxter Healthcare Corporation | 2021-06-10 |
| 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) (K211061) | Thrombolex, Inc. | 2021-06-10 |
| IDx-DR (K203629) | Digital Diagnostics, Inc. | 2021-06-10 |
| Surgical Face Mask (K210015) | Sample King Manufacturing, Ltd. | 2021-06-10 |
| 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 (K210986) | CC Wellness, LLC | 2021-06-10 |
| Spirometer (K201493) | Mehow Innovative, Ltd. | 2021-06-10 |
| Fiducial Marker (K211590) | Carbon Medical Technologies, Inc. | 2021-06-10 |