| MyHomeDoc (K202483) | Myhomedoc , Ltd. | 2021-03-23 |
| TE7/TE5/TE7 Max/TE5 Max/TE9 Diagnostic Ultrasound System (K203391) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2021-03-23 |
| Tigertriever and Tigertriever 17 Revascularization Devce (K203592) | Rapid Medical Ltd. | 2021-03-23 |
| Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit (K203295) | Gold Standard Diagnostics | 2021-03-22 |
| Capture-CMV (K203612) | Immucor, Inc. | 2021-03-22 |
| Probe Cover: JZ-KBT-001, JZ-KBT-002, JZ-KBT-005, JZ-KBT-007, JZ-KBT-008, JZ-KBT-009, JZ-KBT-010, JZ-KBT-015, JZ-KBT-025, JZ-KBT-026 (K202009) | Shenzhen Juzhong Technology Co., Ltd. | 2021-03-22 |
| EZ-IO Intraosseous Vascular Access System (K202492) | Teleflex Medical | 2021-03-22 |
| Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit (K203292) | Gold Standard Diagnostics | 2021-03-22 |
| Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit (K203296) | Gold Standard Diagnostics | 2021-03-22 |
| Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit (K203289) | Gold Standard Diagnostics | 2021-03-22 |
| Spark Clear Aligner System (K203737) | Ormco Corporation | 2021-03-22 |
| Movement and Compressions System (the MAC System) (K203052) | Recovery Force, LLC | 2021-03-21 |
| LightWalker Laser System Family (K202985) | Fotona D.O.O. | 2021-03-19 |
| IMPACT and X-Ranger (K210479) | Minxray, Inc. | 2021-03-19 |
| BonOs HV Genta, BonOs MV Genta, BonOs LV Genta (K210125) | Osartis GmbH | 2021-03-19 |
| SensorX (K203116) | Durr Dental SE | 2021-03-19 |
| Patient Examination Gloves (K203593) | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 2021-03-19 |
| ZIDA Wearable Neuromodulation System (K192731) | Exodus Innovations | 2021-03-19 |
| Invacare AVIVA Storm RX Power Chair (K202379) | Invacare Corporation | 2021-03-19 |
| BonOs HV, BonOs MV, BonOs LV (K210120) | Osartis GmbH | 2021-03-19 |
| VBrain (K203235) | Vysioneer, Inc. | 2021-03-19 |
| Disposable Medical Face Mask (K202628) | Qinghai Zhong Dao Win-Win Medical Protective Equipment Co., | 2021-03-19 |
| Biodegradable DriTek Powder Free Nitrile Examination Glove, Low Dermatitis Potential Claim, Blue (K202081) | Shen Wei USA, Inc. | 2021-03-19 |
| Sovereign America Surgical Face Mask (K201095) | Homtex, Inc. | 2021-03-19 |
| SPINEART Navigation Instrument System (K210472) | Spineart | 2021-03-19 |
| CONSTRUX Mini Ti Spacer System (K203342) | Orthofix, Inc. | 2021-03-18 |
| HySil Plus Impression Materials (K210041) | Osstem Implant Co., Ltd. | 2021-03-18 |
| Spin Care Disposable Protective Mask (K201624) | Spintech, LLC | 2021-03-18 |
| Y207 Electric Wheelchair (K202482) | Jiangsu Intco Medical Products Co., Ltd. | 2021-03-18 |
| Adaptable Ortho Innovations Intramedullary Nail System (K210285) | Adaptable Ortho Innovations, LLC | 2021-03-18 |
| BEE HA Cage (K203444) | NGMedical GmbH | 2021-03-18 |
| DYNATAPE Suture (K203186) | Medos International SARL | 2021-03-18 |
| Automatic Registration (K203679) | Brainlab AG | 2021-03-18 |
| Persona Revision Knee System (K210551) | Zimmer, Inc. | 2021-03-18 |
| Infinity™ OCT System, PASS OCT® Spinal System (K210449) | Medtronic | 2021-03-18 |
| Ceragem Automatic Thermal Massager Model CGM-MB-1701 & CGM-MB-1702 (K202937) | Ceragem Co., Ltd. | 2021-03-18 |
| s-Clean SQ-SL Implant System Mini (K202773) | Dentis Co., Ltd. | 2021-03-18 |
| Clarus Peel-Away Introducer Sheath (K200925) | Clarus Medical, LLC | 2021-03-18 |
| SDC3 HD Information Management System with Wireless Device Control Capability (K210584) | Stryker | 2021-03-18 |
| Cure 2.0 Anterior Cervical Plate (ACP) System (K210286) | Meditech Spine, LLC | 2021-03-18 |
| Straumann Immediate Temporary Abutments (K201681) | Institut Straumann AG | 2021-03-18 |
| Biodegradable Powder Free Nitrile Examination Glove, Green-White and Orange-White Colors with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid (K202082) | Shen Wei USA, Inc. | 2021-03-17 |
| ProLift Wedge Expandable Spacer System (K203361) | Life Spine, Inc. | 2021-03-17 |
| BBX-PET Scanner (K210450) | Prescient Imaging, LLC | 2021-03-17 |
| Ziehm Vision RFD (K203428) | Ziehm Imaging GmbH | 2021-03-17 |
| Neurosign V4 Intraoperative Nerve Monitor (K203684) | Magstim Company, Ltd. | 2021-03-17 |
| Magic 360 Power Wheelchair (K203083) | Magic Mobility | 2021-03-17 |
| BioFire Respiratory Panel 2.1 (RP2.1) (DEN200031) | Biofire Diagnostics, LLC | 2021-03-17 |
| MIPLNI YK-244 Disposable Surgical Mask (K210487) | Hunan Yuankang Biological Technology Co., Ltd. | 2021-03-16 |
| Biodegradable Powder Free Nitrile Examination Glove, Low Dermatitis,Potential Claim, Blue, Green, Black, White, Orange, Black-White, Teal-Gray, White-Green, White-Orange, White-Blue, Blue-White, Green-White, Orange-White Colors (K202086) | Shen Wei USA, Inc. | 2021-03-16 |
| Reprocessed HARMONIC ACE+ 7, 5 mm Diameter Shears with Advanced Hemostasis (K202554) | Stryker Sustainability Solutions | 2021-03-16 |
| Multi-unit Abutments for CONELOG (K203252) | BioHorizons Implant Systems, Inc. | 2021-03-16 |
| F&P Optiflow Nasal Oxygen Cannula with CO2 Sampling (K201723) | Fisher & Paykel Healthcare, Ltd. | 2021-03-16 |
| Single-Use Surgical Mask (K201924) | Qiqihar Hengxin Medical Supplies, Ltd. | 2021-03-15 |
| Neodent Implant System-Easy Pack (K203382) | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2021-03-15 |
| Medical Surgical Mask (K201698) | Hangzhou Mycode Bio-Medicine Co., Ltd. | 2021-03-15 |
| Ensure Single-Use Coagulation Forceps (K202438) | Micro-Tech (Nanjing) Co., Ltd. | 2021-03-15 |
| DB-Composite (K210193) | Dimensional Bioceramics, LLC | 2021-03-15 |
| VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced Infusion Pack, VERITAS Swivel Handpiece, VERITAS Advanced Foot Pedal, VERITAS Remote Control (K203060) | Johnson & Johnson Surgical Vision, Inc. | 2021-03-12 |
| Infrared Forehead Thermometer, Model JZK-601, JZK-602, JZK-603 (K203707) | Shenzhen Zhengkang Technology Co., Ltd. | 2021-03-12 |
| Medline Cautery Tip Cleaner (K210526) | Medline Industries, Inc. | 2021-03-12 |
| Vinyl Examination Gloves(Yellow) (K203666) | Lutai Medical Technology Co., Ltd. | 2021-03-12 |
| Oncospace (K202284) | Oncospace, Inc. | 2021-03-12 |
| BC Reflex Uni Knee System (K203697) | Bodycad Laboratories, Inc. | 2021-03-12 |
| TaiChiC (K203250) | Our United Corporation | 2021-03-12 |
| ProFound AI Software V3.0 (K203822) | Icad, Inc. | 2021-03-12 |
| ADD (K203188) | H&abyz Co., Ltd. | 2021-03-12 |
| TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU)) (K201617) | Schoelly Fiberoptic GmbH | 2021-03-12 |
| VENUS Bracket, ROSE Bracket (K201410) | Gni Co., Ltd. | 2021-03-12 |
| CoLink Mfx Implant System (K210060) | In2bones USA, LLC | 2021-03-12 |
| Groshong NXT PICC Catheter (K201452) | C.R. Bard, Inc. | 2021-03-12 |
| Endo Motor (K192649) | Foshan Cicada Dental Instrument Co, Ltd. | 2021-03-12 |
| AIC disposable medical mask (K203775) | The Aleen International Corporation | 2021-03-12 |
| AquaBeam Robotic System (K202961) | Procept Biorobotics, Corporation | 2021-03-11 |
| Stryker ProCinch Adjustable Loop Device (K210078) | Stryker Endoscopy | 2021-03-11 |
| wheezo WheezeRate Detector (K202062) | Respiri Limited | 2021-03-11 |
| Monarch Bronchoscope (K203614) | Auris Health, Inc., A Johnson and Johnson Family Company | 2021-03-11 |
| Fiber Dust (K210142) | Quanta System Spa | 2021-03-11 |
| Smart Kit Basic, Smart Kit Pro (K202443) | Bsl Co., Ltd. | 2021-03-11 |
| Ritleng®+ and Ritleng®+ PVP (K201892) | Fci (France Chirurgie Instrumentation) Sas | 2021-03-11 |
| WorkMate Claris System (K210392) | Abbott | 2021-03-11 |
| miha bodytec II (K201975) | Miha Bodytec GmbH | 2021-03-11 |
| Surgical Face Mask (K202548) | Wanxinda (Guangzhou) Technology Product Co., Ltd. | 2021-03-10 |
| Vantage Elan 1.5T, MRT-2020, V6.0 (K210164) | Canon Medical Systems Corporation | 2021-03-10 |
| AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory (K201809) | Baxter Healthcare Corportation | 2021-03-10 |
| Surgical Face Mask (K202161) | Hunan Eexi Technology & Service Co., Ltd. | 2021-03-10 |
| HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2 (K203574) | Hivox Biotek, Inc. | 2021-03-10 |
| Surgical Mask (K202411) | Allmed Medical Products Co., Ltd. | 2021-03-10 |
| Lumbar Spine Truss System Plating Solution (LSTS-PS) (K203065) | 4Web, Inc. | 2021-03-10 |
| Hexanium TLIF (K210359) | Spinevision, S.A.S. | 2021-03-10 |
| PROPHECY Preoperative Navigation Alignment System (K202815) | Wrightmedicaltechnologyinc | 2021-03-10 |
| FloPump 57mL Centrifugal Pump (K193663) | International Biophysics Corporation | 2021-03-10 |
| NovaLine Tubing Sets for Hemodialysis (K201866) | Bain Medical Equipment (Guangzhou) Co., Ltd. | 2021-03-10 |
| Non-Sterile Zirconia Block (K201492) | Bioden Co., Ltd. | 2021-03-10 |
| Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA) (K203606) | Meris Investment Group | 2021-03-10 |
| Imbio RV/LV Software (K203256) | Imbio, LLC | 2021-03-09 |
| VersaWrap (K203600) | Alafair Biosciences, Inc. | 2021-03-09 |
| Quicktome (K203518) | Omniscient Neurotechnology Pty Ltd (O8t) | 2021-03-09 |
| Body Infrared Thermometer HT-820D (K202591) | Dongguan Xintai Instrument Co., Ltd. | 2021-03-09 |
| Surgical Face Mask (K202205) | Jiangsu Micsafe Medical Technology Co., Ltd. | 2021-03-09 |