| K203158 — BioWave BioWraps | Biowave Corporation Jul 8, 2021 |
| K193490 — SensiTox C. difficile Toxin Test | First Light Diagnostics, Inc. Jul 8, 2021 |
| K210267 — Disposable Surgical Mask | Xiamen Eagledon Pharmaceutical Co., Ltd. Jul 8, 2021 |
| K203148 — Youha Electric Breast Pump (Models: THE ONE, YH-8011, YH-8012, YH-8019, YY-5030); Bebebao Electric Breast Pump (Model: BB-5020); Yiyadodo Electric Breast Pump (Model: YY-5030) | Ningbo Youhe Electrical Appliance Technology Co., Ltd. Jul 8, 2021 |
| K210215 — Surgical Gowns | Jiangsu Province Jianerkang Medical Dressing Co., Ltd. Jul 7, 2021 |
| K201726 — Arterial Catheter | Haolang Medical USA Corporation Jul 7, 2021 |
| K201740 — Hydrozid | Medilink A/S Jul 7, 2021 |
| K202741 — Infrared Forehead Thermometer | Shenzhen Combei Technology Co., Ltd. Jul 7, 2021 |
| K211002 — Grappler Suture Anchor System | Paragon 28, Inc. Jul 7, 2021 |
| K210653 — ONE Planner Hip | Orthosoft D/B/A Zimmer Cas Jul 7, 2021 |
| K203003 — Pantheon IBFD | Pantheon Spinal Jul 7, 2021 |
| K203432 — Axium Detachable Coil; Axium Prime Detachable Coil | Micro Therapeutics, Inc. D/B/A Ev3 Neurovascular Jul 7, 2021 |
| K211818 — Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System | Hyperfine, Inc. Jul 7, 2021 |
| K210524 — Surgical Mask | Changzhou Holymed Products Co., Ltd. Jul 7, 2021 |
| K210497 — SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu aPOD-L NanoMetalene, SeaSpine Vu ePOD System, SeaSpine Vu aPOD Prime NanoMetalene Intervertebral, SeaSpine Shoreline ACS - Anterior Cervical Standalone, SeaSpine Cervical Interbody RT System, SeaSpine Cambria System, SeaSpine Regatta Lateral System, SeaSpine Reef TO/TA System, SeaSpine Reef TH System, SeaSpine Meridian System | SeaSpine Orthopedics Corporation Jul 7, 2021 |
| K203198 — KARL STORZ Metal Sterilization Trays | Karl Storz Endoscopy America, Inc. Jul 6, 2021 |
| K203459 — SafeCross Transseptal Puncture and Introducer (TSP/I) System | East End Medical I, LLC Jul 6, 2021 |
| K210480 — AcuPebble SA | Acurable Limited Jul 6, 2021 |
| K193622 — TRIOCLEAR System | Perfection Aligner System Hong Kong Limited Jul 6, 2021 |
| K203309 — NUVO CF Implant System | JJGC Indústria E Comércio De Materiais Dentários S.A. Jul 6, 2021 |
| K211821 — DEKA Motus AZ | El.En Electronic Engineering Spa Jul 6, 2021 |
| K202954 — Disposable Surgical Mask | Xiamen Probtain Medical Techology Co., Ltd. Jul 2, 2021 |
| K202241 — LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS) | Hamilton Thorne, Inc. Jul 2, 2021 |
| K200256 — ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay | Siemens Healthcare Diagnostics, Inc. Jul 2, 2021 |
| K202570 — Insulin Syringe, Insulin Syringe with Safety Retractable | Jiangsu Micsafe Medical Technology Co., Ltd. Jul 2, 2021 |
| K211422 — Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced Surgical Gown | Jiangsu Medplus Non-Woven Manufacturer Co., Ltd. Jul 2, 2021 |
| K203498 — LX9max | Daesung Maref Co., Ltd. Jul 2, 2021 |
| K203347 — Sleep Apnea Breathing Therapy Mask: YF-01 Full Face Mask, YF-02 Full Face Mask, YF-03 Full Face Mask, YN-02 Nasal Mask, YN-03 Nasal Mask, YP-01 Nasal Pillow Mask | Suzhou Yuyue Medical Technology Co., Ltd. Jul 2, 2021 |
| K203441 — The Alma Hybrid Laser System | Alma Lasers , Ltd. Jul 2, 2021 |
| K211393 — Selethru(TM) NC PTCA Balloon Dilatation Catheter | Kossel Medtech (Suzhou) Co., Ltd. Jul 2, 2021 |
| K203591 — Single-use Medical Face Mask | Conod Medical Co., Limited Jul 2, 2021 |
| K210199 — RICOH MEG | Ricoh Company, Ltd. Jul 2, 2021 |
| K210127 — iQ200 System, iChemVELOCITY Automated Urine Chemistry System | Beckman Coulter, Inc. Jul 2, 2021 |
| K210097 — Estar-Z | Osstem Implant Co., Ltd. Jul 2, 2021 |
| K203800 — SyntrFuge System | Syntr Health Technologies, Inc. Jul 2, 2021 |
| K211511 — decimal Bolus | .Decimal, LLC Jul 1, 2021 |
| K211007 — EZ-TRAXTM Persona Knee Containment Device | K1 Medical, LLC Jul 1, 2021 |
| K203262 — Cannula for Organ Perfusion | Bridge TO Life, Ltd. Jul 1, 2021 |
| K210611 — MAGNETOM Free.Max | Siemens Medical Solutions USA, Inc. Jul 1, 2021 |
| K211782 — ControlRad Select Model Z, ControlRad Trace Model 8, ControlRad Trace Model 9 | Controlrad, Inc. Jul 1, 2021 |
| K211337 — DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Jul 1, 2021 |
| K203575 — GlidePath Retro Long-Term Hemodialysis Catheter | C.R. Bard, Inc. Jul 1, 2021 |
| K211411 — Penumbra System (RED 68 Reperfusion Catheter) | Penumbra, Inc. Jul 1, 2021 |
| K210910 — Snore Bandit | Snorebandit, LLC Jul 1, 2021 |
| K202171 — Pulmogine Vibrating Mesh Nebulizer | Hcmed Innovations Co., Ltd. Jul 1, 2021 |
| K203672 — MAZIC Claro CAD and MAZIC Claro Press | Vericom Co., Ltd. Jul 1, 2021 |
| K210326 — Bravo G4 Chamber Autoclave | Scican , Ltd. Jul 1, 2021 |
| K203369 — Avance Solo Negative Pressure Wound Therapy (NPWT) System | Molnlycke Health Care Us, LLC Jul 1, 2021 |
| K210542 — aprevo Transforaminal IBF | Carlsmed, Inc. Jun 30, 2021 |
| K210753 — KardiaMobile 6L | AliveCor, Inc. Jun 30, 2021 |