| DEN200072 — Lumipulse G ß-Amyloid Ratio (1-42/1-40) | Fujirebio Diagnostics,Inc. May 4, 2022 |
| K214065 — ROSA ONE Brain application | Medtech S.A.S May 4, 2022 |
| K213420 — WaveForm L System, WaveForm TO System, WaveForm TA System | SeaSpine Orthopedics Corporation May 4, 2022 |
| K211707 — BioTeke Sterile Disposable Virus Sampling Kit | Bioteke Corporation (Wuxi) Co., Ltd. May 4, 2022 |
| K220628 — LINK Endo-Model EVO Knee System | Waldemar Link GmbH & Co. KG May 3, 2022 |
| K220311 — Cardiovascular Angiography System | Allengers Medical Systems Limited May 3, 2022 |
| K220306 — ECGenius System | Cath Vision Aps May 3, 2022 |
| K213594 — ECHOLASER X4 | Elesta S.P.A May 3, 2022 |
| K220791 — Surgical and Prosthetic Trays | Dentsply Sirona May 3, 2022 |
| K220013 — X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application | Scopio Labs , Ltd. May 3, 2022 |
| K213302 — exoplan | Exocad GmbH May 3, 2022 |
| K212915 — MVision AI Segmentation | MVision AI May 3, 2022 |
| K212064 — Orchid Safety Release Valve(TM) | Linear Health Sciences, LLC May 3, 2022 |
| K221010 — Intra.Ox 2.0 Handheld Tissue Oximeter | Vioptix, Inc. May 3, 2022 |
| DEN200063 — Kerasave | Al.Chi.Mi.A. S.R.L May 2, 2022 |
| K220341 — ARx Modular Spinal System | Life Spine, Inc. May 2, 2022 |
| K213837 — Arthrx Fracture Plates | Arthrex, Inc. May 2, 2022 |
| K213877 — ExactechGPS® System | Blue Ortho May 2, 2022 |
| K220283 — TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033) | Hong Qiangxing (Shenzhen) Electronics Limited May 2, 2022 |
| K211180 — Liver Suite | GE Medical Systems SCS May 2, 2022 |
| K212348 — ALPHALOK Plating System | Vilex, LLC May 2, 2022 |
| K220243 — Ultiri Measurement System | ABBOTT MEDICAL Apr 30, 2022 |
| K220590 — aPROMISE X | Exini Diagnostics AB Apr 29, 2022 |
| K220684 — Oryx Cloud Imaging | Oryx Dental Software, Inc. Apr 29, 2022 |
| K220417 — Spectrum IQ Infusion System with Dose IQ Safety Software | Baxter Healthcare Corporation Apr 29, 2022 |
| K212422 — Disposable Surgical Isolation Gown | Crown Name Disposable Hygiene Products Fty., Ltd. Apr 29, 2022 |
| K201956 — Zeus IFA ANA HEp-2 Test System, Zeus dIFine | Zeus Scientific, Inc. Apr 29, 2022 |
| K221006 — GIA Stapler with Tri-Staple Technology | Covidien Apr 29, 2022 |
| K220608 — Accu-Chek FastClix Blood Lancing System | Roche Diabetes Care, Inc. Apr 29, 2022 |
| K212430 — BONREE Nelaton Catheter | Bonree Medical Co., Ltd. Apr 29, 2022 |
| DEN200066 — BioFire Joint Infection (JI) Panel | Biofire Diagnostics, LLC Apr 29, 2022 |
| K220939 — MAGNETOM Lumina and MAGNETOM Vida Fit with syngo MR XA50A | Siemens Medical Solutions USA, Inc. Apr 29, 2022 |
| K214045 — FreedomEdge Syringe Infusion System | Repro-Medical System, Inc., Dba Koru Medical Systems Apr 29, 2022 |
| K220383 — LOBO Vascular Occlusion System (models LOBO-7 and LOBO-9) | Okami Medical Apr 29, 2022 |
| K202977 — Alinity m STI Assay | Abbott Molecular, Inc. Apr 29, 2022 |
| K220295 — ARIETTA 50 | Fujifilm Healthcare Corporation Apr 29, 2022 |
| K220271 — Hand Diagnostic Radiography Imaging System | Nanoray Biotech Co., Ltd. Apr 29, 2022 |
| K213334 — Monarch Platform, Urology | Auris Health, Inc. Apr 29, 2022 |
| K212514 — Safety Pen Needle for Single Use, Insulin Pen Needles | Berpu Medical Technology Co., Ltd. Apr 29, 2022 |
| K220038 — Camber Spine Navigation System | Camber Spine Technologies Apr 29, 2022 |
| K221005 — EEA Circular Stapler with Tri-Staple Technology | Covidien Apr 29, 2022 |
| K212711 — SteriTite Container System with MediTray Products | Case Medical, Inc. Apr 29, 2022 |
| K220695 — Elite Biomedical Solutions Dose Request Cord | Elite Biomedical Solutions Apr 29, 2022 |
| K220899 — Oxehealth Vital Signs | Oxehealth Limited Apr 29, 2022 |
| K213649 — BodyTom 64 | Neurologica Corporation Apr 29, 2022 |
| K220189 — LISA Laser Surgical Fibers | Omni-Guide Holdings, Inc. Apr 29, 2022 |
| K211350 — Bindex BI-2 | Bone Index Finland , Ltd. Apr 29, 2022 |
| K213482 — TIA Tip, Cariosity, Transillumination Accessory Tip | D4D Technologies, LLC Apr 29, 2022 |
| K220338 — ExacTrac Dynamic | Brainlab AG Apr 29, 2022 |
| K213278 — Planmed Verity | Planmed OY Apr 28, 2022 |