| K230384 — PolyWear® Personal Protective Level 3 Gown | PolyConversions, Inc. Aug 11, 2023 |
| K231493 — NITINEX Memory Compression Staple | Vilex, LLC Aug 11, 2023 |
| K231408 — Basic Synguard Nitrile Exam Gloves, Powder Free, Blue Colored, Non-Sterile | Shandong Intco Medical Products Co, Ltd. Aug 11, 2023 |
| K222888 — BlueStar CGM insulin dose calculator | Welldoc, Inc. Aug 11, 2023 |
| K231439 — Powder Free White, Black, and Purple Nitrile Examination Glove | S&S Glove Corporation Aug 11, 2023 |
| K223840 — eRapid Nebulizer System | Pari Respiratory Equipment, Inc. Aug 11, 2023 |
| K230632 — VersiHD with GuideMe software | Nxstage Medical, Inc. Aug 11, 2023 |
| K230626 — Portrait Central Viewer Application (Portrait CV A01), Portrait Core Services (Portrait CSS01), Portrait Clinical Alarming Unit (Portrait CAU01); Portrait Mobile Patient Monitor (Portrait HUB01), Portrait Sensor Battery (Portrait SBT01), Portrait Bedside Charger (Portrait BCH01); Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01, Portrait SpO2 P-SP01, Portrait SpO2 P-W01 and Portrait SpO2 P-SE01); Portrait SpO2 Attachment Accessory Band (Portrait AAB01), Portrait | Ge Medical Systems Information Technologies, Inc. Aug 11, 2023 |
| K231409 — Erchonia FX-405 | Erchonia Corporation Aug 11, 2023 |
| K221925 — ID NOW COVID-19 2.0 | Abbott Diagnostics Scarborough, Inc. Aug 10, 2023 |
| K213131 — Accu-Chek Guide Solo diabetes manager blood glucose monitoring system | Roche Diabetes Care GmbH Aug 10, 2023 |
| K231415 — EnSite X EP System | ABBOTT MEDICAL Aug 10, 2023 |
| K223711 — ANNE One | Sibel Health, Inc. Aug 10, 2023 |
| K230625 — ReliOn Premier BLU Blood Glucose Monitoring System | I-Sens, Inc. Aug 10, 2023 |
| K223500 — SuperBall Meniscal Repair System | Arcuro Medical , Ltd. Aug 10, 2023 |
| K223608 — GEM Premier 7000 with IQM3 | Instrumentation Laboratory Company Aug 10, 2023 |
| K213134 — Accu-Chek Solo micropump system with interoperable technology | Roche Diabetes Care GmbH Aug 10, 2023 |
| K223445 — ArtiFascia | Nurami Medical , Ltd. Aug 10, 2023 |
| K222850 — HAVAb IgG II | Abbott Laboratories Aug 10, 2023 |
| K230428 — Ambu® aScope 5 Broncho 2.7/1.2, Ambu® aScope 5 Broncho 4.2/2.2, Ambu® aBox 2 | Ambu A/S Aug 10, 2023 |
| K231380 — AirLife DuoTherm Humidification System | Vyaire Medical, Inc. Aug 10, 2023 |
| K231420 — Aura 10 PET/CT | Xeos Medical Aug 10, 2023 |
| K230268 — ZenPro 40 | BLUECORE COMPANY Co., Ltd. Aug 10, 2023 |
| K232039 — Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Grand Work Plastic Products Co., Ltd. Aug 9, 2023 |
| K231164 — Conductive carbon film electrode | Guangzhou Xinbo Electronic Co., Ltd. Aug 9, 2023 |
| K231167 — Conductive Silicone Rubber Electrode | Guangzhou Xinbo Electronic Co., Ltd. Aug 9, 2023 |
| K231525 — VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack | Ortho Clinical Diagnostics Aug 9, 2023 |
| K231885 — Medline UNITE® REFLEX® Nitinol Staple System | Medline Industries, LP Aug 9, 2023 |
| K231114 — Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail System | Zimmer Switzerland Manufacturing GmbH Aug 9, 2023 |
| K222443 — Air Smart Extra Spirometer | Feellife Health, Inc. Aug 9, 2023 |
| K230304 — Polyisoprene Surgical Gloves | Puyang Linshi Medical Supplies Co., Ltd. Aug 9, 2023 |
| K231394 — Intense Pulsed Light System | Smedtrum Medical Technology Co., Ltd. Aug 9, 2023 |
| K231376 — Q-FIX With Needles (Q-FIX With Needles, #0 Suture & Q-FIX With Needles, Minitape) | Smith & Nephew, Inc. Aug 9, 2023 |
| K232100 — Efai Pacs Picture Archiving and Communication System Pro | Ever Fortune.Ai, Co., Ltd. Aug 8, 2023 |
| K222128 — Protective Gown AAMI Level 4 | Kenpax International Limited Aug 8, 2023 |
| K230551 — Visual-ICE Cryoablation System | Boston Scientific Corporation Aug 8, 2023 |
| K223633 — Rubicon Control Support Catheter (H749394323506A1) | Boston Scientific Corporation Aug 8, 2023 |
| K232052 — Ceribell Instant EEG Headband | Ceribell, Inc. Aug 8, 2023 |
| K222439 — Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc) | Siemens Healthcare Diagnostics, Inc. Aug 8, 2023 |
| K231857 — Arthrex TightRope II | Arthrex, Inc. Aug 8, 2023 |
| K230620 — Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter | Gentuity, LLC Aug 8, 2023 |
| K232008 — Disposable Medical Examination Nitrile Gloves | Raxwell Industrial, LLC Aug 8, 2023 |
| K223924 — LW Implant System | Ossvis Co., Ltd. Aug 8, 2023 |
| K220828 — SQA-iO Sperm Quality Analyzer | Medical Electronic Systems , Ltd. Aug 7, 2023 |
| K231488 — Celerity HP Chemical Indicator; Celerity HP Multivariable Chemical Indicator; VERIFY HPU Chemical Indicator; VERIFY VH2O2 Indicator Tape | Steris Aug 7, 2023 |
| K231500 — Vis-U-All Low Temperature Sterilization Pouches | STERIS Corporation Aug 7, 2023 |
| K231490 — Celerity 20 HP Biological Indicator; VERIFY V24 Self-Contained Biological Indicator | STERIS Corporation Aug 7, 2023 |
| K223713 — Powder Free Nitrile Examination Glove (Grey) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Better Care Plastic Technology Co., Ltd. Aug 7, 2023 |
| K231501 — PRO-LITE Sterilization Tray | STERIS Corporation Aug 7, 2023 |
| K231098 — LineSider® Spinal System | Integrity Implants, Inc. Aug 7, 2023 |