| K231960 — NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Capsule and NaviCam Tether | Anx Robotica Corporation Oct 3, 2023 |
| K230085 — Lung-CAD | Imagen Technologies, Inc. Oct 3, 2023 |
| K232230 — YJ-K1/K2 Wheelchair (YJ-K1F 16 NDE; YJ-K1F 16 NDS; YJ-K1F 18 NDE; YJ-K1F 18 NDS; YJ-K1F 20 NDE; YJ-K1F 20 NDS; YJ-K1F 18 NDEE; YJ-K1F 16 VDE; YJ-K1F 16 VDS; YJ-K1F 18 VDE; YJ-K1F 18 VDS; YJ-K1F 20 VDE; YJ-K1F 20 VDS; YJ-K2 16 VDFE; YJ-K2 16 VDFS; YJ-K2 18 VDFE; YJ-K2 18 VDFS; YJ-K2 20 VDFE; YJ-K2 20 VDFS; YJ-K1G 18 NFFE; YJ-K1G 18 NFFS; YJ-K2TC 16 NAFE; YJ-K2TC 18 NAFE; YJ-K2TC 20 NAFE) | Zhenjiang Assure Medical Equipment Co., Ltd. Oct 3, 2023 |
| K232064 — Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with Chemotherapy Drugs and Fentanyl Citrate) | Isikel Manufacturing, LLC Oct 2, 2023 |
| K232359 — Surgical face mask | Kingstar Medical (Xianning) Co., Ltd. Oct 2, 2023 |
| K221972 — Warantec Custom Abutment | Warantec Co., Ltd. Oct 2, 2023 |
| K230681 — Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl | Central Medicare Sdn Bhd Oct 2, 2023 |
| K231716 — OsteoFlo® HydroPutty | SurGenTec, LLC Oct 2, 2023 |
| K231520 — tmCMF Solution | Techmah Cmf Oct 2, 2023 |
| K221890 — Elecsys Tg II | Roche Diagnostics Sep 30, 2023 |
| K231622 — REGER Nebulizer Irrigation Cannula | Reger Medizintechnik, GmbH Sep 29, 2023 |
| K231649 — Intraosseous Fusion Device System | Auxano Medical, LLC Sep 29, 2023 |
| K231957 — SafeBreak® Vascular | Lineus Medical Sep 29, 2023 |
| K223085 — Miris Human Milk Analyzer (HMA) | Miris AB Sep 29, 2023 |
| K221274 — StarFormer, TightWave | Fotona D.O.O. Sep 29, 2023 |
| K230591 — TriLEAP Plating System | Crossroads Extremity Systems Sep 29, 2023 |
| DEN220023 — Procise ADL | Procisedx, Inc. Sep 29, 2023 |
| K232299 — CeraPutty | Meta Biomed Co., Ltd. Sep 29, 2023 |
| DEN210056 — Procise IFX | Procisedx, Inc. Sep 29, 2023 |
| K221508 — AnemoCheck Home | Sanguina, Inc. Sep 29, 2023 |
| K231527 — TriALTIS Navigation Enabled Instruments | Medos International Sàrl Sep 29, 2023 |
| K230045 — HipCheck | Stryker Corp. Sep 29, 2023 |
| K230847 — Chemotherapy Gloves | 3A Glove Sdn. Bhd. Sep 29, 2023 |
| K232690 — Amulet Steerable Delivery Sheath | ABBOTT MEDICAL Sep 29, 2023 |
| K223873 — Boppli Infant Blood Pressure Monitor | Pyrames, Inc. Sep 29, 2023 |
| K212769 — DYNEX SmartPLEX MMRV IgG Assay Kit | Dynex Technologies, Inc. Sep 29, 2023 |
| K231628 — BeShape One Device | Beshape Technologies , Ltd. Sep 29, 2023 |
| K232651 — BLAZER Dx-20 Bidirectional Steerable Diagnostic Catheter | Boston Scientific Corporation Sep 29, 2023 |
| K221900 — Stat Profile Prime Plus Analyzer System | Nova Biomedical Corporation Sep 29, 2023 |
| K232701 — Guardenia (GAR-1) | Advanced Surgical Concepts Sep 29, 2023 |
| K221570 — Antibacterial bandage | Allmed Medical Products Co., Ltd. Sep 29, 2023 |
| K231702 — WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystoscope, WiScope® Medical Tablet | OTU Medical, Inc. Sep 29, 2023 |
| K231973 — PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove | Ineo Tech Sdn Bhd Sep 29, 2023 |
| K232650 — KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O Sep 29, 2023 |
| K220458 — UltraFlo-R Push Button Blood Collection Set | Innovative Medical Technologies, Inc. Sep 29, 2023 |
| K232647 — Microcatheter | Surmodics,Inc. Sep 29, 2023 |
| K230187 — Terran NM-101 | Terran Biosciences, Inc. Sep 29, 2023 |
| K232669 — TBI | Abbott Laboratories Sep 29, 2023 |
| K213403 — Aptiva CTD Essential Reagent | Inova Diagnostics, Inc. Sep 29, 2023 |
| DEN210011 — Invitae Common Hereditary Cancers Panel | Invitae Corporation Sep 29, 2023 |
| K221359 — ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM | Instrumentation Laboratory CO Sep 29, 2023 |
| K233257 — 3M ClarityAligners with Quick Attachments | 3M Company, Unitek Orthodontic Products Sep 29, 2023 |
| K230865 — PIVO Pro Needle-free Blood Collection Device | Becton Dickinson Infusion Therapy Systems, Inc. Sep 28, 2023 |
| K231013 — DNA/RNA Shield SafeCollect Saliva Collection kit | Zymo Research Sep 28, 2023 |
| K232605 — Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue® MAX + Invue Inset Anterior Cervical Plate System, and FacetFuse® Screw Fixation System | Lesspine Innovations Sep 28, 2023 |
| K232699 — Low Ejection Fraction AI-ECG Algorithm | Anumana, Inc. Sep 28, 2023 |
| K233161 — BeautiLink SA | Shofu Dental Corporation Sep 28, 2023 |
| K231837 — Brainomix 360 Triage LVO | Brainomix Limited Sep 28, 2023 |
| K231901 — Hakon, Hakon Smart | Medical San Indústria DE Equipamentos Médicos Ltda. Sep 28, 2023 |
| K231792 — VeriSafe Safety sterile syringes | Promisemed Hangzhou Meditech Co., Ltd. Sep 28, 2023 |