| K232835 — Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System | Canon Medical Systems Corporation Apr 2, 2024 |
| K233975 — Zoom 6F Insert Catheters | Imperative Care, Inc. Apr 2, 2024 |
| K232112 — R&G Surgical Mask | R&G Seguridad E Higiene Industrial S.A.C. Apr 2, 2024 |
| K240888 — Calibra Abutment Resin Cement | Dentsply Sirona Apr 2, 2024 |
| K240080 — Aloe Vera Nitrile Examination Gloves (Green) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Syntex Healthcare Products Co., Ltd. Apr 2, 2024 |
| K240601 — SnapshotNIR model KD205 | Kent Imaging, Inc. Apr 2, 2024 |
| DEN230036 — Sepsis ImmunoScore | Prenosis, Inc. Apr 2, 2024 |
| K233750 — ECG-less Cardiac | Ge Medical Systems, LLC Apr 2, 2024 |
| K211815 — LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System | Affinity Biosensors Apr 2, 2024 |
| K240397 — AlphaVac MMA F1885 System (H787253020) | AngioDynamics, Inc. Apr 1, 2024 |
| K233990 — Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (D5000) | Shandong Xingyu Gloves Co., Ltd. Apr 1, 2024 |
| K232726 — External Hex Implant System | Southern Implants (Pty), Ltd. Apr 1, 2024 |
| K240043 — EVOLUTION® Hinge Knee System;GUARDIAN limb Salvage System;DCW Modular Distal Femoral System;REPIPHYSIS Limb Salvage System;EVOLUTION® MP Total Knee System; EVOLUTION® MP Total Knee System; EVOLUTION® MP Adaptive CS Insert; EVOLUTION® MP Adaptive PS Tibial Insert; EVOLUTION® MP CS/CR Porous Femur/EVOLUTION® Adaptive CS and PS Inserts; EVOLUTION® Revision CCK System; ADVANCE® Double High Insert; ADVANCE® A-CLASS® Tibial Insert; ADVANCE® Knee System; ADVANCE® Ultra-Congruent Tibial Inse | Microport Orthopedics, Inc. Apr 1, 2024 |
| K233676 — Us2.v2 | Eko.Ai Pte Ltd. D/B/A Us2.Ai Apr 1, 2024 |
| K230895 — CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMr L FLUO, i-MMs, i-MMs FLUO; i-XR3, i-XR3 L, i-XR3 L FLUO, i-XS4, | Cefla S.C. Apr 1, 2024 |
| K240635 — ENDOCOLLECT Specimen Retrieval Bag, 8mm, ENDOCOLLECT Specimen Retrieval Bag, 12mm, ENDOCOLLECT Specimen Retrieval Bag, 15mm | Ximedica Apr 1, 2024 |
| K233133 — Talis EMR with Talis +ACG (Talis EMR with +ACG) | Talis Clinical, LLC Apr 1, 2024 |
| K240442 — MagnetOs Putty | Kuros Biosciences B.V Apr 1, 2024 |
| K240288 — SF Push- in Anchor | Surgical Fusion Technologies GmbH Apr 1, 2024 |
| K231209 — Rejoyn | Otsuka America Pharmaceutical, Inc. Mar 30, 2024 |
| K233211 — AVIEW CAC | Coreline Soft Co., Ltd. Mar 29, 2024 |
| K233068 — Disposable Surgical Gown | Nanning Tecbod Biological Technology Co., Ltd. Mar 29, 2024 |
| K240310 — LCD Monitors C310S, G310S, C316S, G316S, C616W | Shenzhen Beacon Display Technology Co., Ltd. Mar 29, 2024 |
| K233622 — AlignRT Plus | Vision Rt, Ltd. Mar 29, 2024 |
| K232031 — LUNA 3D | Lap GmbH Laser Applikationen Mar 29, 2024 |
| K233595 — Genesys Spine Sacroiliac Joint Fusion System with Navigation | Genesys Spine Mar 29, 2024 |
| K232018 — Citrated: K, KH, RTH, FFH | Haemonetics Corporation Mar 29, 2024 |
| K230665 — Dose IQ Safety Software | Baxter Healthcare Corporation Mar 29, 2024 |
| K211122 — Novum IQ Large Volume Pump | Baxter Healthcare Corporation Mar 29, 2024 |
| K240608 — MAGNETOM Viato.Mobile | Siemens Medical Solutions USA, Inc. Mar 29, 2024 |
| K232825 — Disposable Sphincterotome | Jiangsu Vedkang Medical Science And Technology Co., Ltd. Mar 29, 2024 |
| K240587 — SmoothSkin Pure Unplugged (SSB3) | Cyden Limited Mar 29, 2024 |
| K233609 — CORE 500 Digital Stethoscope | Eko Health, Inc. Mar 28, 2024 |
| K240171 — ProSeal Injector Plus (Model no. 421050) | Epic Medical Pte. , Ltd. Mar 28, 2024 |
| K240284 — Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex 60H) | Shenzhen Browiner Tech Co., Ltd. Mar 28, 2024 |
| K233657 — NAEOTOM Alpha | Siemens Medical Solutions USA, Inc. Mar 28, 2024 |
| K232013 — Aperta NSE PTA Balloon Dilatation Catheter (AW18-05040040/AA18-05040040, AW18-09040040/AA18-09040040, AW18-14540040, AW18-05050040/AA18-05050040, AW18-09050040/AA18-09050040, AW18-14550040, AW18-05060040/AA18-05060040, AW18-09060040/AA18-09060040, AW18-14560040 AW18-05070040/AA18-05070040, AW18-09070040/AA18-09070040, AW18-14570040, AW18-05080040/AA18-05080040, AW18-09080040/AA18-09080040, AW18-14580040) | Goodman Co., Ltd. Mar 28, 2024 |
| K232047 — VIVACE | Unimom.Co Mar 28, 2024 |
| K233719 — FDR Visionary Suite | Shimadzu Corporation Mar 28, 2024 |
| K233838 — Emprint Ablation System with Thermosphere Technology (Overall System Name); Emprint Ablation Generator (CAGEN1); Emprint Ablation Generator HP (CAGENHP); Emprint Ablation Pump (CAPUMP1); Covidien Ablation Footswitch (RFASW); Emprint Reinforced Percutaneous Antenna 15cm (CA15L2); Emprint Reinforced Percutaneous Antenna 20cm (CA20L2); Emprint Reinforced Percutaneous Antenna 30cm (CA30L2); Covidien Remote Temperature Probe (RTP20); Covidien Remote Temperature Probe, Bulk (RTP20B) | Medtronic, Inc. Mar 28, 2024 |
| K232079 — Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (Green); Natural Rubber Latex (Strip&Coat)/(Strip&Pack) Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl | Wrp Asia Pacific Sdn. Bhd. Mar 28, 2024 |
| K233669 — OEC 3D | Ge Oec Medical Systems, Inc. Mar 28, 2024 |
| K233409 — Eko Low Ejection Fraction Tool (ELEFT) | Eko Health, Inc. Mar 28, 2024 |
| K240295 — InstaStrip Fentanyl Rapid Test (Urine); InstaStrip Fentanyl Dipstick Test (Urine) | Instanosis, Inc. Mar 28, 2024 |
| K233909 — Cleaner Plus 18F Thrombectomy System - Cleaner Plus 18F Aspiration Catheter, Cleaner Plus 18F Handpiece with Maceration Wire, Cleaner Plus 18F Aspiration Canister | Argon Medical Devices, Inc. Mar 28, 2024 |
| K240693 — LINQ II Insertable Cardiac Monitor (ICM) | Medtronic, Inc. Mar 28, 2024 |
| K232049 — IS-III active Short Implant | Neobiotech Co., Ltd. Mar 28, 2024 |
| K233604 — BTL-785S | BTL Industries, Inc. Mar 28, 2024 |
| K240567 — CustomizedBone Service | Fin-Ceramica Faenza S.P.A. Mar 28, 2024 |
| K231972 — Advanta VXT Vascular Graft, Flixene Vascular Graft | Atrium Medical Corporation Mar 28, 2024 |