| Digital Wireless Intraoral X-Ray Sensor (K230998) | Iray Imaging Technology (Haining) Limited | 2023-10-20 |
| Lucitone Digital Print Denture System (K231578) | Dentsply Sirona | 2023-10-20 |
| Nitrile Examination Gloves, Dual Color Black-Blue (K232550) | Shanxi Hongjin Plastic Technology Co., Ltd. | 2023-10-20 |
| BioShield Biopsy Valve (00711124); BioShield Biopsy Valve (00711125); BioShield Biopsy Valve (00711126); BioShield Biopsy Valve (00711127); BioShield Biopsy Valve (00711129); BioShield Biopsy Valve (00711135); BioShield Biopsy Valve (00711136); BioShield Biopsy Valve - sterile (00711128); BioShield Irrigator (00711133); BioShield Irrigator (00711137); BioShield Irrigating Adaptor (00711131); BioShield Irrigator - extension tubing (00711134) (K232951) | Steris | 2023-10-20 |
| NextDent Base (K231388) | Vertex-Dental B.V. | 2023-10-20 |
| R2GATE Lite TM (K223909) | Megagen Implant Co., Ltd. | 2023-10-20 |
| EasyOne Sky Spirometer (K230178) | Ndd Medizintechnik AG | 2023-10-19 |
| Actinia® hip stems (K232371) | Implantcast GmbH | 2023-10-19 |
| KeyLift™ Expandable Interlaminar Stabilization System (K232484) | Amplio Spine, LLC | 2023-10-19 |
| Oran Park Mask (K230476) | Resmed Pty Ltd (Registration Number: 3004604967) | 2023-10-19 |
| StealthStation Cranial Software, v3.1.5 (9735585) (K231976) | Medtronic Navigation, Inc. | 2023-10-19 |
| Acro Composites Interbody System (K230478) | Acro Composites, LLC | 2023-10-19 |
| Xpert Xpress MVP; GeneXpert Xpress System (K231381) | Cepheid | 2023-10-19 |
| C.C. Life 21 (K230459) | 21 Equipment S.R.L. | 2023-10-19 |
| CombiDiagnost R90 (K232910) | Philips Medical Systems Dmc GmbH | 2023-10-19 |
| IRRAflow Active Fluid Exchange System (AFES) (K231664) | Irras USA, Inc. | 2023-10-19 |
| Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer System (K231704) | Life Spine, Inc. | 2023-10-19 |
| Radio Frequency System (K231749) | Shenzhenshi Sincoheren S&T Development Co., Ltd. | 2023-10-19 |
| Medline UNITE® REFLEX® Nitinol Staple Kit (K232905) | Medline Industries, LP | 2023-10-19 |
| EConsole1 (K231225) | DRTECH Corporation | 2023-10-18 |
| SmartBolus Calculator (K231824) | Insulet Corporation | 2023-10-18 |
| Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set (K232524) | Perfuze, Ltd. | 2023-10-18 |
| Portable Oxygen Concentrator (Model: P2-S4, P2-S3,P2-K4,P2-K3) (K230702) | Qingdao Kingon Medical Science and Technology Co., Ltd. | 2023-10-18 |
| Byte Aligner System (K230199) | Dentsply Sirona, Inc. | 2023-10-18 |
| OptiMesh Multiplanar Expandable Interbody Fusion System (K231781) | Spineology, Inc. | 2023-10-18 |
| T-Line® Hernia Mesh (K232924) | Deep Blue Medical Advances, Inc. | 2023-10-18 |
| Omnipod 5 ACE Pump (K231826) | Insulet Corporation | 2023-10-18 |
| Arthrex Small External Fixation System (K232897) | Arthrex, Inc. | 2023-10-18 |
| MectaLIF Anterior Lag Extension (K232123) | Medacta International S.A. | 2023-10-18 |
| Terumo Injection Filter Needle (NF-3013RBKE05M) (K230951) | Terumo Europe N.V. | 2023-10-18 |
| INNO SLA Submerged Narrow Implant System (K231395) | Cowellmedi Co., Ltd. | 2023-10-18 |
| Medline Safety Insulin and TB Syringes (K231907) | Medline Industries, LP | 2023-10-18 |
| TransLoc 3D (K232878) | Foundation Fusion Solutions, LLC (Dba Cornerloc) | 2023-10-17 |
| Dynamic TiBase (K232151) | Talladium España, SL | 2023-10-17 |
| ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood) (K222214) | Thi Total Healthcare Innovation GmbH | 2023-10-17 |
| Infinity CentralStation Wide, Infinity M300, Infinity M300+ (K231477) | Draeger Medical Systems, Inc. | 2023-10-17 |
| Lumen 155-SF (K223911) | Intricon Corporation | 2023-10-17 |
| Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US) (K231105) | Shanghai AnQing Medical Instrument Co., Ltd. | 2023-10-17 |
| Legend X Platform (K232903) | Pollogen, Ltd. | 2023-10-17 |
| HAtetracell™-C Titanium Cervical IBF System (K231899) | Innovasis, Inc. | 2023-10-17 |
| SOZO Pro (K232089) | ImpediMed Limited | 2023-10-17 |
| Laparoscope (4KA0, 4KA0R, 4KA30, 4KA30R, 4KA45, 4KA45R) (K231725) | Hunan Endoso Life Technology Co., Ltd. | 2023-10-16 |
| ANDORATE® Valve Kit (K232118) | Ga Health Company Limited | 2023-10-16 |
| Ikshana (K230249) | Immersivetouch | 2023-10-16 |
| Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BL (K230104) | Anthogyr | 2023-10-16 |
| Iontophoresis Electrodes (K232020) | Top-Rank Health Care Co., Ltd. | 2023-10-16 |
| Willow Generation 3 Breast Pump (K230570) | Willow Innovations, Inc. | 2023-10-16 |
| Infrared Thermometer (AOJ-20A); Infrared Thermometer (AOJ-20Y) (K232128) | Shenzhen AOJ Medical Technology Co., Ltd. | 2023-10-14 |
| BONHAWA Respiratory Humidifier (K223863) | Telesair, Inc. | 2023-10-13 |
| Titan Dental Design (K232429) | Clearadvance, LLC | 2023-10-13 |
| Motiva Flora SmoothSilk Tissue Expander (K211676) | Motiva USA, LLC | 2023-10-13 |
| VyLink™ Spinal Screw System (K231744) | Vy Spine, LLC | 2023-10-13 |
| Macro & Micro-Test HCG Pregnancy Test Midstream (K230741) | Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. | 2023-10-13 |
| Veuron-Brain-pAb3 (K231642) | Heuron Co., Ltd. | 2023-10-13 |
| Neuroblade System (K230125) | Clearmind Biomedical | 2023-10-13 |
| APIS (R), VERIS (TM) (K222143) | Sweetbio, Inc. | 2023-10-13 |
| Paragon 8F Balloon Guide Catheter (K232437) | Wallaby Medical | 2023-10-13 |
| Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior cervical interbody fusion - ACIF (The Peridot-TD Anterior Cervical Intervertebral body fusion system) (K232822) | Gbs Commonwealth Co., Ltd. | 2023-10-13 |
| Serena Sleep Night Guard (K230495) | Meris Investment Group | 2023-10-13 |
| RIGEL™ 3DR Anterior Cervical Corpectomy System (K232481) | MiRus, LLC | 2023-10-13 |
| Calibrate CCX Interbody System (K232504) | Alphatec Spine, Inc. | 2023-10-13 |
| S1 (K231672) | Medpark Co., Ltd. | 2023-10-13 |
| Xpert® Xpress CoV-2 plus (K230440) | Cepheid® | 2023-10-13 |
| The Evolve System with the Transform Applicator (K231495) | InMode , Ltd. | 2023-10-13 |
| MRI compatibility for existing BioHorizons dental implants and abutments (K223697) | BioHorizons Implant Systems, Inc. | 2023-10-13 |
| SpotLight/SpotLight Duo (with DLIR option) (K230370) | Arineta , Ltd. | 2023-10-13 |
| Stable-L Standalone Lumbar Interbody System (K231486) | Nexus Spine, LLC | 2023-10-12 |
| ORi (DEN200076) | Masimo Corporation | 2023-10-12 |
| Stethophone (K231551) | Sparrow Acoustics, Inc. | 2023-10-12 |
| Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard HA+ Nerve Protector (AGHA24); Axoguard HA+ Nerve Protector (AGHA36); Axoguard HA+ Nerve Protector (AGHA48) (K231708) | Axogen Corporation | 2023-10-12 |
| ValvuloPro Valvuloplasty Balloon Catheter (K231814) | Dongguan TT Medical, Inc. | 2023-10-12 |
| MONTAGE-QS Settable, Resorbable Bone Putty (K231475) | Orthocon, Inc. | 2023-10-12 |
| Scenaria View 4.2 (K231574) | FUJIFILM Healthcare Americas Corporation | 2023-10-12 |
| Monopolar Electrode Surgical Instrument (K230650) | Vhmed (Nantong) Co. , Ltd. | 2023-10-12 |
| Collagen Wound Dressing (K231152) | Winner Medical Co., Ltd. | 2023-10-12 |
| MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation Devices (K231231) | Paragon 28, Inc. | 2023-10-12 |
| Skypro, Surgical Gown 6021 (K230707) | Skypro Medical Supplies Company | 2023-10-12 |
| Artemis, Artemis TPO, Artemis MX (K222222) | Eigen | 2023-10-12 |
| FREEPRINT® splintmaster (K232448) | Detax GmbH | 2023-10-12 |
| TMINI™ Miniature Robotic System (K232802) | THINK Surgical, Inc. | 2023-10-12 |
| Monkey RingsTM External Fixation System (K232838) | Paragon 28, Inc. | 2023-10-12 |
| Montage- XT Settable, Resorbable Hemostatic Bone Putty (K232998) | Orthocon, Inc. | 2023-10-12 |
| Exactech® Vantage® Total Ankle System (K230717) | Exactech, Inc. | 2023-10-12 |
| Cross Vascular RF Generator and Footswitch (optional accessory) (K232809) | Cross Vascular, Inc. | 2023-10-12 |
| Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable (K232852) | Cross Vascular, Inc. | 2023-10-12 |
| VASSALLO GT Crossing14 (K232574) | Filmec Co. , Ltd. | 2023-10-11 |
| Vital™ Spinal Fixation System (K230116) | Zimvie Spine (Zimmer Biomet Spine, Inc.) | 2023-10-11 |
| Synq Software Version 1.3 (K232981) | Synaptive Medical, Inc. | 2023-10-11 |
| EMPHASYS Femoral Stems (K233233) | Depuy Ireland UC | 2023-10-11 |
| IPL Hair Removal Device (LS-T106, LS-T107, LS-T108) (K232499) | Shenzhen Lescolton Electrical Appliance Co., Ltd. | 2023-10-11 |
| Biodegradable Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black, Green) (K232070) | Better Care Plastic Technology Co., Ltd. | 2023-10-11 |
| Vlab (K230148) | Dormotech Medical, Ltd. | 2023-10-11 |
| Arm Blood Pressure Monitor (K231050) | Alicn Medical Shenzhen, Inc. | 2023-10-11 |
| SurgiAid® Collagen Wound Dressing (K223126) | Maxigen Biotech, Inc. | 2023-10-11 |
| MegaGen Dental Implant Systems Portfolio - MR Conditional (K230618) | Megagen Implant Co., Ltd. | 2023-10-11 |
| Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR (K232344) | GE Medical Systems SCS | 2023-10-11 |
| Disposable electrosurgical pencil (MD1000) (K232460) | Shenzhen Mecun Medical Supply Co., Ltd. | 2023-10-11 |
| Anterion (K230897) | Heidelberg Engineering GmbH | 2023-10-11 |
| NeuViz 128 Multi-Slice CT Scanner System (K230220) | Neusoft Medical Systems Co., Ltd. | 2023-10-11 |
| JO Coconut Hybrid Warming Personal Lubricant (K232090) | CC Wellness, LLC | 2023-10-11 |