| K231184 — CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. May 26, 2023 |
| K222640 — Sweden & Martina Surgical Trays | Sweden & Martina S.P.A. May 26, 2023 |
| K230044 — Pre-Sure | Lazarus 3D May 26, 2023 |
| K213289 — Gammex® PI Plus Glove-in-Glove System Tested For Use with Chemotherapy Drugs | Ansell Healthcare Products, LLC May 26, 2023 |
| K230679 — WellsForm Tricuspid Annuloplasty Band (WF) | Genesee Biomedical, Inc. May 26, 2023 |
| K230316 — FlexBand; FlexPatch; FlexBand Plus | International Life Sciences May 26, 2023 |
| K230580 — Diode Laser System | Smedtrum Medical Technology Co., Ltd. May 26, 2023 |
| K223329 — Electric Breast Pump (model: YY-A46, YY-A203, YY-A204, YY-TC201) | Guangzhou Yongyi Industrial Co., Ltd. May 26, 2023 |
| K230739 — Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608, FZ-608G, FZ-100, FZ-200 | Shenzhen Ionka Medical Technology Co., Ltd. May 26, 2023 |
| K223651 — Cerebral Adaptive Index (CAI) Algorithm | Edwards Lifesciences, LLC May 26, 2023 |
| K222606 — V-HYADASE | Vitromed GmbH May 26, 2023 |
| K231176 — Stingray LP Catheter | Boston Scientific May 25, 2023 |
| K220759 — Armis VeriCyn Wound Wash | Armis Biopharma, Inc. May 25, 2023 |
| K222852 — Nipro SafeTouch Needle; Nipro Syringe with SafeTouch Needle | Nipro Medical Corporation May 25, 2023 |
| K230246 — Dentis s-Clean SQ-SL Narrow Implant System | Dentis Co., Ltd. May 25, 2023 |
| K230273 — Saranas Early Bird Bleed Monitoring System | Saranas, Inc. May 25, 2023 |
| K223814 — Genesis ACTIVE Implant System | Keystone Dental, Inc. May 25, 2023 |
| K231169 — STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) | Plasmapp Co,., Ltd. May 25, 2023 |
| K213256 — ThermoTK | Zimmer Medizinsysteme GmbH May 25, 2023 |
| K230259 — Soreal Press, Soreal CAD | Shenzhen Up3D Technology Co., Ltd. May 25, 2023 |
| K230258 — BB 8 Sinus Dilation Kit | Excelent, Inc. May 25, 2023 |
| K223818 — Model 9160 VitaloQUB | Vitalograph Ireland, Ltd. May 25, 2023 |
| K222624 — KLS Martin LINOS Wrist System | KLS-Martin L.P. May 25, 2023 |
| K222229 — Advanced LumFix Spinal Fixation System | CG Bio Co., Ltd. May 25, 2023 |
| K222311 — CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System | Circa Scientific, Inc. May 25, 2023 |
| K222891 — Dental Desensitizer | Guangzhou Beogene Biotech Co., Ltd. May 25, 2023 |
| K223491 — Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite | Ge Medical Systems, LLC May 25, 2023 |
| K231229 — S-COMP Reform® POCT Navigation Instruments | Precision Spine, Inc. May 25, 2023 |
| K230106 — General Cutting Straight | Nakanishi, Inc. May 24, 2023 |
| K221634 — Oxymag - Transport and Emergency Ventilator | Magnamed Tecnologia Medica S/A May 24, 2023 |
| K230523 — s-Clean Link Abutment Narrow | Dentis Co., Ltd. May 24, 2023 |
| K223620 — Reprieve by RegenesisTM | Regenesis Biomedical, Inc. May 24, 2023 |
| K223663 — SIMDA Abutment | Simda Co., Ltd. May 24, 2023 |
| K222035 — Avatar Medical Software V1 | Avatar Medical May 24, 2023 |
| K223259 — coactiv+ Antimicrobial Wound Gel | Kane Biotech, Inc. May 24, 2023 |
| K230152 — uMR Omega | Shanghai United Imaging Healthcare Co., Ltd. May 23, 2023 |
| K231178 — ACTERA hip system | Conformis, Inc. May 23, 2023 |
| K230096 — Genius AI Detection 2.0 with CC-MLO Correlation | Hologic, Inc. May 23, 2023 |
| K230874 — Syntheface PEEK Interference Screw, Syntheface PEEK Screw Sheath | Suzhou Endophix Co., Ltd. May 23, 2023 |
| K230564 — Green Non Sterile Powder Free Nitrile Examination Gloves | Central Medicare Sdn Bhd May 23, 2023 |
| K230134 — Laser Therapy Hair Growth Comb, Model: Lasercomb-001 & Lasercomb-002 | Hubei Yjt Technology Co.,Ltd May 23, 2023 |
| K231162 — ROSA Hip System | Orthosoft Inc (D/B/A Zimmer Cas) May 23, 2023 |
| K230803 — ADAS 3D | Adas3D Medical S.L. May 23, 2023 |
| K223504 — Ceribell Status Epilepticus Monitor | Ceribell, Inc. May 23, 2023 |
| K231168 — TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support | Imperative Care, Inc. May 22, 2023 |
| K230443 — TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04) | Jiangxi Royall Smart Technology Co., Ltd. May 22, 2023 |
| K223860 — Integrity Bone Staple Fixation System | Anika Therapeutics, Inc. May 22, 2023 |
| K231464 — 3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex) | 3M Company, Unitek Orthodontic Products May 22, 2023 |
| K230465 — Hi-Bond Universal | Mediclus Co., Ltd. May 22, 2023 |
| K222705 — Introducer Needle | Youcare Technology Co.,Ltd. (Wuhan) May 22, 2023 |