| StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue Elite Reverse Deflection (K233645) | Boston Scientific Corporation - | 2023-12-12 |
| Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction Changeable Lumbar Cage System, KEYSTONE Cage System (K230872) | Shanghai Sanyou Medical Co, Ltd. | 2023-12-12 |
| Sterile Hypodermic Needles for Single Use (K233037) | Zhejiang Kindly Medical Device Co., Ltd. | 2023-12-12 |
| TriALTIS™ Spine System (K233684) | Medos International SARL | 2023-12-12 |
| Aygün Sterilization Container Systems (K233222) | Aygun Surgical Instruments Co., Inc. | 2023-12-12 |
| SIRA™ RFA Electrosurgical Device (K232947) | Innoblative Designs, Inc. | 2023-12-12 |
| Ziehm Solo FD (K231669) | Ziehm Imaging GmbH | 2023-12-12 |
| NaviCam ProScan (DEN230027) | Ankon Technologies Co., Ltd. | 2023-12-12 |
| ARx MIS Spinal Screw System (K233455) | Life Spine, Inc. | 2023-12-12 |
| Insulia Bolus Companion (K232451) | Voluntis Sa. | 2023-12-12 |
| Signature™ ONE System (K232425) | Orthosoft Inc. (D/B/A) Zimmer Cas) | 2023-12-12 |
| Intri24 Introducer Sheath (52-101) (K233646) | Inari Medical, Inc. | 2023-12-12 |
| Wrist Blood Pressure Monitor (K232815) | Zhuhai Yueja Medical Device Technology Co., Ltd. | 2023-12-11 |
| ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology (K232303) | Depuy Ireland UC | 2023-12-11 |
| 24HR513C (K232985) | Lg Electronics.Inc | 2023-12-11 |
| Transpara Density 1.0.0 (K232096) | Screenpoint Medical B.V. | 2023-12-11 |
| EDS Calculus Softener TURBO CR (K223340) | Essential Dental Systems, Inc. | 2023-12-11 |
| FARADRIVE™ Steerable Sheath (K233248) | Boston Scientific Corporation | 2023-12-11 |
| Nio Color 8MP (MDNC-8132) (K233693) | Barco N.V. | 2023-12-11 |
| Hygenix (K232797) | Shenzhen Hygenix Industrial Co., Ltd. | 2023-12-11 |
| iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C) (K223690) | Shenzhen Yhlo Biotech Co., Ltd. | 2023-12-11 |
| INTELLIO SHIFT System (K232290) | ArthroCare Corporation | 2023-12-11 |
| PowerPort™ ClearVUE™ Slim ECG Enabled Implantable Port; PowerPort™ ClearVUE™ isp ECG Enabled Implantable Port; PowerPort™ isp M.R.I.™ ECG Enabled Implantable Port; PowerPort™ Slim ECG Enabled Implantable Port (K232737) | Bard Peripheral Vascular, Inc. | 2023-12-08 |
| F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro Lateral Plate System (K231743) | Corelink, LLC | 2023-12-08 |
| 10F Sheath and Dilator Set (K233432) | Argon Medical Devices, Inc. | 2023-12-08 |
| BTI Interna Prosthetic Components (K232750) | B.T.I. Biotechnology Institute, Sl. | 2023-12-08 |
| Eagle device (K230722) | Belkin Vision, Ltd. | 2023-12-08 |
| Global Modular Replacement System (K233261) | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | 2023-12-08 |
| Transcutaneous Electrical Nerve Stimulator For Pain Relief (Model: KTR-2302, KTR-2401, KTR-2402, KTR-2411, KTR-2412) (K232517) | Shenzhen Kentro Medical Electronics Co., Ltd. | 2023-12-08 |
| Vibrant System (K232830) | Vibrant, Ltd. | 2023-12-08 |
| Novii+ Wireless Patch System (K231964) | Datex Ohmeda | 2023-12-08 |
| SimpleSense-BP, SimpleSense-BP Software Application (K232053) | Nanowear, Inc. | 2023-12-08 |
| Lumina-PTFE Titanium (K221851) | Criteria Industria E Comercio DE Produtos Medicinais | 2023-12-08 |
| DTX Studio Clinic (4.0) (K231898) | Nobel Biocare AB | 2023-12-08 |
| Bonelogic (K223757) | Disior, Ltd. | 2023-12-08 |
| DVAS (DVAS-M, DVAS-W) (K232085) | Genoray Co., Ltd. | 2023-12-08 |
| Valkyrie Thoracic Fixation System (K232515) | Jm Longyear Manufacturing, LLC D/B/A Able Medical Devices | 2023-12-08 |
| NeuroBlate System (K231061) | Monteris Medical, | 2023-12-08 |
| VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems (K233654) | Steris | 2023-12-08 |
| ProNephro AKI™ (NGAL) (K232761) | Bioporto Diagnostic, Inc. | 2023-12-07 |
| MySpine Cervical Guides (K231515) | Medacta International S.A. | 2023-12-07 |
| Led Mask Platinum Exclusive MD (K232795) | Stg24 Co., Ltd. | 2023-12-07 |
| LOGIQ Totus (K232381) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2023-12-07 |
| ARi ExCon Implant System (K231967) | Megagen Implant Co., Ltd. | 2023-12-07 |
| OTS 25 (100-1) (K233429) | Ots Medical , Ltd. | 2023-12-07 |
| Reliance® Fusion Sterilization Wraps (K230137) | Ahlstrom-Munksjo Nonwovens, LLC | 2023-12-07 |
| DLP Silicone Coronary Artery Ostial Cannulae (K231206) | Medtronic, Inc. | 2023-12-07 |
| Light Based Hair Removal Device (K232846) | Shenzhen Meik Beauty Industry Co., Ltd. | 2023-12-07 |
| RM Electrode (RMH 23-01) (K232273) | Retmap, Inc. | 2023-12-07 |
| Myocardial Strain Software Application (K232661) | Circle Cardiovascular Imaging | 2023-12-07 |
| S.I.N. Dental Implant System (K231127) | S.I.N. - Sistema DE Implante Nacional S.A. | 2023-12-07 |
| Evolve Nitric Oxide Delivery System (K222930) | Mallinckrodt Manufacturing, LLC | 2023-12-06 |
| Cork Medical VERSA Negative Pressure Wound System (VCMPP-100) (K230677) | Cork Medical | 2023-12-06 |
| SG Lanset I, SG Lancets, Soft Lancets (K230712) | Sewon Medical Co. | 2023-12-06 |
| QT ECG (QTERD100) (K233521) | QT Medical, Inc. | 2023-12-06 |
| BeaMed Laser Surgery Fibers (K232769) | Bt Beamedical Tachnoogies Ltd. (Beamed) | 2023-12-06 |
| SOMATOM Pro.Pulse (K232206) | Siemens Medical Solutions USA, Inc. | 2023-12-06 |
| Aquilion Serve SP (TSX-307B/1) V1.3 (K233334) | Canon Medical Systems Corporation | 2023-12-06 |
| LINQ II Insertable Cardiac Monitor (K233562) | Medtronic, Inc. | 2023-12-06 |
| OneRF Ablation System (K231675) | Neuroone Medical Technologies Corp. | 2023-12-06 |
| 2008T BlueStar Hemodialysis Machine (K231125) | Fresenius Medical Care Renal Therapies Group, LLC | 2023-12-06 |
| Sonosite LX Ultrasound System (K233597) | FUJIFILM Sonosite, Inc. | 2023-12-06 |
| Q-Pad Test System (K231465) | Qurasense | 2023-12-06 |
| Sterile Nitrile Examination Gloves Powder Free Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K233042) | Shandong Intco Medical Products Co, Ltd. | 2023-12-06 |
| THERMOCLICK (K222057) | T&R BIOFAB CO., Ltd. | 2023-12-05 |
| Electronic Blood Pressure Monitor (K232814) | Zhuhai Yueja Medical Device Technology Co., Ltd. | 2023-12-05 |
| Ceevra Reveal 3+ (K233568) | Ceevra, Inc. | 2023-12-05 |
| Adravision Perio (K232440) | Adra Corporation | 2023-12-05 |
| BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived Kit (K232434) | Bd | 2023-12-05 |
| SS Abutment System (K232220) | Osstem Implant Co., Ltd. | 2023-12-05 |
| Tablo® Hemodialysis System (K233335) | Outset Medical, Inc. | 2023-12-05 |
| Aurelia Surgical Mask ASTM Level 1; Aurelia Surgical Mask ASTM Level 2 (K231005) | Supermax Healthcare Canada-Supermax Medical | 2023-12-05 |
| SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE Putty (K233490) | Bioventus, LLC | 2023-12-05 |
| Optina-4C (MHRC-C1N) (K231230) | Optina Diagnostics, Inc. | 2023-12-05 |
| Electronic Blood Pressure Monitor, model: HTD6602US (K223170) | Hetaida Technology Co., Ltd. | 2023-12-05 |
| Disposable Endoscopic Bipolar (K231615) | Jiangsu Hope Biomedical Science & Technology Co., Ltd. | 2023-12-05 |
| Liberty SI Lateral Implant System (K231923) | Spinal Simplicity, LLC | 2023-12-05 |
| Multispectral Imager Kit (MSI Kit) (300-00015), Multispectral Imager (MSI) (300-00009) (K230734) | Precision Healing, LLC | 2023-12-05 |
| cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System (K223783) | Roche Molecular Systems, Inc. | 2023-12-04 |
| Monarch Blood Collection Set (K232308) | The Monarch Company | 2023-12-04 |
| Intense Pulse Light Therapeutic Apparatus (K232932) | Shenzhen Greatro Electronic Technology Co., Ltd. | 2023-12-04 |
| Medical Disposable Sterile Needle Electrode (K232581) | Suzhou Haishen Medical Device Associates Co., Ltd. | 2023-12-04 |
| Sonu (DEN230045) | Sound Health Systems, Inc. | 2023-12-04 |
| arcad® 2.0 Duo & Quadro osteosynthesis compressive staples (K230724) | Novastep | 2023-12-04 |
| RESPONDER Polysaccharide Hemostat (K220525) | Starch Medical, Inc. | 2023-12-04 |
| Access hsTnI (K230648) | Beckman Coulter, Inc. | 2023-12-04 |
| Verruca-Freeze® H (K233347) | Cryosurgery, Inc. | 2023-12-04 |
| Maxtec MaxBlend2+p (K231895) | Maxtec, LLC | 2023-12-04 |
| Tyber Medical Distal Radius Plating System (K232693) | Tyber Medical, LLC | 2023-12-04 |
| Cosine-10TM Diagnostic Catheter (K233397) | Medtronic, Inc. | 2023-12-02 |
| Align Cervical Interbody Fusion System (K230639) | Acuity Surgical Devices, LLC | 2023-12-01 |
| PENTAX Medical Gas/Water Feeding Valve OE-B14 (K232249) | Pentax of America, Inc. | 2023-12-01 |
| Woo More Play Coconut Love Oil (K232093) | Woo Essentials, Inc. | 2023-12-01 |
| CATHTONG III Tapered PICC Catheter (K233149) | L&Z Us, Inc. | 2023-12-01 |
| AlignerFlow LC (K231817) | Voco GmbH | 2023-12-01 |
| Vial2Bag Advanced® 13mm Admixture Device (K230988) | West Pharma. Services IL, Ltd. | 2023-12-01 |
| Slinky Catheter (K231179) | Anoxia Medical, Inc. | 2023-12-01 |
| Syngo Carbon Clinicals (K232856) | Siemens Healthcare GmbH | 2023-12-01 |
| Single Platform SP1 Implant System (K232418) | Southern Implants (Pty), Ltd. | 2023-12-01 |
| Intense pulsed light therapy device (K232708) | Hebei Zhemai Technology Co., Ltd. | 2023-12-01 |