| Omni Legend (K241665) | Ge Medical Systems Israel, Functional Imaging | 2024-08-08 |
| HipXpert and HipInsight System (K233315) | Surgical Planning Associates, Inc. | 2024-08-08 |
| Illusion Aligner Pro: Illusion Aligner FLX (K233356) | Laxmi Dental Export Pvt., Ltd. | 2024-08-08 |
| HALYARD* SMART-FOLD* Sterilization Wrap (H450); HALYARD* SMART-FOLD* Sterilization Wrap (H650) (K240330) | O&M Halyard, Inc. | 2024-08-07 |
| Stellar Imaging System (K241530) | Guangdong Optomedic Technologies, Inc. | 2024-08-07 |
| Ultra RapidWarm™ Blast (K240605) | Vitrolife Sweden AB | 2024-08-07 |
| Electric Wheelchair (JLE-W01A-2023) (K240255) | Zhejiang Jianrui Technology Company Limited | 2024-08-07 |
| ADVIA Centaur EBV-EBNA IgG (K233605) | Biokit, S.A. | 2024-08-07 |
| Liposaver (K212969) | Lhbiomed Co., Ltd. | 2024-08-07 |
| SofWave System (K241685) | Sofwave Medical, Ltd. | 2024-08-07 |
| ADVIA Centaur EBV-VCA IgM (K233606) | Biokit, S.A. | 2024-08-07 |
| SPINEART Navigation Instrument System (K241644) | Spineart SA | 2024-08-07 |
| Sphere-9Dx Diagnostic Catheter (AFR-00009) (K233433) | Medtronic | 2024-08-07 |
| Abiomed 14Fr Low Profile Introducer Kit (K241708) | Abiomed, Inc. | 2024-08-06 |
| Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential (K241528) | Comfort Rubber Gloves Industries Sdn. Bhd. | 2024-08-06 |
| EOSedge (K233920) | Eos Imaging | 2024-08-06 |
| myAblation Guide (VB80A) (K240796) | Siemens Healthcare GmbH | 2024-08-06 |
| Sleepio® (K233577) | Big Health, Inc. | 2024-08-05 |
| PlumeSafe X5 Smoke Management System (K240127) | Conmed Corporation | 2024-08-05 |
| Precision AI Surgical Planning System (PAI-SPS) (K233992) | Precision AI Pty, Ltd. | 2024-08-05 |
| CellFX Percutaneous Electrode System (SYS3000); CellFX Percutaneous Electrode, 13G (CPE013); CellFX Percutaneous Electrode, 18G (CPE018) (K240782) | Pulse Biosciences, Inc. | 2024-08-05 |
| Universal Seal (5-12 mm) (K241360) | Intuitive Surgical, Inc. | 2024-08-05 |
| AI Platform 2.0 (AIP002) (K240953) | Exo Imaging | 2024-08-05 |
| Orthopaedic Surgery Planning Software (AIJOINT) (K233761) | Longwood Valley Medical , Ltd. | 2024-08-05 |
| da Vinci E-200 Electrosurgical Generator (K241635) | Intuitive Surgical | 2024-08-05 |
| Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga (3269.M05-00); Midfield Light Pipe, 27ga (3269.M04-00) (K233653) | Peregrine Surgical, LLC | 2024-08-05 |
| HybridTherm System (K240932) | Erbe Elektromedizin GmbH | 2024-08-05 |
| Fixone Meniscal Repair (K233601) | Aju Pharm Co., Ltd. | 2024-08-02 |
| Cortera™ Spinal Fixation System (K241892) | Xtant Medical Holdings, Inc. | 2024-08-02 |
| MYOTouch Muscle Stimulator (K233098) | Sunmed, LLC | 2024-08-02 |
| Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS) (K241268) | Exceleron Medical | 2024-08-02 |
| Innovita HCG Pregnancy Rapid Combo Test (K241919) | Innovita (Tangshan) Biological Technology Co., Ltd. | 2024-08-02 |
| Medline UNITE® MIS Foot Recon Screw System (K241359) | Medline Industries, LP | 2024-08-02 |
| Thermoforming Sheet Materials (Track A); Thermoforming Sheet Materials (Track B); Thermoforming Sheet Materials (Track E); Thermoforming Sheet Materials (Track Bleach) (K241311) | Bernhard Förster GmbH | 2024-08-02 |
| Moda-flx Hemodialysis System and Cartridge (K233798) | Diality, Inc. | 2024-08-02 |
| Viral Transport Medium (K233534) | Hardy Diagnostics | 2024-08-02 |
| Da Vinci Monopolar and Bipolar Adapters (378896) (K241621) | Intuitive Surgical | 2024-08-02 |
| Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component (K241716) | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2024-08-02 |
| MENTOR™ CPX™4 PLUS Enhance Breast Tissue Expander (K241918) | Mentor Worldwide, LLC | 2024-08-02 |
| Samsung ECG App v 1.3 (ECG) (K240909) | Samsung Electronics Co., Ltd. | 2024-08-02 |
| Diode Laser Hair Removal System (MBT-Diode Laser) (K241642) | Beijing Mega Beauty Technology Co., Ltd. | 2024-08-02 |
| Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS,S,M,L,XL,XXL) (K241970) | Kanglongda Vietnam Protection Technology Company Limited | 2024-08-02 |
| Air compression leg massager (K240981) | Huizhou Xinyi Technology Co., Ltd. | 2024-08-02 |
| Acumen Assisted Fluid Management (AFM) Software Feature (K233984) | Edwards Lifesciences, LLC | 2024-08-02 |
| Disposable Ureteral Guide Sheath (K241181) | Dongguan Zsr Biomedical Technology Company Limited | 2024-08-02 |
| Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101) (K241987) | Guangzhou Red Pine Medical Instrument Co., Ltd. | 2024-08-02 |
| Coronis OneLook (K242008) | Barco N.V. | 2024-08-02 |
| Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MIS (K241564) | Baxter Healthcare Corporation | 2024-08-02 |
| GCI Surgical Gown (K233571) | George Courey, Inc. | 2024-08-02 |
| Bendini Cloud Application (K233706) | Nuvasive | 2024-08-02 |
| CardIQ Suite (K233731) | GE Medical Systems SCS | 2024-08-01 |
| LOOP™ LED Curing Light System (CLK01) (K241238) | Garrison Dental Solutions, LLC | 2024-08-01 |
| Logical Liner; World Liner; World Knee Patella (K241690) | Signature Orthopaedics Pty, Ltd. | 2024-08-01 |
| Rüsch Latex Gold Foley Catheter (K232469) | Teleflexmedical, Inc. | 2024-08-01 |
| 3MP Color LCD Monitor (CL-S301) (K241105) | Jvckenwood Corporation | 2024-08-01 |
| PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor (EPK-i8020c); PENTAX Medical Single Use, Sterile Distal End Cap with Elevator (OE-A63); Gas/Water Feeding Valves (OF-B194 ) (K233942) | Pentax of America, Inc. | 2024-08-01 |
| A Breathing System (ABS) (K233580) | Deepwell Dtx, Inc. | 2024-08-01 |
| DePuy Synthes Retrograde Femoral Nail Advanced System (K233696) | DePuy Synthes | 2024-08-01 |
| EXULT Knee Replacement System (K242046) | Corentec Co., Ltd. | 2024-08-01 |
| AISAP Cardio V1.0 (K234141) | Aisap | 2024-08-01 |
| TLAB® Transvenous Liver Biopsy System (TF-18C) (K241145) | Argon Medical Devices, Inc. | 2024-08-01 |
| Infinity CentralStation Wide (K240312) | Draeger Medical Systems, Inc. | 2024-08-01 |
| Freefix Forearm Plating System (K242055) | Skeletal Dynamics, Inc. | 2024-08-01 |
| ViroZap Indoor Air Purifier, In Duct Model 1008 (K241140) | Applied Photonix, LLC | 2024-08-01 |
| KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278AC2); KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278ACU1) (K241945) | Karl Storz SE & CO. KG | 2024-08-01 |
| TACTIX Vector Syndesmosis System (K240035) | Vilex, LLC | 2024-08-01 |
| PGDx elio plasma focus Dx (DEN230046) | Personal Genome Diagnostics, Inc. | 2024-08-01 |
| Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5) (K240805) | Pelvital USA, Inc. | 2024-08-01 |
| MammoScreen® (3) (K240301) | Therapixel | 2024-08-01 |
| Clear Moves Aligner (K241137) | Clear Moves Aligners | 2024-08-01 |
| CarboClear® X Pedicle Screw System (K233793) | CarboFix Orthopedics , Ltd. | 2024-08-01 |
| Silverlon® Wound Contact, Burn Contact Dressing (K241225) | Argentum Medical, LLC | 2024-07-31 |
| AF531 Oro-Nasal EE Leak 1 Face Mask; AF531 Oro-Nasal EE Leak 2 Face Mask (K233555) | Philips Respironics | 2024-07-31 |
| LW Narrow Implant System (K233808) | Ossvis Co., Ltd. | 2024-07-31 |
| SteriTite rigid reusable sterilization container with MediTray Products (K240898) | Case Medical | 2024-07-31 |
| EARP Nerve Cuff Electrode (K241917) | Retropsoas Technologies, LLC | 2024-07-31 |
| ARCHITECT Active-B12 (Holotranscobalamin) (K233541) | Axis-Shield Diagnostics, Ltd. | 2024-07-31 |
| VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter System (K240578) | B.Braun Medical, Inc. | 2024-07-31 |
| NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule/Tether (NaviCam Xpress Stomach System with NaviCam Capsule/Tether) (K241934) | Anx Robotica Corp | 2024-07-31 |
| ValvuloPro Valvuloplasty Balloon Catheter (K240967) | Dongguan TT Medical, Inc. | 2024-07-31 |
| Activmotion S (K241539) | Newclip Technics | 2024-07-30 |
| SmartShape™ Healing Abutment; Wide Custom Milled Ti-Blank Abutment (K240531) | BioHorizons Implant Systems, Inc. | 2024-07-30 |
| WERAY (K241963) | Picopack Co., Ltd. | 2024-07-30 |
| Calx-O, Calcium Hydroxide Powder, Calahyd RC, CeraSeal B, MTA, Rootfyx, Sealmax R, Sealmax + (K240446) | Shiva Products | 2024-07-30 |
| Nano-Check™ RSV Test (K240280) | Nano-Ditech Corporation | 2024-07-30 |
| BIOCHARGE (K241912) | Nanofiber Solutions, LLC | 2024-07-29 |
| Solar™ Lumbar Interbody Fusion System (K240326) | Degen Medical, Inc. | 2024-07-29 |
| Montage Settable Bone Putty (K242050) | Orthocon, Inc. | 2024-07-29 |
| BioBrace® Reinforced Implant (K241906) | Conmed Corporation | 2024-07-29 |
| ARx® SAI Implant System (K241464) | Life Spine, Inc. | 2024-07-29 |
| AtriClip FLEX-Mini LAA Exclusion System (ACHM) (K234125) | AtriCure, Inc. | 2024-07-29 |
| PowerGlide Pro™ Midline Catheter (K240359) | Becton, Dickinson and Company (Bard Access Systems, Inc.) | 2024-07-29 |
| Medical surgical mask (K233723) | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 2024-07-29 |
| EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19) (K241209) | Cook Ireland, Ltd. | 2024-07-29 |
| Resolv Endoscopic Hemostat System (K234131) | Hemostasis, LLC | 2024-07-26 |
| EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS DEXi-D402S-FRM); EXSYS DEXi (EXSYS DEXi-A402S-FRM); EXSYS DEXi (EXSYS DEXi-D401P-FRM); EXSYS DEXi (EXSYS DEXi-A401P-FRM); EXSYS DEXi (EXSYS DEXi-D402P-FRM); EXSYS DEXi (EXSYS DEXi-A402P-FRM); EXSYS DEXi (EXSYS DEXi-D503T-FRM); EXSYS DEXi (EXSYS DEXi-A503T-FRM) (K233530) | DRTECH Corporation | 2024-07-26 |
| ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS-Op5001, EHS-Op6001, EHS-IPS01US) (K240401) | Origyn Medical Technology (Hangzhou) Co., Ltd. | 2024-07-26 |
| Introcan Safety® 2 IV Catheter (K241845) | B.Braun Medical, Inc. | 2024-07-26 |
| Spine Navigation System (K233725) | Medivis, Inc. | 2024-07-26 |
| Vent Vial Adapter (K233287) | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | 2024-07-26 |