| K233725 — Spine Navigation System | Medivis, Inc. Jul 26, 2024 |
| K241187 — Alien Aligners | Alien Milling Technologies Jul 26, 2024 |
| K241494 — Pantheon Pedicle Screw and Iliac Bolt Fixation System | Pantheon Spinal Jul 26, 2024 |
| K241078 — Tandem Mobi Insulin Pump with interoperable technology | Tandem Diabetes Care, Inc. Jul 26, 2024 |
| K240169 — Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455) | Bausch And Lomb, Incorporated Jul 26, 2024 |
| K231776 — Cell-Free DNA BCT | Streck, Inc. Jul 26, 2024 |
| K240509 — STAR Apollo Mapping System | Rhythm AI, Ltd. Jul 26, 2024 |
| K241515 — NEXA NPWT System | Nexa Medical Limited Jul 26, 2024 |
| K240401 — ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS-Op5001, EHS-Op6001, EHS-IPS01US) | Origyn Medical Technology (Hangzhou) Co., Ltd. Jul 26, 2024 |
| K233530 — 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) | DRTECH Corporation Jul 26, 2024 |
| K240246 — Accusafe Transseptal Guidewire (GTR31180, GTR31230) | Synaptic Medical Corporation Jul 26, 2024 |
| K241883 — DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs) (3006-00); DORO Sterile Disposable Skull Pins Stainless Steel, Pediatric (36 pcs) (3006-10); DORO Sterile Disposable Skull Pin Titanium, Adult (36 pcs) (3006-20); DORO Sterile Disposable Skull Pin Titanium, Pediatric (36 pcs) (3006-30); DORO Sterile Disposable Skull Pin Stainless Steel, Adult (36 pcs) (3006-50) | Pro Med Instruments GmbH Jul 26, 2024 |
| K241898 — Symbia SPECT and SPECT/CT Systems | Siemens Healthineers Jul 26, 2024 |
| K241845 — Introcan Safety® 2 IV Catheter | B.Braun Medical, Inc. Jul 26, 2024 |
| K233287 — Vent Vial Adapter | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. Jul 26, 2024 |
| K241028 — Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056) | Coloplast Jul 26, 2024 |
| K241800 — Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC) | Siemens Healthcare Diagnostics, Inc. Jul 26, 2024 |
| K220328 — EasyStat 300 | Medica Corporation Jul 26, 2024 |
| K233501 — LARGAN Health AI-Tech Sleep Apnea and Sleep Quality Examination System (ST-SLP03A) | Largan Medical Co., Ltd. Jul 26, 2024 |
| K241864 — Grappler Interference Screw System | Paragon 28, Inc. Jul 25, 2024 |
| K241165 — Atellica® IM High-Sensitivity Troponin I (TnIH) | Siemens Healthcare Diagnostics, Inc. Jul 25, 2024 |
| K241887 — GI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO 4.0 (CPRO40.US); GI Genius Module 300 (GGM300-US); ColonPRO 4.0 (CPRO40S-US) | Cosmo Artificial Intelligence - Ai, Ltd. Jul 25, 2024 |
| K233563 — Navident | Claronav, Inc. Jul 25, 2024 |
| K241171 — Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2 Console; CORE Q Footswitch; PI Drive 2 Motors; Elite Q Attachments and Cutting Accessories | Stryker Leibinger GmbH & Co KG Jul 25, 2024 |
| K240886 — Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System Disposable Procedure Kit (6-pack) (FLT-212); Fluent Pro Fluid Management System Disposable Procedure Kit (1-pack) (FLT-212S); Fluent Pro Fluid Management System Tissue Trap Multipack (10-pack) (FLT-210); Fluent Pro Fluid Management System Waste Bag Multipack (5-pack) (FLT-205) | Hologic, Inc. Jul 25, 2024 |
| K241361 — Arthrex Synergy Vision Endoscopic Imaging System | Arthrex, Inc. Jul 25, 2024 |
| K241063 — s-Clean ScanHealing Abutment | Dentis Co., Ltd. Jul 25, 2024 |
| K233372 — KARL STORZ Fiber Telescopes for Urology | Karl Storz SE & CO. KG Jul 25, 2024 |
| K241203 — PMD Clean Redvolution (4005-moab-NA, 4005-moab-INT, 4005-pepper-NA, 4005-pepper-INT, 4005-cream-NA, 4005-cream-INT, 4005-twilight-NA , 4005-twilight-INT, 4005-grey-NA, 4005-grey- INT) | Dongguan Hunter Electronic Technology Co., Ltd. Jul 25, 2024 |
| K230305 — THE Graft Collagen | Purgo Biologics, Inc. Jul 24, 2024 |
| K233352 — Aptima HCV Quant Dx Assay | Hologic, Inc. Jul 24, 2024 |
| K240044 — CADDIE | Odin Medical Limited Jul 24, 2024 |
| K241789 — Non-Sterile Ultrasound Transmission Gels | Hony Medical Co., Ltd. Jul 24, 2024 |
| K241150 — MISTI Silicone Implant | Keosan Trading Co. Jul 24, 2024 |
| K240780 — InMode RF System | InMode , Ltd. Jul 24, 2024 |
| K241863 — Erisma® Lp Spinal Fixation System; Erisma® LP MIS | Clariance Jul 24, 2024 |
| K241130 — POINT Kinguide Agile Hybrid Navigation System (PSHF01-000) | Point Robotics MedTech, Inc. Jul 24, 2024 |
| K241243 — Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning System (IOPS®) Viewpoint (Double Curve Catheters) | Centerline Biomedical, Inc. Jul 24, 2024 |
| K240714 — Insure® Universal; Insure® Universal Automix | Cosmedent, Inc. Jul 24, 2024 |
| K231251 — FlexWing Anterior Cervical Plate System | Jeil Medical Corporation Jul 24, 2024 |
| K241502 — P-SCOPE | Oui Medical, Inc. Jul 24, 2024 |
| K233865 — X-Smart Pro; X-Smart Pro+ | Dentsply Sirona, Inc. Jul 24, 2024 |
| K240457 — C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System) | Pentax Of America, Inc. Jul 24, 2024 |
| K240431 — ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface | Brainlab AG Jul 24, 2024 |
| K241114 — EzDent-i / E2 / Prora View / Smart M Viewer (v3.5) | Ewoosoft Co., Ltd. Jul 23, 2024 |
| K240756 — AITRICS-VC | Aitrics Co., Ltd. Jul 23, 2024 |
| K240906 — TE Air Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Jul 23, 2024 |
| K241296 — Gaudi Proximal Humerus Plate | Netbiologics, LLC Jul 23, 2024 |
| K241445 — K-Bond Universal | Spident Co., Ltd. Jul 22, 2024 |
| K240339 — Electric Wheelchair (Robooter E60) (BBR-E60-01); Electric Wheelchair (Robooter E60) (BBR-E60-02); Electric Wheelchair (Robooter E60) (BBR-E60-03); Electric Wheelchair (Robooter E60) (BBR-E60-04); Electric Wheelchair (Robooter E60) (BBR-E60-05); Electric Wheelchair (Robooter E60) (BBR-E60-06); Electric Wheelchair (Robooter E60) (BBR-E60-07); Electric Wheelchair (Robooter E60) (BBR-E60-08) | Shanghai Bangbang Robotics Co., Ltd. Jul 22, 2024 |