| K240863 — Freedom® Total Knee System | Maxx Orthopedics, Inc. Jul 2, 2024 |
| K241574 — iFuse TORQ® Implant System | SI-BONE, Inc. Jul 2, 2024 |
| K232824 — FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White (41802); FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White, Wrap Around Visor (41803); FLUIDSHIELD* 1 Surgical Mask with SO SOFT* Lining, White, (41805) | Owens & Minor (O&M) Halyard, Inc. Jul 2, 2024 |
| K241300 — ViewPoint 6 | Ge Healthcare GmbH Jul 2, 2024 |
| K241330 — Fogarty Fortis Arterial Embolectomy Catheter | Edwards Lifesciences Jul 2, 2024 |
| K233440 — Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341) | Philips Medizin Systeme Boeblingen GmbH Jul 2, 2024 |
| K240707 — Ultrasonic Scaler (WD-JY-B002,WD-JY-W001,WD-JY-R003,WD-JY-G004,WD-JY-B003,WD-JY-C006,WD-JY-M0014, WD-JY-N0015,WD-JY-N0016,WD-JY-N0017,WD-JY-E007, WD-JY-F008,WD-JY-A005,WD-JY-H009,WD-JY-I0011, WD-JY-K0012,WD-JY-K0013,WD-JY-K0014, WD-JY-L0013,WD-JY-L0014,WD-JY-L0015, WD-JY-L0016,WD-JY-L0017) | Shenzhen Micro Electric Intelligence Co., Ltd. Jul 2, 2024 |
| DEN240013 — MagDI System | Gt Metabolic Solutions, Inc. Jul 2, 2024 |
| K241622 — Extended Reservoir; MiniMed Reservoir | Medtronic Minimed Jul 2, 2024 |
| K233477 — Cryo-straw (Type I, Type III); Warming Kit (A-4ML, B-8ML); Vitrification Kit (A-3ML, B-6ML) | Shandong Wego Ruisheng Medical Device Co., Ltd. Jul 1, 2024 |
| K231015 — Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic Catheters | Innovative Health, LLC Jul 1, 2024 |
| K232989 — Pulse Oximeter (AOJ-70A); Pulse Oximeter (AOJ-70B); Pulse Oximeter (AOJ-70C); Pulse Oximeter (AOJ-70D); Pulse Oximeter (AOJ-70E) | Shenzhen AOJ Medical Technology Co., Ltd. Jul 1, 2024 |
| DEN240007 — BioHealx Anal Fistula Device | Signum Surgical Limited Jul 1, 2024 |
| K240353 — Hyper Insight - ICH | Sk, Inc. Jul 1, 2024 |
| K241202 — Electric nasal aspirator (HTD2601US) | Hetaida Technology Co., Ltd. Jul 1, 2024 |
| K241598 — LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard (with pressure monitoring) (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope - Reverse (with pressure monitoring) (M0067940500); LithoVue Elite Single-Use Digital Flexible Ureteroscope Standard (without pressure monitoring) (M0067941000); LithoVue Elite Single-Use Digital Flexible Ureteroscope Reverse (without pressure monitoring) (M0067941500) | Boston Scientific Corporation Jul 1, 2024 |
| K233908 — cNeuro cDAT | Combinostics OY Jul 1, 2024 |
| K240801 — BioSonic US200 Ultrasonic Scaler (60034537) | Dent4You AG Jul 1, 2024 |
| K240477 — Saview SH 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens | St. Shine Optical Co., Ltd. Jul 1, 2024 |
| K232777 — FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender (25868); FLUIDSHIELD* 1 FogFree Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender, Wrap Around Visor (41798) | Owens & Minor (O&M) Halyard, Inc. Jul 1, 2024 |
| K234061 — StarFormer | Fotona D.O.O. Jul 1, 2024 |
| K240536 — Wearable Breast Pump (Model S32) | Shenzhen TPH Technology Co., Ltd. Jul 1, 2024 |
| K240070 — Profound Matrix | Candela Corporation Jul 1, 2024 |
| K240221 — SPECTRALIS HRA+OCT and variants | Heidelberg Engineering GmbH Jul 1, 2024 |
| K240572 — Valleylab SM Smoke Management Pencil with Edge Blade Electrode, 10 (3m) (VSMP10); Valleylab SM Smoke Management Pencil with Edge Blade Electrode, 15 (4.6m) (VSMP15); Valleylab SM Smoke Management Pencil with Edge Blade Electrode, 10 (3m), Non-Sterile Bulk (VSMP10NSB); Valleylab SM Smoke Management Extended Nozzle (for use with 4 (100mm) electrode) (VSMEN4); Valleylab SM Smoke Management Extended Nozzle (for use with 6.5 (165mm) electrode) (VSMEN6) | Covidien, LLC Jul 1, 2024 |
| K241639 — Single-use Video Ureterorenoscope (SVU-220US) | Huger Medical Instrument Co., Ltd. Jul 1, 2024 |
| K232865 — Magseed Pro Magnetic Marker System | Endomagnetics Ltd., Jun 28, 2024 |
| K240320 — Patient Monitor (RespArray) | Edan Instruments, Inc. Jun 28, 2024 |
| K241608 — nordicMEDiVA | Nordicneurolab AS Jun 28, 2024 |
| K240927 — Access Thyroglobulin | Beckman Coulter, Inc. Jun 28, 2024 |
| K241204 — TopCEM-Veneer Light Cure Veneer Cement | Rizhao Huge Biomaterials Company, Ltd. Jun 28, 2024 |
| K241154 — Electric Wheelchair (YFWB-63) | If Health (Xiamen) Intelligent Technology Co.,Ltd Jun 28, 2024 |
| K240164 — NovaLine SP-C35 Transducer Protector (956007) | Bain Medical Equipment (Guangzhou) Co., Ltd. Jun 28, 2024 |
| K241229 — Hello,eyes® BIO Plug | Bio Optics Co., Ltd. Jun 28, 2024 |
| K240215 — BLUE 400; BLUE 400 S | Carl Zeiss Meditec, AG Jun 28, 2024 |
| K233823 — Ultrasonic Fetal Doppler | Shenzhen Jamr Technology Co., Ltd. Jun 28, 2024 |
| K241406 — Lavieen | Wontech Co., Ltd. Jun 28, 2024 |
| K240892 — XSense Cryoablation System with Cryoprobes | IceCure Medical , Ltd. Jun 28, 2024 |
| K233637 — Cordis BRITECROSS Support Catheter | Cordis US Corp Jun 28, 2024 |
| K240893 — ARTFX MEDICAL Cervical PEEK Cages | Artfx Medical Jun 28, 2024 |
| K241540 — NUVISION Ultrasound Catheter; NUVISION NAV Ultrasound Catheter | Biosense Webster, Inc. Jun 28, 2024 |
| K240938 — The Optimotion Blue Plus Knee System | Optimotion Implants, LLC Jun 27, 2024 |
| K233762 — SteroScope® Sterilization Technology System | Ideate Medical, Inc. Jun 27, 2024 |
| K233398 — Faros Surgical System | Oertli Instrumente AG Jun 27, 2024 |
| K241506 — Annabella Double Breast Pump (ADO-US23-1000) | Annabella Tech Jun 27, 2024 |
| K240853 — Pathfinder® CR System | Neptune Medical, Inc. Jun 27, 2024 |
| K241542 — 3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD) | 3M Company Jun 27, 2024 |
| K241520 — Mojo 2 Full Face Non-Vented Mask; Mojo 2 Full Face AAV Non-Vented Mask; Veraseal 3 Full Face Non-Vented Mask; Veraseal 3 Full Face AAV Non-Vented Mask | Sleepnet Corporation Jun 27, 2024 |
| K241553 — Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic Coating | Eximo Medical, Ltd. Jun 27, 2024 |
| DEN230055 — FSYX Ocular Pressure Adjusting Pump (FSYX OPAP) System | Balance Ophthalmics, Inc. Jun 27, 2024 |