| K240182 — Access EPO | Beckman Coulter, Inc. Apr 22, 2024 |
| K234068 — ART-Plan (v.2.2.0) | Therapanacea Sas Apr 22, 2024 |
| K233311 — Acumed Wrist Plating System | Acumed, LLC Apr 22, 2024 |
| K232149 — BowTie SI Joint Fusion System | Sail Fusion, LLC Apr 20, 2024 |
| K232566 — NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System; Mariner Pedicle Screw Systems: Mariner Outrigger Revision System; Mariner MIS Pedicle Screw System; Mariner Deformity System; Mariner RDX System | SeaSpine Orthopedics Corporation Apr 19, 2024 |
| K232377 — Healgen Rapid COVID-19 Antigen Test | Healgen Scientific,, LLC Apr 19, 2024 |
| K240508 — Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel) | Laclede, Inc. Apr 19, 2024 |
| K233106 — AccuCath Ace Intravascular Catheter | Bard Access Systems, Inc. (C.R. Bard, Inc.) Apr 19, 2024 |
| K232216 — Hemoblock_S (Prescription); Hemoblock_S (OTC) | Incore Co., Ltd. Apr 19, 2024 |
| K232204 — ReyaGel (RG03 - MTP gel 3mL) | Fettech Apr 19, 2024 |
| K240753 — Miro3D Fibers Wound Matrix | Reprise Biomedical, Inc. Apr 19, 2024 |
| K240378 — FAQ 201, FAQ 202 | Foreo, Inc. Apr 19, 2024 |
| K232962 — Patient Monitor (iX10, iX12, iX15) | Edan Instruments, Inc. Apr 19, 2024 |
| K234073 — ICE Aspiration System | Expanse Medical, Inc. Apr 19, 2024 |
| K234119 — UniSpace® Stand-Alone C Cage | Innosys Co., Ltd. Apr 19, 2024 |
| K230120 — KeYi Total Knee System | Beijing Keyi Medical Device Technology Co., Ltd. Apr 19, 2024 |
| K233373 — Flowflex® Plus COVID-19 Home Test | ACON Laboratories, Inc. Apr 19, 2024 |
| K232105 — APTUS Foot System 2.8-3.5 | Medartis AG Apr 19, 2024 |
| K240534 — Bio-Medicus Life Support Catheter and Introducer | Medtronic, Inc. Apr 19, 2024 |
| K240781 — SKOUT® system | Iterative Scopes, Inc. Apr 19, 2024 |
| K232259 — Patriot-SI Posterior Implant System | Spinal Simplicity, LLC Apr 19, 2024 |
| K240162 — LIFEPAK® 35 AC Power Adapter (41335-000001) | Stryker Physio-Control Apr 19, 2024 |
| K233046 — Electrical Neuromuscular Stimulator, Cure Trio | Oriental Inspiration Limited Apr 19, 2024 |
| K233737 — ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180) | Ulrich GmbH & Co. KG Apr 19, 2024 |
| K234092 — SafeOp 3: Neural Informatix Systeem | Alphatec Spine, Inc. Apr 19, 2024 |
| K232325 — RAYSCAN a-Expert | Ray Co., Ltd. Apr 18, 2024 |
| K233924 — EMBOGUARD Balloon Guide Catheter | Neuravi Limited Apr 18, 2024 |
| K240155 — Cochlear Osia System | Cochlear Americas Apr 18, 2024 |
| K233850 — Difiney Anti Snoring Device | Fissiontech, LLC Apr 18, 2024 |
| K240085 — zLOCK Lumbar Facet Fixation System | Zygofix , Ltd. Apr 18, 2024 |
| K232627 — HotDog Warming Mattress + Return Electrode | Augustine Temperature Management, LLC Apr 18, 2024 |
| K240258 — Disposable Medical Face Mask (M643BE) | Makrite Industries, Inc. Apr 18, 2024 |
| K240046 — Ethylene Oxide Sterilization Supplier Change for MPO Hips | Microport Orthopedics Apr 18, 2024 |
| K234098 — Mobility Scooter (C4+) | Yongkang Yile Vehicle Co., Ltd. Apr 18, 2024 |
| K230233 — Prospera Spectruum Negative Pressure Wound Therapy System | Deroyal Industries, Inc. Apr 18, 2024 |
| K232238 — Goyo Mouthpiece S | Dimedikorea Apr 17, 2024 |
| K240057 — TraumaGuard Intra-abdominal Pressure Sensing System | Sentinel Medical Technologies, LLC Apr 17, 2024 |
| K240484 — MSFX Mikron Cervical Anterior Plate System | Mikron Makina Sanayi VE Ticaret Ltd. Sti. Apr 17, 2024 |
| K233863 — TriMed ASET Foot Plating System (1ST MTP 9-hole Long Plate), TriMed ASET Foot Plating System (1st Met Osteotomy Plate), TriMed ASET Foot Plating System (H-Plate), TriMed ASET Foot Plating System (Talonavicular Plate), TriMed ASET Foot Plating System (Calcaneal Slide Osteotomy Plate), TriMed ASET Foot Plating System (Evans Osteotomy Plate), TriMed ASET Foot Plating System (Medial Column Fusion Plate), TriMed ASET Foot Plating System (Straight Plate), TriMed ASET Foot Plating System (T- | TriMed, Inc. Apr 17, 2024 |
| K240519 — Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens | Innova Vision, Inc. Apr 17, 2024 |
| K240032 — Celerity Chemical Indicator for enspire 3000 CLCSPS | STERIS Corporation Apr 17, 2024 |
| K240039 — Enteral Feeding Sets | Hangzhou Primecare Medical Co., Ltd. Apr 17, 2024 |
| K231646 — Carilex VT¿200-i NX | Carilex Medical, Inc. Apr 17, 2024 |
| K233186 — uOmnispace.MR | Shanghai United Imaging Healthcare Co., Ltd. Apr 17, 2024 |
| K232256 — Alcantara Thoracolumbar Plate System | Camber Spine Technologies, LLC Apr 16, 2024 |
| K240748 — nextaro® v, 20/20 | Sfm Medical Devices GmbH Apr 16, 2024 |
| K233962 — ReBorn (1050nm) | Lightfective , Ltd. Apr 16, 2024 |
| K232202 — Aperio GT 450 DX | Leica Biosystems Imaging, Inc. Apr 16, 2024 |
| K232133 — Co2 Laser System, Models: PureLase And VanLase | Cpmt Laser (Canadian Pioneer Medical Technology Corporation) Apr 16, 2024 |
| K233886 — Ambu® aScope Duodeno 2, Ambu® aBox 2 | Ambu A/S Apr 16, 2024 |