| K242241 — Sunny | ShenB Co., Ltd. Mar 19, 2025 |
| K243443 — EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343NP; EXPD 3643N1; EXPD 3643N; EXPD 3643U1; EXPD 3643NU; EXPD 3643NP | DRTECH Corporation Mar 19, 2025 |
| K242486 — Tyber Medical Anatomical Plating System | Tyber Medical, LLC Mar 19, 2025 |
| DEN240018 — CORIS System | Nanosonics Limited Mar 19, 2025 |
| K243689 — AVIEW | Coreline Soft Co., Ltd. Mar 19, 2025 |
| K250042 — PeekMed web | Peek Health, S.A. Mar 19, 2025 |
| K242533 — Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Better Care Plastic Technology Co., Ltd. Mar 18, 2025 |
| K243556 — Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43) | Iray Imaging Technology (Haining) Limited Mar 18, 2025 |
| K243807 — Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432P | Olympus Medical Systems Corp. Mar 18, 2025 |
| K250413 — Aglaia LED Beauty Device (BP-D2309) | Shenzhen Perfect Idea Technology Limited Mar 18, 2025 |
| K242683 — QP-Prostate® CAD | Quibim S.L. Mar 18, 2025 |
| K243553 — QuikClot Control+ Hemostatic Device | Teleflex Medical Mar 18, 2025 |
| K240933 — CarbonCool® System | Global Healthcare SG Sdn. Bhd Mar 18, 2025 |
| K240287 — LYHER® Oral fluid Multi-Drug Test Kit (Cube) | Hangzhou Laihe Biotech Co., Ltd. Mar 18, 2025 |
| K242161 — Radlink GPS Pro Imaging | Radlink, Inc. Mar 18, 2025 |
| K241783 — FortiVy OsteoVy Lumbar IBF | Vy Spine, LLC Mar 18, 2025 |
| K241729 — Hard Splint & Thermo-Adaptive Splint | Whip Mix Corporation Mar 18, 2025 |
| K241937 — Klarity SGRT System (ARSG-E1A, ARSG-E3A) | Klarity Medical & Equipment (GZ) Co., Ltd. Mar 18, 2025 |
| K250494 — The OsteoCentric Bone Plate and Screw System | OsteoCentric Technologies Mar 18, 2025 |
| K250514 — UPT Series Medical RO Water Treatment System | Specialty Water Technologies, Inc. Mar 17, 2025 |
| K250498 — BPS Wrist Fracture System | Orthonovis, Inc. Mar 17, 2025 |
| K243802 — aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar interbody fusion device with interfixation | Carlsmed, Inc. Mar 17, 2025 |
| K244056 — DOC Band 3D | Cranial Technologies, Inc. Mar 17, 2025 |
| K242140 — Air Compression Leg Massager (K-705) | Jiale Health Technology Shenzhen Co., Ltd. Mar 17, 2025 |
| K241975 — SERV MEDICAL CDSS | Serv Medical Pte., Ltd. Mar 17, 2025 |
| K243862 — LVivo Software Application | Dia Imaging Analysis, Ltd. Mar 17, 2025 |
| K243869 — Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0 TMS Therapy System (Horizon 3.0 with StimGuide Pro); Horizon® 3.0 TMS Therapy System (Horizon 3.0) | The Magstim Company Limited Mar 17, 2025 |
| K243646 — Ziehm Solo FD | Ziehm Imaging GmbH Mar 17, 2025 |
| K243504 — MAIA (AHMACME001) | Centervue S.P.A. Mar 17, 2025 |
| K250379 — SIGNA Prime Elite | Ge Medical Systems, LLC Mar 17, 2025 |
| K243867 — LAGIS Suction Irrigation System | Lagis Enterprise Co., Ltd. Mar 17, 2025 |
| K250439 — Catapult Guide Sheath; 4F; 15cm (US-34015-F-ST-H); Catapult Guide Sheath; 4F; 45cm (US-34045-F-ST-H); Catapult Guide Sheath; 4F; 60cm (US-34060-F-ST-H); Catapult Guide Sheath; 4F; 90cm (US-34090-F-ST-H); Catapult Guide Sheath; 4F; 130cm (US-34130-F-ST-H); Catapult Guide Sheath; 5F; 15cm (US-35015-F-ST-H); Catapult Guide Sheath; 5F; 45cm (US-35045-F-ST-H); Catapult Guide Sheath; 5F; 45cm; Hockey Stick (US-35045-F-HS-H); Catapult Guide Sheath; 5F; 45cm; Multipurpose (US-35045-F-MP-H); Ca | Contract Medical International, GmbH Mar 16, 2025 |
| K243931 — CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A Subtyping Kit (VER 4); Influenza B Lineage Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4) | Centers For Disease Control And Prevention Mar 14, 2025 |
| K242811 — BodyTom 64 | Neurologica Corporation, A Subsidiary Of Samsung Mar 14, 2025 |
| K242323 — Maestro System (REF100) | Moon Surgical Mar 14, 2025 |
| K242244 — Viewer+ | Lumea, Inc. Mar 14, 2025 |
| K241765 — PLANET Onco Dose (3.2) | Dosisoft SA Mar 14, 2025 |
| K241960 — DeepRESP | Nox Medical Ehf Mar 14, 2025 |
| K243529 — Solution Administration Sets | Baxter Healthcare Corporation Mar 14, 2025 |
| K243353 — One-Fil Putty | Mediclus Co., Ltd. Mar 14, 2025 |
| K250401 — AION TempShield | Aion Biosystems, Inc. Mar 14, 2025 |
| K250091 — KOROT Blood Pressure Monitor (KOROT P3 Accurate) | Korot Co., Ltd. Mar 14, 2025 |
| K242121 — mBôs (Monogram mBôs TKA System) | Monogram Orthopaedics, Inc. Mar 14, 2025 |
| K234012 — VITEK COMPACT PRO | bioMerieux, Inc. Mar 14, 2025 |
| K241816 — VerteGlide Spinal Growth Guidance System | OrthoPediatrics Corp. Mar 14, 2025 |
| K250267 — Visalys® Bulk Fill 1 x 4 g Syringe (15060); Visalys® Bulk Fill 15 x 0.25 g Caps (15062); Visalys® Bulk Flow 1 x 2 g Syringe (15064); Visalys® Bulk Flow 15 x 0.25 g Caps (15066); Visalys® Bulk Flow Intro pack (15067); Visalys® Bulk Intro pack (15068) | Kettenbach GmbH & Co. KG Mar 14, 2025 |
| K242010 — Bronchoscope System, The Single-use Bronchoscope (Single-use Bronchoscope: SP-Y-ZQGJ2.8, SP-Y-ZQGJ3.8, SP-Y-ZQGJ4.2, SP-Y-ZQGJ4.8, SP-Y-ZQGJ5.2, SP-Y-ZQGJ5.8; Electronic Endoscope Imaging Processor: SP-TXCLQ12.1) | Shenzhen Sanping Image Technology Co., Ltd. Mar 14, 2025 |
| K250025 — Porcelain Powder (Enamel/ Modifier,Stain/Glaze,Stain/Glaze-A,Modeling Fluid ) | Aidite (Qinhuangdao) Technology Co., Ltd. Mar 14, 2025 |
| K250526 — Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture Anchor | Arthrex, Inc. Mar 14, 2025 |
| K243599 — Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00818) | Arrow International, LLC (A Subsidiary Of Teleflex, Inc.) Mar 14, 2025 |