| K241842 — Luer-Split MAJ-2092 | Olympus Medical Systems Corporation Wed Mar 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250210 — Broncho Videoscope System (Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P); Full HD Visualization Endoscopic Image Processor (HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D); Endoscopic Image Processor (HDVS-S100A, HDVS-S100D)) | Scivita Medical Technology Co., Ltd. Wed Mar 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243443 — EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343NP; EXPD 3643N1; EXPD 3643N; EXPD 3643U1; EXPD 3643NU; EXPD 3643NP | DRTECH Corporation Wed Mar 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243472 — 1NEED Pro | Campomats S.R.L. Wed Mar 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250171 — IPL Hair Removal Device (BE965A, BE965B, BE965C) | Shenzhen Yang WO Electronic Co., Ltd. Wed Mar 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250429 — DSPS-Prominent® baseplate, MR (113820); DSPS-Prominent® baseplate (113120); DSPS-Prominent® Cradle-I (113140); DSPS-Prominent® Cradle-II (113150); DSPS-Prominent® Cradle-III (113160); DSPS-Prominent® Cradle-IV (113170); DSPS-Prominent® Cradle-VI (113180); DSPS-Prominent® Cradle-VII (113260); Mask DSPS®-PROSCVRL set/5 (113760); Mask DSPS®-PROSC set/5 (113770); Mask DSPS®-PROSCVR set/5 (113780); Mask DSPS®-PROSCL set/5 (113790); Mask DSPS®-PROSHVRL set/5 (113890); Mask DSPS®-PROSH set | Macromedics BV Wed Mar 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250131 — IPL Hair Removal Device (M8011, M8012, M8013, M8015, M8021, M8022, M8023, M8025, M7011, M7012, M7021, M7023) | Mustech Electronics Co., Limited Wed Mar 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241729 — Hard Splint & Thermo-Adaptive Splint | Whip Mix Corporation Tue Mar 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250494 — The OsteoCentric Bone Plate and Screw System | OsteoCentric Technologies Tue Mar 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| 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. Tue Mar 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250413 — Aglaia LED Beauty Device (BP-D2309) | Shenzhen Perfect Idea Technology Limited Tue Mar 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243807 — Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432P | Olympus Medical Systems Corp. Tue Mar 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240933 — CarbonCool® System | Global Healthcare SG Sdn. Bhd Tue Mar 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242683 — QP-Prostate® CAD | Quibim S.L. Tue Mar 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242161 — Radlink GPS Pro Imaging | Radlink, Inc. Tue Mar 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241783 — FortiVy OsteoVy Lumbar IBF | Vy Spine, LLC Tue Mar 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243553 — QuikClot Control+ Hemostatic Device | Teleflex Medical Tue Mar 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241937 — Klarity SGRT System (ARSG-E1A, ARSG-E3A) | Klarity Medical & Equipment (GZ) Co., Ltd. Tue Mar 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243556 — Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43) | Iray Imaging Technology (Haining) Limited Tue Mar 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240287 — LYHER® Oral fluid Multi-Drug Test Kit (Cube) | Hangzhou Laihe Biotech Co., Ltd. Tue Mar 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243802 — aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar interbody fusion device with interfixation | Carlsmed, Inc. Mon Mar 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243862 — LVivo Software Application | Dia Imaging Analysis, Ltd. Mon Mar 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K244056 — DOC Band 3D | Cranial Technologies, Inc. Mon Mar 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250498 — BPS Wrist Fracture System | Orthonovis, Inc. Mon Mar 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243867 — LAGIS Suction Irrigation System | Lagis Enterprise Co., Ltd. Mon Mar 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243504 — MAIA (AHMACME001) | Centervue S.P.A. Mon Mar 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241975 — SERV MEDICAL CDSS | Serv Medical Pte., Ltd. Mon Mar 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250514 — UPT Series Medical RO Water Treatment System | Specialty Water Technologies, Inc. Mon Mar 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250379 — SIGNA Prime Elite | Ge Medical Systems, LLC Mon Mar 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243646 — Ziehm Solo FD | Ziehm Imaging GmbH Mon Mar 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| 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 Mon Mar 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242140 — Air Compression Leg Massager (K-705) | Jiale Health Technology Shenzhen Co., Ltd. Mon Mar 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| 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 Sun Mar 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242244 — Viewer+ | Lumea, Inc. Fri Mar 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243529 — Solution Administration Sets | Baxter Healthcare Corporation Fri Mar 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243332 — Promisemed Safety Huber Needles | Promisemed Hangzhou Meditech Co., Ltd. Fri Mar 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| 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 Fri Mar 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241960 — DeepRESP | Nox Medical Ehf Fri Mar 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250526 — Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture Anchor | Arthrex, Inc. Fri Mar 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250025 — Porcelain Powder (Enamel/ Modifier,Stain/Glaze,Stain/Glaze-A,Modeling Fluid ) | Aidite (Qinhuangdao) Technology Co., Ltd. Fri Mar 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242121 — mBôs (Monogram mBôs TKA System) | Monogram Orthopaedics, Inc. Fri Mar 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241765 — PLANET Onco Dose (3.2) | Dosisoft SA Fri Mar 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243838 — NEXXT MATRIXX® SI System | Nexxt Spine Fri Mar 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250401 — AION TempShield | Aion Biosystems, Inc. Fri Mar 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243353 — One-Fil Putty | Mediclus Co., Ltd. Fri Mar 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243599 — Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00818) | Arrow International, LLC (A subsidiary of Teleflex, Inc.) Fri Mar 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234012 — VITEK COMPACT PRO | bioMerieux, Inc. Fri Mar 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242323 — Maestro System (REF100) | Moon Surgical Fri Mar 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250079 — Ruby XL System | Penumbra, Inc. Fri Mar 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250091 — KOROT Blood Pressure Monitor (KOROT P3 Accurate) | Korot Co., Ltd. Fri Mar 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |