| K233147 — PiXel8-RF | Rohrer Aesthetics Oct 25, 2023 |
| K233113 — ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L, 7-4B33S, 7-4B33L) | Starmed Co., Ltd. Oct 25, 2023 |
| K221315 — UNIdental Symphony Implant System | Unidental Co., Ltd. Oct 25, 2023 |
| K231069 — PERLA® TL Posterior Thoraco-lumbar Fixation System | Spineart SA Oct 25, 2023 |
| K222997 — VVR Generator system | Starmed Co., Ltd. Oct 25, 2023 |
| K230842 — SignalHF (IM008) | Implicity, Inc. Oct 25, 2023 |
| K233210 — sam CS Long Duration Ultrasound Device | ZetrOZ Systems, LLC Oct 25, 2023 |
| K230511 — K3900 Ultrasound Imaging System | Maui Imaging Oct 25, 2023 |
| K232235 — Magstim®Horizon® 3.0 TMS Therapy System; Horizon® 3.0 System; Horizon® 3.0; Horizon® 3.0 with Navigation; Horizon® 3.0 with StimGuide Pro | The Magstim Company , Ltd. Oct 25, 2023 |
| K232436 — Rapid SDH | Ischemaview, Inc. Oct 25, 2023 |
| K221615 — Newclip Patient-matched instrumentation non sterile PSI | Newclip Technics Oct 25, 2023 |
| K231995 — AcuityUDR | Radmedix, LLC Oct 25, 2023 |
| K231509 — Aco Apache Ultrasound System | Aco Healthcare Co., Ltd. Oct 24, 2023 |
| K232683 — Knotilus+ PEEK Knotless Anchor | Stryker Endoscopy Oct 24, 2023 |
| K232570 — Steerant Super Stiff Guidewire | Medtronic Vascular Oct 24, 2023 |
| K232584 — Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum ST Rx Digital IVUS Catheter | Vein 360, LLC Oct 24, 2023 |
| K233348 — 16 Breast Coil | Philips Medical System Nederlands B.V. Oct 24, 2023 |
| K230472 — Sonopuls 190 | Enraf-Nonius, B.V. Oct 24, 2023 |
| K233185 — MODEL P8400 Controller for C2DXs Hemostatix Thermal Scalpel System | C2Dx, Inc. Oct 24, 2023 |
| K232356 — Laser Cap, Model: Hat-01 | Hubei Yjt Technology Co.,Ltd Oct 24, 2023 |
| K230919 — Acumen IQ finger cuff | Edwards Lifesciences, LLC Oct 24, 2023 |
| K232223 — PlaDuo System | ShenB Co., Ltd. Oct 24, 2023 |
| K232211 — REUNION Sacroiliac Joint Fusion System | Astura Medical Oct 24, 2023 |
| K232086 — spineEOS | Eos Imaging Oct 24, 2023 |
| K232051 — VISULAS green | Carl Zeiss Meditec Oct 24, 2023 |
| K232586 — Rexious Spinal Fixation System, Statera Spinal System, Statera-M Spinal System | K&J Consulting Corp. Oct 24, 2023 |
| K232638 — FilteredFlo Warming Blankets | Iob Medical, Inc. Oct 24, 2023 |
| K232201 — VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus Penicillin (<=0.06 - >=8 µg/mL), VITEK 2 Streptococcus Penicillin | bioMerieux, Inc. Oct 23, 2023 |
| K230893 — Swiss LthoClast Trilogy | E.M.S Electro Medical Systems S.A Oct 23, 2023 |
| K232205 — Vesco Q Enteral Feeding Pump; Vesco Q 500mL Bag Feed Set; Vesco Q 1000mL Bag Feed Set; Vesco Q 40mm Screw Cap Feed Set; Vesco Q ENPlus Feed Set | Vesco Medical, LLC Oct 23, 2023 |
| K230281 — PICOCLAMP | Kono Seisakusho Co., Ltd. Oct 23, 2023 |
| K232143 — Applanation Tonometer HT-5000 | Huvitz Co., Ltd. Oct 23, 2023 |
| K232305 — AI-Rad Companion Brain MR | Siemens Medical Solutions U.S.A. Oct 23, 2023 |
| K231732 — CleanSeal Advanced Bipolar Vessel Sealer Maryland | Conmed Corporation Oct 23, 2023 |
| K233258 — Shadow Knotless All-Suture Anchors | Responsive Arthroscopy, LLC Oct 23, 2023 |
| K231764 — Ultrasound System 1300 | Bk Medical Aps Oct 23, 2023 |
| K232561 — Ripley Spinal Screw System by SAGICO | Sagico VA USA, LLC Oct 23, 2023 |
| K231560 — MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM Prisma fit | Siemens Medical Solutions USA, Inc. Oct 23, 2023 |
| K232091 — JO Coconut Hybrid Cooling Personal Lubricant | CC Wellness, LLC Oct 22, 2023 |
| K231539 — pRESET LITE Thrombectomy Device | Phenox Limited Oct 21, 2023 |
| K232552 — TuxDeluxe (Size 1 6100B, Size 2 6101B) | Tuxedo Imaging, LLC Oct 20, 2023 |
| K231902 — GAMMEX PI Hybrid Micro (340002055); GAMMEX PI Hybrid Micro (340002060); GAMMEX PI Hybrid Micro (340002065); GAMMEX PI Hybrid Micro (340002070); GAMMEX PI Hybrid Micro (340002075); GAMMEX PI Hybrid Micro (340002080); GAMMEX PI Hybrid Micro (340002085); GAMMEX PI Hybrid Micro (340002090) | Ansell Healthcare Oct 20, 2023 |
| K232922 — Pure-Vu EVS System | Motus GI Medical Technologies , Ltd. Oct 20, 2023 |
| K232236 — Echo | Quanta System Spa Oct 20, 2023 |
| K230998 — Digital Wireless Intraoral X-Ray Sensor | Iray Imaging Technology (Haining) Limited Oct 20, 2023 |
| K231809 — Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS Posterior Spinal Fixation System with G21 V-STEADY Bone Cement | Ulrich Medical USA Oct 20, 2023 |
| K223557 — SPECTRALIS HRA+OCT and variants | Heidelberg Engineering GmbH Oct 20, 2023 |
| K230983 — Unicare (K-UNICARE-USA) | Tenscare, Ltd. Oct 20, 2023 |
| K223909 — R2GATE Lite TM | Megagen Implant Co., Ltd. Oct 20, 2023 |
| K231578 — Lucitone Digital Print Denture System | Dentsply Sirona Oct 20, 2023 |