| K230490 — PMD Clean Acne, Model: 4004-CABLUE-NA, 4004-GREY-NA, 4004-YELLOW-NA, 4004-PSTO-NA, 4004-LPUR-NA, 4004-CABLUE-NA-INT, 4004-GREY-INT, 4004-YELLOW-INT, 4004-PSTO-INT, 4004-LPUR-INT | Dongguan Hunter Electronic Technology Co., Ltd. Oct 27, 2023 |
| K231761 — PodSKAN HF Diagnostic X-ray System | Skanray Technologies Limited Oct 27, 2023 |
| K231908 — 45 Micron Polyisoprene Condom | Suretex Limited Oct 27, 2023 |
| K231165 — Shina Syringe; Shina Safety Syringe | Shina Med Corporation Oct 27, 2023 |
| K232667 — OR3O Dual Mobility Liners | Smith & Nephew, Inc. Oct 27, 2023 |
| K232346 — Digital Expert Access with Remote Scanning | GE Healthcare Oct 27, 2023 |
| K233292 — ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress | Inomed Medizintechnik GmbH Oct 27, 2023 |
| K233187 — Celerity Vaporized VH2O2 Process Indicator Adhesive Label (PCC078) | Steris Oct 27, 2023 |
| K232618 — Aurora Surgiscope System | Rebound Therapeutics Corporation Oct 27, 2023 |
| K233318 — AXIOS Stent and Electrocautery-Enhanced Delivery System (6mmx8mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (8mmx8mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (10mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (20mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mmx15mm) | Boston Scientific Corporation Oct 27, 2023 |
| K233234 — PressON Spinal Fixation System | Nexus Spine, LLC Oct 26, 2023 |
| K232500 — Lumify Diagnostic Ultrasound System | Philips Ultrasound Oct 26, 2023 |
| K230559 — Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI® Disposable Humidifier with 6 PSI Pressure Relief Valve (3260) | Medline Industries, Inc. Oct 26, 2023 |
| K233170 — cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP-L); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX-L) | AtriCure, Inc. Oct 26, 2023 |
| K231595 — Electric Breast Pump | Shenzhen Changkun Technology Co., Ltd. Oct 26, 2023 |
| K213473 — Antimicrobial Gelling Fiber Dressing with PHMB | Advanced Medical Solutions, Ltd. Oct 26, 2023 |
| K231579 — MOLLI 2 | Molli Surgical, Inc. Oct 26, 2023 |
| K232271 — SIMDA abutment | Simda Co., Ltd. Oct 26, 2023 |
| K233091 — Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT); Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors (CP22V-VT) | Qura S.R.L Oct 26, 2023 |
| K230320 — NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube | Medtronic Xomed, Inc. Oct 26, 2023 |
| K233223 — OGmend® Implant Enhancement System | Woven Orthopedic Technologies Oct 26, 2023 |
| K230662 — Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, And Select Other Drugs | Zhonghong Pulin Medical Products Co., Ltd. Oct 26, 2023 |
| K231737 — ANAX 5.5 Spinal System | Innosys Co., Ltd. Oct 26, 2023 |
| K231685 — TE Air Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Oct 26, 2023 |
| K233101 — Luja Coude (20108 Male CH18 - large packaging) | Coloplast Corp. Oct 26, 2023 |
| K230500 — Air Compression Therapy Recovery System (model: MF-AWI, MF-AWI.LED.A-801, MF-AWI.LED.B-801, MF-AWI.OLED.A-601, MF-AWI.LED.A-601, MF-AWI.LED.B-601, MF-AWI.OLED.A-401, MF-AWI.LED.A-401, MF-AWI.LED.B-401) | Jiangsu Maxf Electric Appliance Co., Ltd. Oct 26, 2023 |
| K231550 — Sontro® OTC Hearing Aids (AI) | Soundwave Hearing, LLC Oct 26, 2023 |
| K233417 — AllTest Fentanyl Urine Test Cassette | Hangzhou AllTest Biotech Co., Ltd. Oct 26, 2023 |
| K231327 — POWERSEAL Sealer and Divider | Gyrus Acmi, Inc. Oct 25, 2023 |
| K233093 — Balanced Knee® System TriMax PS Plus Tibial Insert | Ortho Development Corporation Oct 25, 2023 |
| K230284 — Penumbra LP Coil System | Penumbra, Inc. Oct 25, 2023 |
| K230645 — BeneHold Surgical Incise Drape with CHG antimicrobial II | Avery Dennison Medical , Ltd. Oct 25, 2023 |
| 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 |