| K232578 — VASSALLO GT 018 G12; VASSALLO GT 018 G30 | Filmec Co. , Ltd. Wed Oct 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232981 — Synq Software Version 1.3 | Synaptive Medical, Inc. Wed Oct 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223126 — SurgiAid® Collagen Wound Dressing | Maxigen Biotech, Inc. Wed Oct 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232090 — JO Coconut Hybrid Warming Personal Lubricant | CC Wellness, LLC Wed Oct 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232344 — Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR | GE Medical Systems SCS Wed Oct 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230148 — Vlab | Dormotech Medical, Ltd. Wed Oct 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230897 — Anterion | Heidelberg Engineering GmbH Wed Oct 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232775 — ID NOW Influenza A & B 2 | Abbott Diagnostics Scarborough, Inc. Tue Oct 10 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230961 — Zeus Spinal System | Shanghai Sanyou Medical Co, Ltd. Tue Oct 10 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231413 — IPD Dental Implant Abutments | Implant Protesis Dental 2004, S.L. Tue Oct 10 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232471 — Vy Spine VyLam Laminoplasty System | Vy Spine, LLC Tue Oct 10 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230916 — WeSensor | Picopack, Inc. Tue Oct 10 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231658 — VEOS Spinal Fixation System | Spineway Tue Oct 10 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230130 — Micromate Navi+ | Isys Medizintechnik GmbH Tue Oct 10 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223027 — NeuroTrigger Basic (NTB) | Neurotrigger Tue Oct 10 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232341 — CarboClear® Pedicle Screw System | CarboFix Orthopedics , Ltd. Tue Oct 10 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223905 — Vivio® LVEDP System | Avicena, LLC Fri Oct 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230265 — MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System | Infobionic, Inc. Fri Oct 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232411 — JuggerKnot Soft Anchor OC | Riverpoint Medical, LLC Fri Oct 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN220087 — Edison System | HistoSonics, Inc. Fri Oct 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232407 — Cautery Protective Actuation System (CPAS) | Safer Surgeries Medical Devices, LLC Fri Oct 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232492 — 2.7 mm GRYPHON Flex Knotless PEEK Anchor; 2.7 mm GRYPHON Flex Knotless Biocomposite Anchor | Medos International SARL Fri Oct 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230853 — EARP Nerve Cuff Electrode | Nvision Biomedical Technologies, Inc. Fri Oct 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232044 — Invictus Robotic Navigation Instruments | Alphatec Spine, Inc. Fri Oct 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232760 — Swoop® Portable MR Imaging System® | Hyperfine, Inc. Fri Oct 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223802 — accufit | Mettler Electronics Corporation Fri Oct 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232755 — Arthrex FiberTape and TigerTape Cerclage Sutures | Arthrex, Inc. Fri Oct 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232276 — Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg) SUD20 | Oxoid Limited (Part of Thermo Fisher Scientific) Fri Oct 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232480 — ProtekDuo Veno-Venous Cannula Sets | Cardiacassist, Inc. Fri Oct 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230091 — THE Cover | Purgo Biologics, Inc. Fri Oct 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232787 — ScanNav Anatomy Peripheral Nerve Block | Intelligent Ultrasound Limited Fri Oct 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231863 — ProBeam 360° Proton Therapy System v2.0 (Multiroom) | Varian Medical Systems, Inc. Fri Oct 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232173 — Ascend VBR System, Ascend NanoTec VBR System | Alphatec Spine, Inc. Fri Oct 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231603 — Standard Staple-Line Reinforcement (SSLR23) | Standard Bariatrics, Inc. Fri Oct 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232055 — Vial Adapter | Shanghai Lingfu Technology Co., Ltd. Fri Oct 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230777 — Patient Examination Gloves | 3A Glove Sdn. Bhd. Fri Oct 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223926 — VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box | Medimaging Integrated Solution, Inc (Miis) Fri Oct 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K221777 — Disposable Sterile Syringe | Weihai Shengjie Medical Technology Co., Ltd. Fri Oct 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231300 — Nutricair Enteral Syringe with ENFit | Cair Lgl Fri Oct 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230144 — Denti.AI Detect | Denti.Ai Technology, Inc. Fri Oct 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232056 — IPL Hair Removal Device, Model(s): PB1, PB2, PB3, PB4, TM002 | Dongguan Lide Electric Appliance Co., Ltd. Fri Oct 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232046 — Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection | Xeridiem Medical Devices, A Spectrum Plastics Group Company Fri Oct 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K220451 — Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT | Randox Laboratories Limited Thu Oct 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232279 — LifeStyles NRL Textured Condom | Suretex Limited Thu Oct 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232395 — ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD | Biomérieux Thu Oct 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223740 — Oxygen Concentrator (Model: KSW-5, KSN-5, KSOC-5) | Jiangsu Konsung Bio-Medical Science and Technology Co., Ltd. Thu Oct 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232367 — cmAngio® V1.0 | Curemetrix, Inc. Thu Oct 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233044 — Tandem Mobi insulin pump with interoperable technology | Tandem Diabetes Care, Inc. Thu Oct 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231001 — DeepTek CXR Analyzer v1.0 | Deeptek Medical Imaging Pvt, Ltd. Thu Oct 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230780 — MFG-05 | Zimmer Medizinsysteme GmbH Thu Oct 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |