| K233482 — Equinoxe® Central Screw Baseplate System | Exactech, Inc. Thu Jul 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241060 — HardyDisk AST Cefiderocol 30µg (FDC30) | Hardy Diagnostics Thu Jul 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241240 — Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay | Hologic, Inc. Thu Jul 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240845 — Rayvolve | Azmed Sas Wed Jul 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240609 — S.I.N. Dental Implant System | S.I.N. - Sistema DE Implante Nacional S.A. Wed Jul 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241467 — Stable-C Interbody System | Nexus Spine, LLC Wed Jul 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241121 — MICSI-RMT | Microstructure Imaging, Inc. Wed Jul 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241413 — sagAlign Lumbar Cage System (Various PNs) | Acuity Surgical Devices, LLC Wed Jul 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240705 — Vitrea Software Package, VSTP-002A V2.0 | Canon Medical Systems Corporation Wed Jul 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233904 — ACIST RXi System (016616); ACIST Navvus II Catheter (016675_ | Acist Medical Systems, Inc. Wed Jul 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240503 — Sonata Transcervical Fibroid Ablation System 2.2 | Gynesonics, Inc. Wed Jul 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241081 — 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data System | Topcon Corporation Wed Jul 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241050 — CrossRoads Modular Tray System | Crossroads Extremity Systems Tue Jul 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240272 — Electric Scooter (M2085, S2091) | Guangdong Prestige Technology Co., Ltd. Tue Jul 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241441 — RadiForce RX670; RadiForce RX670-AR | Eizo Corporation Tue Jul 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241056 — Light Cure Adhesive | Sincera Technology (Changchun) Co., Ltd. Tue Jul 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN230061 — allay Nerve Cap | Tulavi Therapeutics Tue Jul 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241740 — Finesse Injectable PTA Balloon Dilatation Catheter | Summa Therapeutics Tue Jul 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240944 — Swoop® Portable MR Imaging® System | Hyperfine, Inc. Tue Jul 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241741 — SAFElife Fentanyl Urine Home Test (Cassette); SAFElife Fentanyl (FTY) Urine Test Cassette; SAFElife T-Dip Fentanyl Urine Home Test (Dip Card); SAFElife T-Dip Fentanyl (FTY) Urine Test Panel | Guangzhou Wondfo Biotech Co., Ltd. Tue Jul 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233778 — Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video Ureteroscope (PU3033H, PU3033AH) | Zhuhai Pusen Medical Technology Co., Ltd. Tue Jul 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN230092 — Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa C. auris Sample Prep Kit (MOL3950, MOL3960, MOL5390) | Diasorin Molecular, LLC Mon Jul 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233458 — CM005 Standard (CM005); CM004 Mini (CM004) | Connexicon Medical , Ltd. Mon Jul 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241739 — Endoscopic Applicator, 41 cm | Micromedics, Inc. Mon Jul 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240616 — FAQ (102) | Foreo, Inc. Mon Jul 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241751 — NeuroLF (Basic); NeuroLF (Pro); NeuroLF (Advanced); NeuroLF Seat | Positrigo AG Mon Jul 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241032 — BellaTek Bars | Biomet 3i, LLC Mon Jul 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233460 — CM00622 LINC Skin Closure System (CM00622 LINC) | Connexicon Medical , Ltd. Mon Jul 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240178 — RFG-01 | Zimmer Medizinsysteme GmbH Mon Jul 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240285 — Huxley SANSA Home Sleep Apnea Test (1000-00) | Huxley Medical Mon Jul 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233449 — Avantik VTM | Hanchang Medic Co., Ltd. (Han Chang Medic) Mon Jul 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241385 — Omnifix Syringe NRFit | B.Braun Medical, Inc. Sat Jul 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240651 — MRI Universal | Stryker Leibinger GmbH & Co KG Fri Jul 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241031 — TMINI Miniature Robotic System (TMINI 1.1) | THINK Surgical, Inc. Fri Jul 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241018 — KLS Martin Orthopedic Implants - MR Conditional | KLS-Martin L.P. Fri Jul 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233457 — RUS | Hutom, Inc. Fri Jul 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240661 — Geistlich Bio-Oss® | Geistlich Pharma AG Fri Jul 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240247 — MoFi Cell Culture Basal Medium | Duogenic Stemcells Corporation Fri Jul 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233644 — Megadyne Patient Return Electrode Pad - Universal Dual (model 0846), Megadyne Patient Return Electrode Pad - Universal Plus (model 0847), Megadyne Patient Return Electrode Pad - Universal Dual Plus (model 0848) | Megadyne Medical Products, Inc. Fri Jul 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241715 — Dental Glass Ceramics Blocks (HT,LT,ST) | Aidite (Qinhuangdao) Technology Co., Ltd. Fri Jul 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241085 — Valleylab FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN VLFT10LSGEN) | Covidien, LLC Fri Jul 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241713 — HiRise (1040-230) | Curvebeam, LLC Fri Jul 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234077 — SPIRA® Anterior Lumbar Spacers | Camber Spine Technologies Fri Jul 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN220042 — Terragene Bionova Photon Biological Indicator (BT225); Terragene Bionova Photon Auto-Reader Incubator (BPH) | Terragene S.A. Fri Jul 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240240 — Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent® GM, Straumann® BLX, Implant Direct® Legacy®, Implant Direct® InterActive®, Implant Direct® RePlant® Implant Systems | Prismatik Dentalcraft, Inc. Fri Jul 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234009 — Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) | Mighty Oak Medical Fri Jul 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241378 — S.I.N. Instrument Kits | S.I.N. - Sistema DE Implante Nacional S.A. Fri Jul 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241500 — Endoscopic Video Image Processor (RP-IPD-V2000EF); Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS) | Guangzhou Red Pine Medical Instrument Co., Ltd. Fri Jul 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232372 — Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME) | Peters Surgical Fri Jul 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241727 — BriefCase-Triage | Aidoc Medical , Ltd. Fri Jul 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |