| K230817 — TORPEDO Implant System® | Deltacor GmbH Fri Jan 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231237 — BD Vacutainer® Fluoride Blood Collection Tubes | Becton, Dickinson and Company Fri Jan 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231213 — HKT Anatomical Locking Trauma System | Hankil Tech Medical Co., Ltd. Fri Jan 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231873 — DePuy SUMMIT Porocoat Hip Prosthesis MR Conditional, DePuy SUMMIT DuoFix Hip Prosthesis MR Conditional, DePuy SUMMIT Cemented Hip Prosthesis MR Conditional, DePuy SUMMIT FX Cemented Hip Prosthesis MR Conditional, DePuy SUMMIT Basic Press-Fit Hip Prosthesis MR Conditional | Depuy Ireland UC Fri Jan 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232347 — MagnetOs Granules | Kuros Biosciences B.V Fri Jan 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233436 — IlluminOss Photodynamic Bone Stabilization System | Illuminoss Medical, Inc. Fri Jan 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233461 — Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A) | Hi-Dow International, Inc. Fri Jan 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233728 — SIGNA Champion | Ge Healthcare (Tianjin) Company Limited Fri Jan 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231071 — Mix2Vial® Transfer Device | West Pharma. Services IL, Ltd. Fri Jan 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230133 — Plenity | Gelesis, Inc. Fri Jan 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231192 — RIGHTEST Blood Glucose Monitoring System Max Tel | Bionime Corporation Fri Jan 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN220009 — VerTouch Spinal Imaging Device | Intuitap Medical, Inc. Fri Jan 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232783 — Power wheelchair (Model: JMPW-01W) | Jiangsu Jumao X-Care Medical Equipment Co., Ltd. Fri Jan 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231218 — Distal Access Catheter | Accumedical Beijing , Ltd. Fri Jan 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233736 — LifeSPARC System | Cardiacassist, Inc. Fri Jan 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233142 — EndoSign® Cell collection device (ES-CYT-102) | Cyted Limited Fri Jan 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232466 — Electric Breast Pump, model: YM-8166 | Guangdong Youmeng Electrical Technology Co., Ltd. Fri Jan 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232156 — Rapid ASPECTS (v3) | Ischemaview, Inc. Fri Jan 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230524 — Cold Compression Wrap Pro | Chengdu Cryo-Push Medical Technology Co.,Ltd Fri Jan 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231573 — ThinkQA (Edition 2) | Dosisoft SA Thu Jan 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232860 — PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Bronchoscope EB11-J10, PENTAX Medical Video Bronchoscope EB15-J10, PENTAX Medical Video Bronchoscope EB19-J10U, PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U | Pentax of America, Inc. Thu Jan 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233077 — FlashHeal 2 (FlashHeal 2.0) | Inwound Aps Thu Jan 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233242 — Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2) | Siemens Healthcare Diagnostics, Inc. Thu Jan 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233213 — NxStage PureFlow Solution | Nxstage Medical, Inc. Thu Jan 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234040 — TriMed Threaded Intramedullary Nail System | TriMed, Inc. Thu Jan 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234011 — AMF TT Cones | Lima Corporate S.P.A. Thu Jan 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232698 — NemoScan | Software Nemotec S.L. Thu Jan 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233447 — CeQur Simplicity On-Demand Insulin Delivery System | Cequr SA Thu Jan 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231166 — Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe Electrodes | Zmi Electronics , Ltd. Thu Jan 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233190 — ENFit Adaptor | Jiangsu Caina Medical Co.,Ltd Thu Jan 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233451 — Arthrex Synergy Vision Endoscopic Imaging System | Arthrex, Inc. Thu Jan 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231860 — TDM Screw System | Tdm Co., Ltd. Thu Jan 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234031 — Medline UNITE Ancillary Foot Recon Plating System | Medline Industires, LP Thu Jan 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232373 — Progrip Self-Gripping Polypropylene Mesh | Sofradim Production Thu Jan 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232577 — Radial Compression Device | Ningbo Dizegens Medical Science Co.,Ltd Thu Jan 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233744 — Curiteva Porous PEEK Lumbar Interbody Fusion System | Curiteva, Inc. Thu Jan 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233507 — EVOLUTION® Tibial Cones | Microport Orthopedics, Inc. Thu Jan 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K221866 — S-Plant Dental Implant System | Newton Implant Systems, Inc. Thu Jan 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231405 — Sterile Single Use Electrosurgical Pencil with Non-Coated Electrode, Sterile Single Use Electrosurgical Pencil with Non-Stick Electrode | Jiangsu Rong FU Kang Medical Instruments Co., Ltd. Thu Jan 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231416 — Air Next (NVD-02) | Nuvoair AB Thu Jan 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230592 — LuxCreo Dental Night Guard Resin | LuxCreo, Inc. Thu Jan 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234051 — Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3 | Spinal Simplicity, LLC Thu Jan 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231762 — uEXPLORER | Shanghai United Imaging Healthcare Co., Ltd. Thu Jan 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233680 — Celect Platinum Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-CELECT-PT); Celect Platinum Vena Cava Filter Set for Jugular Vein Approach (IGTCFS-65-1-JUG-CELECT-PT); Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach (IGTCFS-65-1-UNI-CELECT-PT); Günther Tulip Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-TULIP); Günther Tulip Vena Cava Filter Set for Jugular Vein Approach (IGTCFS-65-1-JUG-TULIP); Günther Tulip Vena Cava Filter | William Cook Europe Aps Thu Jan 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233730 — Footprint Mini PK, 3.5mm Suture Anchor | Smith & Nephew Wed Jan 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233445 — Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter | Integra Lifesciences Production Corporation Wed Jan 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233226 — FlexView Diagnostic (v1.1.20) | Radical Imaging, LLC Wed Jan 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233031 — M·Biopsy /SureCore Automatic Disposable Biopsy Needle, M·Biopsy /SureCore Semi-automatic Disposable Biopsy Needle, M·Biopsy /SureAim Coaxial Biopsy Needle | Canyon Medical, Inc. Wed Jan 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234030 — Clear Guide SCENERGY | Clear Guide Medical Wed Jan 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233988 — Cerenovus Large Bore Catheter; Cerenovus Aspiration Tubing Set | Cerenovus, Inc. Wed Jan 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |