| K241335 — Eversense 365 Continuous Glucose Monitoring (CGM) System | Senseonics, Incorporated Mon Sep 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241201 — TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite/Anesus TEX20 Pro/Eagus TEX20/Eagus TEX20T/Eagus TEX21/Eagus TEX21T/Eros/TE X Plus/Anesus TEX10 Pro/TEX9U/TEX9M/Eagus TEX11/Eagus TEX11T/EagusTEX10/Eagus TEX10T/Eagus TEX/Ares Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Mon Sep 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241379 — Powered Wheelchair (NXN20-205, NXN20-205M) | Zhejiang Nysin Medical Co., Ltd. Mon Sep 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241156 — Medline ReNewal Reprocessed St. Jude Medical Response Electrophysiology Catheter, Supreme Electrophysiology Catheter (401150, 401206, 401207, 401210, 401211, 401212, 401222, 401223, 401226, 401227, 401228, 401260, 401261, 401271, 401305, 401306, 401309, 401310, 401311, 401312, 401317, 401353, 401357, 401381, 401392, 401399, 401400, 401425, 401430, 401433, 401434, 401435, 401436, 401438, 401441, 401442, 401443, 401444, 401445, 401448, 401449, 401450, 401451, 401453, 401466, 401468, 401 | Surgical Instrument Service and Savings, Inc. Sat Sep 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240977 — DenQ Sub SLA Implant System | Denq Fri Sep 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240188 — Vitruvian Liposaber | Black & Black Surgical, Inc. Fri Sep 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240176 — V-VITFREEZE and V-VITWARM | Vitromed GmbH Fri Sep 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240544 — Epitomee | Epitomee Medical , Ltd. Fri Sep 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233399 — Microdacyn Wound Care Solution | Sonoma Pharmaceuticals, Inc. Fri Sep 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241722 — Elos Accurate® Hybrid Base; Elos Accurate® Customized Abutment | Elos Medtech Pinol A/S Fri Sep 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240929 — Sleep Apnea Notification Feature (SANF) | Apple, Inc. Fri Sep 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241875 — TheRay Collared and Collarless Femoral Stem | Nextstep Arthropedix Fri Sep 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242441 — Revian Lyte (10011) | Revian, Inc. Fri Sep 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240087 — RT Carbon ECG Leads | Ivy Biomedical Systems, Inc. Fri Sep 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234063 — T2Candida 1.1 Panel | T2biosystems, Inc. Fri Sep 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240232 — EK D3.3 and Ultra Wide Implants | Hiossen, Inc. Fri Sep 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241280 — Constellation (CON-001) | Q Bio, Inc. Thu Sep 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240803 — Surgikor Fixation One, Abutment Blanks and Abutments | Surgikor, LLC Thu Sep 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240880 — VitalFlow Set with Balance Biosurface | Medtronic, Inc. Thu Sep 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241249 — Orthopantomograph OP 3D LX (PAN 3D); Orthopantomograph OP 3D LX (PAN CEPH 3D) | Palodex Group OY Thu Sep 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241493 — Glidewell 3DP Denture Base Resin | Prismatik Dentalcraft, Inc. Thu Sep 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241524 — Elucid PlaqueIQ | Elucid Bioimaging, Inc. Thu Sep 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241695 — Extremity All Suture System | Field Orthopaedics Thu Sep 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240168 — N7-S | Nuga Medical Co., Ltd. Thu Sep 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K220999 — Hipro Glycosylated Hemoglobin (HbA1c) Test System | Shijiazhuang Hipro Biotechnology Co., Ltd. Thu Sep 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240787 — Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool (383119); Selectra Accessory Kit (375518) | Biotronik, Inc. Thu Sep 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241582 — Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800, TUS-AI700) | Canon Medical Systems Corporation Thu Sep 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN230081 — Hearing Aid Feature (HAF) | Apple, Inc. Thu Sep 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242136 — Electric wheelchair (C001) | Zhejiang Hfizer Medical Equipment Co., Ltd. Thu Sep 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242401 — EXULT Knee Replacement System | Corentec Co., Ltd. Thu Sep 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241432 — MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Thu Sep 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233732 — CoolSculpting Elite System | Zeltiq Aesthetics, Inc. (Acquired by Allergan Aesthetics Thu Sep 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240942 — CINA-CSpine | Avicenna.Ai Thu Sep 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231982 — Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2 | Qura S.R.L Thu Sep 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241710 — 3M Attest Super Rapid Readout Biological Indicator 1492V; 3M Attest Auto-reader 490; 3M Attest Auto-reader 490H; 3M Attest Mini Auto-reader 490M | 3M Company Thu Sep 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240683 — Rx Knee System | Signature Orthopaedics Pty, Ltd. Wed Sep 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241745 — Powder Free Nitrile Examination Glove, Non-sterile, Tested for Use with 46 Chemotherapy Drugs, the Opioid Fentanyl citrate, simulated Gastric Acid, Fentanyl in Gastric Acid, the tranquilizer Xylazine, and Xylazine in Fentanyl citrate (Blue) | Ksg Medicare Sdn. Bhd. Wed Sep 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241380 — FETOLY-HEART | Diagnoly Wed Sep 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241010 — HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchors | Depuy Mitek Wed Sep 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241362 — Pounce XL Thrombectomy System (PTS-1011-7F135) | Surmodics,Inc. Wed Sep 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241954 — SonoBlock; SonoBlock II | PAJUNK GmbH Medizintechnologie Wed Sep 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241438 — Signus Tetris St; Signus Tetris R St | Signus Medizintechnik GmbH Wed Sep 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240271 — Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) | Linshom Medical, Inc. Wed Sep 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232559 — C&B NFH Hybrid | Arum Dentistry Co., Ltd. Wed Sep 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241161 — Ultrasound Imaging System (LK128L); Ultrasound Imaging System (LK128LH); Ultrasound Imaging System (LK128C); Ultrasound Imaging System (LK128M); Ultrasound Imaging System (LK128PA); Ultrasound Imaging System (LK128E); Ultrasound Imaging System (LU700C); Ultrasound Imaging System (LU700L); Ultrasound Imaging System (LU710L); Ultrasound Imaging System (LU710LH); Ultrasound Imaging System (LU710C); Ultrasound Imaging System (LU710M); Ultrasound Imaging System (LU710PA); Ultrasound Imaging | Leltek, Inc. Wed Sep 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241004 — Wearable Breast Pump (ABP-1508PRO, ABP-1506, ABP-1306, ABP-1306 PRO, M1, M3, M8, M5, M6, K1, K2, K3, K5, ABP-1306PLUS, ABP-1308, M2) | Huizhou Lvb Maternal and Infant Supplies Co., Ltd. Wed Sep 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240990 — Mobility Scooter | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd Tue Sep 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240094 — LumiNE US; Lumi | Augmedit B.V. Tue Sep 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241609 — Tornier Humeral Reconstruction System (Tornier HRS) | Stryker Corporation (Tornier, Inc.) Tue Sep 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241214 — ProPel SG3 Surgical Gown | Standard Textile Co., Inc. Tue Sep 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |