| K250664 — Navigo Workstation 2.3 (FPRMC00039) | UC-CARE , Ltd. Aug 7, 2025 |
| K251667 — LED Light Therapy Mask (M01, M02, M06, M07, M08, M09) | Shenzhen Liyoutong Technology Co., Ltd. Aug 7, 2025 |
| K250622 — Succession AFN System | Ortho Solutions UK , Ltd. Aug 7, 2025 |
| K250309 — BTL-199 | BTL Industries, Inc. Aug 7, 2025 |
| K243021 — Longboard Revision Hip Stem | Signature Orthopaedics Pty, Ltd. Aug 7, 2025 |
| K243765 — LuMon(TM) System | Sentec AG Aug 7, 2025 |
| K251247 — GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit (RFG-X1-220V); GX1 Radiofrequency Generator Kit (RFG-X1-240V); GX1 System Release Rest of World (GX1-SYS-ROW); GX1 Radiofrequency Generator (51779845-01); GX1 Radiofrequency Generator (51779845-02); GX1 Radiofrequency Generator (51779845-03) | Boston Scientific Neuromodulation Corporation Aug 7, 2025 |
| K250569 — Cardiologs Holter Platform | Philips France Commercial Aug 6, 2025 |
| K252326 — InterSpace GV Hip Spacer | Tecres S.P.A. Aug 6, 2025 |
| K251038 — Digital Radiographic Imaging Acquisition Software - DR (RiasDR) | Shen Zhen Cambridge-Hit Co., Ltd. Aug 6, 2025 |
| K251120 — Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP Progress (BP3T01-1B) | Microlife Corporation Aug 6, 2025 |
| K251854 — SteadiSet infusion set | Tandem Diabetes Care Aug 6, 2025 |
| K252239 — InVision 3T Recharge Operating Suite | Imris Imaging, Inc. Aug 6, 2025 |
| K250130 — Viction Disposable Irrigation and suction System (VC-FLA0514; VC-FLA0523; VC-FLA0532; VC-FLB0514; VC-FLB0523; VC-FLB0532; VC-FLC0514; VC-FLC0523; VC-FLC0532; VC-FLD0514; VC-FLD0523; VC-FLD0532) | Hangzhou Viction Medical Technology Co.,Ltd Aug 6, 2025 |
| K251432 — Olo | El.En S.P.A. Aug 6, 2025 |
| K242895 — Aevumed PHANTOM Suture Anchors | Aevumed, Inc. Aug 6, 2025 |
| K250124 — Viction Disposable Irrigation and suction catheter (VC-IRA0532, VC-IRA0523, VC-IRB0532, VC-IRB0523, VC-IRC0532, VC-IRC0523, VC-IRD0532, VC-IRD0532) | Hangzhou Viction Medical Technology Co.,Ltd Aug 6, 2025 |
| K243552 — Codman Libertís 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821761); Codman Libertís 1.9 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821762) | Integra Lifesciences Production Corporation Aug 6, 2025 |
| K252141 — AltiVate Reverse® Glenoid | Encore Medical L.P. Aug 5, 2025 |
| K252113 — PRADO Lumbar Interbody Fusion System | Bethesda Medical Devices Aug 5, 2025 |
| K244016 — iPETcertum (v1.0) | Claritas Healthtech Pte, Ltd. Aug 5, 2025 |
| K250246 — uMR Jupiter | Shanghai United Imaging Healthcare Co., Ltd. Aug 5, 2025 |
| K251411 — Chemfort Female Luer Lock Adaptor | Simplivia Healthcare , Ltd. Aug 5, 2025 |
| K250434 — trophon2 | Nanosonics Aug 5, 2025 |
| K250934 — Respiree Cardio- Respiratory Monitor System | Respiree Pte, Ltd. Aug 5, 2025 |
| K251122 — Terragene® Bionova® BT20 Biological Indicator | Terragene Aug 4, 2025 |
| K251762 — Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG) | Spectrum Medical S.R.L. Aug 4, 2025 |
| K251113 — iHealth Compare Wireless Blood Pressure Monitor(BP-300C);iHealth Compare Pro Wireless Blood Pressure Monitor(BP-300CV);iHealth Compare S Wireless Blood Pressure Monitor(BP-300V);iHealth Wireless Blood Pressure Monitor(BPX1);iHealth Blood Pressure Monitor(KD-595);iHealth Track Pro Connected Blood Pressure Monitor(KN-550LT);Semi Automatic Blood Pressure Monitor(KD-388N);Arm Blood Pressure Monitor(KD-553);Arm Blood Pressure Monitor(KD-557BR);Arm Blood Pressure Monitor(KD-558);Arm Blood Pr | Andon Health Co, Ltd. Aug 4, 2025 |
| K250950 — CUTIVA Topical Skin Adhesive (RM1700); CUTIVA PLUS Skin Closure System (RM1739) | Okapi Medical, LLC Dba Resivant Medical Aug 4, 2025 |
| K251087 — Blood Volume Analyzer (200) | Daxor Corporation Aug 4, 2025 |
| K251223 — HnX-P1, HnX-PB | H&Abyz Co., Ltd. Aug 4, 2025 |
| K243841 — Sparta Infusion Set for Insulin | Deka Research And Development Aug 1, 2025 |
| K250508 — AK 98 Dialysis Machine (955607) | Vantive US Healthcare, LLC Aug 1, 2025 |
| K250790 — INNOVISION-DXII | Dk Medical Systems Co., Ltd. Aug 1, 2025 |
| K251707 — IPL Hair Removal Device (HCT-1208/HCT-1208B/HCT-1208L) | Shenzhen Huachuangtong Industrial Co., Ltd. Aug 1, 2025 |
| K250541 — Self-Forming Magnet (Flexagon Plus OTOLoc) | GI Windows, Inc. Aug 1, 2025 |
| K250941 — Revolution Vibe | Ge Medical Systems, LLC Aug 1, 2025 |
| K250315 — RONAVIS FX (FX-001) | AIRS, Inc. Aug 1, 2025 |
| K243427 — QuickSleeper 5 | Dentalhitec Aug 1, 2025 |
| K250381 — Deepsight NeedleVue LC1 Ultrasound System | DeepSight Technology, Inc. Aug 1, 2025 |
| K243496 — MycoMEIA Aspergillus Assay | Pearl Diagnostics, Inc. Aug 1, 2025 |
| K251252 — NOBILCAM IMPAK Disc | Shandong Huge Dental Material Corporation Aug 1, 2025 |
| K243448 — Equinoxe® Shoulder System | Exactech, Inc. Aug 1, 2025 |
| K251652 — Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, STS-2040-302AA HD-endoscope, STS-2040-302BA HD-endoscope, STS-2040-302BSA HD-endoscope, STS-2040-302ESA HD-endoscope, STS-2040-302CA HD-endoscope, STS-2029-302AA HD-endoscope, STS-2029-302BA HD-endoscope, STS-2040-298DSA-RWF-endoscope, STS-2040-298ASA-RWF-endoscope, STS-2040-300GSA-RWF-endoscope, STS-2040-303CA-RWF-endoscope, STS-2040-280ASA-OLY-endoscope, STS-2040-280ESA-OLY-endoscope, STS-2040-283BSA-OLY-endo | American Medical Endoscopy, Inc. Aug 1, 2025 |
| K250495 — MINI VP1 (PL67_F); MINI VP1 (PL61_F) | Avizor S.A. Aug 1, 2025 |
| K252094 — eZSURE Empty Fluid Container | Epic Medical Pte. , Ltd. Aug 1, 2025 |
| K243462 — Diazyme Colorimetric Lithium Assay | Diazyme Laboratories, Inc. Aug 1, 2025 |
| K243458 — HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001302); HydroPICC 4Fr Single Lumen Marked catheter - Maximal Barrier kit (70001304); HydroPICC 5Fr Dual Lumen Marked catheter, 130 cm guidewire - Basic Kit (70002301); HydroPICC 5Fr Dual Lumen Marked catheter, 70 cm guidewire - Basic Kit (70002302); HydroPICC 5Fr Dual Lumen Marked catheter - Maximal Barrier kit (70002304); Hydr | Access Vascular, Inc. Aug 1, 2025 |
| K243483 — Access hsTnI | Beckman Coulter, Inc. Aug 1, 2025 |
| K250738 — YSIO X.pree | Siemens Medical Solutions Jul 31, 2025 |