| SD TL Implant System (K250280) | Arum Dentistry Co., Ltd. | 2025-07-23 |
| Intermittent pressure compression system (Compression Pump PT1005A; Leg Compression Cuffs; L-1001S, L-1001L, L-1001XL, L-1001XXL, L-1001XXXL) (K242615) | Xiamen Taotao Technology Co., Ltd. | 2025-07-23 |
| Neuro Insight V1.0 (K243681) | Olea Medical S.A.S. | 2025-07-23 |
| Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments) (K251073) | Innovasis, Inc. | 2025-07-23 |
| DESS® Dental Implants (K251280) | Terrats Medical SL | 2025-07-23 |
| Resilience Fully Covered Esophageal Stent System (K251265) | Merit Medical Systems, Inc. | 2025-07-23 |
| Da Vinci Surgical System (IS5000) (K251213) | Intuitive Surgical, Inc. | 2025-07-23 |
| Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter - Pre-curved 230 mm (REF 17500); EmbryoCath Embryo Transfer Catheter - Straight Malleable 180 mm (REF 17501); EmbryoCath Embryo Transfer Catheter - Straight Malleable 230 mm (REF 17502); EmbryoCath Stylet - 180 mm (REF 17510); EmbryoCath Stylet - 230 mm (REF 17511) (K243373) | Vitrolife Sweden AB | 2025-07-23 |
| Clear Miracle (K251616) | Ods Co., Ltd. | 2025-07-22 |
| CardioTag™ (K243566) | Cardiosense, Inc. | 2025-07-22 |
| Disposable Biopsy Needle (K244018) | Zhejiang Curaway Medical Technology Co., Ltd. | 2025-07-22 |
| VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1) (K251505) | Alafair Biosciences | 2025-07-22 |
| Plastic Surgical Kits (K251300) | Dentsply Sirona, Inc. | 2025-07-22 |
| Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle) (K243367) | Minnesota Medical Technologies | 2025-07-22 |
| OTS 25-L (100-5) (K251310) | Ots Medical , Ltd. | 2025-07-22 |
| Granudacyn® Wound Irrigation Solution (K243415) | P.G.F. Industry Solutions GmbH | 2025-07-22 |
| Mobility Scooter (MS160C) (K251638) | Suzhou Master Machinery Manufacturing Co.,Ltd | 2025-07-22 |
| GyriCalc (Version 1.0.0) (K250686) | Neurospectrum Insights Corp. | 2025-07-22 |
| Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR (K250901) | Canon Medical Systems Corporation | 2025-07-22 |
| LymphaTech Mobile 3D Measuring Tool (K251255) | Lymphatech, Inc. | 2025-07-22 |
| Vascular Navigation PAD 2.0; Navigation Software Vascular PAD (K243432) | Brainlab AG | 2025-07-22 |
| Guided DAS Surgical Kit (K243425) | Talladium España, SL | 2025-07-22 |
| Yushan X-Ray Flat Panel Detector (K250211) | Innocare Optoelectronics Corp. | 2025-07-22 |
| microINR System (K251564) | Iline Microsystems, S.L. | 2025-07-21 |
| TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System (K250913) | Jiangsu Tingsn Technology Co., Ltd. | 2025-07-19 |
| SPY Cystoscope/Hysteroscope (K252012) | Stryker Endoscopy | 2025-07-18 |
| HyHub™ and HyHub™ Duo Vial Access Devices (K243404) | Takeda Pharmaceuticals | 2025-07-18 |
| VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1) (K251655) | Alafair Biosciences | 2025-07-18 |
| Arthrex FiberTak Suture Anchor (K251809) | Arthrex, Inc. | 2025-07-18 |
| Z1 Hip System (K251906) | Zimmer, Inc. | 2025-07-18 |
| InstaFAN (K251542) | Onepass Medical , Ltd. | 2025-07-18 |
| MF SC GEN2 Facial Toning System (K252218) | Micro Current Technology, Inc. | 2025-07-18 |
| True Non-Surgical Spinal Decompression System (DRX9000-SL) (K243775) | Excite Medical of Tampa Bay, LLC | 2025-07-18 |
| V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System; V5 Diagnostic Ultrasound System; cV5 Diagnostic Ultrasound System; V4 Diagnostic Ultrasound System; cV4 Diagnostic Ultrasound System (K250999) | Samsung Medison Co., Ltd. | 2025-07-18 |
| HeartFlow Analysis (K250902) | HeartFlow, Inc. | 2025-07-18 |
| Profoject™ Enteral Feeding Syringe (K251585) | CMT Health PTE., Ltd. | 2025-07-18 |
| ELEC ENGINE (Model: ISE-170L) (K231562) | Micro-Nx Co., Ltd. | 2025-07-18 |
| INNOVISION-P5 (K250750) | Dk Medical Systems Co., Ltd. | 2025-07-18 |
| Tomey Cornea/Anterior Segment OCT (CASIA2) (K250553) | Tomey Corporation | 2025-07-18 |
| Baby Gorilla®/Gorilla® Plating System (K250952) | Paragon 28, Inc. | 2025-07-18 |
| MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/mL) (K250084) | Beckman Coulter, Inc. | 2025-07-18 |
| Masimo O3 Regional Oximeter (K243324) | Masimo Corporation | 2025-07-17 |
| MectaLIF 3D Metal (K251016) | Medacta International S.A. | 2025-07-17 |
| uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) (K251839) | Shanghai United Imaging Healthcare Co., Ltd. | 2025-07-17 |
| uMR Ultra (K243547) | Shanghai United Imaging Healthcare Co., Ltd. | 2025-07-17 |
| 0.014” Willow Guidewire (K243756) | Arbor Endovascular, LLC | 2025-07-17 |
| Elecsys Cortisol III (K242505) | Roche Diagnostics | 2025-07-17 |
| HESTIA (K243420) | Genoray Co., Ltd. | 2025-07-17 |
| e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector (K243428) | Dxtx Medical, Inc. | 2025-07-17 |
| DualView Catheter (K250751) | Terumo Corporation | 2025-07-17 |
| Device 300423 Granules (K251556) | Geistlich Pharma AG | 2025-07-17 |
| VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201) (K251175) | Alafair Biosciences | 2025-07-17 |
| K5 Cart, K5 Mount, K5 Swing (K251491) | Osstem Implant Company., Ltd. Chair Business | 2025-07-17 |
| HyperVue™ Software (K251198) | Spectrawave, Inc. | 2025-07-16 |
| ARCHIMEDES Biodegradable Pancreatic Stent (K243412) | Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) | 2025-07-16 |
| Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444) (K250949) | Olympus Medical Systems Corporation | 2025-07-16 |
| da Vinci Surgical System (IS5000) (K251202) | Intuitive Surgical, Inc. | 2025-07-16 |
| Automatic Blood Pressure Monitor (CH-S691L, CH-B607, CH-B606, CH-S692L, CH-S602, CH-W701L, CH-S693L, CH-B601L, CP-B01, CH-S603) (K251102) | Cemho Medical Technology (Guangdong) Co., Ltd. | 2025-07-16 |
| Rapid CTA 360 (K251151) | Ischemaview | 2025-07-16 |
| EchoPAC Software Only / EchoPAC Plug-in (K251342) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2025-07-16 |
| Marigen Wound Extra; Kerecis Silicone; Kerecis Parvus (K251845) | Kerecis Limited | 2025-07-16 |
| StimTrial Neuromodulation System (K243782) | Bioventus, LLC | 2025-07-16 |
| uMR 680 (K243397) | Shanghai United Imaging Healthcare Co., Ltd. | 2025-07-16 |
| Jewel Soft Tissue Reinforcement Device (102-6005) (K242237) | Xiros Limited | 2025-07-15 |
| Thrive 2-in-1 Breast Pump (Model P3) (K250350) | Shenzhen TPH Technology Co., Ltd. | 2025-07-15 |
| Shinetell PlusTM Digital Early Pregnancy Test (K251053) | Hangzhou AllTest Biotech Co., Ltd. | 2025-07-15 |
| Kerecis SurgiBind (50241) (K251844) | Kerecis Limited | 2025-07-15 |
| Disposable Neonatal NIBP Cuff (U1682S-C51N); Disposable Neonatal NIBP Cuff (U1683S-C51N); Disposable Neonatal NIBP Cuff (U1684S-C51N); Disposable Neonatal NIBP Cuff (U1685S-C51N) (K251045) | Unimed Medical Supplies, Inc. | 2025-07-15 |
| IsoSphere (K242818) | Isoaid, LLC | 2025-07-15 |
| Tempus ECG-Low EF (K250119) | Tempus AI, Inc. | 2025-07-15 |
| AV Viewer (K250181) | Philips Medical Systems Nederland B.V. | 2025-07-15 |
| PeekMed web (K251096) | Peek Health, S.A. | 2025-07-14 |
| LUMINOS Q.namix T; LUMINOS Q.namix R (K250660) | Siemens Medical Solutions | 2025-07-14 |
| Materialise TKA Guide System (K251554) | Materialise NV | 2025-07-14 |
| FLOWRUNNER Aspiration System (K251488) | Expanse Medical, Inc. | 2025-07-14 |
| Intense Pulsed Light (IPL) System (T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T002AQ, T002AD, T002AF, T002BQ, T002BD, T002BF, T050KQ, T050KD, T050KF) (K251173) | Shenzhen Fansizhe Science and Technology Co., Ltd. | 2025-07-14 |
| F&P Optiflow Air/Oxygen Flow Source (K243917) | Fisher & Paykel Healthcare, Ltd. | 2025-07-14 |
| Phantom® Hindfoot TTC/TC Nail System (K251850) | Paragon 28, Inc. | 2025-07-14 |
| The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - Screws (K251132) | Acumed, LLC | 2025-07-14 |
| Electronic Sphygmomanometers (ZH-X9, ZH-X12, ZH-X16, ZH-X17, ZH-X18, ZH-X19, ZH-X23, ZH-X24) (K250185) | Jiangxi Aicare Medical Technology Co., Ltd. | 2025-07-14 |
| GECHO (K250120) | Narnar, LLC | 2025-07-14 |
| Leonardo Duster (K250504) | Ceramoptec GmbH | 2025-07-14 |
| CoolTone (K251378) | Zimmer Medizinsysteme GmbH | 2025-07-14 |
| Welch Allyn Connex® 360 (Multiple) (K243598) | Welch Allyn, Inc. | 2025-07-13 |
| NightWatch+ US (K243199) | Livassured BV | 2025-07-12 |
| Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable Fixation System (K251472) | Inion OY | 2025-07-11 |
| KALA Therapy Wand (Model: KALA-03) (K250761) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2025-07-11 |
| Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i, 620i, 630i series enabled to retrofit RFID features); Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-1, SLS XXX, Multiple Models Pending Configuration) (K251352) | Codonics.Incorporated | 2025-07-11 |
| Disposable Trocars (K250820) | Sinolinks Medical Innovation, Inc. | 2025-07-11 |
| TurbAlign (K243655) | Spirair, Inc. | 2025-07-11 |
| Choice 2 DC (K250156) | Bisco, Inc. | 2025-07-11 |
| Achieva; Intera; Ingenia 1.5T; Ingenia 3.0T; Ingenia 1.5T CX; Ingenia 3.0T CX; Ingenia Elition S; Ingenia Elition X; Ingenia Ambition S; Ingenia Ambition X; and MR 5300 MR Systems (K251808) | Philips Medical Systems Nederland B.V. | 2025-07-11 |
| Natural rubber latex male condom (K250034) | Shaoguan Regenex Pharmaceuticals Co., Ltd. | 2025-07-11 |
| B-Scan (K243227) | Accutome, Inc. Doing Business AS Keeler USA | 2025-07-11 |
| ResiCem EX (K251470) | Shofu Dental Corporation | 2025-07-11 |
| Resolve Anterior Cervical Plate System (K251436) | Pioneer Surgical Technology, Inc. | 2025-07-11 |
| FreeStyle Comfort (AS200 / FreeStyle Comfort) (K250671) | Caire, Inc. | 2025-07-11 |
| ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R) (K250762) | Olympus Medical Systems Corporation | 2025-07-11 |
| AviClear Laser System (K251149) | Cutera, Inc. | 2025-07-11 |
| RipCord (K251134) | TriMed, Inc. | 2025-07-11 |