| OneRF Trigeminal Nerve Radiofrequency Probes (K251243) | Neuroone Medical Technologies Corp. | 2025-08-15 |
| MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL) (K250036) | Beckman Coulter, Inc. | 2025-08-15 |
| Atlas Spine Project X Expandable Posterior Lumbar Interbody System (K251969) | Atlas Spine, Inc. | 2025-08-15 |
| Persona Partial Knee (K251834) | Zimmer Biomet | 2025-08-15 |
| PHAROS (K250170) | Brightonix Imaging | 2025-08-15 |
| Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180) (K251972) | Healgen Scientific,, LLC | 2025-08-15 |
| Nerveblox (K250818) | Smart Alfa Teknoloji San. Ve Tic. A.S. | 2025-08-15 |
| VEA Align; spineEOS (K251747) | Eos Imaging | 2025-08-15 |
| CP Relief Wand Rx - TENS/NMES (K252236) | N & C Holdings, LLC | 2025-08-15 |
| FEATHER 01 02 03 04 (Model:01) (K251871) | Heat IN A Click, LLC | 2025-08-15 |
| KLS Martin Ixos System (K250620) | KLS Martin L.P. | 2025-08-15 |
| Dunamis Screw and Suture Locking System (K250867) | Dunamis Medical, LLC | 2025-08-15 |
| Cassette Autoclave (ACA5) (K250164) | Guangzhou Ajax Medical Equipment Co., Ltd. | 2025-08-14 |
| Geistlich Bio-Gide; Geistlich Bio-Gide® Shape; Geistlich Bio-Gide® Compressed; Geistlich Bio-Gide® Forte; Geistlich Bio-Gide® Perio; Geistlich Combi-Kit Collagen®; Geistlich Perio-System Combi Pack (K251062) | Geistlich Pharma AG | 2025-08-14 |
| Stitch Cerclage – Suture Tapes (K243905) | GM Dos Reis Industria e Comercio Ltda. | 2025-08-14 |
| mOm Essential Incubator (ME1) (K243437) | Mom Incubators Limited | 2025-08-14 |
| Reprocessed HARMONIC 700 Shears (HAR723/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 23cm); Reprocessed HARMONIC 700 Shears (HAR736/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 36cm); Reprocessed HARMONIC 700 Shears (HAR745/Reprocessed HARMONIC 700, 5mm Diameter SHears with Advanced Hemostasis x 45cm) (K250898) | Stryker Sustainability Solutions | 2025-08-14 |
| FilmArray GI Control Panel M238 (K251526) | Maine Molecular Quality Controls, Inc. | 2025-08-14 |
| 3nethra neo HD FA; 3nethra neo HD (K243600) | Forus Health Pvt.Ltd | 2025-08-14 |
| BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel Mini (K243544) | Biofire Diagnostics, LLC | 2025-08-14 |
| IPL Hair Removal Device (Model(s): T14B, T16B, T19B, T15B, T17C, T18B, T21A, T21B, T21C, T21D, T22A, T22B, T25B, T25C) (K251176) | Shenzhen Mlay Intelligent Technology Co., , Ltd. | 2025-08-14 |
| WinForth (LM-E470KA) (K250916) | Shenzhen Leaflife Technology Co., Ltd. | 2025-08-14 |
| TRUDERMAL Pro (ZLD-390) (K251012) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2025-08-14 |
| MBT Compass HT CA Software; MBT FAST Shuttle US IVD (K251495) | Bruker Daltonics GmbH & Co. KG | 2025-08-13 |
| Wearable Breast Pump (P9, P10, P16, P20, P21, P22, P23, P25) (K252192) | Huizhou Lvb Maternal and Infant Supplies Co., Ltd. | 2025-08-13 |
| Electrotherapy Electrodes (K250841) | Baisheng Medical Co., Ltd. | 2025-08-13 |
| Unscented menstrual long applicator tampon; Unscented menstrual Compact Applicator Tampon; Unscented menstrual Cardboard Applicator Tampon; Unscented menstrual Digital Tampons (K251033) | Unibeauty (Hubei) Technology Co., Ltd. | 2025-08-13 |
| RelieVRx (Pico G3) (K251519) | Appliedvr | 2025-08-13 |
| S.I.N. Dental Implant System (K251046) | S.I.N. Implant System Ltda | 2025-08-13 |
| Dual Lumen Extended Length Catheter (dELC), 6F, 12cm (320101); Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102) (K252226) | Nuwellis, Inc. | 2025-08-13 |
| Bone Screw (K251569) | Osstem Implant Co., Ltd. | 2025-08-13 |
| T2 Alpha Femur Retrograde Nailing System (K250163) | Stryker GmbH | 2025-08-13 |
| HS Fiber (K252201) | Riverpoint Medical | 2025-08-13 |
| Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-117); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U103-117); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U410-121); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U110-121) (K250931) | Unimed Medical Supplies, Inc. | 2025-08-13 |
| KARL STORZ HOPKINS Telescopes for Urology (K243653) | Karl Storz SE & CO. KG | 2025-08-13 |
| AeroJet Ventilation Catheter (K243579) | Pipeline Medical Products, LLC | 2025-08-13 |
| DOLORCLAST Focused Shock Waves (K243279) | E.M.S Electro Medical Systems S.A | 2025-08-13 |
| 14F Duo-Flow® Side X Side Double Lumen Catheter (K250836) | Medical Components, Inc. | 2025-08-12 |
| CuffGuard (K243562) | Idmed | 2025-08-12 |
| Straumann® RidgeFit Implants (K250294) | Institut Straumann AG | 2025-08-12 |
| HOTWIRE™ System RF Generator and Footswitch (optional accessory) (K252083) | Atraverse Medical, Inc. | 2025-08-12 |
| Eko Foundation Analysis Software with Transformers (EFAST) (K251494) | Eko Health, Inc. | 2025-08-12 |
| Sulopenem SPM 2 µg (K251879) | Liofilchem | 2025-08-12 |
| DS Core Diagnosis (K250755) | Dentsply Sirona, Inc. | 2025-08-12 |
| RW-1 (K232456) | Mediott, Inc. | 2025-08-11 |
| Outlook Surgical Versa One System (8900139) (K241731) | Resnent, LLC | 2025-08-11 |
| UE BRONCHO Single-Use Bronchoscopes (EBS-380C); UE BRONCHO Single-Use Bronchoscopes (EBS-500C); UE BRONCHO Single-Use Bronchoscopes (EBS-600C); UE Display (UE-M10S) (K251823) | Zhejiang UE Medical Corp. | 2025-08-11 |
| UL UHD-Clear View 4K Camera System (UL-3Chip 4K) (K250462) | Univlabs Technologies Private Limited | 2025-08-11 |
| Saige-Dx (K251873) | DeepHealth, Inc. | 2025-08-11 |
| XERF (K251327) | Lutronic Corporation | 2025-08-11 |
| External Fixation Bone Distractor (K251862) | Paragon 28, Inc. | 2025-08-11 |
| OxyMinder Pro (10310) (K251245) | Bio-Med Device, Inc. | 2025-08-11 |
| Identity Revision Humeral Stems (K251098) | Zimmer, Inc. | 2025-08-11 |
| Duoblade Plus SE (DB1EP, DB1EP-T, DB1EP-H, DB1EP-TH); Duoblade Prime (DB1P, DB1P-T, DB1P-H, DB1P-TH) (K252211) | Cnc Technologies | 2025-08-11 |
| MagVenture TMS Therapy System (K251125) | Tonica Elektronik A/S | 2025-08-11 |
| eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03) (K250207) | Anker Innovations Limited | 2025-08-11 |
| Water-based Lubricant (K250142) | Global Protection Corp. | 2025-08-08 |
| BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL) (K251713) | Becton, Dickinson and Company | 2025-08-08 |
| SABER-C System (K250540) | Elevation Spine | 2025-08-08 |
| Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS) (K252176) | Guangzhou Red Pine Medical Instrument Co., Ltd. | 2025-08-08 |
| Aqua Medical RF Vapor Ablation System (K251226) | Aqua Medical, Inc. | 2025-08-08 |
| Coretech Compression System (Coretech RHB3003) (K250817) | Vive Health, LLC | 2025-08-08 |
| Parkell Pit and Fissure Sealant (K243254) | Parkell, Inc. | 2025-08-08 |
| Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology (K243531) | Integra Lifesciences Production Corporation | 2025-08-08 |
| MagVenture TMS Therapy System (K251119) | Tonica Elektronik A/S | 2025-08-08 |
| Diode laser device (BM091) (K251801) | Hebei Newangie Technology Co., Ltd. | 2025-08-08 |
| MICOR 700 with Auto I/A (K243395) | Carl Zeiss Meditec Cataract Technology, Inc. | 2025-08-08 |
| Plain Water-based Lubricant (K243972) | Global Protection Corp. | 2025-08-08 |
| swiftPro System (SWF-SPS); Swift System (SWF-SYS) (K250718) | Emblation Limited | 2025-08-08 |
| OptiVu™ Shoulder (K252170) | Mr Surgical Solutions, LLC | 2025-08-08 |
| SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) (K250472) | Amdt Holdings, Inc. | 2025-08-08 |
| Longboard Revision Hip Stem (K243021) | Signature Orthopaedics Pty, Ltd. | 2025-08-07 |
| LED Light Therapy Mask (M01, M02, M06, M07, M08, M09) (K251667) | Shenzhen Liyoutong Technology Co., Ltd. | 2025-08-07 |
| BTL-199 (K250309) | BTL Industries, Inc. | 2025-08-07 |
| Succession™ AFN System (K250622) | Ortho Solutions UK , Ltd. | 2025-08-07 |
| Navigo Workstation 2.3 (FPRMC00039) (K250664) | UC-CARE , Ltd. | 2025-08-07 |
| UNiD™ Spine Analyzer (K251629) | Medicrea International S.A.S. (Medtronic) | 2025-08-07 |
| LuMon(TM) System (K243765) | Sentec AG | 2025-08-07 |
| 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) (K251247) | Boston Scientific Neuromodulation Corporation | 2025-08-07 |
| InVision™ 3T Recharge Operating Suite (K252239) | Imris Imaging, Inc. | 2025-08-06 |
| Aevumed PHANTOM Suture Anchors (K242895) | Aevumed, Inc. | 2025-08-06 |
| Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP Progress (BP3T01-1B) (K251120) | Microlife Corporation | 2025-08-06 |
| 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) (K243552) | Integra Lifesciences Production Corporation | 2025-08-06 |
| InterSpace GV Hip Spacer (K252326) | Tecres S.P.A. | 2025-08-06 |
| 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) (K250130) | Hangzhou Viction Medical Technology Co.,Ltd | 2025-08-06 |
| SteadiSet infusion set (K251854) | Tandem Diabetes Care | 2025-08-06 |
| Digital Radiographic Imaging Acquisition Software - DR (RiasDR) (K251038) | Shen Zhen Cambridge-Hit Co., Ltd. | 2025-08-06 |
| Cardiologs Holter Platform (K250569) | Philips France Commercial | 2025-08-06 |
| Viction Disposable Irrigation and suction catheter (VC-IRA0532, VC-IRA0523, VC-IRB0532, VC-IRB0523, VC-IRC0532, VC-IRC0523, VC-IRD0532, VC-IRD0532) (K250124) | Hangzhou Viction Medical Technology Co.,Ltd | 2025-08-06 |
| Olo (K251432) | El.En S.P.A. | 2025-08-06 |
| PRADO™ Lumbar Interbody Fusion System (K252113) | Bethesda Medical Devices | 2025-08-05 |
| trophon2 (K250434) | Nanosonics | 2025-08-05 |
| uMR Jupiter (K250246) | Shanghai United Imaging Healthcare Co., Ltd. | 2025-08-05 |
| Chemfort Female Luer Lock Adaptor (K251411) | Simplivia Healthcare , Ltd. | 2025-08-05 |
| AltiVate Reverse® Glenoid (K252141) | Encore Medical L.P. | 2025-08-05 |
| Respiree Cardio- Respiratory Monitor System (K250934) | Respiree Pte, Ltd. | 2025-08-05 |
| iPETcertum (v1.0) (K244016) | Claritas Healthtech Pte, Ltd. | 2025-08-05 |
| HnX-P1, HnX-PB (K251223) | H&abyz Co., Ltd. | 2025-08-04 |
| Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG) (K251762) | Spectrum Medical S.R.L. | 2025-08-04 |
| CUTIVA™ Topical Skin Adhesive (RM1700); CUTIVA™ PLUS Skin Closure System (RM1739) (K250950) | Okapi Medical, LLC Dba Resivant Medical | 2025-08-04 |