| K260189 — MagVenture Accelerated TMS (aTMS) Therapy System | Tonica Elektronik A/S May 22, 2026 |
| K253569 — Atmo Gas Capsule System | Atmo Biosciences, Ltd. May 22, 2026 |
| K261098 — TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN 2012)TetraSens Pediatric (SEN 2013)TetraSensitive (SEN 2016)TetraHub (SEN 2017) | Senzime AB May 22, 2026 |
| K252917 — ATLAAS (Atraumatic Left Atrial Appendage System) (AD) | Genesee Biomedical, Inc. May 22, 2026 |
| K253949 — SonoPort Series Digital Color Doppler Ultrasound System (SonoPort 1, SonoPort 1 Exp, SonoPort 1 Pro, SonoPort 1 Elite, SonoPort 1 Plus, SonoPort 2, SonoPort 2 Exp, SonoPort 2 Pro, SonoPort 2 Elite, SonoPort 2 Plus, SonoPort 3, SonoPort 3 Exp, SonoPort 3 Pro, SonoPort 3 Elite, SonoPort 3 Plus, SonoPort 4, SonoPort 4 Exp, SonoPort 4 Pro, SonoPort 4 Elite, SonoPort 4 Plus, SonoPort 5, SonoPort 5 Exp, SonoPort 5 Pro, SonoPort 5 Elite, SonoPort 5 Plus, SonoPort 6, SonoPort 6 Exp, SonoPort 6 | CHISON Medical Technologies Co., Ltd. May 22, 2026 |
| K260580 — Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS) | Olympus Medical Systems Corp. May 21, 2026 |
| K261315 — Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia Pro.specta VA40 Family | Siemens Medical Solutions USA, Inc. May 21, 2026 |
| K253191 — DCMhotbond zircon | Dental Creativ Management GmbH May 21, 2026 |
| K261325 — Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU) | Shenzhen Ulike Smart Electronics Co., Ltd. May 21, 2026 |
| K253245 — Boston 2910 (Boston 2910) | Boston Aesthetics, Inc. May 21, 2026 |
| K254141 — Manual Wheelchair (DY01903(2)) | Guangdong Dayang Medical Technology Co., Ltd. May 21, 2026 |
| K260618 — Ulthera® System | Ulthera, Inc. May 21, 2026 |
| K260582 — ROSA® Shoulder System | Orthosoft Inc. (D/B/A) Zimmer CAS May 21, 2026 |
| K260234 — MSK Go | Smart Alfa Teknoloji San. Ve Tic. A.S. May 21, 2026 |
| K253720 — uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita Elite, uSONIQUE Grace, uSONIQUE Grace Elite | Wuhan United Imaging Healthcare Co.,Ltd May 21, 2026 |
| K251920 — Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face Mask | Dcstar, Inc. May 21, 2026 |
| K260068 — pjur NATURE Touch, 100 ml | Pjur Group Luxembourg S.A. May 21, 2026 |
| K260066 — PanopticAI Vital Signs (1.6.1-22) | PanopticAI Technologies Limited May 21, 2026 |
| K253112 — Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe) | Hlb Lifescience Co., Ltd. May 21, 2026 |
| K253816 — MuCover (proposed name) Oral Wound Dressing | MoleculeX Co., Ltd. May 21, 2026 |
| K254244 — Wearable Breast Pump (Model S39) | Shenzhen TPH Technology Co., Ltd. May 21, 2026 |
| K252746 — Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL) | Drägerwerk AG Co. Kgaa May 21, 2026 |
| K253956 — ProGrip advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030) | Sofradim Production May 21, 2026 |
| DEN250028 — DeepView AI® System | Spectralmd, Inc. May 21, 2026 |
| K253352 — Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Color Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Color Soft (Hydrophilic) Contact Lenses | Pegavision Corporation May 21, 2026 |
| K260649 — OES ELITE Cystoscope and Accessories; Obturator, 17 Fr. (WA2C17BO); Obturator, 19.8 Fr. (WA2C19BO); Obturator, 21 Fr. (WA2C21BO); Obturator, 21 Fr., for sheath with ramp (WA2C21RO); Obturator, 21 Fr., long (WA2C21LO); Obturator, 21 Fr., for straight sheath (WA2C21SO); Obturator, 22.5 Fr. (WA2C22BO); Obturator, 25 Fr. (WA2C25BO); Obturator, optical, 19.8 Fr. (WA2C19BV); Obturator, optical, 21 Fr. (WA2C21BV); Obturator, optical, 21 Fr., for straight sheath (WA2C21SV); Obturator, optical, | Olympus Winter & Ibe GmbH May 21, 2026 |
| K254131 — BAC | DeepHealth, Inc. May 21, 2026 |
| K261359 — Stelo Glucose Biosensor System | Dexcom, Inc. May 21, 2026 |
| K260962 — Sphincterotome | Taewoong Medical Co., Ltd. May 21, 2026 |
| K261291 — Nisus NPWT Canister 500-mL (CPC-500) | Cork Medical May 21, 2026 |
| K261286 — The Circadia C300 System (C300) | Circadia Health, Inc. May 20, 2026 |
| K252717 — MAASTRO Rectal Applicator Set | Varian Medical Systems May 20, 2026 |
| K253134 — LAGIS Endoscopic Instruments- Scissors (EI-330S EI-330S-T EI-330MS EI-330MS-T) | Lagis Enterprise Co., Ltd. May 20, 2026 |
| K253774 — Elos Accurate® Denture Fixation System | Elos Medtech Pinol A/S May 20, 2026 |
| K260098 — ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C /ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. May 20, 2026 |
| K253570 — Blood Pressure Monitor (W06LT) | Shenzhen Jamr Technology Co., Ltd. May 20, 2026 |
| K260594 — IPL Hair Removal Device (FL-B505AG, FL-B505AP, FL-B505AM, FL-B507AG, FL-B507AP, FL-B507AM, FL-B508AG, FL-B508AP, FL-B508AM, FL-B509AG, FL-B509AP, FL-B509AM, FL-B510G, FL-B510P, FL-B510M, FL-B511G, FL-B511P, FL-B511M, FL-B512AG, FL-B512AP, FL-B512AM, FL-B513AG, FL-B513AP, FL-B513AM) | Shenzhen Xiazhifeng Electronic Co., Ltd. May 20, 2026 |
| K260304 — WAVE PTA Balloon Catheter | WAVE Medical AG May 20, 2026 |
| K253911 — Derma-2 | Neko Health AB May 20, 2026 |
| K260717 — Mobility Scooter (Air Carbon) | Suzhou Sweetrich Vehicle Industry Technology Co., Ltd. May 20, 2026 |
| K252707 — Zenith Aspiration Catheter; Disposable Aspiration Tubing Set | Suzhou Zenith Vascular SciTech Limited May 20, 2026 |
| K253596 — Aquilion ONE (TSX-308A/TSX-306A) V2.0 | Canon Medical Systems Corporation May 20, 2026 |
| K260351 — Numen Helia Coil Embolization System; NumenFR Detachment System | MicroPort NeuroTech (Shanghai) Co., Ltd. May 20, 2026 |
| K252985 — Laport | Sejong Medical Co., Ltd. May 19, 2026 |
| K253722 — LIAISON PLEX Gastrointestinal Flex Assay | Luminex Corporation May 19, 2026 |
| K261299 — Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses | Pegavision Corporation May 19, 2026 |
| K253309 — SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy system family of the Dental diode laser ( ILaser III Pro) | Shenzhen Soga Technology Co., Ltd. May 19, 2026 |
| K260268 — OrthoEasy Pal; OrthoEasy Pal Long Neck | Bernhard Förster GmbH (Bernhard Foerster Ltd.) May 19, 2026 |
| K260146 — FITBONE® TRANSPORT AND LENGTHENING SYSTEM | Orthofix Srl May 19, 2026 |
| K261071 — DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g) | DiaDent Group International May 19, 2026 |