| K251603 — Tigertriever 17 Ultra Revascularization Device | Rapid Medical , Ltd. Mon Oct 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252007 — BlineSlide | Deep Breathe, Inc. Mon Oct 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251565 — Wheelchair (N817) | Zhejiang Topwe Tools Manufacturing Co.,Ltd Mon Oct 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252140 — Heylo System | Coloplast Corp. Mon Oct 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN240073 — PainChek (PainChek Adult) | Painchek Limited (Ltd.) Mon Oct 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250173 — Shiley Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley Nasal RAE Tracheal Tube Cuffless, Murphy Eye (114-XX) Shiley Oral RAE Tracheal Tube Cuffed, Murphy Eye (115-XX) Shiley Oral RAE Tracheal Tube with TaperGuard Cuff, Murphy Eye (115-XXOR) Shiley Nasal RAE Tracheal Tube with TaperGuard Cuff, Murphy Eye (119-XXNR) | Covidien, LLC Mon Oct 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250031 — Amplatzer Guidewire | ABBOTT MEDICAL Fri Oct 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252806 — Flexible Suction Ureterorenoscope (US27G-12-EU, US27G-12-US, US33G-17-EU, US33G-17-US, US38G-20-EU, US38G-20-US.) | Shanghai AnQing Medical Instrument Co., Ltd. Fri Oct 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251468 — Sleeved IC 3 Family Sleeved IC 3 SWT (name not finalized) Sleeved IC 3 Pocket (name not finalized) Sleeved IC 3 Plus (name not finalized) Sleeved IC 3 Plus Pocket (name not finalized) (N/A) | Hollister Incorporated Fri Oct 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN220077 — ProSense System | Icecure Medical Fri Oct 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243968 — Revolve Surgical System | Revolve Surgical, Inc. Fri Oct 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250028 — Anti Snore Mouthpiece | Dongguan Yiyao Science & Technology Development Co., Ltd. Fri Oct 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251426 — da Vinci SP Surgical System (SP1098) | Intuitive Surgical, Inc. Fri Oct 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252517 — Manual Wheelchair (SYIV100A008) | Ningbo Shenyu Medical Equipment Co.,Ltd Fri Oct 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251464 — TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit) | Jeisys Medical Incorporated Fri Oct 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250039 — HPACS | Healthhub Fri Oct 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251859 — EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190) | Olympus Medical Systems Corporation Fri Oct 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252820 — PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Odysseus) | Internacional Farmacéutica S.A DE C.V Fri Oct 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252178 — MAGENTIQ-COLO (ME-APDS) | Magentiq Eye, Ltd. Fri Oct 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250662 — Bunkerhill MAC | BunkerHill Health Fri Oct 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242946 — HESTIA (L200-A) | Senbitec Co., Ltd. Fri Oct 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251639 — xvision Spine system | Augmedics, Ltd. Fri Oct 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250073 — Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 | Tosoh Bioscience, Inc. Fri Oct 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251646 — extriCARE® 1000 Negative Pressure Wound Therapy System | Alleva Medical Devices Fri Oct 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252129 — AETOS Shoulder System Stemless Humeral Prosthesis | Smith & Nephew, Inc. Fri Oct 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252114 — MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL | Liofilchem s.r.l. Thu Oct 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251124 — G-Bond Universal | GC America, Inc. Thu Oct 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250523 — Archimedes Pro Automated Peritoneal Dialysis Cycler (3014-00000-1); Archimedes Standard Automated Peritoneal Dialysis Cycler (3014-00000-3); Archimedes Pro Disposable Tubing Set (3014-50000-1); Archimedes Standard Disposable Tubing Set (3014-50000-3); Archimedes Pro Plus Disposable Tubing Set (3014-50000-5) | Simergent, LLC Thu Oct 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252769 — Upper Arm Electronic Blood Pressure Monitor (FC-BP107, FC-BP123, FC-BP125, FC-BP126, FC-BP127, FC-BP116) | Shenzhen Finicare Co., Ltd. Thu Oct 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250860 — BreatheBand® (Model 1000) | Exemplar Medical, LLC Thu Oct 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250766 — LungQ 4 | Thirona BV Thu Oct 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252440 — EasyTeleMed (2.0.2) | Ingeniars S.R.L. Thu Oct 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252758 — Cannulated Screw and Kirschner (K wire) System | Orthonovis, Inc. Thu Oct 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251442 — TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1) | Ningbo Tianyi Medical Appliance Co., Ltd. Thu Oct 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250551 — 4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N) | Shenzhen Sophway Technology Co., Ltd. Thu Oct 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251215 — Philips IntelliSpace Cardiovascular | Philips Medical Systems Nederland B.V. Thu Oct 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252059 — CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit (SGPV00) | Artivion, Inc. Thu Oct 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243152 — GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device | Applied Medical Resources Corp. Thu Oct 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251398 — IPL Hair Removal Device (IPL-001, IPL-002) | Shenzhen Enmind Technology Co., Ltd. Thu Oct 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252096 — Light Therapy Decollete Mask (1019135) | Merchsource, LLC Wed Oct 01 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251899 — E Blator | New Deantronics Taiwan , Ltd. Wed Oct 01 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250026 — Shear Wave Quantificational Ultrasound Diagnostic System (FH9000/FH7000/FH6000/FH5000/FH3000/FH1000) | Wuxi Hisky Medical Technologies Co., Ltd. Wed Oct 01 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251825 — Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG) | Shenzhen Ulike Smart Electronics Co., Ltd. Wed Oct 01 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252804 — Ice Cooling IPL Hair Removal Device (UI20S BK, UI20S BS, UI20S DB, UI20S GP, UI20S GR, UI20S MP, UI20S PW, UI20S RE, UI20S WH, UI20WG;UI20 BK, UI20 BL, UI20 BR, UI20 BS, UI20 DB, UI20 GP, UI20 GR, UI20 MP, UI20 PN, UI20 PW, UI20 RE, UI20 WH; UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB,UI06 PR, UI06 OG,UI06RD,UI06 WH, UI06 MG, UI06 OB, UI06 LY, UI06 IG; UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU; UI04 MK, UI04 BN, UI04 BU, UI04 CB, UI04 GY, UI04 LG, UI04 DG, UI04 PL, | Shenzhen Ulike Smart Electronics Co., Ltd. Wed Oct 01 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251501 — Visby Medical Men's Sexual Health Test | Visby Medical, Inc. Wed Oct 01 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252447 — Picosecond laser device (BMPS4) | Hebei Newangie Technology Co., Ltd. Wed Oct 01 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250083 — PRO-DOSE System | Nu-Rise, SA Wed Oct 01 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251767 — Vena MicroAngioscope System | Vena Medical Holdings Corp Wed Oct 01 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250767 — Newclip Patient-matched instrumentation non sterile PSI | Newclip Technics Wed Oct 01 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252106 — External Fixation Mini Rail System | Paragon 28, Inc. Tue Sep 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |