| Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT) (K252655) | Shenzhen Imdk Medical Technology Co., Ltd. | 2026-05-11 |
| SAYA 86 Radial Access Guide Catheter (K254178) | Asahi Intecc Co., Ltd. | 2026-05-11 |
| Lynx Aspiration Catheter System (K254276) | Q’Apel Medical, Inc. | 2026-05-07 |
| BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000) (K253152) | Biozen, LLC | 2026-05-06 |
| YP-710T Series NIBP Cuff;YP-840T Series Disposable Cuff (K260747) | Nihon Kohden Corporation | 2026-05-06 |
| KardiaPSI Balloon Catheter (K253855) | Intervention Tech, Inc. ; dba Corvention | 2026-05-06 |
| Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401) (K253887) | Philips Medizin Systeme | 2026-05-01 |
| BIOMONITOR IV (471155) (K261074) | Biotronik, Inc. | 2026-05-01 |
| c-med0 alpha (K253436) | Cosinuss GmbH | 2026-04-30 |
| Echo Large Bore Introducer Sheath (K260606) | Echo Medical, LLC | 2026-04-29 |
| Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire (K253579) | Scientia Vascular, Inc. | 2026-04-29 |
| Automatic Digital Blood Pressure Monitor (LD-587, LD-528, LD-562, LD-581, LD-521, LD-527, LD-572 & LD-569) (K260260) | Honsun (Nantong) Co., Ltd. | 2026-04-28 |
| Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62E3B, DBP-62E2B, DBP-62E1B, DBP-61E3, DBP-61E2, DBP-61E1, DBP-61D7G, DBP-6281L, DBP-6282L, DBP-6285L) (K252501) | Joytech Healthcare Co. , Ltd. | 2026-04-28 |
| Fusion Bioline Vascular Graft (K252445) | Maquet Cardiovascular, LLC | 2026-04-27 |
| Vista CMS (K250349) | Shanghai Draeger Medical Instrument Co., Ltd. | 2026-04-24 |
| INDIGO® Aspiration System – INDIGO Link (K260599) | Penumbra, Inc. | 2026-04-24 |
| FloPatch FP120 (K252810) | Flosonics Medical | 2026-04-24 |
| Compression Therapy Device (LGT-2202DVT) (K250242) | Guangzhou Longest Medical Technology Co., Ltd. | 2026-04-24 |
| Amplatzer TorqVue Delivery System (K260993) | Abbott | 2026-04-24 |
| Introducer Sheath Set (K254248) | Cardiocycle Medical(Suzhou) Co., Ltd. | 2026-04-23 |
| OptiMap Catheter - 60mm (OPTI-CATH2-60) (K261012) | Cortex, Inc. | 2026-04-23 |
| Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae (K260195) | Medtronic, Inc. | 2026-04-23 |
| Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX) (K252389) | Smwmed, Inc. | 2026-04-23 |
| Liberant™ RX Aspiration Catheter (K253589) | Medtronic Interventional Vascular, Inc. | 2026-04-23 |
| Korotkoff sound blood pressure monitor (K253982) | Beijing Hanvon Health Technology Co., Ltd. | 2026-04-21 |
| BosCATH Support Catheter (K254046) | Sonorous NV, Inc. | 2026-04-21 |
| RhythmStar System (SL) (K250793) | RhythMedix, LLC | 2026-04-21 |
| EnSite™ X EP System (K260212) | ABBOTT MEDICAL | 2026-04-20 |
| XplantR Explant Tool (DEN250033) | Hjarta Care, LLC | 2026-04-17 |
| Novasight Hybrid System (K252945) | Conavi Medical, Inc. | 2026-04-17 |
| Edwards eSheath+ introducer set (K254279) | Edwards Lifesciences | 2026-04-17 |
| Hot Pink Pad Warming System (K260903) | Xodus Medical, Inc. | 2026-04-16 |
| Zenith Micro Guidewire (K252317) | Suzhou Zenith Vascular SciTech Limited | 2026-04-16 |
| Next Generation 088 Catheter (K254223) | Balt USA, LLC | 2026-04-16 |
| High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer Tube (K253048) | Shenzhen Maiwei Biotech Co., Ltd. | 2026-04-16 |
| uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors (K253170) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2026-04-16 |
| PATH BGC (K260938) | Crossroads Neurovascular, Inc. | 2026-04-15 |
| Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R) (K260931) | Unimed Medical Supplies, Inc. | 2026-04-14 |
| TriMemo™ SEMIRIGID ANNULOPLASTY RING (K260498) | Corcym S.r.l. | 2026-04-14 |
| Aventus Introducer Sheath (K260091) | Inquis Medical | 2026-04-13 |
| ACORYS MAPPING SYSTEM (K253861) | Corify Care S.L | 2026-04-13 |
| Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model C, US (2601065); Vista 300 S Non-Inv Model A, US (2602425); Vista 300 S Invasive Model B, US (2602426); Vista 300 S Invasive Model C, US (2602427) (K252250) | Shanghai Draeger Medical Instrument Co., Ltd. | 2026-04-10 |
| Protaryx Transseptal Puncture Device (PTX2-001) (K260839) | Protaryx Medical, Inc. | 2026-04-10 |
| Teleport Glide Microcatheter (K253361) | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2026-04-10 |
| Auryon Atherectomy System (K260244) | Eximo Medical | 2026-04-10 |
| LOBO Vascular Occlusion System (K260508) | Okami Medical, Inc. | 2026-04-10 |
| Radical 6F Access Catheter (K253975) | Maduro Medical, Inc. | 2026-04-09 |
| OptiCross Coronary Imaging Catheter (H749518110); OptiCross 6 Coronary Imaging Catheter (H7495181160); OptiCross HD Coronary Imaging Catheter (H74939352040); OptiCross 6 HD Coronary Imaging Catheter (H74939354080); OptiCross Coronary Imaging Catheter (Bagless) (H749518130); OptiCross 6 Coronary Imaging Catheter (Bagless) (H7495181360); OptiCross HD Coronary Imaging Catheter (Bagless) (H74939352050); OptiCross 6 HD Coronary Imaging Catheter (Bagless) (H74939354090) (K260816) | Boston Scientific | 2026-04-08 |
| ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040) (K253801) | Anumana, Inc. | 2026-04-07 |
| Warming System (K252861) | Hangzhou Tappa Medical Technology Co., Ltd. | 2026-04-07 |
| AuST Steerable Sheath (K260942) | CenterPoint Systems, LLC | 2026-04-07 |
| Firefighter™ Pro PTCA Balloon Catheter (K252116) | Shanghai MicroPort Medical (Group) Co., Ltd. | 2026-04-07 |
| VANES Delivery System (VDS) (K260459) | Zoll Respicardia, Inc. | 2026-04-06 |
| Life Saving Tourniquet (K254060) | TW Medical | 2026-04-03 |
| Etiometry Platform (K254066) | Etiometry, Inc. | 2026-04-03 |
| FLASH Flex™ Aorto-Ostial Angioplasty System (K254022) | Verge Medical, Inc. | 2026-04-02 |
| Synchrony (K253473) | Stereotaxis, Inc. | 2026-04-01 |
| Arm Blood Pressure Monitor Models: ARM-30C+; ARM-30M+; ARM-HA101+; ARM-3060; XS Pro; ARM-30G1; ARM-30H; Visomat double comfort; Visomat comfort 20/40 BT; ARM-3080; ARM-3081; ARM-3082; ARM-3103; ARM-3200; ARM-115; ARM-111; ARM-3102; ARM-3100; ARM-3101; SBM 15; ARM-30W; ARM-30J; ARM-30F-XL; ARM-3024-XL; ARM-3025-XL; ARM-3062-XL; 9S Pro (K260276) | Shenzhen AOJ Medical Technology Co., Ltd. | 2026-04-01 |
| Arm Blood Pressure Monitor (HH-802CB, HH-802EB, HH-805CB, HH-812CB, HH-808CL, HH-808EL) (K254225) | Shenzhen HanHan Technology Co., Ltd. | 2026-04-01 |
| IntelliVue Measurement Rack 6000 (867317) (K253654) | Philips Medizin Systeme Böblingen GmbH | 2026-03-30 |
| ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020) (K252360) | Anumana, Inc. | 2026-03-28 |
| Ryurei (K252295) | Terumo Corporation | 2026-03-27 |
| Multiflex Steerable Sheath 17.5F (K260626) | Vizaramed, Inc. | 2026-03-26 |
| Automatic Electronic Blood Pressure Monitor (U90B series models including ( U90B,U90B Pro,U90B Plus,U90B Ultra,U90C,U90C Pro,U90C Plus,U90C Ultra).) (K260273) | Shenzhen Urion Technology Co., Ltd. | 2026-03-26 |
| Arterial Pressure Monitoring Set/Tray (K254278) | Spectrum Vascular | 2026-03-25 |
| FLOWRUNNER Aspiration System (K254208) | Expanse Medical, Inc. | 2026-03-20 |
| Valvuloplasty Balloon Catheter (ValvuloPro) (K260437) | Dongguan TT Medical, Inc. | 2026-03-20 |
| FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40 (K260544) | FMD Co., Ltd. | 2026-03-20 |
| Willow 24 Guidewire (K260537) | Arbor Endovascular, LLC | 2026-03-19 |
| Enroute 0.014'' Transcarotid Guidewire (K253746) | Lake Region Medical | 2026-03-19 |
| LimFlow Vector (K260188) | LimFlow, Inc. | 2026-03-18 |
| Lifemotion Disposable Membrane Oxygenator (K253838) | Lifemotion Medical Technology Co., Ltd. | 2026-03-16 |
| Millipede System (K253590) | Perfuze, Ltd. | 2026-03-16 |
| DCwire Micro-guidewire (K252122) | Shanghai Achieva Medical Suzhou Co., Ltd. | 2026-03-16 |
| SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R) (K253799) | Pressure Products Medical Device Manufacturing, LLC | 2026-03-13 |
| OptiMap Catheter - 50mm (OPTI-CATH2-50) (K253205) | Cortex, Inc. | 2026-03-13 |
| Amplatzer™ Trevisio™ Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80 (K260499) | ABBOTT MEDICAL | 2026-03-13 |
| Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood Oxygenator ECC VT200-E3 (VT200-E3); Quantum Perfusion Blood Oxygenator VT75- E3 (VT75- E3); (K240934) | Spectrum Medical S.R.L. | 2026-03-12 |
| Tyto Stethoscope (G3) (K252089) | Tyto Care , Ltd. | 2026-03-12 |
| Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W (K252541) | Spectrum Medical S.R.L. | 2026-03-12 |
| Tigertriever 25 Revascularization Device (K253062) | Rapid Medical Ltd. | 2026-03-12 |
| InVera Infusion Device (K250794) | Invera Medical | 2026-03-12 |
| Venous Return Cannulae (K250937) | LivaNova USA, Inc. | 2026-03-11 |
| EmeryGlide™ (EG18008901) (K253262) | Nano4imaging GmbH | 2026-03-06 |
| YUWELL® Electronic Blood Pressure Monitor (YE630CR) (K252779) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2026-03-05 |
| Extension tube (K251788) | Zhuhai DR Medical Instruments Co., Ltd. | 2026-03-05 |
| AViTA Pulse Oximeter (SP61) (K252448) | Avita Corporation | 2026-02-27 |
| HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX) (K260292) | Atraverse Medical | 2026-02-27 |
| HemoSphere Nano Monitor (HSNANO1) (K253186) | Edwards Lifesciences, LLC | 2026-02-24 |
| NanoPress 760A-BT (760A-BT) (K254267) | Mego Afek , Ltd. | 2026-02-24 |
| Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C) (K260043) | Smart Reactors | 2026-02-23 |
| YUWELL® Electronic Blood Pressure Monitor (YE650AR) (K253228) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2026-02-23 |
| CARTO™ 3 EP Navigation System V8.4 (K252972) | Biosense Webster, Inc. | 2026-02-20 |
| Retrograde Coronary Sinus Perfusion Cannulae (K253203) | Medtronic, Inc. | 2026-02-19 |
| AuST CSP Introducer (K260163) | CenterPoint Systems, LLC | 2026-02-19 |
| IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS Viewpoint Simple Curve Catheter, 125cm (C01251); IOPS Viewpoint Double Curve Catheter, 75cm (C00752); IOPS Viewpoint Double Curve Catheter, 125cm (C02152); IOPS Guidewire 2 (ATW-2); IOPS Fiducial Tracking Pad (T02111); IOPS Guidewire Handle (H01035) (K254089) | Centerline Biomedical, Inc. | 2026-02-17 |
| YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310) (K252805) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2026-02-17 |
| Versus™ Catheter (VS110-9NB) (K260149) | Liquet Medical, Inc. | 2026-02-17 |
| MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2) (K252891) | Bayer Medical Care, Inc. | 2026-02-13 |
| Wrist Blood Pressure Monitor (BPM-W1VL) (K253133) | Shenzhen Imdk Medical Technology Co., Ltd. | 2026-02-13 |