| SOUNDSTAR™ CRYSTAL Ultrasound Catheter (K240050) | Biosense Webster, Inc. | 2024-06-12 |
| Mi-CHORD System (DEN230069) | Lsi Solutions, Inc. | 2024-06-11 |
| JADE PLUS PTA Balloon Dilatation Catheter (K241025) | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2024-06-11 |
| Indigo® Lightning Flash Aspiration System – Select +™ Catheter (K241399) | Penumbra, Inc. | 2024-06-10 |
| Blood Pressure Monitor (BBZ32-AA01) (K240832) | Guangdong Transtek Medical Electronics Co., Ltd. | 2024-06-07 |
| Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter (K233825) | Innovative Health | 2024-06-07 |
| Corvair (K231010) | AliveCor, Inc. | 2024-06-07 |
| Impala (K232035) | AliveCor, Inc. | 2024-06-07 |
| Electrocardiograph, model: ECG301 (K232816) | Shenzhen LE Medical Technology Co., Ltd. | 2024-06-07 |
| FibriCheck (K232804) | Qompium NV | 2024-06-07 |
| Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable (2ACHC) (K240972) | Surgical Instrument Service and Savings, Inc. | 2024-06-07 |
| Swan-Ganz catheter (K233824) | Edwards Lifesciences, LLC | 2024-06-06 |
| TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support (K240948) | Imperative Care, Inc. | 2024-06-06 |
| ANNE Chest (K240251) | Sibel Health, Inc. | 2024-06-03 |
| Amplatz Goose Neck Snare Kit (K241259) | Medtronic, Inc. | 2024-06-03 |
| Ringer perfusion balloon catheter, 2.00 x 20mm (5881); Ringer perfusion balloon catheter, 2.50 x 20mm (5882); Ringer perfusion balloon catheter, 2.50 x 30mm (5883); Ringer perfusion balloon catheter, 3.00 x 20mm (5884); Ringer perfusion balloon catheter, 3.00 x 30mm (5885); Ringer perfusion balloon catheter, 3.50 x 20mm (5886); Ringer perfusion balloon catheter, 3.50 x 30mm (5887); Ringer perfusion balloon catheter, 4.00 x 20mm (5888); Ringer perfusion balloon catheter, 4.00 x 30mm (58 (K233729) | Vascular Solutions, LLC | 2024-05-31 |
| Blood Pressure Monitor (TMB-2296-BT) (K240254) | Guangdong Transtek Medical Electronics Co., Ltd. | 2024-05-31 |
| Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1) (K241248) | Spectrum Medical S.R.L. | 2024-05-31 |
| Sunsphere (K232934) | Hangzhou Yangshun Medical Technology Co.,Ltd | 2024-05-30 |
| The Circadia C200 System (K234003) | Circadia Technologies, Ltd. | 2024-05-30 |
| SmartClaw™ Thrombectomy Catheter, 20 mm (FD0660-01), SmartClaw™ Thrombectomy Catheter, 32 mm (FD0660-02) (K241207) | Devoro Medical, Inc. | 2024-05-29 |
| Laser Speckle Imaging System (RFLSI CZW) (K233076) | Rwd Life Science Co., Ltd. | 2024-05-28 |
| ANNE Limb (K240305) | Sibel Health, Inc. | 2024-05-28 |
| React 71 Catheter (K241177) | Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular | 2024-05-28 |
| INSPIRA ART100 (K232788) | Inspira Technologies Oxy B.H.N. , Ltd. | 2024-05-24 |
| PacePro Wire (K240864) | Opsens, Inc. | 2024-05-24 |
| Impress Angiographic Catheter (K233268) | Merit Medical Systems, Inc. | 2024-05-22 |
| Fogarty Arterial Embolectomy Catheter with Gate Valve (K233820) | Edwards Lifesciences | 2024-05-22 |
| Fogarty Venous Thrombectomy Catheters (K233819) | Edwards Lifesciences, LLC | 2024-05-22 |
| AViTA Pulse Oximeter (K223399) | Avita Corporation | 2024-05-20 |
| Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters (K233619) | Edwards Lifesciences | 2024-05-20 |
| SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198) (K241042) | Pressure Products Medical Device Manufacturing, LLC | 2024-05-17 |
| Wedge XL Delivery Catheter (K232542) | MicroVention, Inc. | 2024-05-16 |
| Sempulse Halo Vital Signs Monitor (K232495) | Sempulse Corporation | 2024-05-16 |
| MVR™ Venous Reservoir Bag 800 mL; MVR™ Venous Reservoir Bag 1600 mL; MVR™ Venous Reservoir Bag with Cortiva™ BioActive Surface 800 mL; MVR™ Venous Reservoir Bag with Cortiva™ BioActive Surface 1600 mL (K241053) | Medtronic Cardiac Surgery | 2024-05-15 |
| BNLE Hydrophilic Jacketed Peripheral Guidewire (K232662) | Biomerics Nle | 2024-05-14 |
| Biofourmis Everion+ (G2) (K233418) | Biofourmis Singapore Pte., Ltd. | 2024-05-09 |
| CEREGLIDE 92 Catheter System (K233982) | Cerenovus, Inc. | 2024-05-09 |
| Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter (K240954) | Shockwave Medical, Inc. | 2024-05-07 |
| LIFEPAK® ECG Cables (K240377) | Stryker Physio-Control | 2024-05-07 |
| ASSURE Wearable ECG (K233864) | Kestra Medical Technologies, Inc. | 2024-05-07 |
| Masimo Stork (K234021) | Masimo Corporation | 2024-05-03 |
| Siege Vascular Plug (SVP2.5-0.021); Siege Vascular Plug (SVP4-0.021); Siege Vascular Plug (SVP6-0.027) (K240261) | Merit Medical Systems, Inc. | 2024-05-02 |
| CSF-4 (CSF-4) (K232445) | Cardiacsense | 2024-05-02 |
| HOTWIRE™ RF Guidewire (K240900) | Atraverse Medical | 2024-05-01 |
| AuST Steerable Sheath (K240829) | CenterPoint Systems, LLC | 2024-05-01 |
| LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack IV Invasive Pressure Transducers (or equivalent)) (11230-000021); LIFEPAK® Invasive Pressure Adapter Cable (interfaces with Edwards Lifesciences TruWave Invasive Pressure Transducers (or equivalent)) (11230-000024) (K240156) | Physio-Control, Inc. | 2024-04-30 |
| Blood Pressure Monitor (TMB-2287-B) (K240102) | Guangdong Transtek Medical Electronics Co., Ltd. | 2024-04-29 |
| TME Temporary Myocardial Electrode (K232261) | Osypka AG | 2024-04-26 |
| Portrait VSM (K233810) | Ge Medical Systems Information Technologies, Inc. | 2024-04-25 |
| CDI OneView Monitoring System (K234065) | Terumo Cardiovascular Systems Corporation | 2024-04-25 |
| Provisio™ SLT IVUS™ System (K233948) | Provisio Medical, Inc. | 2024-04-23 |
| Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing Set (K233329) | Route 92 Medical, Inc. | 2024-04-23 |
| Fully Automatic Electronic Blood Pressure Monitor (KD-5811VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5811BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5810VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5810BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5920VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5920BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5923TS) (K234041) | Andon Health Co, Ltd. | 2024-04-22 |
| Patient Monitor (iX10, iX12, iX15) (K232962) | Edan Instruments, Inc. | 2024-04-19 |
| ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180) (K233737) | Ulrich GmbH & Co. KG | 2024-04-19 |
| LIFEPAK® 35 AC Power Adapter (41335-000001) (K240162) | Stryker Physio-Control | 2024-04-19 |
| ICE Aspiration System (K234073) | Expanse Medical, Inc. | 2024-04-19 |
| Bio-Medicus Life Support Catheter and Introducer (K240534) | Medtronic, Inc. | 2024-04-19 |
| HotDog Warming Mattress + Return Electrode (K232627) | Augustine Temperature Management, LLC | 2024-04-18 |
| EMBOGUARD Balloon Guide Catheter (K233924) | Neuravi Limited | 2024-04-18 |
| Novalung ultimate kit (US) (K232926) | Fresenius Medical Care Renal Therapies Group, LLC | 2024-04-15 |
| Keikku Electronic stethoscope (K233313) | Lapsi Health Holding B.V. | 2024-04-10 |
| TransForm McCarthy Mitral Annuloplasty Ring (TF) (K232599) | Genesee Biomedical, Inc. | 2024-04-09 |
| APPRAISE-HRI (K233249) | The Surgeon General, Department of the Army (TSG-DA) | 2024-04-05 |
| MCG-S (AM1000) (K232823) | Amcg Co., Ltd. | 2024-04-05 |
| CorVista System with PH Add-On (K233666) | Analytics For Life, Inc. | 2024-04-05 |
| Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding Sheath (K232037) | Innovative Health, LLC | 2024-04-04 |
| SnapshotNIR model KD205 (K240601) | Kent Imaging, Inc. | 2024-04-02 |
| Zoom 6F Insert Catheters (K233975) | Imperative Care, Inc. | 2024-04-02 |
| Talis EMR with Talis +ACG (Talis EMR with +ACG) (K233133) | Talis Clinical, LLC | 2024-04-01 |
| AlphaVac MMA F1885 System (H787253020) (K240397) | AngioDynamics, Inc. | 2024-04-01 |
| LINQ II™ Insertable Cardiac Monitor (ICM) (K240693) | Medtronic, Inc. | 2024-03-28 |
| Aperta NSE PTA Balloon Dilatation Catheter (AW18-05040040/AA18-05040040, AW18-09040040/AA18-09040040, AW18-14540040, AW18-05050040/AA18-05050040, AW18-09050040/AA18-09050040, AW18-14550040, AW18-05060040/AA18-05060040, AW18-09060040/AA18-09060040, AW18-14560040 AW18-05070040/AA18-05070040, AW18-09070040/AA18-09070040, AW18-14570040, AW18-05080040/AA18-05080040, AW18-09080040/AA18-09080040, AW18-14580040) (K232013) | Goodman Co., Ltd. | 2024-03-28 |
| Advanta VXT Vascular Graft, Flixene Vascular Graft (K231972) | Atrium Medical Corporation | 2024-03-28 |
| Eko Low Ejection Fraction Tool (ELEFT) (K233409) | Eko Health, Inc. | 2024-03-28 |
| CORE 500 Digital Stethoscope (K233609) | Eko Health, Inc. | 2024-03-28 |
| Cleaner™ Plus 18F Thrombectomy System - Cleaner™ Plus 18F Aspiration Catheter, Cleaner™ Plus 18F Handpiece with Maceration Wire, Cleaner™ Plus 18F Aspiration Canister (K233909) | Argon Medical Devices, Inc. | 2024-03-28 |
| MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter; MIDWAY 62 Delivery Catheter) (K233201) | Penumbra, Inc. | 2024-03-27 |
| Clinical Automatic Blood Pressure Monitor (DBP-01P,DBP-01HP) (K231984) | Shenzhen Hingmed Medical Instrument Co., Ltd. | 2024-03-26 |
| Micropuncture Introducer Sets; Micropuncture Pedal Access Sets (K240589) | Cook Medical | 2024-03-25 |
| Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software (K232354) | Murata Vios, Inc. | 2024-03-22 |
| Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter (K240225) | Shockwave Medical, Inc. | 2024-03-22 |
| Corsano CardioWatch 287-2 System (K232548) | Corsano Health B.V. | 2024-03-22 |
| Aneroid Sphygmomanometer with Stethoscope; Aneroid Sphygmomanometer (K240165) | Wenzhou Longwan Medical Device Factory | 2024-03-20 |
| Portrait™ Mobile Monitoring Solution consists of: • Portrait™ Central Viewer Application (Portrait CVAXB) • Portrait™ Core Services (Portrait CSSXB) • Portrait™ Clinical Alarming Unit (Portrait CAU01) • Portrait™ Mobile Patient Monitor Hardware (Portrait HUBXB) • Portrait™ Mobile Patient Monitor Software (Portrait HSWXB) • Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01) • Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01) • Portrait™ Wearable Pulse O (K234130) | Ge Medical Systems Information Technologies, Inc. | 2024-03-20 |
| Blood Pressure Monitor (K233146) | Shenzhen Jamr Technology Co., Ltd. | 2024-03-19 |
| APRO 55 Catheter (K234115) | Alembic, LLC | 2024-03-15 |
| Wrist Blood Pressure Monitor (222); Wrist Blood Pressure Monitor (222BT); Wrist Blood Pressure Monitor (W1681BL); Wrist Blood Pressure Monitor (W1681BT); Wrist Blood Pressure Monitor (W1681R) (K233799) | Shenzhen Yuezhongxing Technology Co., Ltd. | 2024-03-15 |
| Aventus Thrombectomy System (IM-2001/IM-0002) (K240117) | Inquis Medical | 2024-03-15 |
| LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D Hub (K233853) | Philips Medical Systems Nederland B.V. | 2024-03-14 |
| SENDERO Microcatheter (K240384) | Okami Medical, Inc. | 2024-03-08 |
| Affera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007); System Cart (AFR-00013) (K233943) | Medtronic, Inc. | 2024-03-08 |
| Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3s (K233038) | Edan Instruments, Inc. | 2024-03-08 |
| Esperance Distal Access Catheter (K231056) | Wallaby Medical | 2024-03-08 |
| D·Kutting™ PTA Scoring Balloon Dilatation Catheter (K232207) | Dk Medical Technology Co., Ltd. | 2024-03-07 |
| DVT Motion Pneumatic Compression Device (K232270) | Koge Micro Tech Co., Ltd. | 2024-03-06 |
| Vyvo (K231288) | Vyvo Technology Corp.(Vt) | 2024-03-04 |
| OxiplexTS200 (K232385) | Iss Medical, Inc. | 2024-03-01 |
| GORE® PROPATEN® Vascular Graft (K240083) | W. L. Gore & Associates, Inc. | 2024-03-01 |