| EKGenius Smart System (K232974) | Ekgenius, LLC | 2023-11-17 |
| D100 KIDS; D101 KIDS (K231652) | Sorin Group Italia S.R.L. | 2023-11-16 |
| UniPearls® Embolic Microspheres (K231554) | Suzhou Haowei Medical Technology Co., Ltd. | 2023-11-14 |
| Cardio P1 (K231150) | Bionet Co., Ltd. | 2023-11-09 |
| Dream Sock (DEN220091) | Owlet Babycare, Inc. | 2023-11-08 |
| Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT75-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT75-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT160-C1U (K231773) | Qura S.R.L | 2023-11-08 |
| Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System (K231182) | Zoll Circulation, Inc. | 2023-11-03 |
| Endophys Blood Pressure Monitor model BPM-30 (K231586) | Endophys Technologies, LLC | 2023-11-03 |
| Aventus Thrombectomy System (K232730) | Inquis Medical | 2023-11-01 |
| CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009) (K231414) | Chalice Medical , Ltd. | 2023-11-01 |
| OCS Heart Leukocyte Depleting Filter (K231362) | TransMedics, Inc. | 2023-10-31 |
| LINQ II™ Insertable Cardiac Monitor (LNQ22) (K233320) | Medtronic, Inc. | 2023-10-31 |
| Finger Clip Pulse Oximeter (K231243) | Guangdong Genial Technology Co., Ltd. | 2023-10-31 |
| HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart Recovery); HemoSphere Alta™ Advanced Monitor (Cardiac); HemoSphere Alta™ Advanced Monitor (All-on-One) (K232294) | Edwards Lifesciences, LLC | 2023-10-31 |
| 091 Balloon Guide Catheter (K231629) | Eosolutions, Corp. | 2023-10-31 |
| FlexCath Contour™ Steerable Sheath (K232321) | Medtronic, Inc. | 2023-10-31 |
| Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal (K230457) | Empatica S.r.l. | 2023-10-30 |
| Mighty Wire Guide Wire (K230418) | Merit Medical Systems, Inc. | 2023-10-28 |
| AcuNav Crystal Ultrasound Catheter (K233270) | Siemens Medical Solutions USA, Inc. | 2023-10-28 |
| Polaris X™ Unidirectional Steerable Diagnostic Catheter (K233207) | Boston Scientific Corporation | 2023-10-27 |
| Electronic Blood Pressure Monitor (K231310) | Shenzhen Jumper Medical Equipment Co., Ltd. | 2023-10-27 |
| Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT); Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors (CP22V-VT) (K233091) | Qura S.R.L | 2023-10-26 |
| SignalHF (IM008) (K230842) | Implicity, Inc. | 2023-10-25 |
| Steerant™ Super Stiff Guidewire (K232570) | Medtronic Vascular | 2023-10-24 |
| Acumen IQ finger cuff (K230919) | Edwards Lifesciences, LLC | 2023-10-24 |
| Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum ST Rx Digital IVUS Catheter (K232584) | Vein 360, LLC | 2023-10-24 |
| FilteredFlo Warming Blankets (K232638) | Iob Medical, Inc. | 2023-10-24 |
| PICOCLAMP (K230281) | Kono Seisakusho Co., Ltd. | 2023-10-23 |
| Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set (K232524) | Perfuze, Ltd. | 2023-10-18 |
| Infinity CentralStation Wide, Infinity M300, Infinity M300+ (K231477) | Draeger Medical Systems, Inc. | 2023-10-17 |
| SOZO Pro (K232089) | ImpediMed Limited | 2023-10-17 |
| Paragon 8F Balloon Guide Catheter (K232437) | Wallaby Medical | 2023-10-13 |
| Stethophone (K231551) | Sparrow Acoustics, Inc. | 2023-10-12 |
| ValvuloPro Valvuloplasty Balloon Catheter (K231814) | Dongguan TT Medical, Inc. | 2023-10-12 |
| Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable (K232852) | Cross Vascular, Inc. | 2023-10-12 |
| VASSALLO GT Crossing14 (K232574) | Filmec Co. , Ltd. | 2023-10-11 |
| Arm Blood Pressure Monitor (K231050) | Alicn Medical Shenzhen, Inc. | 2023-10-11 |
| VASSALLO GT 018 G12; VASSALLO GT 018 G30 (K232578) | Filmec Co. , Ltd. | 2023-10-11 |
| Vivio® LVEDP System (K223905) | Avicena, LLC | 2023-10-06 |
| MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System (K230265) | Infobionic, Inc. | 2023-10-06 |
| ProtekDuo Veno-Venous Cannula Sets (K232480) | Cardiacassist, Inc. | 2023-10-06 |
| The IQoolTM System (K232844) | Braincool AB | 2023-10-04 |
| Nautilus VF ECMO Oxygenator (K232767) | Mc3, Inc. | 2023-10-04 |
| Microcatheter (K232647) | Surmodics,Inc. | 2023-09-29 |
| BLAZER™ Dx-20 Bidirectional Steerable Diagnostic Catheter (K232651) | Boston Scientific Corporation | 2023-09-29 |
| Boppli Infant Blood Pressure Monitor (K223873) | Pyrames, Inc. | 2023-09-29 |
| Amulet™ Steerable Delivery Sheath (K232690) | ABBOTT MEDICAL | 2023-09-29 |
| Low Ejection Fraction AI-ECG Algorithm (K232699) | Anumana, Inc. | 2023-09-28 |
| Talon Transseptal Sheath (K231108) | Inari Medical, Inc. | 2023-09-27 |
| Volta AF-Xplorer (K232616) | Volta Medical | 2023-09-27 |
| Micro Ace™ Advanced Micro Access System (K232609) | Merit Medical Systems, Inc. | 2023-09-27 |
| Thinline Sheath Introducer (K232260) | Inneuroco, Inc. | 2023-09-27 |
| FreedomFlow Orbital Circumferential Atherectomy System (K231538) | Cardio Flow Inc., | 2023-09-27 |
| AVVIGO'+ Multi-Modality Guidance System (K230884) | Boston Scientific Corporation | 2023-09-26 |
| VasQ (DEN220026) | Laminate Medical Technologies , Ltd. | 2023-09-26 |
| Holter ECG and ABP System (K230184) | Edan Instruments, Inc. | 2023-09-25 |
| Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform (K231248) | Edwards Lifesciencess, LLC | 2023-09-21 |
| Socrates Aspiration System (K223913) | Scientia Vascular, Inc. | 2023-09-20 |
| Millipede 088 Access Catheter (K231802) | Perfuze, Ltd. | 2023-09-19 |
| Q Distal Access Catheter (K222948) | Mivi Neuroscience, Inc. | 2023-09-19 |
| Wrist Electronic Blood Pressure Monitor(Model FC-BP200, FC-BP201, FC-BP210,FC-BP211, FC-BP220, FC-BP221) (K231367) | Shenzhen Finicare Co., Ltd. | 2023-09-18 |
| Sensis Vibe (VD15) (K223812) | Siemens Medical Solutions USA, Inc. | 2023-09-15 |
| Barrier EasyWarm Active Self-Warming Blanket (K232508) | Molnlycke Health Care Us, LLC | 2023-09-15 |
| SOFIA EX Intracranial Support Catheter (K230775) | MicroVention, Inc. | 2023-09-14 |
| AlloMap Heart Molecular Expression Testing (K221640) | Caredx, Inc. | 2023-09-13 |
| ensoETM (DEN230021) | Advanced Cooling Therapy, Inc. D/B/A Attune Medical | 2023-09-13 |
| NG Delivery Catheter (K230609) | Balt USA, LLC | 2023-09-13 |
| Change Healthcare Cardiology Hemodynamics™ (K230881) | Change Healthcare Israel , Ltd. | 2023-09-11 |
| CorVista® System (K232686) | Corvista Health, Inc. | 2023-09-08 |
| Cleerly ISCHEMIA (K231335) | Cleerly, Inc. | 2023-09-08 |
| Arm Blood Pressure Monitor (K230649) | Alicn Medical Shenzhen, Inc. | 2023-09-07 |
| Pounce™ Sheath (K231828) | Surmodics,Inc. | 2023-09-07 |
| CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U) (K231207) | Biosense Webster, Inc. | 2023-09-07 |
| Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit (K232443) | Argon Medical Devices, Inc. | 2023-09-07 |
| Digital Blood Pressure Monitor WBP Series (K231542) | Weony (Shenzhen) Technology Co., Ltd. | 2023-09-07 |
| AeroDVx Arm System (K222823) | Sun Scientific, Inc. | 2023-09-07 |
| Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVue (K232389) | Masimo Corporation | 2023-09-07 |
| esolution (DEN230006) | S4 Medical Corp. | 2023-09-06 |
| ICHOR 14F Embolectomy System (K230743) | Ichor | 2023-09-05 |
| FaceHeart Vitals Software Development Kit (FH vitals SDK) (K223622) | Faceheart Corp. | 2023-09-01 |
| SmartCardia 7L Platform (K231276) | Smartcardia SA | 2023-08-30 |
| AC3™ Series IABP (K232343) | Arrow International, LLC | 2023-08-30 |
| NIBPCuff (K231961) | Shenzhen Sino-K Medical Technology Co.,Ltd | 2023-08-30 |
| S-Patch Ex Wearable ECG Patch (K231289) | Wellysis Corp. | 2023-08-30 |
| Ventrax™ Delivery System (VTR851) (K231246) | Merit Medical Systems, Inc. | 2023-08-30 |
| circul™ pro Ring (K221361) | Bodimetrics, LLC | 2023-08-29 |
| SoundBite® Crossing System XS Peripheral (K230159) | Soundbite Medical Solutions, Inc. | 2023-08-28 |
| Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure Monitor (K230566) | Joytech Healthcare Co. , Ltd. | 2023-08-25 |
| VitalFlow™ Console (K230364) | Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.) | 2023-08-25 |
| Wrist Type Blood Pressure Monitor (W05,W1101L) (K230409) | Shenzhen Jamr Technology Co., Ltd. | 2023-08-25 |
| VitalFlowTM Centrifugal Pump (K223898) | Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.) | 2023-08-25 |
| 072 Aspiration System (K222786) | Q'Apel Medical, Inc. | 2023-08-25 |
| Vein360 Reprocessed Visions PV.018 Digital IVUS Catheter (K230928) | Vein 360, LLC | 2023-08-25 |
| Essenz HLM, Essenz ILBM (K232291) | Livanova Deutschland, GmbH | 2023-08-24 |
| Current Health System (K231506) | Current Health , Ltd. | 2023-08-24 |
| Withings Scan Monitor 2.0 (K230812) | Withings | 2023-08-23 |
| IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062), IntelliVue Patient Monitor MX500 (866064), IntelliVue Patient Monitor MX550 (866066) (K223574) | Philips Medizin Systeme Boeblingen GmbH | 2023-08-22 |
| 6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter (K232190) | Medtronic Vascular | 2023-08-22 |
| Plato 17 Microcatheter (K223560) | Scientia Vascular, Inc. | 2023-08-21 |
| LUX-Dx II (M302); LUX-Dx II+ (M312) (K231328) | Boston Scientific Corp | 2023-08-19 |