| Smart Wedge algorithm (K230579) | Edwards Lifesciences, LLC | 2023-08-18 |
| Sleepiz One+ (K223163) | Sleepiz AG | 2023-08-18 |
| Route 92 Medical Full Length 054 Access System (K231583) | Route 92 Medical, Inc. | 2023-08-15 |
| Pulse Oximeter (K230172) | Beijing Choice Electronic Technology Co., Ltd. | 2023-08-12 |
| Electronic Blood Pressure Monitor (K230642) | Dongguan Kangweile Electronic Technology Co., Ltd. | 2023-08-11 |
| Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core Services (Portrait CSS01), Portrait™ Clinical Alarming Unit (Portrait CAU01); Portrait™ Mobile Patient Monitor (Portrait HUB01), Portrait™ Sensor Battery (Portrait SBT01), Portrait™ Bedside Charger (Portrait BCH01); Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01, Portrait SpO2 P-SP01, Portrait SpO2 P-W01 and Portrait SpO2 P-SE01); Portrait™ SpO2 Attachment Accessory Band (Portrait AAB01), Portrait™ (K230626) | Ge Medical Systems Information Technologies, Inc. | 2023-08-11 |
| EnSite™ X EP System (K231415) | ABBOTT MEDICAL | 2023-08-10 |
| ANNE One (K223711) | Sibel Health, Inc. | 2023-08-10 |
| Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter (K230620) | Gentuity, LLC | 2023-08-08 |
| Rubicon™ Control Support Catheter (H749394323506A1) (K223633) | Boston Scientific Corporation | 2023-08-08 |
| Reprocessed Agilis NxT Steerable Introducer (K230376) | Innovative Health, LLC | 2023-08-07 |
| ECGenius System (K223787) | Cath Vision Aps | 2023-08-04 |
| LEGACY® IPC (K232006) | Ig Technology, Ltd. | 2023-08-04 |
| Viz HCM (DEN230003) | Viz. Ai, Inc. | 2023-08-03 |
| LifeSPARC System (K232132) | Cardiacassist, Inc. | 2023-08-03 |
| BPBIO750 (K231174) | Inbody Co., Ltd. | 2023-08-02 |
| SKEEPER (K230613) | Smartsound Corporation | 2023-08-02 |
| Aristotle 18 Guidewire; Aristotle 24 Guidewire (K231954) | Scientia Vascular, Inc. | 2023-08-01 |
| Nuubo Smart (K231620) | Smart Solutions Technologies SL | 2023-08-01 |
| CNS-2101 Central Monitor (K223567) | Nihon Kohden Corporation | 2023-07-31 |
| MESI mTablet ECG Diagnostic System, MESI mTablet ECG (K223670) | Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O. | 2023-07-28 |
| Electrocardiograph: SE-1200 Pro and SE-1201 Pro (K222902) | Edan Instruments, Inc. | 2023-07-28 |
| R2P Navicross (K231044) | Terumo Medical Corporation | 2023-07-27 |
| Arm Blood Pressure Monitor, models AOJ-33A and AOJ-33B (K222994) | Shenzhen AOJ Medical Technology Co., Ltd. | 2023-07-26 |
| Global Hypoperfusion Index (GHI) Algorithm (K231038) | Edwards Lifesciences, LLC | 2023-07-26 |
| Reprocessed ViewFlex Xtra ICE Catheter (D087031) (K231621) | Stryker Sustainability Solutions | 2023-07-25 |
| Triever20 Curve (21-201) (K231848) | Inari Medical, Inc. | 2023-07-21 |
| Irregular Rhythm Notification Feature (IRNF) (K231173) | Apple, Inc. | 2023-07-21 |
| Firefighter™ NC Pro PTCA Balloon Catheter (K223189) | Shanghai MicroPort Medical (Group) Co., Ltd. | 2023-07-21 |
| CROSSLEAD Penetration Peripheral Guide Wire (K230377) | Asahi Intecc Co., Ltd. | 2023-07-20 |
| Pulse Oximeter (K211143) | Shenzhen Brav Electronic Technologies Co., Ltd. | 2023-07-17 |
| TalWire (K223791) | Embrace Medical , Ltd. | 2023-07-14 |
| Micro Rx (K223728) | Imds Operations B.V. | 2023-07-13 |
| AusculThing ACC (K230823) | Ausculthing OY | 2023-07-12 |
| FusedCO Algorithm (K231035) | Edwards Lifesciences, LLC | 2023-07-12 |
| PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS Catheter with Auto ID, Webster® CS Catheter with EZ Steer Technology, Webster® CS Catheter with EZ Steer Technology with Auto ID (K231312) | Biosense Webster, Inc. | 2023-07-10 |
| AcQMap High Resolution Imaging and Mapping System (K231091) | Acutus Medical, Inc. | 2023-07-10 |
| CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath (D-1385-01-S, D-1385-02-S, D-1385-03-S) (K231412) | Biosense Webster, Inc. | 2023-07-10 |
| T3 Platform software (K223578) | Etiometry, Inc. | 2023-07-07 |
| AeviceMD (K223382) | Aevice Health Pte. , Ltd. | 2023-07-07 |
| ARGUS PB-3000 (K221056) | Schiller AG | 2023-07-06 |
| Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3-4 mm (K231279) | Ablative Solutions, Inc. | 2023-07-05 |
| BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular Catheter (K231653) | Thrombolex, Inc. | 2023-07-03 |
| 5F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide Catheter, 8F Launcher Guide Catheter (K230156) | Medtronic Vascular | 2023-06-30 |
| preCARDIA Occlusion System (K221294) | Abiomed, Inc. | 2023-06-30 |
| IOB Temperature Management System (K231596) | Iob Medical, Inc. | 2023-06-30 |
| Blood Pressure Monitor (K223374) | Guangdong Transtek Medical Electronics Co., Ltd. | 2023-06-30 |
| ViewFlex™ Eco Reprocessed ICE Catheter (K231588) | ABBOTT MEDICAL | 2023-06-30 |
| Coronary Dilatation Balloon Catheter (VesPenetrator®), Coronary Dilatation Balloon Catheter (VesTraveler®), Coronary Dilatation Balloon Catheter (VexPander®) (K230374) | Dongguan TT Medical, Inc. | 2023-06-29 |
| Upper Arm Blood Pressure Monitor (K230176) | Shenzhen Yolanda Technology Co., Ltd. | 2023-06-29 |
| HotDog Warming Mattress + Return Electrode (K230866) | Augustine Temperature Management, LLC | 2023-06-29 |
| Aneroid Sphygmomanometer (K230859) | Wenzhou Kangshun Medical Devices Co.,Ltd | 2023-06-28 |
| Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KVl-5K (K230075) | Microlife Intellectual Property GmbH | 2023-06-28 |
| EMBOLD™ Soft Detachable Coil System (K230706) | Boston Scientific Corporation | 2023-06-27 |
| GORE® ACUSEAL Vascular Graft (K231505) | W. L. Gore & Associates, Inc. | 2023-06-23 |
| AccurECG Analysis System (K223013) | Accurkardia, Inc. | 2023-06-23 |
| SelectFlex Neurovascular Access System Family (K230322) | Q'Apel Medical, Inc. | 2023-06-22 |
| Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1) and IOPS Reverse Curve Catheter (RCC-1); IOPS Guidewire (ATW-2); IOPS Tracking Pad (TP-1); IOPS Guidewire Handle (SSH-1) (K230309) | Centerline Biomedical, Inc. | 2023-06-21 |
| Accurate 24 Non-invasive blood pressure monitor (K222658) | Accurate Meditech, Inc. | 2023-06-21 |
| ScleroSafe™ 150 mm, ScleroSafe™ 350 mm (K231148) | Vvt Medical , Ltd. | 2023-06-20 |
| Zynex Monitoring System, Model CM-1600 (K223217) | Zynex Medical, Inc. | 2023-06-16 |
| BabySat 3 (K222597) | Owlet Babycare, Inc. | 2023-06-16 |
| SpassageQ (K230386) | Spass, Inc. | 2023-06-15 |
| Electronic Blood Pressure Monitor (K223291) | Shenzhen Pango Medical Electronics Co., Ltd. | 2023-06-14 |
| Pounce™ Thrombectomy System (K231022) | Surmodics,Inc. | 2023-06-12 |
| BMR 1900 PHISIO (K223361) | Sorin Group Italia S.R.L. | 2023-06-10 |
| HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid Management software feature with Acumen AFM Cable and Acumen IQ fluid meter, Pressure Controller, Heart Reference Sensor (K223865) | Edwards Lifesciences, LLC | 2023-06-09 |
| Auryon Atherectomy System (K230709) | Eximo Medical, Ltd. | 2023-06-09 |
| AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D Hub (K223918) | Philips Medical Systems Nederland B.V. | 2023-06-08 |
| Acumen Hypotension Prediction Index (HPI) Algorithm (K230057) | Edwards Lifesciences, LLC | 2023-06-08 |
| Ablamap® System (K230008) | Ablacon, Inc. | 2023-06-08 |
| Pantheris LV Atherectomy Catheter (K230005) | Avinger, Inc. | 2023-06-06 |
| Vein360 Reprocessed Visions PV.035 Digital IVUS Catheter (K230584) | Vein 360, LLC | 2023-06-06 |
| ARC Intensive Care Information System (ARC System) (K220117) | Ordinatrum Solutions | 2023-06-06 |
| CPS Direct™ Universal slittable outer guide catheter (DS2C029) (K231311) | ABBOTT MEDICAL | 2023-06-02 |
| Huma RPM (RPM) (K230214) | Medopad, Inc. | 2023-06-02 |
| Laguna™ Clot Retriever System and Malibu™ Aspiration Catheter System (Laguna Thrombectomy System) (K223929) | Innova Vascular, Inc. | 2023-06-01 |
| Radius VSM and Accessories (K223498) | Masimo Corporation | 2023-06-01 |
| Drakon™ and Sequre® Microcatheters (K231293) | Accurate Medical Therapeutics | 2023-06-01 |
| Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology Catheter (K221067) | Surgical Instrument Service and Savings, Inc. | 2023-05-31 |
| PrecisionTAVI (v1.1) (K223809) | Dasi Simulations | 2023-05-30 |
| RFP-100A Connector Cable (Single Use) (K230571) | Baylis Medical Technologies, Inc. | 2023-05-30 |
| Excipio SV Aspiration Catheter and Tubing (K230030) | Contego Medical, Inc. | 2023-05-30 |
| Cerebral Adaptive Index (CAI) Algorithm (K223651) | Edwards Lifesciences, LLC | 2023-05-26 |
| WellsForm Tricuspid Annuloplasty Band (WF) (K230679) | Genesee Biomedical, Inc. | 2023-05-26 |
| Finesse™ Injectable PTA Balloon Dilatation Catheter (K230263) | Summa Therapeutics, LLC | 2023-05-26 |
| CORE 500 Digital Stethoscope (K230111) | Eko Devices, Inc. | 2023-05-26 |
| Saranas Early Bird Bleed Monitoring System (K230273) | Saranas, Inc. | 2023-05-25 |
| Stingray LP Catheter (K231176) | Boston Scientific | 2023-05-25 |
| Kodiak™ Dual Port Coaxial Introducer Kit (K230631) | Argon Medical Devices | 2023-05-22 |
| TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support (K231168) | Imperative Care, Inc. | 2023-05-22 |
| Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors (K220842) | Qura S.R.L | 2023-05-19 |
| BIOMONITOR IV (K230375) | Biotronik, Inc. | 2023-05-19 |
| Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KV1-5W (K222979) | Microlife Intellectual Property GmbH | 2023-05-19 |
| PrevisEA Device (K230769) | Entac Medical, Inc. | 2023-05-19 |
| OptiCrossTM HD Coronary Imaging Catheter, OptiCrossTM 6 HD Coronary Imaging Catheter (K230453) | Boston Scientific Corporation | 2023-05-18 |
| Assert-IQ™ Insertable Cardiac Monitor (K230286) | ABBOTT MEDICAL | 2023-05-17 |
| Gunther Tulip Vena Cava Filter Retrieval Set (K222254) | Cook Incorporated | 2023-05-16 |
| HD+12, HD+15 (K220526) | Cardioline S.P.A | 2023-05-15 |
| Wattson temporary pacing guidewire (2250) (K230637) | Vascular Solutions, LLC | 2023-05-05 |