| Hemolung Respiratory Assist System (DEN210006) | Alung Technologies, Inc. | 2021-11-13 |
| EnSite X EP System (K213364) | ABBOTT MEDICAL | 2021-11-11 |
| Venen-trainer (Model: FM150, SFM90) (K203746) | Shenzhen Pango Electronic Co., Ltd. | 2021-11-10 |
| eKuore Pro 4T - REF EP0098 (K212013) | Chip Ideas Electronics S.L. | 2021-11-10 |
| ESSENZ Patient Monitor (K212003) | Livanova Deutschland, GmbH | 2021-11-10 |
| RMU-2000 Automated Chest Compression System (K211289) | Defibtech, LLC | 2021-11-09 |
| Vektor Computational ECG Mapping System (vMap) (K211546) | Vektor Medical, Inc. | 2021-11-09 |
| Quantum Perfusion Single Lumen Cannula 22F, Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F (K203067) | Qura S.R.L | 2021-11-08 |
| Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B (K211288) | Microlife Intellectual Property GmbH | 2021-11-04 |
| ASAP Aspiration Catheter, ASAPLP Aspiration Catheter (K212199) | Merit Medical Systems, Inc. | 2021-11-03 |
| Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor (K201320) | Qura S.R.L | 2021-11-03 |
| IM007 (K210543) | Implicity, Inc. | 2021-11-03 |
| Electronic Blood Pressure Monitor (K212171) | Dongguan Kangweile Electronic Technology Co., Ltd. | 2021-11-01 |
| CARTO 3 EP Navigation System Version 7.2 (K213264) | Biosense Webster, Inc. | 2021-10-29 |
| Thrombuster II Aspiration Catheter (K213166) | Kaneka Medical America, LLC | 2021-10-26 |
| EnSite X EP System (K212061) | Abbott | 2021-10-22 |
| IRNF App (K212516) | Apple, Inc. | 2021-10-22 |
| Belun Ring BLR-100X (K211407) | Belun Technology Company Limited | 2021-10-21 |
| XO Cross Support Catheter (K210322) | Transit Scientific, LLC | 2021-10-21 |
| AVVIGO Guidance System II (K212490) | Boston Scientific Corporation | 2021-10-20 |
| Sterile High-pressure Angiographic Syringes for Single-use (K211564) | Shenzhen Boon Medical Supply Co., Ltd. | 2021-10-19 |
| Aneroid Sphygmomanometer, Aneroid Sphygmomanometer with stethoscope (K211084) | Shanghai Caremate Medical Device Co., Ltd. | 2021-10-19 |
| WOLF Thrombectomy System, 14F (K210911) | Devoro Medical, Inc. | 2021-10-19 |
| Capsule Vitals Plus Patient Monitoring System (K210204) | Capsule Technologie Sas | 2021-10-19 |
| ClotTriever Thrombectomy System (K212632) | Inari Medical, Inc. | 2021-10-18 |
| Arm Blood Pressure Monitor (K210563) | Alicn Medical Shenzhen, Inc. | 2021-10-15 |
| ACUSON AcuNav Volume Intracardiac Echocardiography(ICE) Catheter (K212959) | Siemens Medical Solutions USA, Inc. | 2021-10-15 |
| ViaCath, AcQRate Dx Steerable Catheter (K212593) | Biotronick, Inc. | 2021-10-15 |
| SCORPION Portal Vein Access Set (K213002) | Argon Medical Devices | 2021-10-14 |
| Sapphire NC 24 (K211807) | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2021-10-14 |
| EmboTrap II Revascularization Device, EMBOTRAP III Revascularization Device (K212908) | Neuravi, Ltd. | 2021-10-13 |
| Carescape SpO2 - Masimo (K212876) | Masimo Corporation | 2021-10-08 |
| IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot module rack FMX-4 (K210906) | Philips Medizin Systeme Boeblingen GmbH | 2021-10-07 |
| VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger (K212065) | Remington Medical, Inc. | 2021-10-07 |
| Vital Signs Monitors (K211475) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2021-10-05 |
| Scan Monitor (K201456) | Withings SA | 2021-10-05 |
| Prelude Guide Sheath (K211405) | Merit Medical Systems, Inc. | 2021-10-04 |
| HRSpheres Narrow-Size Embolic Microspheres (K210562) | Suzhou Hengrui Hongyuan Medical Co., Ltd. | 2021-10-01 |
| Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09 (K210139) | Edan Instruments, Inc. | 2021-10-01 |
| electrocardiograph: SE-1202 (K210140) | Edan Instruments, Inc. | 2021-10-01 |
| Philips MR Patient Care Portal (K212227) | Invivo Corporation | 2021-09-30 |
| AngioVac F18 85 (K212386) | AngioDynamics, Inc. | 2021-09-30 |
| Philips IntelliVue GuardianSoftware (Rev. E.0X) (K212208) | Philips Medizin Systeme Boeblingen GmbH | 2021-09-30 |
| Amplatzer Talisman Delivery Sheath (K212738) | ABBOTT MEDICAL | 2021-09-27 |
| Amplatzer Steerable Delivery Sheath (K212026) | ABBOTT MEDICAL | 2021-09-27 |
| ViperCross Support Catheters (K212725) | Cardiovascular Systems, Inc. | 2021-09-24 |
| Reusable NIBP Cuff (K211747) | Shenzhen Coreray Technology Co., Ltd. | 2021-09-23 |
| Automatic Digital Blood Pressure Monitor (K210152) | Aviche Shandong Medical Technology Co, Ltd. | 2021-09-23 |
| Halo One Thin-Walled Guiding Sheath (K212708) | C.R. Bard, Inc. | 2021-09-23 |
| SimpleSENSE Platform (K212160) | Nanowear, Inc. | 2021-09-22 |
| Dayspring Lite (K212287) | Koya Medical, Inc. | 2021-09-21 |
| TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform (K212224) | Imperative Care, Inc. | 2021-09-20 |
| Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System (K203111) | Medtronic | 2021-09-16 |
| Reprocessed Dynamic Tip and XT Steerable Diagnostic Electrophysiology Catheters (K211276) | Innovative Health, LLC | 2021-09-15 |
| Rotarex Atherectomy System (K211738) | C.R. Bard, Inc. | 2021-09-14 |
| Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital Atherectomy system (K210586) | Cardiovascular Systems, Inc. | 2021-09-14 |
| Polaris X Unidirectional Steerable Diagnostic Catheter (K211494) | Boston Scientific Corporation | 2021-09-14 |
| ANNE One (K211305) | Sibel, Inc. | 2021-09-14 |
| AlertWatch:AC (K210160) | Alertwatch, Inc. | 2021-09-10 |
| Blazer™ Dx-20 Bidirectional Steerable Diagnostic Catheter (K211375) | Boston Scientific Corporation | 2021-09-10 |
| Rocket Platinum Cured Cathter (K210509) | Rocket Medical Plc | 2021-09-09 |
| FEops HEARTguide (DEN200030) | Feops NV | 2021-09-08 |
| Full Automatic (NIBP) Blood Pressure Monitor, Model HL858DM (K211127) | Health & Life Co., Ltd. | 2021-09-08 |
| CIRCUL8 Luxe DVT Prevention Device (K211235) | Ortho8, Inc. | 2021-09-08 |
| Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter (K202049) | Applied Medical Resources Corporation | 2021-09-07 |
| Current Health Monitoring System Gen 2 (G2) (K210133) | Current Health | 2021-09-03 |
| WoundExpress (K211200) | Huntleigh Healthcare , Ltd. | 2021-09-03 |
| MultiCath, AcQRate Dx Fixed Curve Catheter (K201445) | Biotronik, Inc. | 2021-09-02 |
| Leadtek Fingertip Pulse Oximeter (Wireless), Leadtek Fingertip Pulse Oximeter (Wireless) (K210032) | Leadtek Research, Inc. | 2021-09-01 |
| Ablamap Software (K203084) | Ablacon, Inc. | 2021-08-31 |
| Wrist Blood Pressure Monitor, Model Name:W203, Wrist Blood Pressure Monitor, Model Name:W202, Wrist Blood Pressure Monitor, Model Name:W1681 (K211041) | Shenzhen Yuezhongxing Technology Co., Ltd. | 2021-08-30 |
| AXS Vecta 46 Intermediate Catheter (K202752) | Stryker Neurovascular | 2021-08-27 |
| WOLF Thrombectomy System, 6F (K210530) | Devoro Medical, Inc. | 2021-08-27 |
| AcQMap High Resolution Imaging and Mapping System (K212345) | Acutus Medical, Inc. | 2021-08-27 |
| ViperCross Support Catheters (K211240) | Cardiovascular Systems, Inc. | 2021-08-26 |
| Balloon Guiding Catheter (K202916) | Shanghai Heartcare Medical Technology Co., Ltd. | 2021-08-25 |
| PROWLER SELECT PLUS; PROWLER EX (K210838) | Medos International SARL | 2021-08-25 |
| TurboHawk Plus Directional Atherectomy System (K212027) | Medtronic, Inc. | 2021-08-24 |
| RenovoCath (K212324) | Renovorx, Inc. | 2021-08-23 |
| Multi-Link X2 ECG Cable and Leadwire System (K211294) | Vyaire Medical, Inc. | 2021-08-16 |
| Penumbra System (Reperfusion Catheter RED 72) (K211654) | Penumbra, Inc. | 2021-08-16 |
| iMap 3D Mapping & Navigation System (iMap System) (K201094) | Cardionxt, Inc. | 2021-08-16 |
| Digital Blood Pressure Monitor WBP Series, including: WBP101, WBP102, WBP103, WBP104, WBP105, WBP106, WBP107 (K210671) | Weony (Shenzhen) Technology Co., Ltd. | 2021-08-13 |
| Caretaker Platform, VitalStream Platform, CT5 (K211588) | Caretaker Medical | 2021-08-13 |
| WATCHMAN FXD Curve Access System (K212228) | Boston Scientific Corporation | 2021-08-13 |
| Jot Dx Insertable Cardiac Monitor (K212206) | Abbott (St. Jude Medical) | 2021-08-13 |
| Crosser iQ CTO Recanalization System (K203363) | C.R. Bard, Inc. | 2021-08-12 |
| ulrichINJECT CT motion (K210541) | Ulrich GmbH & Co. KG | 2021-08-06 |
| AcQMap High Resolution Imaging and Mapping System (K210680) | Acutus Medical, Inc. | 2021-08-05 |
| SelectFlex Neurovascular Access System Family (K211893) | Q'Apel Medical, Inc. | 2021-08-05 |
| PrevisEA Device (K211068) | Entac Medical, Inc. | 2021-08-04 |
| PTA Balloon Catheter (PVQ), MIT PTA Balloon Catheter (PVQ) (K201246) | Qualimed USA, LLC | 2021-08-03 |
| Bullfrog Micro-Infusion Device (K210339) | Mercator Medsystems, Inc. | 2021-08-02 |
| Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform (K203224) | Edwards Lifesciences, LLC | 2021-07-30 |
| Wrist Blood Pressure Monitor, Blood Pressure Monitor (K210768) | Andon Health Co, Ltd. | 2021-07-30 |
| Fingertip Pulse Oximeter (K210274) | Zhuhai Linte Medical Instrument Co., Ltd. | 2021-07-30 |
| EMBOTRAP III Revascularization Device (K211338) | Neuravi, Ltd. | 2021-07-30 |
| Pounce Thrombectomy System (K211492) | Surmodics,Inc. | 2021-07-30 |
| Arm Blood Pressure Monitor, Wireless Blood Pressure Monitor (K210770) | Andon Health Co, Ltd. | 2021-07-29 |
| Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava Filter Set for Jugular Vein Approach, Günther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach (K211874) | William Cook Europe Aps | 2021-07-28 |