| PathBuilder Transseptal Guiding Introducer (K212626) | Shanghai Microport EP Medtech Co., Ltd. | 2022-03-23 |
| Pounce Thrombectomy System (K220501) | Surmodics,Inc. | 2022-03-23 |
| Solus Gold Embolization Device (K213200) | Artio Medical, Inc. | 2022-03-21 |
| Cardio Flow Peripheral Guide Wire (K213834) | Cardio Flow Inc., | 2022-03-18 |
| OPTRELL Mapping Catheter with TRUEref Technology (K211438) | Biosense Webster, Inc. | 2022-03-18 |
| VoqX Electronic Stethoscope (K212709) | Sanolla , Ltd. | 2022-03-15 |
| CerusEndo Microcatheter (027) (K213314) | Cerus Endovascular, Inc. | 2022-03-15 |
| OPN NC PTCA Dilatation Catheter (K212393) | Sis Medical AG | 2022-03-14 |
| Reprocessed Carto Vizigo Bi-Directional Guiding Sheath (K212165) | Innovative Health, LLC | 2022-03-10 |
| Amplatzer Steerable Delivery Sheath (K220340) | ABBOTT MEDICAL | 2022-03-09 |
| Reprocessed Pulse Oximeter Sensor (D-25), Reprocessed Pulse Oximeter Sensor (D-25L), Reprocessed Pulse Oximeter Sensor (D-20), Reprocessed Pulse Oximeter Sensor (N-25), Reprocessed Pulse Oximeter Sensor (I-20), Reprocessed Pulse Oximeter Sensor (Max-A), Reprocessed Pulse Oximeter Sensor (Max-AL), Reprocessed Pulse Oximeter Sensor (Max-P), Reprocessed Pulse Oximeter Sensor (Max-N), Reprocessed Pulse Oximeter Sensor (Max-I) (K211138) | Stryker Sustainability Solutions | 2022-03-08 |
| Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (1860 Pediatric O2 Transducer), Reprocessed Masimo Pulse Oximeter (1861 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (1862 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2317 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2319 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (2320 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2328 Infant O2 (K211140) | Stryker Sustainability Solutions | 2022-03-08 |
| Patient Information Center iX (K211900) | Philips Medizin Systeme Böblingen GmbH | 2022-03-04 |
| Wrist-type Fully Automatic Digital Blood Pressure Monitor (K213189) | Joytech Healthcare Co. , Ltd. | 2022-03-01 |
| GoBack Crossing Catheter (K211802) | Upstream Peripheral Technologies, Ltd. | 2022-03-01 |
| DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System (K220109) | Cardiovascular Systems, Inc. | 2022-03-01 |
| Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion System, EOS (K212057) | Artventive Medical Group, Inc. | 2022-03-01 |
| FEops HEARTguide (K214066) | Feops NV | 2022-02-25 |
| Pulse Oximeter (K212300) | Shenzhen Mericonn Technology Co., Ltd. | 2022-02-25 |
| Cleaner Plus Thrombectomy System (K211798) | Argon Medical Devices, Inc. | 2022-02-24 |
| Wrist Blood Pressure Monitor, models AOJ-35A, AOJ-35B, AOJ-35C, AOJ-35D, AOJ-35E (K213503) | Shenzhen AOJ Medical Technology Co., Ltd. | 2022-02-18 |
| SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbands (K212977) | Cordis Corporation | 2022-02-17 |
| Mac-Lab Recording Systems AltiX, CardioLab Recording Systems AltiX, ComboLab Recording Systems AltiX, MLCL Client Software AltiX (K213972) | Ge Healthcare Information Technologies, Inc. | 2022-02-17 |
| Lunderquist Extra Stiff Wire Guide (K220137) | William Cook Europe Aps | 2022-02-17 |
| Xtractor device (K211679) | Xcardia Innovation , Ltd. | 2022-02-17 |
| Fogarty Occlusion Catheter (K211610) | Edwards Lifesciences, LLC | 2022-02-14 |
| RithmID-SD Steerable Diagnostic Electrophysiology Catheter (K203793) | Synaptic Medical Corporation | 2022-02-14 |
| Pulse Oximeter (K211400) | Beijing Choice Electronic Technology Co., Ltd. | 2022-02-11 |
| Zyter RPM (K212622) | Zyter, Inc. | 2022-02-11 |
| Khelix Steerable Electrophysiology Catheters, Khelix Loop Fixed Electrophysiology Catheters, Khelix Fixed Loop Steerable Electrophysiology Catheters, Khelix Variable Loop Steerable Electrophysiology Catheters (K211327) | CathRx, Ltd. | 2022-02-10 |
| Micro Catheter (K202926) | Shanghai Heartcare Medical Technology Co., Ltd. | 2022-02-10 |
| Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike Gold catheter, GuideLiner V3 catheter, TrapLiner catheter (K212211) | Vascular Solutions, LLC | 2022-02-09 |
| Veinoflow SCD (Model: LBTK-M-I 5006) (K213313) | Dalian Labtek Science & Development Co., Ltd. | 2022-02-09 |
| R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire (K212167) | Vascular Solutions, LLC | 2022-02-09 |
| AcQCross Qx Integrated Transseptal Dilator/Needle (K220047) | Acutus Medical, Inc. | 2022-02-08 |
| PathBuilder Steerable Introducer (K211530) | Shanghai Microport EP Medtech Co., Ltd. | 2022-02-08 |
| LifePath Remote Patient Monitoring Platform (K211822) | Elastic Care Incorporated | 2022-02-03 |
| JETi AIO Peripheral Thrombectomy System (K213565) | Walk Vascular, LLC | 2022-02-01 |
| Infinity Acute Care System (IACS) Monitoring System (K203088) | Draeger Medical Systems, Inc. | 2022-02-01 |
| 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,Quantum Perfusion Blood Oxygenator with Integrated AF VT160-C2U (K212341) | Qura S.R.L | 2022-01-28 |
| QuikPass Catheter (K214106) | Traverse Vascular, Inc. | 2022-01-28 |
| VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger (K211589) | Remington Medical, Inc. | 2022-01-27 |
| RA-T59 Wrist blood pressure monitor (K212312) | Lotusnine Medical Limited | 2022-01-27 |
| 9Line (K211941) | Energetic Designs, Inc. | 2022-01-27 |
| Merlin Aspiration System (K213771) | Mivi Neurovascular, Inc. | 2022-01-27 |
| LASSOSTAR NAV Circular Mapping Catheter (K211219) | Biosense Webster, Inc. | 2022-01-26 |
| Biotres (K211709) | Biotricity | 2022-01-19 |
| Arm Blood Pressure Monitor, model OB30, OB31, OB32, OB33 (K211532) | Yibin Junxin Electronics Technology Co., Ltd. | 2022-01-19 |
| OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HD (K213593) | Boston Scientific Corporation | 2022-01-14 |
| Capsule Surveillance System (K213335) | Capsule Surveillance Technologies, Sas /Capsule Tech, Inc. | 2022-01-14 |
| Bio-Medicus Life Support Catheter and Introducer (K201057) | Medtronic, Inc. | 2022-01-14 |
| Pulse Oximeter (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204, FRO-100, FRO-101, FRO-102, FRO-103, FRO-104) (K211632) | Shenzhen Narig Bio-Medical Technology Co., Ltd. | 2022-01-14 |
| BIB Stent Placement Catheter (K213915) | NuMED, Inc. | 2022-01-12 |
| Arm Blood Pressure Monitor (K212877) | Alicn Medical Shenzhen, Inc. | 2022-01-12 |
| Cardiovascular Suite 4.2.1 (K202094) | Quipu S.R.L | 2022-01-11 |
| Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat Exchanger (K212688) | Qura S.R.L | 2022-01-10 |
| Selebrek PTCA Balloon Dilatation Catheter (K211349) | Kossel Medtech (Suzhou) Co., Ltd. | 2022-01-07 |
| Agile Devices Angler Steerable, Deflectable Microcatheter (K211110) | Agile Devices, Inc. | 2022-01-07 |
| Prelude IDeal 9F Hydrophilic Sheath Introducer (K212152) | Merit Medical Systems | 2022-01-07 |
| Tigereye CTO-Crossing Catheter (K212468) | Avinger, Inc. | 2022-01-06 |
| Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure Monitor (K212115) | Joytech Healthcare Co. , Ltd. | 2022-01-05 |
| Pulse Oximeter (K210305) | Dongguan Lingxin Technologies Co., Ltd. | 2021-12-22 |
| CavaClear Laser Sheath (DEN210024) | Spectranetics, Inc. | 2021-12-21 |
| Progreat Lambda (K211078) | Terumo Clinical Supply Co., Ltd. | 2021-12-21 |
| CardiaMend Pericardial and Epicardial Reconstruction Matrix (K210331) | Helios Cardio, Inc. | 2021-12-21 |
| Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled (K212776) | Innovative Health, LLC | 2021-12-20 |
| Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Start-Up Kit, Coolgard 3000 Console, Thermogard XP Console (K213031) | Zoll Circulation, Inc. | 2021-12-20 |
| TR BAND Radial Compression Device (K213531) | Terumo Medical Corporation | 2021-12-20 |
| EMBOGUARD Balloon Guide Catheter (K212340) | Neuravi Limited | 2021-12-17 |
| Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood Oxygenator ECC VT200-E2, Quantum Perfusion Blood Oxygenator ECC VT160-E1, Quantum Perfusion Blood Oxygenator ECC VT160-E2 (K203424) | Qura S.R.L | 2021-12-17 |
| MIVI Q Distal Access Catheter (K212402) | Mivi Neuroscience, Inc. | 2021-12-16 |
| Revolution Peripheral Atherectomy System (K212351) | Rex Medical, L.P. | 2021-12-15 |
| Chocolate PTA Balloon Catheter (K213631) | Medtronic, Inc. | 2021-12-15 |
| Merit Siege Vascular Plug (K212817) | Merit Medical System, Inc. | 2021-12-15 |
| Serranator PTA Serration Balloon Catheter (K213728) | Cagent Vascular, LLC | 2021-12-15 |
| EkoSonic Endovascular Device, EKOS+ Endovascular Device (K213422) | Boston Scientific Corporation | 2021-12-14 |
| Branchor Balloon Guide Catheter (K203723) | Asahi Intecc Co., Ltd. | 2021-12-10 |
| AMG PMP Infant (K202510) | Eurosets S.R.L | 2021-12-10 |
| Traveler 0.038 Stylet Portal Vein Access (TPS001), Traveler 21ga Needle Portal Vein Access Set (TPS002), Traveler 16ga Needle Portal Vein Access Set (TPS003) (K213638) | Argon Medical Devices | 2021-12-10 |
| Infinity Acute Care System (IACS) Monitoring Solution (K201764) | Draeger Medical Systems, Inc. | 2021-12-09 |
| AirStrip ONE Web Client with Alarm Communication Management (ACM) (K211949) | Airstrip Technologies, Inc. | 2021-12-09 |
| ASAHI PCI Guide Wire ASAHI CONFIANZA PRO 8-20 (K211898) | Asahi Intecc Co., Ltd. | 2021-12-08 |
| INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also referred to as OxyAlert NIRSensor) (K211561) | Covidien, LLC | 2021-12-05 |
| AHI System (K212219) | Fifth Eye, Inc. | 2021-12-03 |
| KardiaMobile Card (K211668) | AliveCor, Inc. | 2021-11-30 |
| Trevo Trak 21 Microcatheter (K211594) | Stryker Neurovascular | 2021-11-26 |
| Guiding Catheter (K210009) | CenterPoint Systems, LLC | 2021-11-24 |
| Hypotension Decision Assist Model HDA-OR2 (K212529) | Directed Systems, Ltd. | 2021-11-23 |
| Pre-Formed Extra Support Guidewire (K211741) | Lake Region Medical | 2021-11-22 |
| Spartan MC 0165 (K213451) | Spartan Micro | 2021-11-22 |
| Eclipse PRO (K211651) | Spacelabs Healthcare, Ltd. | 2021-11-22 |
| EkoSonic Endovascular Device (K211080) | Boston Scientific | 2021-11-19 |
| Capiox iCP Centrifugal Pump (K200091) | Terumo Cardiovascular Systems Corporation | 2021-11-18 |
| SyneCare 1100 Deep Vein Thrombosis Prevention Therapy System (K211937) | Jiangsu Synecoun Medical Technology Co., Ltd. | 2021-11-18 |
| Cardiologs Holter Platform (K212112) | Cardiologs Technologies | 2021-11-18 |
| Reprocessed IntellaMap Orion High Resolution Mapping Catheter (K211662) | Innovative Health, LLC | 2021-11-18 |
| Pantheris System (K212047) | Avinger, Inc. | 2021-11-16 |
| Esperance Aspiration Catheter System (K211697) | Wallaby Medical | 2021-11-16 |
| Vital Signs Monitor (K211754) | Beijing Choice Electronic Technology Co., Ltd. | 2021-11-15 |
| Circul8 Pro (K212731) | Ortho8, Inc. | 2021-11-15 |