| Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled (K200205) | Stryker Sustainability Solutions | 2020-05-13 |
| Disposable ECG Cable (K200026) | Shenzhen Changke Connect Electronics Co., Ltd. | 2020-05-12 |
| Critical Alert CommonPath Enterprise (K193043) | Critical Alert | 2020-05-11 |
| Patient Monitor (K192972) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2020-05-07 |
| LiteSaber Wire Torque Assist Device (K200120) | Vesatek, LLC | 2020-05-07 |
| MEDRON Vessel Dilator - 6F x 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F - 17.5F HDPE Dilator (K192283) | Medron, LLC | 2020-05-06 |
| XO Cross Support Catheter (K193420) | Transit Scientific | 2020-05-06 |
| Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical Aspirator (K200871) | Control Medical Technology | 2020-05-04 |
| BOSS Balloon Guide Catheter (K200910) | Marblehead Medical | 2020-05-02 |
| RIST Radial Access Catheter (K200417) | Rist Neurovascular, Inc. | 2020-05-02 |
| Carnation Ambulatory Monitor (K200870) | Bardy Diagnostics, Inc. | 2020-05-01 |
| PulsioFlex Monitoring System with ProAQT Sensor (K192169) | Pulsion Medical Systems SE | 2020-04-30 |
| WOLF Thrombectomy V System (K200101) | Devoro Medical, Inc. | 2020-04-27 |
| Oxi-W System (K200141) | Ld Technology, LLC | 2020-04-27 |
| Leadtek Fingertip Pulse Oximeter (K193350) | Leadtek Research, Inc. | 2020-04-27 |
| Gatekeeper Balloon Catheter (K192786) | Arch Catheter, LLC | 2020-04-25 |
| Biomonitor III, Biomonitor IIIm (K200444) | Biotronik, Inc. | 2020-04-23 |
| Masimo Centroid System (K191882) | Masimo Corporation | 2020-04-22 |
| Indigo Aspiration System Lightning Aspiration Tubing (K200771) | Penumbra, Inc. | 2020-04-22 |
| Instylla Microcatheter (K200744) | Instylla, Inc. | 2020-04-21 |
| Globalcare Blood Pressure Monitor (K192609) | Globalcare Medical Technology Co., Ltd. | 2020-04-21 |
| QuickClear Mechanical Thrombectomy System (K193197) | Volcano Atheromed, Inc. | 2020-04-20 |
| Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2 (Boxed) (K193343) | Vitalconnect, Inc. | 2020-04-20 |
| Route 92 Medical 088 Access System, 110 cm (K200121) | Route 92 Medical, Inc. | 2020-04-18 |
| Traxcess 14 SELECT Guidewire (K200547) | MicroVention, Inc. | 2020-04-16 |
| Philips Biosensor BX100 (K192875) | Philips Medical Systems | 2020-04-16 |
| Serranator PTA Serration Balloon Catheter (K193181) | Cagent Vascular, LLC | 2020-04-15 |
| Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22 (K192850) | Qura S.R.L | 2020-04-13 |
| Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure (K192838) | Spectrum Medical , Ltd. | 2020-04-13 |
| Arrow FiberOptix Intra-Aortic Balloon Catheter Kit (K200634) | Arrow International, Inc. | 2020-04-09 |
| Unified Arrhythmia Diagnostic System PocketECG IV (K193104) | Medicalgorithmics S.A. | 2020-04-09 |
| Nautilus Smart ECMO Module (K191935) | Mc3 Incorporated | 2020-04-09 |
| OxSAT 100 (K191574) | S.L.P. , Ltd. | 2020-04-09 |
| HI-TORQUE Steelcore Bare Guide Wire (K200144) | Abbott Vascular | 2020-04-08 |
| Go2Wire Guide Wire (K193571) | Merit Medical System, Inc. | 2020-04-08 |
| Q3 Distal Access Catheter, Q4 Distal Access Catheter, Q5 Distal Access Catheter, Q6Distal Access Catheter (K192558) | Mivi Neurovascular | 2020-04-06 |
| Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometer (K192500) | Honsun (Nantong) Co., Ltd. | 2020-04-06 |
| Eko CORE (K200776) | Eko Devices, Inc. | 2020-04-06 |
| ADAPT Tissue (K200566) | Admedus Regen Pty, Ltd. | 2020-04-03 |
| Aria System (K200564) | Inova Labs | 2020-04-03 |
| NovaCross CTO Microcatheter (K193322) | Nitiloop , Ltd. | 2020-04-02 |
| Patient Monitor (K192514) | Edan Instruments, Inc. | 2020-04-02 |
| SiteSeal Femoral Compression Device (K192413) | Ensite Vacular, LLC | 2020-03-31 |
| CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRES (K200494) | GE Healthcare | 2020-03-29 |
| QuickDraw Venous Cannula (K200499) | Edwards Lifesciences, LLC | 2020-03-29 |
| BodyGuardian Remote Monitoring System (K192732) | Preventice Technologies, Inc. | 2020-03-26 |
| OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip (K192886) | Volcano Corporation | 2020-03-26 |
| Disposable NIBP Cuff (K193629) | Shenzhen Changke Connect Electronics Co., Ltd. | 2020-03-25 |
| FloPatch (FP120) (K200337) | Flosonics Medical (R/A 1929803 Ontario Corp.) | 2020-03-24 |
| AZUR Vascular Plug (K191680) | MicroVention, Inc. | 2020-03-20 |
| AI-ECG Tracker (K200036) | Shenzhen Carewell Electronics Co., Ltd. | 2020-03-20 |
| ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter (K193183) | Acist Medical Systems, Inc. | 2020-03-20 |
| Super Sheath (K200379) | Togo Medikit Co., Ltd. | 2020-03-19 |
| Compression Therapy Device (K191856) | Guangzhou Longest Science & Technology Co., Ltd. | 2020-03-19 |
| speX LP Support Catheter (K200094) | Reflow Medical | 2020-03-18 |
| WIRION (K200198) | Cardiovascular Systems, Inc. | 2020-03-18 |
| myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS) (K193310) | Abbott (St. Jude Medical) | 2020-03-17 |
| Sunmed Disposable Angio-Closure Pads (K191827) | Sunny Medical Device (Shenzhen) Co., Ltd. | 2020-03-16 |
| Fem-Flex II Femoral Arterial Cannula, Fem-Flex II Femoral Venous Cannula, Femoral Venous Cannula, FemTrak Femoral Venous Cannula (K200358) | Edwards Lifesciences, LLC | 2020-03-13 |
| Disposable SpO2 Sensor (K200069) | Shenzhen Changke Connect Electronics Co., Ltd. | 2020-03-13 |
| Indigo Aspiration System – Lightning Aspiration Tubing (K193244) | Penumbra, Inc. | 2020-03-13 |
| Edwards eSheath Introducer Set (K200258) | Edwards Lifesciences | 2020-03-09 |
| CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula Kit (K200306) | Abbott (Formerly Thoratec Corporation) | 2020-03-06 |
| Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System (K193147) | Stereotaxis, Inc. | 2020-03-05 |
| Capere Thrombectomy System (K200314) | Vascular Medcure, Inc. | 2020-03-04 |
| Sapphire II PRO (K200269) | Orbusneich Medical Trading, Inc. | 2020-03-04 |
| CARDIOVIT AT-102 G2 (K183425) | Schiller AG | 2020-03-02 |
| Paragon Adult Maxi PMP Oxygenator (Model: XCMOP405PMP) (K191246) | Chalice Medical , Ltd. | 2020-02-28 |
| Arctic Sun Stat Temperature Management System (K200225) | Medivance, Inc. | 2020-02-28 |
| AXS Vecta 71 Intermediate Catheter, AXS Vecta 74 Intermediate Catheter (K200206) | Stryker Neurovascular | 2020-02-27 |
| Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and Accessories, Masimo Radius-7 Pulse CO-Oximeter and Accessories (K193242) | Masimo Corporation | 2020-02-27 |
| Penumbra System Penumbra JET 7X (K191946) | Penumbra, Inc. | 2020-02-27 |
| CEREBASE DA Guide Sheath, 95cm, CEREBASE DA Guide Sheath, 90cm, CEREBASE DA Guide Sheath, 80cm, CEREBASE DA Guide Sheath, 70cm (K192804) | Medos International SARL | 2020-02-27 |
| Heater-Cooler System 3T (K191402) | Livanova Deutschland, GmbH | 2020-02-25 |
| Novalung System (K191407) | Fresenius Medical Care Renal Therapies Group, LLC | 2020-02-21 |
| Cardiac Monitor 1500 (K191697) | Zynex Medical, Inc. | 2020-02-21 |
| Upper Arm Blood Pressure Monitor (K191894) | Shenzhen Zhengkang Technology Co., Ltd. | 2020-02-21 |
| Wingman 14, Wingman 14C, Wingman 18, Wingman 35 (K193596) | Reflow Medical | 2020-02-20 |
| speX Support Catheter (K193012) | Reflow Medical | 2020-02-19 |
| Sentinel Cerebral Protection System (K192460) | Boston Scientific Corporation | 2020-02-19 |
| Swan-Ganz Catheters (K193466) | Edwards Lifesciences, LLC | 2020-02-16 |
| EMBA Hourglass Peripheral Embolization Device (PED) (K200083) | Embolic Acceleration, LLC | 2020-02-14 |
| XenoSure Biologic Patch (K190882) | Lemaitre Vascular | 2020-02-13 |
| AcQMap High Resolution Imaging and Mapping System (K193013) | Acutus Medical, Inc. | 2020-02-11 |
| Surfacer Inside-Out Access Catheter System (DEN190038) | Bluegrass Vascular Technologies, Inc. | 2020-02-10 |
| VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single, VitalPatch 5D Biosensor – bag of 20, VitalPatch 7D Biosensor – bag of 20 (K192757) | Vitalconnect, Inc. | 2020-02-06 |
| The Caterpillar and Caterpillar Micro Arterial Embolization Devices (K191532) | C.R. Bard, Inc. | 2020-02-04 |
| Ezvena IPC, Ezvena SQS (K191937) | Eezcare Medical Corp | 2020-01-29 |
| Carescape B850 (K191323) | GE Healthcare Finland Oy | 2020-01-29 |
| WVSM (Wireless Vital Signs Monitor) RWC + miniCap (K191989) | Athena Gtx | 2020-01-29 |
| KardiaMobile, KardiaStation (K191406) | AliveCor, Inc. | 2020-01-24 |
| CARESCAPE B450 (K191249) | GE Healthcare Finland Oy | 2020-01-24 |
| Reprocessed Achieve Catheter Connecting Cable (K193263) | Innovative Health, LLC | 2020-01-24 |
| Disposable SpO2 Sensor (K192608) | Shenzhen Sino-K Medical Technology Co.,Ltd | 2020-01-24 |
| Seca Medical Vital Signs Analyzer 535, Seca mVSA 535, Seca mVSA, Seca 535 (K192092) | Seca GmbH & Co. KG | 2020-01-23 |
| TrapIt (K191229) | Imds Operations B.V. | 2020-01-21 |
| CARESCAPE B650 (K191149) | GE Healthcare Finland Oy | 2020-01-21 |
| Mirage Hydrophilic Guidewire, X-pedion Hydrophilic Guidewire (K193548) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2020-01-18 |
| Merit ONE Snare System (K193507) | Merit Medical Systems, Inc. | 2020-01-17 |
| Study Watch with Irregular Pulse Monitor (K192415) | Verily Life Sciences, LLC | 2020-01-17 |