| Arm type Blood Pressure Monitor, Digital Blood Pressure Monitor-Automatic Upper Arm Style (K181104) | Shenzhen Combei Technology Co., Ltd. | 2018-08-29 |
| Universal SmartECG (K173952) | Vectracor, Inc. | 2018-08-28 |
| CARTO 3 EP Navigation System, Version 5.2 and Accessories with CARTOFINDER Module (K173978) | Biosense Webster, Inc. | 2018-08-24 |
| NC TREK™ RX Coronary Dilatation Catheter; NC TREK™ OTW Coronary Dilatation Catheter; TREK™ RX Coronary Dilatation Catheter; TREK™ OTW Coronary Dilatation Catheter; MINI TREK™ RX Coronary Dilatation Catheter; MINI TREK™ OTW Coronary Dilatation Catheter; MINI TREK™ II OTW Coronary Dilatation Catheter (K180040) | Abbott Vascular | 2018-08-24 |
| Non-invasive blood pressure measurement systems (K173024) | Joytech Healthcare Co. , Ltd. | 2018-08-22 |
| exGraft, exGraft Carbon ePTFE Vascular Grafts (K180957) | Peca Labs | 2018-08-21 |
| Medtronic Model 5392 External Pulse Generator (EPG) (K181973) | Medtronic, Inc. | 2018-08-21 |
| Reusable NIBP Cuff (K173197) | Orantech, Inc. | 2018-08-21 |
| MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT (K173773) | Bayer Medical Care, Inc. | 2018-08-17 |
| Optical Topography System ETG-4100 (K172492) | Hitachi Healthcare Americas | 2018-08-17 |
| Electronic Stethoscope DS3011A (K173663) | Imediplus, Inc. | 2018-08-17 |
| Penumbra System Reperfusion Catheter JET 7 (K173761) | Penumbra, Inc. | 2018-08-17 |
| Quantum Workstation 12.1 (K181923) | Spectrum Medical , Ltd. | 2018-08-17 |
| Multi-parameter Patient Monitor, models C30 (K173454) | Shenzhen Comen Medical Instruments Co.,Ltd | 2018-08-16 |
| RAIN Sheath Transradial (K181592) | Cordis Corporation | 2018-08-15 |
| Pulse Oximeter (K173123) | Shenzhen Imdk Medical Technology Co., Ltd. | 2018-08-13 |
| CARDIOSKIN (K173248) | Bioserenity Sas | 2018-08-11 |
| Altrix Precision Temperature Management System (K180834) | Stryker Medical | 2018-08-10 |
| physiQ Heart Rhythm Module (K180234) | Physiq, Inc. | 2018-08-10 |
| Presygen/si-1 (K171245) | Christie Medical Holdings, Inc. | 2018-08-09 |
| 4F Infiniti Angiographic Catheter, 4F & 5F Nylex Angiography Catheters, 4F & 5F Tempo Angiography Catheters (K181836) | Cordis, A Cardinal Health Company | 2018-08-08 |
| Pure EP (K180805) | Biosig Technologies | 2018-08-08 |
| SmartLinx Vitals Plus Patient Monitoring System (K180734) | Capsule Technologie | 2018-08-08 |
| EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths, EagleRay Access Catheter, 0.071 ID, 137cm Length, EagleRay Access Catheter, 0.055 ID, 137cm Length, EagleRay Access Catheter, 0.045 ID, 144cm Length, EagleRay Access Catheter, 0.035 ID, 158cm Length (K180169) | Imperative Care, Inc. | 2018-08-08 |
| VascuEase IC-1200-WH (K180248) | Bio Compression Systems, Inc. | 2018-08-07 |
| Volo 14 Guidewire, 200cm, Soft Profile, Volo 14 Guidewire, 200cm, Standard Profile, Volo 14 Guidewire, 300cm, Soft Profile, Volo 14 Guidewire, 300cm, Standard Profile (K181828) | Scientia Vascular, LLC | 2018-08-07 |
| VesoFlow Lite DVT Compression Device (K181217) | Caremed Supply, Inc. | 2018-08-05 |
| Arm Type Blood Pressure Monitor (K180155) | Avita Corporation | 2018-08-03 |
| ECG recorder and Arrhythmia Detector (K173461) | Smart Solutions Technologies SL | 2018-08-03 |
| Atlas Gold PTA Dilatation Catheter (K181323) | C.R. Bard, Inc. | 2018-08-03 |
| Glidesheath Slender Tibial Pedal Kit (K181237) | Terumo Medical Corporation | 2018-08-03 |
| Temporary Cardiac Pacing Wire (K173923) | ETHICON, Inc. | 2018-08-02 |
| Med-link Reusable Blood Pressure Cuff (K173869) | Shenzhen Med-Link Electronics Tech Co., Ltd. | 2018-08-02 |
| Epiphany Cardio Server Mobile (K181720) | Epiphany Healthcare, LLC | 2018-07-30 |
| FlowTriever Retrieval/Aspiration System (K181694) | Inari Medical | 2018-07-27 |
| Pulse Oximeter (K172616) | Beijing Safe Heart Technology , Ltd. | 2018-07-27 |
| Vios Central Station Monitor Software, Vios Central Server Software (K173107) | Vios Medical, Inc. | 2018-07-26 |
| Level 1 Convective Warmer (K181699) | Smiths Medical Asd, Inc. | 2018-07-26 |
| RadialSeal Introducer Kit (K181855) | Great Batch Medical | 2018-07-26 |
| Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular Lithotripsy (IVL) Generator And Connector Cable, Intravascular Lithotripsy (IVL) Connector Cable (K180958) | Shockwave Medical, Inc. | 2018-07-26 |
| RHYTHMIA HDx Mapping System (with software Version 2.0) (K173837) | Boston Scientific Corporation | 2018-07-25 |
| CipherOx CRI M1 (K173929) | Flashback Technologies, Inc. | 2018-07-24 |
| MX40 Release C.01 (K180017) | Philips Medical Systems | 2018-07-24 |
| Portable ECG Monitor (ECG3) (K172862) | Andon Health Co, Ltd. | 2018-07-24 |
| Bandit guidewire (K181647) | Vascular Solutions, Inc. | 2018-07-20 |
| WATCHMAN TruSeal Access System (K180864) | Boston Scientific | 2018-07-20 |
| Clarifi Imaging System (K181623) | Modulated Imaging, Inc. | 2018-07-19 |
| ASAHI PTCA Guide Wire ASAHI Gladius Mongo 14, ASAHI Gladius Mongo 14 ES (K180784) | Asahi Intecc Co., Ltd. | 2018-07-18 |
| AngioDynamics, Inc. Soft-Vu and Mariner Angiographic Catheters (K173762) | AngioDynamics, Inc. | 2018-07-18 |
| Embosphere Microspheres (K181300) | Biosphere Medical, S.A. | 2018-07-16 |
| Philips IntelliVue GuardianSoftware (K180534) | Philips Medizin Systeme Boeblingen GmbH | 2018-07-16 |
| MC3 Jugular Dual Lumen Catheter (K180151) | Mc3 Incorporated | 2018-07-16 |
| Medicalgorithmics Unified Cardiac Rehabilitation System (K173969) | Medicalgorithmics S.A. | 2018-07-11 |
| Sterile Disposable Syringes (K172694) | Shenyang Mastech Medical Device Co., Ltd. | 2018-07-06 |
| CheckMyHeart Plus (K172778) | Dailycare Biomedical, Inc. | 2018-07-05 |
| ASAHI PTCA Guide Wire ASAHI SION black (K173277) | Asahi Intecc Co., Ltd. | 2018-07-05 |
| Riptide Aspiration System React 68 Catheter (K180705) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2018-07-04 |
| React 68 Catheter (K180715) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2018-07-04 |
| Venera 508 Deep Vein Thrombosis (DVT) Prevention System (K180389) | Suzhou Minhua Medical Apparatus Supplies Co., Ltd. | 2018-06-29 |
| Sapphire II PRO Balloon Dilatation Catheter (K180921) | Orbusneich Medical Trading, Inc. | 2018-06-28 |
| Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM (K172457) | Deltex Medical Limited | 2018-06-28 |
| Shockwave Medical Intravascular Lithotripsy (IVL) System (K180454) | Shockwave Medical, Inc. | 2018-06-27 |
| Terumo Capiox NX19 Oxygenator with Reservoir (east Orientation), Terumo Capiox NX19 Oxygenator with Reservoir (west Orientation), Terumo Capiox NX19 Oxygenator (east Orientation), Terumo Capiox NX19 Oxygenator (west Orientation) (K180950) | Terumo Cardiovascular Systems Corporation | 2018-06-22 |
| Vios Monitoring System™ Model 2050 (K172586) | Vios Medical, Inc. | 2018-06-22 |
| Ellipsys Vascular Access System (DEN170004) | Avenu Medical, Inc. | 2018-06-22 |
| everlinQ endoAVF System (DEN160006) | Tva Medical, Inc. | 2018-06-22 |
| AIROS 6 Sequential Compression Device (K172770) | Airos Medical, Inc. | 2018-06-22 |
| iSLEEVE Introducer Set (K180785) | Boston Scientific Corporation | 2018-06-22 |
| AIROS 8 Sequential Compression Device (K172779) | Airos Medical, Inc. | 2018-06-22 |
| IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug, 10mm (K181051) | Shape Memory Medical | 2018-06-22 |
| BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC Software (K173028) | Healthstats International Pte. , Ltd. | 2018-06-21 |
| Penumbra System (K180008) | Penumbra, Inc. | 2018-06-20 |
| ViSi Mobile Monitoring System (K180472) | Sotera Wireless, Inc. | 2018-06-19 |
| Reprocessed DecaNav Diagnostic Electrophysiology Catheter (K180710) | Innovative Health, LLC | 2018-06-19 |
| AGE Automatic Upper Arm Blood Pressure Monitor with models BA-815, BA-816, BA-818 and BA-819 (K172895) | Ageless Health Industrial Co., Ltd. | 2018-06-18 |
| Savion DLVR Guidewire, Savion FLX Guidewire (K180726) | Boston Scientific, Inc. | 2018-06-18 |
| FlowTriever Retrieval/Aspiration System (K181325) | Inari Medical, Inc. | 2018-06-17 |
| LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System) (K172011) | Hmicro, Inc. | 2018-06-14 |
| CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP Module (K173977) | Biosense Webster, Inc. | 2018-06-14 |
| Double Flexible Tipped Wire Guides (K181351) | Cook Incorporated | 2018-06-14 |
| Phenom 27 Catheter (K180959) | Cathera, Inc. | 2018-06-11 |
| CAPERE Thrombectomy System (K180722) | Kp Medcure, Inc. | 2018-06-11 |
| SOFIA Plus Aspiration Catheter (K173200) | MicroVention, Inc. | 2018-06-11 |
| Integrated CardioRespiratory System (K173156) | Sensydia, Inc. | 2018-06-08 |
| Sniper Infusion Catheter with Balloon Occlusion (K180904) | Embolx, Inc. | 2018-06-08 |
| Reusable SpO2 Sensors, Disposable SpO2 Sensors (K172981) | APK Technology Co., Ltd. | 2018-06-08 |
| Sentry IVC Filter (K181202) | Novate Medical , Ltd. | 2018-06-06 |
| VTRUST Vital Signs Monitor, Model: TD-2300; FORA Vital Signs Monitor, Model: VSM100 (K172221) | Taidoc Technology Corporation | 2018-06-06 |
| Oximeter (K173045) | Shenzhen Greatmade Tech Limited | 2018-06-05 |
| Check-Flo Performer Introducer Micropuncture Radial Artery Access Set (K171609) | Cook Incorporated | 2018-06-04 |
| CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINT (K180238) | Biosense Webster, Inc. | 2018-06-01 |
| Kenz Cardico1211 (K172068) | Suzuken Co., Ltd. | 2018-06-01 |
| CARDIOSAVE Intra-Aortic Balloon Pump (K181122) | Datascope Corp. | 2018-05-31 |
| ANEROID SPHYGMOMANOMETER (K173246) | Wenzhou Bokang Instruments Co., Ltd. | 2018-05-30 |
| ScioCardio ECG Transmitter (K171019) | Synergen Technology Labs, LLC | 2018-05-30 |
| Pure Flow External Counter-Pulsation Device (K173483) | Xtreem Pulse, LLC | 2018-05-30 |
| Belun Ring (K180174) | Belun Technology Company Limited | 2018-05-29 |
| Tri-Ad 2.0 Adams Tricuspid Band (K181132) | Medtronic | 2018-05-29 |
| ProtekDuo Mini Veno-Venous Cannula Set (K181150) | Cardiacassist, Inc. | 2018-05-25 |
| STAR 65 (K172147) | Skanray Technologies Pvt, Ltd. | 2018-05-25 |