| SureLead Cable System (K181089) | Authentic Medical | 2020-01-17 |
| AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QX (K193509) | Acutus Medical, Inc. | 2020-01-17 |
| SoundBite Console, SoundBite Active Wire 18 (K192211) | Soundbite Medical Solution, Inc. | 2020-01-17 |
| VitalScan ANS (K191266) | Medeia, Inc. | 2020-01-15 |
| All’InCath 035M PTA Balloon Dilatation Catheter (K191275) | Nexstep Medical | 2020-01-15 |
| Wattson Temporary Pacing Guidewire (K192454) | Vascular Solutions | 2020-01-15 |
| Eko Analysis Software (K192004) | Eko Devices, Inc. | 2020-01-15 |
| Route 92 Medical Sheath System (K191717) | Route 92 Medical, Inc. | 2020-01-13 |
| FlowMet (K192966) | Laser Associated Sciences, Inc. | 2020-01-10 |
| KardioScreen (K191692) | Imedrix Inc. (Formerly Piitech Inc.) | 2020-01-10 |
| ER-REBOA PLUS Catheter (K193440) | Prytime Medical Devices, Inc. | 2020-01-09 |
| BioCardia 8F Morph DNA Deflectable Guide Catheter (K192774) | Biocardia | 2020-01-07 |
| VV330 Continuous ECG Platform, VivaLNK Adhesive Patch (K191870) | VivaLNK, Inc. | 2020-01-07 |
| R2P Destination Slender Guiding Sheath (K193125) | Terumo Medical Corporation | 2020-01-06 |
| ASAHI PTCA Guide Wire ASAHI Gaia Next (K192599) | Asahi Intecc Co., Ltd. | 2020-01-02 |
| OptoWire III (K191907) | Opsens, Inc. | 2020-01-02 |
| Patient Monitor (K192343) | Shenzhen Creative Industry Co., Ltd. | 2019-12-31 |
| Masimo Rad-97 and Accessories (K191059) | Masimo Corporation | 2019-12-27 |
| VIA Microcatheter (size 17), VIA Microcatheter (size 21), VIA Microcatheter (size 27), VIA Microcatheter (size 33) (K192135) | MicroVention, Inc. | 2019-12-24 |
| Comet II Pressure Guidewire (K193279) | Boston Scientific Corporation | 2019-12-23 |
| Arm Blood Pressure Monitor (K192023) | Truly Instrument Limited | 2019-12-23 |
| RIST Cath Radial Access Long Sheath (K191551) | Rist Neurovascular, Inc. | 2019-12-23 |
| Indigo Aspiration System (K192833) | Penumbra, Inc. | 2019-12-20 |
| Pulse Oximeter (K191403) | Nonin Medical, Inc. | 2019-12-20 |
| Carescape One (K190008) | GE Healthcare | 2019-12-20 |
| ZOLL Arrhythmia Management Sysyem (K190939) | Zoll Manufacturing Corporation | 2019-12-19 |
| Halo One Thin-Walled Guiding Sheath (K192313) | C.R. Bard, Inc. | 2019-12-19 |
| Hereaeus Poseidon Microcatheter (K191305) | Heraeus Medical Components, LLC | 2019-12-19 |
| Electronic Stethoscope (K191667) | Hefei Mintti Medical Technology Co., Ltd. China | 2019-12-18 |
| BioSticker System (K191614) | Biointellisense, Inc. | 2019-12-18 |
| ILUMIEN System with AptiVue Software version D.3 (K192267) | ABBOTT MEDICAL | 2019-12-17 |
| Bashir Plus Endovascular Catheter (K193071) | Thrombolex, Inc. | 2019-12-17 |
| EV1000 Clinical Platform (K193179) | Edwards Lifesciences, LLC | 2019-12-17 |
| Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit (K191758) | Argon Medical Devices, Inc. | 2019-12-17 |
| Physio Flex Annuloplasty Ring (K192762) | Edwards Lifesciences, LLC | 2019-12-16 |
| AXS Vecta Aspiration Catheter (K190833) | Stryker Neurovascular | 2019-12-15 |
| CrossTorq 14 Guidewire (K193194) | Scientia Cardio Access, LLC | 2019-12-13 |
| MEDRAD Stellant FLEX CT Injection System with Certegra Workstation (K192370) | Bayer Medical Care, Inc. | 2019-12-13 |
| C50 and C80 Multi-parameter Patient Monitor (K191106) | Shenzhen Comen Medical Instruments Co.,Ltd | 2019-12-13 |
| OptoMonitor (K192340) | Opsens, Inc. | 2019-12-12 |
| Lumax Guiding Catheter (K191163) | Cook Incorporated | 2019-12-12 |
| HI-TORQUE InfilTrac Guide Wire Family (K193126) | Abbott Vascular | 2019-12-11 |
| Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology Catheter (K191880) | Innovative Health, LLC | 2019-12-11 |
| JETi Peripheral Thrombectomy System (K192439) | Walk Vascular, LLC | 2019-12-09 |
| FFRangio (K192442) | Cathworks, Ltd. | 2019-12-09 |
| T3 Platform software (K190273) | Etiometry, Inc. | 2019-12-08 |
| Disposable SpO2 Sensor (K191279) | Shenzhen Caremed Medical Technology Co., Ltd. | 2019-12-06 |
| MEDRAD Mark 7 Arterion Injection System (K193028) | Bayer Medical Care, Inc. | 2019-12-05 |
| AIROS 6 Sequential Compression Device (K193069) | Airos Medical, Inc. | 2019-12-04 |
| AIROS 8 Sequential Compression Device (K193068) | Airos Medical, Inc. | 2019-12-04 |
| VenaPro Vascular Therapy System (K193020) | Innovamed Health, LLC | 2019-12-04 |
| Glidesheath Slender Tibial Pedal Kit (K193160) | Terumo Medical Coporation | 2019-12-03 |
| TriSalus Infusion System (K193107) | Trisalus Life Sciences | 2019-12-03 |
| Checkme O2 Pulse Oximeter (K191088) | Shenzhen Viatom Technology Co., Ltd. | 2019-12-02 |
| ASAHI CROSSWALK Peripheral Support Catheter (K192782) | Asahi Intecc Co., Ltd. | 2019-11-29 |
| AXS Infinity LS Plus Long Sheath (K193034) | Stryker Neurovascular | 2019-11-29 |
| Rhythmia HDxTM Mapping System (K192438) | Boston Scientific Corporation | 2019-11-27 |
| Upper Arm Blood Pressure Monitor (K191673) | Famidoc Technology Company Limited | 2019-11-27 |
| Hypotension Decision Assist (K190955) | Directed Systems, Ltd. | 2019-11-27 |
| ECG Cable (K191428) | Shenzhen Changke Connect Electronics Co., Ltd. | 2019-11-27 |
| Advocate PTA Catheter (K192907) | Merit Medical Systems, Inc. | 2019-11-26 |
| Heraeus Peripheral Guidewire (K191502) | Heraeus Medical Components, LLC | 2019-11-26 |
| SOZO (K190529) | ImpediMed Limited | 2019-11-25 |
| Trevo Trak 21 Microcatheter (K192122) | Stryker | 2019-11-22 |
| MatriStem UBM Pericardial Patch (K191734) | Acell, Inc. | 2019-11-22 |
| Asahi PTCA Guide Wire Asahi SION Series (K191464) | Asahi Intecc Co., Ltd. | 2019-11-21 |
| Torpedo Gelatin Foam (K192480) | Biosphere Medical, S.A. | 2019-11-21 |
| PG Pro Microcatheter (K192625) | MicroVention, Inc. A TERUMO Group Company | 2019-11-21 |
| Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool (K192996) | Biotronik, Inc. | 2019-11-21 |
| IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient Monitors MX700, MX800, IntelliVue Patient Monitors MP5, MP5SC, Multi-Measurement Module X3 (K182979) | Philips Medizin Systeme Boeblingen GmbH | 2019-11-19 |
| Impella CP Introducer (K192769) | Abiomed, Inc. | 2019-11-18 |
| CAPERE Thrombectomy System (K192935) | Vascular Medcure, Inc. | 2019-11-15 |
| Reprocessed ViewFlex™ Xtra ICE Catheter (K190478) | Sterilmed, Inc. | 2019-11-14 |
| AC3 Series Intra-Aortic Balloon Pump (IABP) (K192238) | Arrow International, Teleflex | 2019-11-12 |
| Dragonfly OpStar™ Imaging Catheter, AptiVue™ Software version E.5.1 (K192019) | ABBOTT MEDICAL | 2019-11-08 |
| CERENOVUS Large Bore Catheter (K191237) | Codman & Shurtleff, Inc. | 2019-11-08 |
| MIMOSA Imager (K190334) | Mimosa Diagnostics, Inc. | 2019-11-01 |
| 087 Balloon Guide Catheter System (K192525) | Q'Apel Medical, LLC | 2019-10-31 |
| ePM Series Patient monitors (K191769) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2019-10-31 |
| Reprocessed Reflexion Spiral Bi-Directional Variable Radius Electrophysiology Catheter (K191170) | Innovative Health, LLC | 2019-10-30 |
| EZE SIT Valvulotome (K190267) | Lemaitre Vascular | 2019-10-30 |
| Okami Medical LOBO Vascular Occlusion System (K192083) | Okami Medical | 2019-10-30 |
| Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri (K192775) | Stereotaxis, Inc. | 2019-10-30 |
| Aristotle 24 Guidewire, 200cm, Soft Profile ; Aristotle 24 Guidewire, 200cm, Standard Profile ; Aristotle 24 Guidewire, 200cm, Support Profile (K192783) | Scientia Vascular, LLC | 2019-10-30 |
| EarlyVue VS30 (K190624) | Philips Medizin Systeme Boeblingen GmbH | 2019-10-27 |
| IntellaMap Orion High Resolution Mapping Catheter (K192360) | Boston Scientific Corporation | 2019-10-25 |
| IOB Warming Blankets (K190221) | Iob Medical, Inc. | 2019-10-25 |
| Cronus HP PTA Balloon Catheter (K190037) | Nipro Medical Corporation | 2019-10-24 |
| FORE-SIGHT ELITE Tissue Oximeter Module (K190270) | Cas Medical Systems, Inc. | 2019-10-21 |
| Pulse Oximeter (K191430) | Shenzhen Yimi Life-Technology Co., Ltd. | 2019-10-18 |
| Bashir S-B Endovascular Catheter, Ref. No. 7101 (K192598) | Thrombolex, Inc. | 2019-10-18 |
| Confirm Rx Insertable Cardiac Monitor (K192593) | Abbott | 2019-10-18 |
| WavelinQ Plus EndoAVF System (K192239) | C.R. Bard, Inc. | 2019-10-17 |
| DyeVert™ Plus Contrast Reduction System, DyeTect™ Contrast Monitoring System, DyeVert™ Plus EZ Contrast Reduction System (K190102) | Osprey Medical, Inc. | 2019-10-17 |
| Carnation Ambulatory Monitor (K192556) | Bardy Diagnostics, Inc. | 2019-10-17 |
| Reusable SpO2 Sensor (K191420) | Shenzhen Changke Connect Electronics Co., Ltd. | 2019-10-11 |
| Belun Ring (K191417) | Belun Technology Company Limited | 2019-10-10 |
| pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire (K191687) | Phenox Limited | 2019-10-09 |
| Steerable Introducer 12F (K192422) | Freudenberg Medical, LLC | 2019-10-04 |
| Vivio System (K183710) | Avicena, LLC | 2019-10-04 |