| Reprocessed Kendall SCD Express Compression Sleeves, Reprocessed Kendall SCD Comfort Compression Sleeves (K163620) | Covidien | 2017-01-19 |
| Quantum Workstation (K163657) | Spectrum Medical , Ltd. | 2017-01-18 |
| Multi-Link X2 ECG Cable and Lead Wire System (K162432) | Carefusion 2200, Inc. | 2017-01-18 |
| Chameleon PTA Balloon Catheter (K163231) | Av Medical Technologies, Ltd. | 2017-01-17 |
| Ostial Sprit Cannulae (K162500) | Spyder Medical | 2017-01-12 |
| R2P Metacross RX (K163479) | KANEKA Corporation | 2017-01-11 |
| Mortara Surveyor Patient Monitor (K161517) | Mortara Instrument, Inc. | 2017-01-11 |
| Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set (K162181) | Cardiacassist, Inc. | 2017-01-06 |
| Trapper Exchange Device (K162253) | Creganna Medical Aslo Business AS Cregganna Tactx Medical | 2017-01-06 |
| Spectre guidewire (K163444) | Vascular Solutions, Inc. | 2017-01-06 |
| NAMIC ClearaCIL Contrast Injection Lines (K163141) | AngioDynamics, Inc. | 2017-01-06 |
| Turbo-Power (2.0mm) Laser Atherectomy Catheters (K162561) | Spectranetics, Inc. | 2017-01-05 |
| YOGA Microcatheter (K162563) | Codman & Shurtleff, Inc. | 2017-01-05 |
| Sapphire II PRO (K163114) | Orbusneich Medical, Inc. | 2017-01-05 |
| Caremed Reusable & Disposable SPO2 Sensors (K153184) | Shenzhen Caremed Medical Technology Co., Ltd. | 2017-01-04 |
| Truscope Ultra Patient Monitor (K162234) | Guangdong Biolight Meditech Co., Ltd. | 2017-01-04 |
| Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter (K162675) | Masimo Corporation | 2016-12-28 |
| AMPLATZER TorqVue 45x45 Delivery Sheath (K163000) | Aga Medical COrporation (Wholly Owned by St. Jude Medical CO | 2016-12-23 |
| Model X-100C CO-Met™ Oximetry System (K160231) | Nonin Medical, Inc. | 2016-12-23 |
| Reprocessed Kendall SCD Express Foot Cuff (K163055) | Covidien | 2016-12-23 |
| Patient Monitor (K160981) | Edan Instruments, Inc. | 2016-12-22 |
| Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector Cable; Lithoplasty Connector Cable (K163306) | Shockwave Medical, Inc. | 2016-12-22 |
| Pantheris Catheter (8F); Pantheris Cather (7F); Lightbox HS Imaging Console; Lightbox Sled (K163264) | Avinger, Inc. | 2016-12-21 |
| Ox-Imager CS (K153426) | Modulated Imaging, Inc. | 2016-12-21 |
| TelePatch Cardiac Monitor (K161916) | Medicomp, Inc. | 2016-12-21 |
| Reprocessed Viking Diagnostic Electrophysiology Catheters (K162251) | Innovative Health, LLC | 2016-12-21 |
| CipherOx CRI Tablet (DEN160020) | Flashback Technologies, Inc. | 2016-12-21 |
| LC Bead LUMI (K162373) | Biocompatibles UK Limited | 2016-12-16 |
| HyperView Hyperspectral Tissue Oxygenation Measurement System (K161237) | Hypermed Imaging, Inc. | 2016-12-16 |
| Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Cathete (K163200) | Boston Scientific Corporation | 2016-12-14 |
| Emerge PTCA Dilatation Catheter (K163174) | Boston Scientific Corporation | 2016-12-14 |
| Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12 Pole 333 Bi D, Advisor FL 20mm 12 Pole 555 Bi D (K160335) | St Jude Medical | 2016-12-13 |
| MediGuide Technology System (K162643) | St Jude Medical | 2016-12-13 |
| Castor, Achilles and Hermes NC PTA Balloon Dilatation Catheter (K160941) | Brosmed Medical Co., Ltd. | 2016-12-13 |
| AutoMark Module (K160218) | St Jude Medical | 2016-12-13 |
| EnSite Precision Cardiac Mapping System v2.0 (K160210) | St Jude Medical | 2016-12-13 |
| Traxcess 7 Mini XSoft Guidewire (K163154) | MicroVention, Inc. | 2016-12-09 |
| Reprocessed Response Diagnostic Electrophysiology Catheters (K161827) | Innovative Health, LLC | 2016-12-08 |
| Worker Guidewire (K160785) | Argon Medical Devices, Inc. | 2016-12-08 |
| Endura guidewire (K161702) | Vascular Solutions, Inc. | 2016-12-06 |
| Reprocessed Supreme Diagnostic Electrophysiology Catheters (K161769) | Innovative Health, LLC | 2016-12-06 |
| Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface (K162896) | Medtronic, Inc. | 2016-12-06 |
| Altrix Precision Temperature Management System (K152266) | Stryker Medical | 2016-12-02 |
| Pioneer Plus Catheter (K162418) | Philips Volcano | 2016-12-02 |
| Protek Solo 24 Fr Venous Cannula Set (K162214) | Cardiacassist, Inc. | 2016-11-30 |
| SimplECG (K161431) | Nanowear, Inc. | 2016-11-30 |
| Med-link Reusable Blood Pressure Cuff, Med-link Disposable Blood Pressure Cuff (K160530) | Shenzhen Med-Link Electronics Tech Co., Ltd. | 2016-11-28 |
| VAMP Venous/Arterial Blood Management Protection System (K161962) | Edwards Lifesciences, LLC | 2016-11-28 |
| Masimo Disposable Transflectance Forehead Sensor (K160940) | Masimo Corporation | 2016-11-23 |
| MRWire Guide Wire (K160594) | Nano4imaging GmbH | 2016-11-22 |
| Pirouette 014 (K162316) | Arravasc, Ltd. | 2016-11-22 |
| Disposable High Pressure Injector Syringe (K152906) | Wuxi Yushou Medical Appliances Co., Ltd. | 2016-11-22 |
| Evolv Model BP7000 Upper Arm Blood Pressure Monitor (K162092) | Omron Healthcare, Inc. | 2016-11-22 |
| Fingertip Pulse Oximeter A310 (K153021) | Amemo, Inc. | 2016-11-22 |
| Pacel Flow Directed Pacing Catheter (K161873) | St Jude Medical | 2016-11-22 |
| Compass Cast and MAP (K161408) | Centurion Medical Products Corporation | 2016-11-22 |
| FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter, Retraction Aspirator (K162970) | Inari Medical | 2016-11-22 |
| Arm automatic blood pressure monitor (K161708) | Shenzhen Pump Medical System Co., Ltd. | 2016-11-22 |
| CXI Support Catheter (K160884) | Cook Incorporated | 2016-11-22 |
| CorSens (K160656) | Corsens Medical , Ltd. | 2016-11-21 |
| SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D Diagnostic eco Ultrasound Catheters (K161700) | Sterilmed, Inc. | 2016-11-21 |
| Fully Automatic Electronic Blood Pressure Monitor (K162230) | Adon Health Co., Ltd. | 2016-11-18 |
| IQvitals Zone (K161909) | Midmark Corporation | 2016-11-17 |
| Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump for the Terumo Advanced Perfusion System 1 (K162843) | Terumo Cardiovascular Systems Corporation | 2016-11-17 |
| InTRAkit (K162097) | Medtronic Vascular | 2016-11-17 |
| the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model (K162322) | Access Scientific, LLC | 2016-11-17 |
| Achieve Advance Mapping Catheter (K162892) | Medtronic, Inc. | 2016-11-15 |
| Vital Sync Informatics Manager & Virtual Patient Monitoring Platform (K160718) | Covidien | 2016-11-14 |
| Sunmed Control Syringes (K160190) | Sunny Medical Device (Shenzhen) Co., Ltd. | 2016-11-10 |
| LUCAS 3 Chest Compression System (K161768) | Jolife AB | 2016-11-09 |
| Pinpoint GT Introducer Needle (K162769) | C.R. Bard, Inc. | 2016-11-04 |
| Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Express SD Biliary Monorail Premounted Stent System, Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Catheter, Sterling Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Ultra-Soft SV Monorail Balloon Dilatation Catheter 0.018 (K162350) | Boston Scientific Corporation | 2016-11-04 |
| SwiftNINJA Microcatheter (K161921) | Merit Medical Systems, Inc. | 2016-11-04 |
| CardioInsight Cardiac Mapping System (K162440) | Cardioinsight Technologies, Inc. | 2016-11-04 |
| Intermittent Pneumatic Compression system (K160180) | Daesung Maref Co., Ltd. | 2016-11-03 |
| Electronic Sphygmomanometer (K160349) | Guangdong Biolight Meditech Co., Ltd. | 2016-11-03 |
| Boosting Catheter (K160561) | Qxmedical, LLC | 2016-11-02 |
| Reprocessed Inquiry Optima Plus Steerable Diagnostic EP Catheter, Reprocessed Inquiry Optima Steerable Diagnostic EP Catheter (K160421) | Innovative Health, LLC | 2016-11-02 |
| CARDIOLINE touchECG (K160746) | Cardioline S.P.A | 2016-11-02 |
| Pleurx Pleural Catheter System (K160450) | Care Fusion | 2016-10-31 |
| Squirt Fluid Delivery System (K162777) | Merit Medical Systems, Inc. | 2016-10-31 |
| Disposable Pressure Transducer (K152472) | Zhejiang Haisheng Medical Device Co., Ltd. | 2016-10-31 |
| Torcon NB Advantage Catheters (K161822) | Cook Incorporated | 2016-10-27 |
| CorPath GRX System (K160121) | Corindus, Inc. | 2016-10-27 |
| REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip (K160583) | Volcano Corporation | 2016-10-26 |
| Reprocessed Orbiter ST Steerable Diagnostic EP Catheter (K161393) | Innovative Health, LLC | 2016-10-26 |
| Tempo Temporary Pacing Lead (K160260) | Biotrace Medical, Inc. | 2016-10-25 |
| NIRO-200NX DP (K162117) | Hamamatsu Photonics K.K. | 2016-10-25 |
| Caremed patient cable and leadwires (K153188) | Shenzhen Caremed Medical Technology Co., Ltd. | 2016-10-24 |
| Automatic Arm Bluetooth Blood Pressure Monitor (K161846) | Truly Instrument Limited | 2016-10-24 |
| TRAcelet Compression Device (K162027) | Medtronic Vascular | 2016-10-21 |
| Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0 (K160187) | St Jude Medical | 2016-10-21 |
| Fluent inflation device (K162272) | Vascular Solutions, Inc. | 2016-10-20 |
| Tyto Stethoscope (K160401) | Tyto Care , Ltd. | 2016-10-19 |
| Pantheris Catheter, Lightbix HS Imaging Console, Lightbox Sled (K162326) | Avinger, Inc. | 2016-10-18 |
| EasyMap MAP Catheter (K151139) | Medfact Engineering GmbH | 2016-10-18 |
| ENROUTE 0.014 Guidewire (K160643) | Lake Region Medical | 2016-10-18 |
| Medtronic Temporary External Pacemaker 53401 (K162054) | Medtronic, Inc. | 2016-10-18 |
| ClearLumen II Thrombectomy System (K161786) | Walk Vascular, LLC | 2016-10-18 |
| Fingertip Pulse Oximeter MD300CG11/MD300CG51 (K160268) | Beijing Choice Electronic Technology Co., Ltd. | 2016-10-14 |