| Kolplast Cervical Sample Collection Kit (K153128) | Kolplast CI SA | 2017-01-13 |
| Lumipulse G Progesterone-N Calibrators (K163546) | Fujirebio Diagnostics,Inc. | 2017-01-13 |
| OsteoVation Impact (K162864) | Skeletal Kinetics, LLC | 2017-01-13 |
| FREND Vitamin D Test System (K162754) | Nanoentek USA, Inc. | 2017-01-12 |
| Ayers Rock Cervical interbody fusion system (K162694) | Spineway | 2017-01-12 |
| Tooth Shade Resin Material (K162323) | Liaoning Upcera Co., Ltd. | 2017-01-12 |
| WellDoc BlueStar, WellDoc BlueStar Rx (K162532) | Welldoc, Inc. | 2017-01-12 |
| Lumipulse G Prolactin (K163544) | Fujirebio Diagnostics,Inc. | 2017-01-12 |
| SpineGuard DSG Zavation Screw System (K162884) | Spineguard S.A. | 2017-01-12 |
| Lumipulse G LH Calibrators (K163521) | Fujirebio Diagnostics,Inc. | 2017-01-12 |
| Meridian M110 Fetal Monitoring System (K161902) | Mindchild Medical | 2017-01-12 |
| EzDent-i; E2; ProraView (K163533) | Ewoosoft Co., Ltd. | 2017-01-12 |
| 48CH Head Coil (K163205) | Ge Healthcare Coils (Usa Instruments, Inc.) | 2017-01-12 |
| VITEK 2 Gram Negative Ceftriaxone (<=0.25->=64 ug/mL) (K161217) | bioMerieux, Inc. | 2017-01-12 |
| Ostial Sprit Cannulae (K162500) | Spyder Medical | 2017-01-12 |
| Contour Next EZ Blood Glucose Monitoring System (K162336) | Ascensia Diabetes Care U.S., Inc. | 2017-01-12 |
| ACUSON S1000/S2000/S3000 Diagnostic Ultrasound Systems (K163635) | Siemens Medical Solutions USA, Inc. Ultrasound Group | 2017-01-12 |
| Exilis XP II (K163176) | BTL Industries, Inc. | 2017-01-12 |
| Elecsys CYFRA 21-1 CalCheck 5 (K162173) | Roche Diagnostics | 2017-01-12 |
| Venus Velocity Diode Laser System (K162765) | Venus Concept , Ltd. | 2017-01-11 |
| Lympha-Flow(LF1200) (K160178) | Daesung Maref Co., Ltd. | 2017-01-11 |
| R2P Metacross RX (K163479) | KANEKA Corporation | 2017-01-11 |
| ConceptoMed Luer-Jack Slip 10ml (K162057) | Conceptomed AS | 2017-01-11 |
| Desara TV, Desara Blue TV (K162201) | Caldera Medical, Inc. | 2017-01-11 |
| CERAMAGE UP (K162261) | Shofu Dental Corporation | 2017-01-11 |
| ENDOCAM Flex HD Camera System 5521 (K161204) | Richard Wolf Medical Instruments Corporation | 2017-01-11 |
| Dentalis Bio Solution Implants (K161281) | Dentalis Bio Solution Implants, LLC | 2017-01-11 |
| InSeca ARC Stylus, Aerin Console (K162810) | Aerin Medical, Inc. | 2017-01-11 |
| SPY Phi Open Field Handheld Fluorescence Imaging System (K162885) | Novadaq Technologies, Inc. | 2017-01-11 |
| Mortara Surveyor Patient Monitor (K161517) | Mortara Instrument, Inc. | 2017-01-11 |
| U-IGNITE Bladeless Trocar (K162387) | Tianjin Uwell Medical Device Manufacturing Co., Ltd. | 2017-01-11 |
| Epic Pro (K163128) | Biolase, Inc. | 2017-01-11 |
| EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50 Diagnostic Ultrasound System; Affiniti 70 Diagnostic Ultrasound System (K163120) | Philips Ultrasound, Inc. | 2017-01-10 |
| osteo-WEDGE II ® Open Wedge Bone Locking Plate System (K162179) | Graham Medical Technologies, LLC Dba Gramedica | 2017-01-10 |
| Akros Fibulink Syndesmosis Repair Kit (K162805) | Akros Medical | 2017-01-10 |
| Mammomat Fusion with Stereotactic Biopsy (K163252) | Siemens Medical Solutions USA, Inc. | 2017-01-10 |
| Neo GBR System (K160991) | Neobiotech Co., Ltd. | 2017-01-10 |
| Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPak (K163015) | Bio-Rad Laboratories | 2017-01-10 |
| Ceruloplasmin (K161508) | Beckman Coulter Ireland, Inc. | 2017-01-09 |
| Love Alchemy's Love Lotion (K151857) | Love Alchemy, LLC | 2017-01-09 |
| Sentinel BreastScan II System (K162767) | First Sense Medical, LLC | 2017-01-09 |
| Symbia Intevo Bold (K162483) | Siemens Medical Solutions USA, Inc. | 2017-01-09 |
| Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue) (K162818) | Hartalega Sdn Bhd | 2017-01-09 |
| Bindex BI-2 (K161971) | Bone Index Finland , Ltd. | 2017-01-09 |
| RII Multi-function Infrared Thermometer, Model TH52Z (K162083) | Radiant Innovation, Inc. | 2017-01-09 |
| D2P (K161841) | 3D Systems, Inc. | 2017-01-09 |
| DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent (K162208) | Beckman Coulter, Inc. | 2017-01-09 |
| Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs (K162819) | Hartalega Sdn Bhd | 2017-01-09 |
| Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set (K162181) | Cardiacassist, Inc. | 2017-01-06 |
| Disc-FX System (K162490) | Elliquence, LLC | 2017-01-06 |
| Oracle EUS Balloon; Oracle EUS latex balloon - Olympus Radial; Oracle EUS latex balloon - Olympus Linear; Oracle EUS latex balloon - Fujinon Radial; Oracle EUS latex balloon - Fujinon Linear (K163492) | United States Endoscopy Group, Inc. | 2017-01-06 |
| Ingenia 1.5T CX and Ingenia 3.0T CX R5.3 (K162931) | Philips Medical Systems Nederland B.V. | 2017-01-06 |
| Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray (K161504) | Cook Incorporated | 2017-01-06 |
| Hospira Extension Set, Hospira Primary Set (K161036) | Hospira, Inc. | 2017-01-06 |
| Trapper Exchange Device (K162253) | Creganna Medical Aslo Business AS Cregganna Tactx Medical | 2017-01-06 |
| LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control Set (K162969) | DiaSorin, Inc. | 2017-01-06 |
| SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White Suture, Blue Cobraid, Black Cobraid, Mixed Pack; SpeedStitch Needle Loader and Unloader (K163142) | ArthroCare Corporation | 2017-01-06 |
| Spectre guidewire (K163444) | Vascular Solutions, Inc. | 2017-01-06 |
| PrismaSATE (K162887) | Baxter Healthcare Corporation | 2017-01-06 |
| Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3 (K163116) | Philips Medical Systems Nederland B.V. | 2017-01-06 |
| MultiStim ECO (K162086) | PAJUNK GmbH Medizintechnologie | 2017-01-06 |
| DuraGen Secure Dural Regeneration Matrix (K163456) | Integra LifeSciences Corporation | 2017-01-06 |
| Quantib Brain 1.2 (K163013) | Quantib B.V. | 2017-01-06 |
| 8ch Knee-Foot SPEEDER (K162946) | Quality Electrodynamics, LLC | 2017-01-06 |
| NAMIC ClearaCIL Contrast Injection Lines (K163141) | AngioDynamics, Inc. | 2017-01-06 |
| StatStrip Xpress 2 Glucose Hospital Meter System (K163490) | Nova Biomedical Corporation | 2017-01-06 |
| NeuraGen 3D Nerve Guide Matrix (K163457) | Integra LifeSciences Corporation | 2017-01-06 |
| SureClip(TM) Repositionable Hemostasis Clip (K161463) | Micro-Tech (Nanjing) Co., Ltd. | 2017-01-06 |
| LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and LIAISON® EBNA IgG Serum Control Set (K162961) | DiaSorin, Inc. | 2017-01-05 |
| Vevazz LED Heat Lamp (K162763) | Vevazz, LLC | 2017-01-05 |
| Arterys Cardio DL (K163253) | Arterys, Inc. | 2017-01-05 |
| Turbo-Power (2.0mm) Laser Atherectomy Catheters (K162561) | Spectranetics, Inc. | 2017-01-05 |
| VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit (K162705) | Maine Standards Company, LLC | 2017-01-05 |
| Poseidon OCT Spinal Fixation System (K161637) | Medyssey USA, Inc. | 2017-01-05 |
| CrossBay IVF Embryo Transfer Catheter Set (K162064) | Crossbay Medical, Inc. | 2017-01-05 |
| Brightway Brand Nitrile Examination Gloves, Powder Free (Lavender) (K162146) | Brightway Holdings Sdn. Bhd. | 2017-01-05 |
| C2 Cryoballoon Ablation System (K161202) | C2 Therapeutics, Inc. | 2017-01-05 |
| ECHELON FLEX 45mm Powered Plus Articulating Endoscopic Linear Cutters, ECHELON ENDOPATH Endoscopic Linear Cutter Reloads, 45mm (K163454) | Ethicon Endo-Surgery, LLC | 2017-01-05 |
| Chaorum Implant System (K160536) | Medimecca Co., Ltd. | 2017-01-05 |
| LOSPA IS ACP System (K161641) | Corentec Co., Ltd. | 2017-01-05 |
| YOGA Microcatheter (K162563) | Codman & Shurtleff, Inc. | 2017-01-05 |
| AGNES (K160469) | Gowoonsesang Cosmetics Co., Ltd. | 2017-01-05 |
| Sapphire II PRO (K163114) | Orbusneich Medical, Inc. | 2017-01-05 |
| EasyOne Air Spirometer (K161536) | Ndd Medizintechnik AG | 2017-01-05 |
| LIAISON® EA IgG and LIAISON® EA IgG Serum Control Set (K162959) | DiaSorin, Inc. | 2017-01-04 |
| ACUSON P500 Ultrasound System (K163396) | Siemens Medical Solutions USA, Inc. | 2017-01-04 |
| AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System CO2 - FUJINON (K163424) | United State Endoscopy Group, Inc. | 2017-01-04 |
| CephSimulation (K161270) | Anatomage, Inc. | 2017-01-04 |
| Relign System (K162770) | Relign Corporation | 2017-01-04 |
| Caremed Reusable & Disposable SPO2 Sensors (K153184) | Shenzhen Caremed Medical Technology Co., Ltd. | 2017-01-04 |
| B6 (K163429) | Beijing East Whale Imaging Technology Co., Ltd. | 2017-01-04 |
| Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A) (K162223) | Supervision Optimax Sdn Bhd | 2017-01-04 |
| DigitalDiagnost C50 (K163410) | Philips Healthcare (Suzhou) Co., Ltd. | 2017-01-04 |
| Truscope Ultra Patient Monitor (K162234) | Guangdong Biolight Meditech Co., Ltd. | 2017-01-04 |
| Axium Prime Detachable Coil System (K162704) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2017-01-03 |
| Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (K162423) | Haemonetics Corporation | 2017-01-03 |
| Isolator Multifunctional Linear Pen (K163408) | AtriCure, Inc. | 2017-01-03 |
| X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound System (K163427) | Sonoscape Medical Corp. | 2017-01-03 |
| syngo.via MI Workflows (K163421) | Siemens Medical Solutions USA, Inc. | 2017-01-03 |
| MOTO Partial Knee System (K162084) | Medacta International S.A. | 2017-01-03 |