| GAP ENDO-EXO MEDULLARY SYSTEM (K160545) | Pega Medical, Inc. | 2016-11-23 |
| PolyPlex Wound Dressing (K160872) | Global Health Solutions, LLC | 2016-11-23 |
| NobelProcera HT ML FCZ Bridge (K162043) | Nobel Biocare AB | 2016-11-22 |
| Multix Fusion Max (K162971) | Siemens Medical Solutions USA, Inc. | 2016-11-22 |
| Reform® POCT System (K162300) | Precision Spine, Inc. | 2016-11-22 |
| U&U Enteral Syringe (K160855) | U&U Medical Technology Co, Ltd. | 2016-11-22 |
| MRWire Guide Wire (K160594) | Nano4imaging GmbH | 2016-11-22 |
| Pirouette 014 (K162316) | Arravasc, Ltd. | 2016-11-22 |
| LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5; LOQTEQ® VA Distal Anterolateral Tibia Plate 3.5; LOQTEQ® VA Distal Fibula Plate 2.7/3.5 (K161747) | Aap Implantate AG | 2016-11-22 |
| Raycast MammoRx Carbon Fibre Breast Board (K162355) | Orfit Industries NV | 2016-11-22 |
| Leva® Anterior Interbody System (K161993) | Spine Wave, Inc. | 2016-11-22 |
| Disposable High Pressure Injector Syringe (K152906) | Wuxi Yushou Medical Appliances Co., Ltd. | 2016-11-22 |
| ViewPoint 6 (K162743) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2016-11-22 |
| ConvertX Nephroureteral Stent System (K161277) | Brightwater Medical | 2016-11-22 |
| Evolv Model BP7000 Upper Arm Blood Pressure Monitor (K162092) | Omron Healthcare, Inc. | 2016-11-22 |
| Disposal Lens Cleaning Sheath (K153773) | Olympus Medical Systems Corp. | 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 |
| Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray, Model #2102 (K162218) | Nuance Medical, LLC | 2016-11-22 |
| ToeTac™ 10° Hammertoe Fixation System (K161778) | Restore Surgical, LLC Dba Instratek | 2016-11-22 |
| NAVILAS Laser System (K162191) | Od-Os GmbH | 2016-11-22 |
| Compass Cast and MAP (K161408) | Centurion Medical Products Corporation | 2016-11-22 |
| Temporary Snap Abutment (K161435) | Nobel Biocare AB | 2016-11-22 |
| FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter, Retraction Aspirator (K162970) | Inari Medical | 2016-11-22 |
| Smith & Nephew TRUCLEAR ULTRA Mini Tissue Removal Device (K161763) | Smith & Nephew, Inc. | 2016-11-22 |
| MAGNETOM Avantofit, MAGNETOM Skyrafit (K162102) | Siemens Medi Cal Solutions, Inc. | 2016-11-22 |
| DW-1C (K160761) | Dongwon Medical Co., Ltd. | 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 |
| WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx System (K162225) | Welldoc, Inc. | 2016-11-22 |
| AltiVate Anatomic Shoulder System (K162024) | Encore Medical L.P. | 2016-11-21 |
| 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 |
| ZELTIQ CoolSculpting System (K162050) | Zeltiq Aesthetics, Inc. | 2016-11-21 |
| Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control Set (K160762) | Diazyme Laboratories | 2016-11-21 |
| HC Primer (K161891) | Shofu Dental Corporation | 2016-11-21 |
| OptiLux LED Illuminator (K163185) | Isolux, LLC | 2016-11-21 |
| Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2 or less (K162175) | Vietglove Corporation | 2016-11-21 |
| Dental Implant Abutment OKTAGON Bone Level RC, Dental Implant Abutment OKTAGON Bone Level NC (K160132) | Hager& Meisinger GmbH | 2016-11-21 |
| Arthrex Univers Revers Shoulder Prosthesis System (K161782) | Arthrex, Inc. | 2016-11-21 |
| RODO Abutment System (K160786) | Rodo Medical, Inc. | 2016-11-21 |
| Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs (K161944) | Shandong Baisheng Medical Products Co., Ltd. | 2016-11-21 |
| XEN Glaucoma Treatment System (K161457) | Allergan, Inc. | 2016-11-21 |
| Electronic Pulse Stimulator (K160508) | Beijing Choice Electronic Technololgy Co., Ltd. | 2016-11-21 |
| DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) Cage (K162220) | Dio Medical Co., Ltd. | 2016-11-21 |
| GFS Ultimate (K162198) | Parcus Medical, LLC | 2016-11-18 |
| RAPIDO HOLLOW-FIBRE DIALYZERS (K160558) | Bellco Srl | 2016-11-18 |
| Preference Elite Pedicle Screw System (K162160) | Amedica Corporation | 2016-11-18 |
| Fully Automatic Electronic Blood Pressure Monitor (K162230) | Adon Health Co., Ltd. | 2016-11-18 |
| Walk-O2-Bout (K161472) | Essex Industries, Inc. | 2016-11-18 |
| V30 system, V-Form Handpiece BC Medium applicator (K162363) | Viora , Ltd. | 2016-11-18 |
| Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay, Diazyme Human Kappa/Lamda Free Light Chain Calibrator, Diazyme Human Kappa/Lamda Free Light Chain Calibrator (K153394) | Diazyme Laboratories | 2016-11-18 |
| Discovery NM 750b Bopsy (K160933) | GE Healthcare | 2016-11-18 |
| PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator (K160595) | Pms Medikal Ambalaj Sanayi VE Ticaret Ltd Sti | 2016-11-18 |
| HyperBand (K162403) | Ge Medical Systems, LLC | 2016-11-18 |
| MAGNETOM ESSENZA (K161795) | Siemens Medical Solutions USA, Inc. | 2016-11-18 |
| LacriPro Punctum Plug (K161673) | Lacrimedics, Inc. | 2016-11-18 |
| Dosimetry Check Version 5 Release 1 (K162577) | Math Resolutions, LLC | 2016-11-18 |
| Capillus302, Capillus312, Capillus352 (K162994) | Capillus, LLC | 2016-11-18 |
| EVOS Small Fragment Plating System (K162078) | Smith & Nephew, Inc. | 2016-11-18 |
| Quest Diagnostics HairCheck-DT (Cocaine) (K152232) | Quest Diagnostics Incorporated | 2016-11-18 |
| Non-contact Forehead Thermometer (K161735) | Shenzhen Dongdixin Technology Co., Ltd. | 2016-11-17 |
| ProMedTek Model C1400 Shortwave Diathermy Device (K162240) | Promedtek, Inc. | 2016-11-17 |
| Xsert Lumbar Expandable Interbody System (K160959) | X-Spine Systems, Inc. | 2016-11-17 |
| Disposable Circular Stapler for Hemorrhoids, Disposable Circular Stapler, Disposable Linear Stapler, Disposable Endoscopic Linear Cutter Stapler and Cartridge, Disposable Linear Cutter Stapler and Stapler Cartridge (K161905) | Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd | 2016-11-17 |
| Luna 3D Interbody Fusion System (K162431) | Benvenue Medical, Inc. | 2016-11-17 |
| MOSS 100 Pedicle Screw System (K162232) | Biedermann Motech GmbH & Co. KG | 2016-11-17 |
| 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 |
| UltraShape System (K162163) | Syneron Medical, Ltd. | 2016-11-17 |
| Avance Abdominal Dressing Kit (K161939) | Molnlycke Health Care Us, LLC | 2016-11-17 |
| Heyman Packing Applicator Set (K160045) | Varian Medical Systems, Inc. | 2016-11-17 |
| CONTOUR NEXT ONE Blood Glucose Monitoring System (K160682) | Ascensia Diabetes Care | 2016-11-17 |
| Powder Free Nitrile Examination Gloves Flock-Lined, Black Color (K161074) | Shen Wei (Usa), Inc. | 2016-11-17 |
| ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator (K162538) | Siemens Healthcare Diagnostics | 2016-11-17 |
| AirFit N20 (K161978) | Resmed, Ltd. | 2016-11-17 |
| InTRAkit (K162097) | Medtronic Vascular | 2016-11-17 |
| REDAPT Anteverted Cemented Liner (K160923) | Smith & Nephew, Inc. | 2016-11-17 |
| TroClose1200 (K160564) | Gordian Surgical, Ltd. | 2016-11-17 |
| LOGIQ E9, LOGIQ E9 XDClear 2.0 (K163077) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2016-11-17 |
| the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model (K162322) | Access Scientific, LLC | 2016-11-17 |
| ALOKA LISENDO 880 (K162583) | Hitachi , Ltd. | 2016-11-17 |
| VenaCure EVLT NeverTouch Procedure Kit (K162914) | AngioDynamics, Inc. | 2016-11-16 |
| CAD/CAMouflage Milling Block (K162537) | Prismatik Dentalcraft, Inc. | 2016-11-16 |
| iPulse SmoothSkin Gold Hair Removal Device, Venus Silk.expert (K162231) | Cyden Limited | 2016-11-16 |
| DuoCem (K160800) | Coltene/Whaledent AG | 2016-11-16 |
| Aixplorer (K161999) | Supersonic Imagine | 2016-11-16 |
| syngo Application Software (K162541) | Siemens Medical Solutions USA, Inc. | 2016-11-16 |
| LenSX Laser System (K161288) | Alcon Laboratories, Inc. | 2016-11-16 |
| Diode Laser Therapy Machine (K161692) | Beijing Adss Development Co., Ltd. | 2016-11-16 |
| Tyber Medical BioTy® Nanotopography Trauma Screw (K161597) | Tyber Medical, LLC | 2016-11-16 |
| Xperius Ultrasound System (K163020) | Philips Health Care | 2016-11-16 |
| CD HORIZON® Spinal System (K162379) | Medtronic Sofamor Danek USA, Inc. | 2016-11-16 |
| Lumbar Interbody Fusion System (ALIF, PLIF, LLIF, TPLIF) (K160663) | Evolution Spine, LLC | 2016-11-16 |
| touchTymp (K162210) | Maico Diagnostics GmbH | 2016-11-16 |
| SynergEyes A&M (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens, SynergEyes KC (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens, SynergEyes PS (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens, SynergEyes SiH (petrafocon A hem-larafilcon A) Hybrid Daily Wear Contact Lens, SynergEyes UltraHealth for Keratoconus (petrafocon A hem-larafilcon A) Hybrid Daily Wear Co (K153714) | Synergeyes, Inc. | 2016-11-15 |
| HardyCHROM ESBL (K160512) | Hardy Diagnostics | 2016-11-15 |
| Tablo Console (K160881) | Outset Medical, Inc. | 2016-11-15 |
| Achieve Advance Mapping Catheter (K162892) | Medtronic, Inc. | 2016-11-15 |
| AmorChem Titanium Porous Fixation Device (K160791) | Amorchem Holdings, Inc. | 2016-11-15 |