| Prestige Ameritech Pediatric/Child’s Face mask (K160100) | Prestige Ameritech | 2016-10-07 |
| Turbo-Flo PICC Sets (K161496) | Cook Incorporated | 2016-10-07 |
| Cryotop Vitrification Kit and Cryotop Thawing Kit (K160864) | Kitazato Biopharma Co., Ltd. | 2016-10-07 |
| AUTION ELEVEN Semi-Automated Urinalysis System (K160062) | Arkray, Inc. | 2016-10-07 |
| 1717WCC / 1717WGC (K162519) | Rayence Co., Ltd. | 2016-10-06 |
| 1012WCC, 1012WGC (K162518) | Rayence Co., Ltd. | 2016-10-06 |
| CuattroDR (K161937) | Cuattro, LLC | 2016-10-06 |
| Pour Acrylic (K161330) | Dentsply Sirona | 2016-10-06 |
| SimulCare II(TM) (K160246) | Xanacare Technologies, LLC | 2016-10-06 |
| Sapphire NC Plus (K162209) | Orbusneich Medical, Inc. | 2016-10-06 |
| HydroSet XT (K161447) | Orthovita, Inc. | 2016-10-06 |
| uVue HSG/SHG Catheter (K160217) | Cook Incorporated | 2016-10-06 |
| ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16 (K161584) | Asahi Intecc Co., Ltd. | 2016-10-06 |
| iSR'obot MRI-US Fusion (K161109) | Biobot Surgical Pte., Ltd. | 2016-10-06 |
| Ziehm Solo FD (K161976) | Ziehm Imaging GmbH | 2016-10-06 |
| Viveve System (K162547) | Viveve, Inc. | 2016-10-06 |
| I.B.S. 2.0 Osteosynthesis screw (K160174) | In2bones Sas | 2016-10-06 |
| MR Syringe Dual Pack for Solaris Injectors (K161471) | Coeur, Inc. | 2016-10-06 |
| Quantum LB (K161684) | Reliance Orthodontic Products, Inc. | 2016-10-06 |
| APAS Compact with Urine Analysis Module (DEN150059) | Clever Culture Systems AG | 2016-10-06 |
| The Cellfina System (K161885) | Ulthera, Inc. | 2016-10-05 |
| Fingertip Pulse Oximeter MD300CN310 (K161560) | Beijing Choice Electronic Technology Co., Ltd. | 2016-10-05 |
| R2 Dermal Cooling System (K161480) | R2 Dermatology | 2016-10-05 |
| CO2 Laser Therapy Machine (K161925) | Beijing Adss Development Co., Ltd. | 2016-10-05 |
| Dentiq3D (K160666) | 3D Industrial Imaging Co., Ltd. | 2016-10-05 |
| e-fix E35/E36 (K161241) | Alber GmbH | 2016-10-05 |
| R:GEN Laser System (K153769) | Lutronic Corporation | 2016-10-05 |
| ALADDIN HW3.0 (K160327) | Visia Imaging S.R.L. | 2016-10-05 |
| Painmaster MCT Patch (K151995) | Newmark, Inc. | 2016-10-05 |
| Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS (K161854) | The Binding Site Group , Ltd. | 2016-10-04 |
| ATTO Mobility Scooter (K160909) | Moving Life, Ltd. | 2016-10-04 |
| ACTABOND Topical Skin Adhesive (K161050) | Bergen Medical Products, Inc. | 2016-10-04 |
| CD HORIZON® Spinal System (K162494) | Medtronic Sofamor Danek USA, Inc. | 2016-10-04 |
| Arrow Epidural Catheter Kit (K161075) | Teleflexmedical, Inc. | 2016-10-04 |
| LumFix Spinal Fixation Sytem (K160731) | CG Bio Co., Ltd. | 2016-10-04 |
| PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings (K161897) | Kci USA, Inc. (Kinetic Concepts, Inc.) | 2016-10-04 |
| Eyenez Ophthalmic Camera (K161727) | Eyenez, LLC | 2016-10-04 |
| Lumify Ultrasound System (K162549) | Philips Health Care | 2016-10-03 |
| Indiba Diathermia Radiofrequency Device - Activ; Indiba Diathermia Radiofrequency Device - Deep Care (K161458) | Indiba USA, Inc. | 2016-10-03 |
| DMi Dental Implant System (K160060) | Dmi Innovative Medical Technology , Ltd. | 2016-10-03 |
| Dynarex Xeroform Petrolatum Dressing (K152970) | Dynarex Corporation | 2016-10-03 |
| RS80A Diagnostic Ultrasound System (K153539) | Samsung Medison Co., Ltd. | 2016-10-03 |
| FilmArray Respiratory Panel EZ (RP EZ) (K152579) | Biofire Diagnostics, LLC | 2016-10-03 |
| Volumetric Infusion Controller (K153760) | DEKA Research & Development | 2016-10-03 |
| Voluson E6, Voluson E8, Voluson E10 (K162269) | GE Healthcare | 2016-10-03 |
| kneeEOS (K161828) | Onefit Medical | 2016-10-03 |
| SKR 3000 (K162504) | Konica Minolta, Inc. | 2016-10-03 |
| PreXion3D Excelsior (K161881) | Prexion Corporation | 2016-10-03 |
| Esophagus Bougie Set (K161576) | Varian Medical Systems, Inc. | 2016-10-02 |
| SeraQuest Herpes Type 1 Specific IgG (K162276) | Quest International, Inc. | 2016-10-01 |
| TempoCem Clear (K160443) | Dmg USA, Inc. | 2016-09-30 |
| Atteris Antimicrobial Skin Protectant (K161212) | Rochal Industries, LLC | 2016-09-30 |
| Traxcess .007 Mini Guidewire (K161803) | MicroVention, Inc. | 2016-09-30 |
| InterForm Cervical Interbody Cage System (K161608) | Next Orthosurgical | 2016-09-30 |
| Electronic Stethoscope DS301 (K160023) | Imediplus, Inc. | 2016-09-30 |
| LaserCap300, LaserCap224, LaserCap120, LaserCap80 (K161875) | Transdermal Cap, Inc. | 2016-09-30 |
| DENTRIa series (K160140) | Hdx Will Corp. | 2016-09-30 |
| i-Sil (K161774) | Spident Co., Ltd. | 2016-09-30 |
| ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit (K161232) | Halyard Health | 2016-09-30 |
| Xario 100 Diagnostic Ultrasound System, V5.0 (K162187) | Toshibamedical Systems Corporation | 2016-09-30 |
| 8MP Color LCD Monitor (C81W+) (K162527) | Shenzhen Beacon Display Technology Co., Ltd. | 2016-09-30 |
| Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology Catheters (K161464) | Innovative Health, LLC | 2016-09-30 |
| eCareManager 4.0.1 (K153156) | Visicu, Inc. | 2016-09-30 |
| Xprecia Stride Coagulation System, Xprecia System PT Controls (K151964) | Siemens Healthcare Diagnostics | 2016-09-30 |
| SpeediCath Flex Coude (K161672) | Coloplast Corp. | 2016-09-29 |
| Ponto 3, Ponto 3 Power and Ponto 3 SuperPower (K161671) | Oticon Medical AB | 2016-09-29 |
| nva, nvp, and nvt (K162426) | Nvision Biomedical Technologies, LLC | 2016-09-29 |
| Nexcore GI Insufflator (K162332) | Nexcore Technology, LLC | 2016-09-29 |
| Phasix Mesh (K161424) | C.R. Bard, Inc. | 2016-09-29 |
| CreoDent Solidex Custom Abutment (K160436) | Creodent Prosthetics, Ltd. | 2016-09-29 |
| Ambient KVac Wand with Integrated Finger Switches (Ambient KVac IFS), KVac Integrated Cable Wand (KVac ICW) (K162126) | ArthroCare Corporation | 2016-09-29 |
| RENASYS GO (K152163) | Smith & Nephew, Inc. | 2016-09-29 |
| EZEE RETRIEVAL (K162059) | Genicon, Inc. | 2016-09-29 |
| ELSA Spacers (K161379) | Globus Medical, Inc. | 2016-09-29 |
| WOlf High Speed Handpieces - Medium head, WOlf High Speed Handpieces - Small head (K160410) | Dental Savings Club | 2016-09-29 |
| IRIDEX Cyclo G6 Laser System, G-Probe Illuminate (K162416) | Iridex Corporation | 2016-09-29 |
| NuVasive® Reline® System (K161014) | Nu Vasive, Incorporated | 2016-09-28 |
| Aprima Smartesis Centesis Pump (K161002) | Cook Incorporated | 2016-09-28 |
| PINK CAD/CAM disc (K153546) | Polident D.O.O., Dental Products Industry | 2016-09-28 |
| Acuson Freestyle Ultrasound System (K162417) | Siemens Medi Cal Solutions, Inc. | 2016-09-28 |
| Avenue® T TLIF Cage (K161173) | Ldr Spine USA, Inc. | 2016-09-28 |
| BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring System (K160365) | Infopia Co, Ltd. | 2016-09-28 |
| Flowable Wound Matrix (K160136) | Cook Biotech Incorporated | 2016-09-28 |
| NuVasive® CoRoent® Small Interlock™ System (K161442) | Nu Vasive, Incorporated | 2016-09-28 |
| Sound Options Tinnitus Treatment (K161562) | Sound Options Tinnitus Treatments, Inc. | 2016-09-28 |
| MIDWEST RDH Freedom Cordless Prophy System with SmartMode Technology (K160825) | Dentsply Sirona | 2016-09-27 |
| CDB Self Ligating Bracket 8F (K160957) | Cdb Corporation | 2016-09-27 |
| Solana Influenza A+B Assay (K161814) | Quidel Corporation | 2016-09-27 |
| Interlocked Circular Small Field Collimators, Elekta Integrated (K161984) | Aktina Medical Corporation | 2016-09-27 |
| TPH Spectra+ Universal Composite Restorative (K162107) | Dentsply Sirona | 2016-09-27 |
| TRACOE smart Cuff Manager (K152865) | Tracoe Medical GmbH | 2016-09-27 |
| Invacare Platinum Mobile Oxygen Concentrator (K160630) | Invacare Corporation | 2016-09-27 |
| Biopor Porous Polyethylene Implants (K161446) | Ceremed , Inc. | 2016-09-27 |
| STERRAD® NX Sterilizer with ALLClear™ Technology (K160818) | Advanced Sterilization Products | 2016-09-27 |
| OrthoPediatrics Locking Proximal Femur System Cortical Screws (K162307) | OrthoPediatrics Corp. | 2016-09-27 |
| DePuy Synthes TFNA Augmentation System (K160167) | Synthes (USA) Products, LLC | 2016-09-26 |
| Penumbra Aspiration System (K161506) | Penumbra, Inc. | 2016-09-26 |
| Sensor Monitored Alimentary Restriction Therapy (SMART) Device (DEN150033) | Scientific Intake | 2016-09-26 |
| Xenocor Xenoscope Laparoscopic System (K161838) | Xenocor, Inc. | 2016-09-26 |
| LUCERNA Dental Laser (K161185) | Viax Dental Lab | 2016-09-26 |