| Elation Pulmonary Balloon Dilation (K161392) | Merit Medical Systems, Inc. | 2016-09-01 |
| EzRay Air (Model VEX-P300) (K161063) | VATECH Co., Ltd. | 2016-09-01 |
| Hi bebe plus (K160274) | Bistos Co., Ltd. | 2016-09-01 |
| Ambu aScope 3 Regular 5.0/2.2, Ambu aScope 3 Slim 3.8/1.2, Ambu aScope 3 Large 5.8/2.8, Ambu aView Monitor (K161656) | Ambu A/S | 2016-09-01 |
| PerkinElmer, XRpad2 3025 HWC-M Flat Panel Detector (K161942) | Perkinelmer, Inc. | 2016-09-01 |
| EMG Pink Nitrile Examination Glove Powder Free (K161320) | Eco Medi Glove Sdn. Bhd. | 2016-09-01 |
| Madsen Zodiac (K161707) | Gn Otometrics | 2016-09-01 |
| MTA2.2 MATERIAL (K161239) | Avalon Biomed, Inc. | 2016-09-01 |
| IBL 5000 Tanning Booth (K152405) | Ibl Acquisitions, LLC | 2016-09-01 |
| SIGNA Voyager (K161567) | GE Healthcare | 2016-09-01 |
| HydroCoil Embolic System (HES) (K161367) | MicroVention, Inc. | 2016-08-31 |
| Exactech® Novation® Element Press-fit Femoral Stem (K153649) | Exactech, Inc. | 2016-08-31 |
| ACCU-CHEK Guide Blood Glucose Monitoring System (K160944) | Roche Diabetes Care, Inc. | 2016-08-31 |
| Trojan Chain Reaction Personal Lubricant (K161544) | Church & Dwight Co., Inc. | 2016-08-31 |
| Vscan Extend (K161588) | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2016-08-31 |
| MTA Repair HP (K151047) | Angelus Industria DE Productos Odontologicos | 2016-08-31 |
| MAGiC (K161397) | Ge Medical Systems, LLC | 2016-08-31 |
| 1.5T and 3.0T 16 CH GE Shoulder Coils (K162001) | Invivo Corporation | 2016-08-31 |
| RENASYS-G Gauze Dressing Kits with Soft Port (K162129) | Smith & Nephew, Inc. | 2016-08-31 |
| Erbe’s CO2 Tubing/Cap Sets (K162152) | Erbe USA, Inc. | 2016-08-31 |
| MicroPlex Coil System (MCS) - HyperSoft 3D (K161452) | MicroVention, Inc. | 2016-08-31 |
| Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System) (K153193) | Zyno Medical, LLC | 2016-08-30 |
| ANAX™ 5.5 Spinal System (K162189) | U&I Corporation | 2016-08-30 |
| CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests (K161251) | Hangzhou Clongene Biotech Co., Ltd. | 2016-08-30 |
| OnSight 3D Extremity System (K160723) | Carestream Health, Inc. | 2016-08-30 |
| Miret Grasper, Alligator, Miret Grasper, Maryland (K160149) | Miret Surgical, Inc. | 2016-08-30 |
| USP Sterile Water, 120 mL cup, USP Sterile Normal Saline (0.9% sodium chloride), 120 mL cup, USP Sterile Water, 100 mL,250 mL and 500 mL bottles, USP Sterile Normal Saline (0.9% sodium chloride), 100 mL, 250 mL and 500 mL bottles (K161311) | Strukmyer Medical, LLC | 2016-08-29 |
| Digital Thermometer (K161211) | Biocare Asia Corporation , Ltd. | 2016-08-29 |
| INDEPENDENCE MIS Spacers (K160597) | Globus Medical, Inc. | 2016-08-29 |
| ATLANTIS Abutment for HIOSSEN ET implant (K160626) | Dentsply Sirona | 2016-08-29 |
| Insulin Pen Needle (K153706) | SteriLance Medical (Suzhou), Inc. | 2016-08-29 |
| Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II Infant Resuscitator (K152931) | Ambu A/S | 2016-08-29 |
| Arthrex VaultLock Glenoid (K161108) | Arthrex, Inc. | 2016-08-29 |
| Philips Avent Comfort Single/Twin Electric Breast Pump (K161532) | Philips Consumer Lifestyle - Innovation Site Eindhoven | 2016-08-29 |
| Theia NPWT Foam Wound Dressing Kit-Small, Theia NPWT Foam Wound Dressing Kit-Medium, Theia NPWT Foam Wound Dressing Kit-Large (K161570) | Lc Medical Concepts, Inc. | 2016-08-29 |
| UreTron PF Series Probe (K162119) | Med-Sonics Corp. | 2016-08-29 |
| Xpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48, Genxpert Infinity-48s and GeneXpert Infinity-80 Systems (K161619) | Cepheid | 2016-08-29 |
| BD Nexiva and BD Nexiva Diffusics Closed IV Catheter Systems (K161777) | Becton Dickinson Infusion Therapy Systems, Inc. | 2016-08-29 |
| LCCS Disposable RF Electrode, LCCS Reusable RF Electrode (K152642) | Lccs Products Limited | 2016-08-26 |
| EYEREVE (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear (K161124) | Vision Science Co., Ltd. | 2016-08-26 |
| RS80A Diagnostic Ultrasound System (K162094) | Samsung Medison Co., Ltd. | 2016-08-26 |
| GPS Angled Abutment (K153509) | Implant Direct Sybron Manufacturing, LLC | 2016-08-26 |
| CompleClear Plastic Orthodontic Bracket and Wire Appliance (K150830) | Oracrew | 2016-08-26 |
| LUNA DENTAL IMPLANT SYSTEM (K160106) | Shinhung Mst Co., Ltd. | 2016-08-26 |
| Vitalograph Model 6300 micro (K160253) | Vitalograph (Ireland) , Ltd. | 2016-08-26 |
| ATLANTIS Abutment for CONELOG implant (K161030) | Dentsply Sirona | 2016-08-26 |
| Freedom Spinal Cord Stimulator System (K160600) | Stimwave Technologies Incorporated | 2016-08-26 |
| Trojan XOXO Thin Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant (K161545) | Church & Dwight Co., Inc. | 2016-08-26 |
| ORION (K161503) | Yerim Engineering Co., Ltd. | 2016-08-26 |
| Skypro, SP01 Mask (K152197) | Skypro Medical Supplies Company | 2016-08-26 |
| FMX314 Surgical Platform (K160797) | Fortimedix Surgical B.V. | 2016-08-26 |
| ORTHODONTIC CERAMIC BRACKETS 1.1 (K160615) | Tomy, Inc. | 2016-08-26 |
| OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy System (K153559) | Accelerated Care Plus (Acp) | 2016-08-26 |
| Bite Away (K160943) | Riemser Pharma | 2016-08-26 |
| Exufiber Ag+ (K160379) | Molnlycke Health Care Us, LLC | 2016-08-25 |
| LifeFlow Rapid Infusion Device (LifeFlow Device) (K153731) | 410 Medical Innovation, LLC | 2016-08-25 |
| ASAHI Corsair Pro (K161126) | Asahi Intecc Co., Ltd. | 2016-08-25 |
| invendoscopy E200 System (K161355) | Invendo Medical GmbH | 2016-08-25 |
| HQS Introducer (Model 2064-HQS) (K153494) | Alseal | 2016-08-25 |
| V10 (K152659) | Mediana Co., Ltd. | 2016-08-25 |
| Royal Condoms (Natural, Black Grape, Coffee, Strawberry, and Chocolate Flavors) (K161195) | M3 Global Enterprises, LLC | 2016-08-25 |
| Integra TITAN Reverse Shoulder System (K161189) | Integra LifeSciences Corporation | 2016-08-25 |
| DragonFly Surgical Drill System (K161376) | Grace Medical, Inc. | 2016-08-25 |
| Optilite Low Level Albumin Kit (K153560) | The Binding Site Group , Ltd. | 2016-08-25 |
| AirLife Autofill Humidification Chamber (K160764) | Carefusion 2200, Inc. | 2016-08-25 |
| AneurysmFlow (K160455) | Philips Medical Systems Nederland B.V. | 2016-08-25 |
| G Surgical Marksman MIS System (K161516) | G Surgical, LLC | 2016-08-25 |
| LIAISON HAV IgM, LIAISON Control HAV IgM (K160650) | DiaSorin, Inc. | 2016-08-25 |
| Anti-Borrelia burgdorferi US Westernblot (IgG) (K161513) | Euroimmun US | 2016-08-25 |
| NuVasive Lumbar Interbody Implants (K161230) | Nu Vasive, Incorporated | 2016-08-25 |
| ResolutionMD (K161130) | Calgary Scientific, Inc. | 2016-08-24 |
| XYcor® Expandable Spinal Spacer System (K160646) | Alphatec Spine, Inc. | 2016-08-24 |
| ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology (K161313) | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | 2016-08-24 |
| Kyphon HV-R Bone Cement (K160983) | Medtronic, Inc. | 2016-08-24 |
| FFRct (K161772) | HeartFlow, Inc. | 2016-08-24 |
| Infrared Forehead Thermometer, FT-100A (K160802) | Hangzhou Universal Electronic Co., Ltd. | 2016-08-24 |
| SOMATOM Drive (K161196) | Siemens Medical Solutions USA, Inc. | 2016-08-24 |
| GalaSHAPE 3D (K161092) | Tepha, Inc. | 2016-08-23 |
| HyperSound Tinnitus Module (K161331) | Turtle Beach Corporation | 2016-08-23 |
| Vantage Titan 1.5T, MRT-1510, V3.6 Software (K160632) | Toshibamedical Systems Corporation | 2016-08-23 |
| KATANA AVENCIA Block (K153476) | Kuraray Noritake Dental, Inc. | 2016-08-23 |
| ZION Anterior Cervical Fixation System (K160702) | Astura Medical | 2016-08-23 |
| sTMS mini (K161663) | Eneura, Inc. | 2016-08-23 |
| Cavilon Advanced High Endurance Skin Protectant (K153571) | 3M Healthcare | 2016-08-23 |
| Accurett (K161615) | H&O Equipments, Nv/Sa | 2016-08-23 |
| Streamline OCT Occipito-Cervico-Thoracic System (K161498) | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | 2016-08-22 |
| PathLoc-L MIS Spinal System (K161766) | L&K BIOMED Co., Ltd. | 2016-08-22 |
| Double Medical Universal Spine System (K151458) | Double Medical Technology, Inc. | 2016-08-22 |
| Werewolf RF20000 Controller, FLOW 50 Wand (K162074) | ArthroCare Corporation | 2016-08-22 |
| ChicView (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/Color) (K161098) | Joowon Innovation Co., Ltd. | 2016-08-22 |
| Premium Plus C01/C02 LED Curing Light (K153514) | Premium Plus International Limited | 2016-08-22 |
| ImPACT Computerized Neurocognitive Concussion Management Aid (DEN150037) | Impact Applications, Inc. | 2016-08-22 |
| H-Max S stem (K160011) | Lima Corporate S.P.A. | 2016-08-22 |
| InMode System MiniFX Handpiece (K160329) | Inmode MD , Ltd. | 2016-08-19 |
| Valeo II Interbody Fusion Device System (K161405) | Amedica Corp. | 2016-08-19 |
| iHealth Align Gluco-Monitoring system (K153286) | Andon Health Co, Ltd. | 2016-08-19 |
| Kerecis SecureMesh (K153364) | Kerecis Limited | 2016-08-19 |
| Electrosurgical disposable grounding pads (K160366) | Top-Rank Health Care Co., Ltd. | 2016-08-19 |
| Codman Microsensor Basic Kit, Codman Microsensor Plastic Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit with Tuohy-Borst Adapter,Codman Microsensor Metal Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit (K153347) | Codman & Shurtleff, Inc. | 2016-08-19 |
| MADgic Laryngo-Tracheal Mucosal Atomization Device (K153470) | Teleflex Medical | 2016-08-19 |