| On Call Pro Blood Glucose Monitoring System (K161867) | Acon Laboratories | 2016-08-05 |
| ArgenIS Titanium Abutments (K160248) | Argen Corporation | 2016-08-05 |
| EP-TRACER System (K161245) | Cardio Tek, BV | 2016-08-05 |
| Image Fast Set, Image Regular Set (K160097) | Sybron Dental Specialties | 2016-08-05 |
| SYSTEM 1E Liquid Chemical Sterilant Processing System (K161683) | STERIS Corporation | 2016-08-05 |
| Burn-out Cylinder and Angled Screw Abutments (K160483) | Dentium Co., Ltd. | 2016-08-05 |
| LOGIQ V5 Expert, LOGIQ V5, LOGIQ V3 (K161224) | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2016-08-05 |
| Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series: 6100CA, 6100CP, 6100CI, 6100CN), Model 6101C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6101C Series: 6101CA, 6101CP, 6101CI, 6101CN), Model 6102C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6102C Series: 6102CA, 6102CP, 6102CI, 6102CN), Model 8100AA/8100AP Reusable, Finger Clip Pulse Oximeter Sensor, Model 8101AA/8101AP Reusable, Finger Clip Pulse Oximeter Senso (K160865) | Nonin Medical, Inc. | 2016-08-05 |
| Vivid iq (K161706) | Ge Medical Systems Ultrasound and Primary Care Diagnostics L | 2016-08-05 |
| Triton System (K160338) | Gauss Surgical, Inc., | 2016-08-05 |
| Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, RegularOpal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, Super, Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, Super Pl (K161877) | First Quality Hygienic, Inc. | 2016-08-05 |
| QXLink (K161113) | Vieworks Co., Ltd. | 2016-08-05 |
| Fehling-Punches (K153243) | Fehling Instruments GmbH & Co. KG | 2016-08-04 |
| Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators (K153540) | Safe Secure Packaging Co., Ltd. | 2016-08-04 |
| Microlyte Ag (K153756) | Imbed Biosciences, Inc. | 2016-08-04 |
| OSSIX PLUS (K160281) | Datum Dental, Ltd. | 2016-08-04 |
| Latex Powder Free Polymer Coated Examination Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove (K161006) | Hartalega Sdn Bhd | 2016-08-04 |
| SIDEKICK and USHER Support Catheters (K161986) | Bard Peripheral Vascular, Inc. | 2016-08-04 |
| Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue) (K160560) | Hartalega Sdn Bhd | 2016-08-04 |
| FacetBRIDGE® System (K161798) | Ldr Spine USA, Inc. | 2016-08-04 |
| OSSIX VOLUMAX (K153549) | Datum Dental, Ltd. | 2016-08-04 |
| MED-TECH Water Systems Inc Exchangeable Carbon Tanks for Dialysis (K153329) | Med-Tech Water Systems, Inc. | 2016-08-04 |
| Surveyor S4 Mobile Monitor (K160685) | Mortara Instrument, Inc. | 2016-08-04 |
| ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials. (K153551) | Axis-Shield Diagnostics Limited | 2016-08-04 |
| RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH Canisters, RENASYS TOUCH Carry Bag, Carry Strap, RENASYS Y-Connector, RENASYS TOUCH IV Pole/Bed Clamp, RENASYS TOUCH Class 2 Power Supply (K153209) | Smith & Nephew Medical, Ltd. | 2016-08-04 |
| IPL Therapy Machine (K161286) | Beijing Adss Development Co., Ltd. | 2016-08-04 |
| A1 Glove Powder Free Latex Patient Examination Gloves with Protein Content Labeling Claim (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein) (K153744) | A1 Glove Sdn Bhd | 2016-08-04 |
| CAPO BULK FILL (K152471) | Schuetz Dental GmbH | 2016-08-04 |
| Med-Tainer Single Deposit Container (K153274) | Snyder Industries, Inc. | 2016-08-04 |
| Fully Automatic Electronic Blood Pressure Monitor (K160563) | Andon Health Co, Ltd. | 2016-08-04 |
| Mont Blanc and Mont Blanc MIS Spinal Systems (K161387) | Spineway SA | 2016-08-04 |
| IMMEDIATELOAD Dental Implant System (K151757) | Immediateload S.A. | 2016-08-03 |
| AFX™ Femoral Implant With Inserter (K161033) | Cayenne Medical, Inc. | 2016-08-03 |
| Hilal Embolization MicroCoils (K160219) | Cook Incorporated | 2016-08-03 |
| IonoStar Plus (K160774) | Voco GmbH | 2016-08-03 |
| JointPoint (K160284) | Jointpoint, Inc. | 2016-08-03 |
| DURAFIBER Ag (K161289) | Smith & Nephew Medical Limited | 2016-08-03 |
| A-Oss (K151542) | Hiossen, Inc. | 2016-08-03 |
| CASSI II Rotational Core Biopsy System (K161234) | Scion Medical Technologies, LLC | 2016-08-03 |
| DyeVert NG Contrast Modulation System (K161505) | Osprey Medical, Inc. | 2016-08-03 |
| iPEP System and vPEP (K160636) | D R Burton Healthcare, LLC | 2016-08-03 |
| Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile (K151750) | Kossan International Sdn Bhd | 2016-08-03 |
| ARIX Foot System (K161864) | Jeil Medical Corporation | 2016-08-02 |
| ARIES® Flu A/B & RSV Assay (K161220) | Luminex Corporation | 2016-08-02 |
| Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs, Powder Free Nitrile Patient Examination Glove, White Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs (K151824) | Kossan International Sdn Bhd | 2016-08-02 |
| Biomet Microfixation Sternal Closure System (K161896) | Biomet Microfixation | 2016-08-02 |
| Sterile Powder Free Nitrile Examination Gloves, Blue Colored. Tested For Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim (K160467) | Kossan International Sdn Bhd | 2016-08-02 |
| 5.0 Fr Arndt Endobronchial Blocker Set (K160542) | Cook Incorporated | 2016-08-02 |
| M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for Sem (K161409) | Mermaid Medical A/S | 2016-08-02 |
| Powder free vinyl patient examination glove, colored (yellow) (K160675) | Kaixing Plastic Products Co., Litd. | 2016-08-02 |
| Vertu® & Vertu® Ti-Bond and Crystal® & Crystal® Ti-Bond Cervical Interbody System (K153352) | Spinal Elements, Inc. | 2016-08-01 |
| 8ch Foot Ankle Coil (K160932) | Shenzhen RF Tech Co., Ltd. | 2016-08-01 |
| Fuse Endoscopic System with FuseBox Processor (K160275) | Endochoice, Inc. | 2016-08-01 |
| IDSS ForceTriad Control Module (K153205) | Black Diamond Video, Inc. | 2016-08-01 |
| Nautilus BrainPulse 1000 (DEN140040) | Jan Medical, Inc. | 2016-08-01 |
| Infra-red forehead thermometer (K160999) | Hangzhou Hua'An Medical&Health Instruments Co.,Ltd | 2016-08-01 |
| Senolris (K160937) | GE Healthcare | 2016-08-01 |
| Aqueduct 100 Cervical Dilator (K160664) | Gtimd, LLC | 2016-08-01 |
| Precision Point Biopsy Needle Guide (K160414) | Corbin Clinical Resources, LLC | 2016-08-01 |
| The Hammertoe Correction System (K153065) | Life Spine, Inc. | 2016-08-01 |
| SynergEyes SiH with Hydra-PEG(petrafocon A hem-larafilcon A) Hybrid Daily Wear Lens (K160938) | Synergeyes, Inc. | 2016-08-01 |
| SpineView X-Pac Expandable Lumbar Cage System (K160856) | Spine View, Inc. | 2016-08-01 |
| EndyMed Contour Handpiece (K161199) | Endymed Medical, Ltd. | 2016-08-01 |
| VIRTU Lumbar Spacer System (K160699) | Met 1 Technologies, LLC | 2016-08-01 |
| Pirouette 035 (K161427) | Arravasc Limited | 2016-07-30 |
| Mozec NC-Rx PTCA Baloon Dilatation Catheter (K160961) | Meril Life Sciences Private Limited | 2016-07-30 |
| Puritan Opti-Tranz Cary-Blair Collection and Transport System (K160082) | Puritan Medical Products, LLC | 2016-07-29 |
| The Luco Hybrid OSA Appliance (K160477) | Luco Hybrid Osa Appliance, Inc. | 2016-07-29 |
| Clip Flow (K153493) | Voco GmbH | 2016-07-29 |
| Cianna Medical SAVI Scout Reflector and SAVI Scout System (K161507) | Cianna Medical, Inc. | 2016-07-29 |
| CrossCath Support Catheter (K161801) | Cook Incorporated | 2016-07-29 |
| VertiForm Posterior Fixation System (K161499) | Next Orthosurgical | 2016-07-29 |
| Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating, Bovie 2.4mm Disposable Bipolar Ablator 55°, Non-Aspirating, Bovie 1.8mm Disposable Bipolar Ablator 60°, Non-Aspirating (K161558) | Bovie Medical Corporation | 2016-07-29 |
| Powder Free Blue Nitrile Examination Glove (K153732) | Qube Medical Product Sdn Bhd | 2016-07-29 |
| 2D Quantitative Analysis (K161839) | Philips Medical Systems Nederland B.V. | 2016-07-29 |
| MEDINAUT Kyphoplasty System (K153296) | Imedicom Co., Ltd. | 2016-07-29 |
| TheraCem (K161256) | Bisco, Inc. | 2016-07-29 |
| Allura Xper FD series and Allura Xper OR Table series (K161563) | Philips Medical Systems Nederland B.V. | 2016-07-29 |
| Cannulated Screw (K161058) | Miami Device Solutions, LLC | 2016-07-29 |
| UniStrip1 Generic Blood Glucose Test Strips (K160038) | Ok Biotech Co., Ltd. | 2016-07-29 |
| Bright (K161849) | Tanda Beauty Canada, Inc. | 2016-07-29 |
| Polux , Minerva and Atropos PTA Balloon Dilatation Catheter (K160256) | Brosmed Medical Co., Ltd. | 2016-07-29 |
| HeatLux Pro II (K152087) | Home Skinovations , Ltd. | 2016-07-29 |
| DiamondTOUCH Inflation Device and Fluid Dispensing Syringe (K160107) | Merit Medical Systems, Inc. | 2016-07-29 |
| PASS LP Spinal System (K161627) | Medicrea International SA | 2016-07-29 |
| ACUSON NX2 Diagnostic Ultrasound Systems (K161787) | Siemens Medical Solutions USA, Inc. | 2016-07-28 |
| Medilas H Laser Fibers (K161771) | Dornier Medtech America, Inc. | 2016-07-28 |
| SIMPLANT Online Case Review and SIMPLANT Editor (K161118) | Dentsply Sirona | 2016-07-28 |
| 8ch Foot Ankle Coil (K160935) | Shenzhen RF Tech Co., Ltd. | 2016-07-28 |
| AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM (K153117) | Aesku Systems GmbH&Co.Kg | 2016-07-28 |
| PBS(-), Phosphate Buffered Saline (K160863) | Kitazato Biopharma Co., Ltd. | 2016-07-28 |
| POLYISOPRENE POWDER FREE SURGICAL UNDERGLOVE, POLYISOPRENE POWDER FREE SURGICAL GLOVE (K161008) | Hartalega Sdn Bhd | 2016-07-28 |
| LVivo Software Application (K161382) | Diacardio, Ltd. | 2016-07-28 |
| Cardinal Health Isolation Gown (K160339) | Cardinal Health200, LLC | 2016-07-28 |
| Waterlase Express (K161669) | Biolase, Inc. | 2016-07-28 |
| Atteris Antimicrobial Skin & Wound Cleanser (K160192) | Rochal Industries, LLC | 2016-07-28 |
| MAMMI (K161631) | General Equipment For Medical Imaging | 2016-07-28 |
| 3D OCT-1 Maestro (K161509) | Topcon Corporation | 2016-07-28 |
| ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE Calibrators/Total IgE Curve Controls, ImmunoCAP Specific IgE Calibrator Strip/Specific IgE Curve Control Strip, ImmunoCAP Specific IgE Calibrators/Specific IgE Curve Controls (K161899) | Phadia AB | 2016-07-28 |
| Genesys Spine Apache® Anchored Cervical Interbody Fusion System (K152099) | Genesys Spine | 2016-07-28 |