| AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access Catheter 058x132cm, AXS Catalyst Distal Access Catheter 060x132cm (K151667) | Stryker | 2015-11-13 |
| Humelock II Reversible Shoulder System (K150488) | Fx Solutions | 2015-11-13 |
| Water Based Personal Lubricant with Flavours (K150743) | Karex Industries Sdn. Bhd. | 2015-11-12 |
| SOMATOM Emotion 6/16 (K151752) | Siemens Medical Solutions USA, Inc. | 2015-11-12 |
| Dental Implant System (K150388) | Bio Concept Co., Ltd. | 2015-11-12 |
| Valved Safety Centesis Catheter (K150800) | B.Braun Medical, Inc. | 2015-11-12 |
| Turbo-Power Laser Atherectomy Catheter (K152181) | Spectranetics, Inc. | 2015-11-12 |
| Entropy Module, E-ENTROPY-01 (K150298) | Ge Healthcare Filand OY | 2015-11-12 |
| ATLANTIS Anterior Cervical Plate System (K152623) | Medtronic Sofamor Danek USA, Inc. | 2015-11-12 |
| Arthrex iBalance TKA System (K152382) | Arthrex, Inc. | 2015-11-12 |
| VLP Mini-Mod Talus Plates (K152976) | Smith & Nephew, Inc. | 2015-11-12 |
| PANTHER Cutter Stapler (K152618) | B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. | 2015-11-12 |
| Eclipse System (K150558) | Pelvalon, Inc. | 2015-11-12 |
| Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test System (K150358) | Gold Standard Diagnostics | 2015-11-12 |
| FUJIFILM SonoSite iViz Ultrasound System (K152983) | FUJIFILM Sonosite, Inc. | 2015-11-12 |
| TR BAND Radial Compression Device (K152525) | Terumo Medical Corporation | 2015-11-10 |
| Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle (K151315) | Boston Scientific Corporation | 2015-11-10 |
| Digital Dental Intra Oral Sensor, EzSensor Classic, EzSensor HD, HDI-P, HDI-S (K153060) | Rayence Co., Ltd. | 2015-11-10 |
| FIBERGRAFT BG Morsels (K151154) | Prosidyan, Inc. | 2015-11-10 |
| Integrity Spine Lumbar Interbody Fusion System (K151819) | Integrity Spine Lumbar Interbody Fusion System | 2015-11-10 |
| illumigene Pertussis DNA Amplification Assay (K152285) | Meridian Bioscience, Inc. | 2015-11-10 |
| HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip First Aid PRO, ChitoFlex PRO (K150916) | Hem Con Medical Technologies, Inc. | 2015-11-10 |
| PacEndo Sodium Hyprochlorite (K151852) | Pac-Dent International, Inc. | 2015-11-10 |
| EzFuze Implant System (K150211) | Vilex IN Tennessee, Inc. | 2015-11-10 |
| ATAL 9 (K152151) | Atlaim Corporation | 2015-11-10 |
| CareView 1500C/ CareView 1500L X-ray Flat Panel Detectors (K153058) | Careray Digital Medical System Co., Ltd. | 2015-11-10 |
| Wrist - Type Fully Automatic Digital Blood Pressure Monitor (K152426) | Sejoy Electronics & Instruments Co., Ltd. | 2015-11-09 |
| First Sign® Drug of Abuse Buprenorphine Cup Test, First Sign® Drug of Abuse Buprenorphine Dip Card Test, First Sign® Drug of Abuse Butalbital Cup Test, First Sign® Drug of Abuse Butalbital Dip Card Test, First Sign® Drug of Abuse Morphine Cup Test, First Sign® Drug of Abuse Morphine Dip Card Test. (K152551) | W.H.P.M., Inc. | 2015-11-09 |
| Divine 9 (K150397) | Carrashield Labs, Inc. | 2015-11-09 |
| Patient Contoured Implant-PEEK (PCI-PEEK) (K151382) | KLS Martin L.P. | 2015-11-09 |
| Thermofit (K151946) | Orfit Industries | 2015-11-09 |
| Nox RIP Belts & Cables (K151361) | Nox Medical Ehf | 2015-11-06 |
| Ablatherm Integrated Imaging (K153023) | Edap Technomed, Inc. | 2015-11-06 |
| LILLIPUP PMP, LILLIPUT PMP INTEGRATED (K151713) | Sorin Group Italia S.R.L. | 2015-11-06 |
| PUR Dental Implant System (K151928) | Sterngold Dental, LLC | 2015-11-06 |
| JDENTALCARE Implant System (K143142) | Jdentalcare Srl | 2015-11-06 |
| CLIP PLUS Disposable Clip Applier,ML;CLIP PLUS Disposable Clip Applier,L (K150259) | Taiwan Surgical Corporation | 2015-11-06 |
| Breast Pump (K150923) | Guangzhou Jinxinbao Electronic Co., Ltd. | 2015-11-06 |
| MEDLINE SHARPS CONTAINERS (K143693) | Medline Industries, Inc. | 2015-11-06 |
| UTERMOHLEN CRYO PROFESSIONAL (K152203) | Koninklijke (Royal) Utermohlen | 2015-11-06 |
| Voluson E6, Voluson E8, Voluson E10 Diagnostic Ultrasound System (K152567) | GE Healthcare | 2015-11-06 |
| Slendertone connect Abs (K151903) | Bio-Medical Research, Ltd. | 2015-11-06 |
| Prevena Incision Management System with Peel & Place Dressing, Prevena Incision Management System with Customizable Dressing (K150006) | Kci USA, Inc. | 2015-11-06 |
| ZeroWire Duo Wireless HD Video Transfer System G2 or ZeroWire G2 (K151609) | Nds Surgical Imaging, LLC | 2015-11-06 |
| CerOX (K150268) | Or-Nim Medical , Ltd. | 2015-11-06 |
| Hevylite Human IgA Kappa Kit for use on SPAPLUS, Hevylite Human IgA Lambda Kit for use on SPAPLUS (K151759) | The Binding Site Group , Ltd. | 2015-11-06 |
| Elation Wireguided Balloon Dilation Catheter (K151925) | Merit Medical Systems, Inc. | 2015-11-06 |
| InterOss (K151209) | Sigmagraft, Inc. | 2015-11-06 |
| RECON system- Grubber Lapidus-, Platar Lapidus-, Tarsalis Plates and Screws (K152256) | Normed Medizin-Technik GmbH | 2015-11-05 |
| Equashield Closed System drug Transfer Device (CSTD) (K150219) | Equashield Medical , Ltd. | 2015-11-05 |
| CD HORIZON Spinal System (K152248) | Medtronic Sofamor Danek USA, Inc. | 2015-11-05 |
| CRIT-LINE CLIP (CLIC) BLOOD CHAMBER (K152953) | Fresenius Medical Care North America | 2015-11-05 |
| Nihon Kohden CSM 1901 Bedside Monitor (K151080) | Nihon Kohden | 2015-11-05 |
| IdentEvent (K150688) | Optima Neuroscience, Inc. | 2015-11-05 |
| AirView (K151901) | Resmed, Ltd. | 2015-11-05 |
| Symphony Breastpump, Symphony reconditioned, Symphony Preemie+ Breastpump, Symphony Plus Breastpump (battery version), Symphony Consignment, Preemie Consignment Pump, Symphony Rental, Symphony Plus Rental, Symphony Preemie+ Rental (K151632) | Medela AG | 2015-11-05 |
| Tyece OTC TENS Device (K150386) | Tyece , Ltd. | 2015-11-05 |
| elance Vital Signs Monitor, Central Monitor Software (K150329) | Spacelabs Healthcare | 2015-11-05 |
| AnsCare ChitoClot Pad (K150963) | Benq Materials Corporation | 2015-11-05 |
| superDimension Navigation System (K151376) | Covidien, LLC | 2015-11-05 |
| NaturalLine Abutment (K151432) | Ot Medical GmbH | 2015-11-05 |
| FDR D-EVO GL Flat Panel Detector System (K152138) | Fujifilm Medical System U.S.A., Inc. | 2015-11-05 |
| BD ChloraShield IV Dressing with CHG Antimicrobial (K152923) | Avery Dennison Belgie Bvba | 2015-11-05 |
| SnoreSounds (K150102) | Appian Medical, Inc. | 2015-11-05 |
| NeuViz 128 Multi-slice CT Scanner System (K151383) | Neusoft Medical Systems Co., Ltd. | 2015-11-04 |
| Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC CAL) (K150168) | Siemens Healthcare Diagnostics | 2015-11-04 |
| Ziostation2 (K151212) | Qi Imaging, LLC | 2015-11-04 |
| KATOR Suture Anchor (K152236) | Kator, LLC | 2015-11-04 |
| Safety Auto-Disable Syrine with Needle (Auto-Lock) (K143497) | Guangdong Intmed Medical Appliance Co., Ltd. | 2015-11-04 |
| Talon DistalFix Antegrade/Retrograde Femoral Nail (K152295) | Orthopedic Designs North America, Inc. | 2015-11-03 |
| SternaLock® 360 Sternal Closure System (K151019) | Biomet Microfixation | 2015-11-03 |
| rescuenet (K152580) | Endochoice, Inc. | 2015-11-03 |
| Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Light Absorbency; Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Regular & Super; Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Super Plus; Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Super Absorbency (K151470) | First Quality Hygienic, Inc. | 2015-11-02 |
| PROBEAT-V (K152592) | Hitachi, Ltd., Health Care Company | 2015-11-02 |
| Avance Y-Connector S (K151872) | Molnlycke Health Care Us, LLC | 2015-11-02 |
| FastFrame External Fixation System - Knee Spanning, FastFrame External Fixation System - Damage Control (K151992) | Zimmer, Inc. | 2015-11-02 |
| HS70A Diagnostic Ultrasound System (K152962) | Samsung Medison Co., Ltd. | 2015-11-02 |
| Powder-Free Polyisoprene Sterile Surgical Gloves in White Color Tested for Use with Chemotherapy Drugs, Powder-Free Polyisoprene Sterile Surgical Gloves in Green Color. (K142941) | Pt. Medisafe Technologies | 2015-11-02 |
| EXELINT SecureTouch Safety Hypodermic Needle (K152183) | Exelint International, Co. | 2015-11-02 |
| syngo.CT Myocardial Perfusion (K150713) | Siemens Medical Solutions USA, Inc. | 2015-11-02 |
| INVOcell (DEN150008) | Invo Bioscience | 2015-11-02 |
| EGENS Urine Test Cup THC-MDMA, EGENS Urine Test DipCard THC-MDMA, EGENS Urine Test Cassette Marijuana (K152643) | Nantong Egens Biotech Co., Ltd. | 2015-11-02 |
| Positron Emission Tomography (PET) and Computed Tomography (CT) System, Positron Emission Tomography (PET) and Computed Tomography (CT) System (K151403) | Neusoft Medical Systems Co., Ltd. | 2015-11-02 |
| PGA RESORBA, PGA RESOQUICK, GLYCOLON (K143584) | Resorba Medical GmbH | 2015-11-02 |
| Bovie J-Plasma Precise 360 Handpiece (K152570) | Bovie Medical Corporation | 2015-11-02 |
| DURAFORM Dural Graft Implant (K152481) | Codman & Shurtleff, Inc. | 2015-10-30 |
| MasterLoc Stem (K151531) | Medacta International | 2015-10-30 |
| Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter (K150046) | Zoll Circulation, Inc. | 2015-10-30 |
| SCENARIA Phase 3 Whole-body X-ray CT System (K150595) | Hitachi Medical Systems America, Inc. | 2015-10-30 |
| Philips Lumify Diagnostic Ultrasound System (K152899) | Philips Healthcare, Inc. | 2015-10-30 |
| Acumed Ankle and Small Fragment Base Set Update (K151886) | Acumed, LLC | 2015-10-30 |
| Frontier Medical Devices In-line Orthopedic Cable Cerclage System (K151888) | Frontier Medical Devices, Inc. | 2015-10-30 |
| X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2 (SP29), X8 System - Stat X8 (XS29) (K152040) | Advanced Brain Monitoring, Inc. | 2015-10-30 |
| Philips CS770 IntelliSpace Critical Care and Anesthesia (K151366) | Philips Medical Systems | 2015-10-30 |
| Cosmedico Ultraviolet Lamps of Various Models (K152273) | Cosmedico Light, Inc. | 2015-10-30 |
| SYMBIS Surgical System (K143420) | Imris, Inc. | 2015-10-30 |
| Prime&Bond Elect Universal Dental Adhesive (K151619) | Dentsply International, Inc. | 2015-10-30 |
| Vera (K150462) | Reflexion Health, Inc. | 2015-10-30 |
| Prelude SNAP Splittable Hydrophilic Sheath Introducer (K152381) | Merit Medical Systems, Inc. | 2015-10-30 |
| MicroSTAAR Injector System Cartridges (K152357) | STAAR Surgical Company | 2015-10-30 |