| Orchestra Hydrophilic Guidewire standard angled, Orchestra Hydrophilic Guidewire straight stiff, Orchestra Hydrophilic Guidewire angled stiff,Orchestra Hydrophilic Guidewire standard straight, Orchestra Hydrophilic Guidewire straight stiff (K150927) | Coloplast A/S | 2015-05-27 |
| SpiroThor (K150137) | Cohero Health, LLC | 2015-05-27 |
| Coating Material (K150511) | Sun Medical Co., Ltd. | 2015-05-27 |
| Shaser Skin Beauty Intense Pulsed Light System Family for Acne (K150282) | Shaser, Inc. | 2015-05-27 |
| Intersept Filtered Cardiotomy Reservoir (K151110) | Medtronic, Inc. | 2015-05-27 |
| IntelePACS (K150707) | Intelerad Medical Systems Incorporated | 2015-05-27 |
| Rapid Aid Instant Disposable Infant Heel Warmer (K150627) | Rapid Aid Corp. | 2015-05-27 |
| Penumbra Embolectomy Aspiration System [INDIGO Aspiration System] (K142870) | Penumbra, Inc. | 2015-05-26 |
| 2.4mm X 127 cm Phoenix Atherectomy Deflecting System (K151145) | Volcano Atheromed, Inc. | 2015-05-26 |
| AMT Bridle - Nasal Tube Retention System (K142971) | Applied Medical Technology, Inc. | 2015-05-26 |
| Ballancer 505 System, Model 1201-AC (K150269) | Mego Afek AC , Ltd. | 2015-05-26 |
| Human Microalbumin kit for use on SPAPLUS (K143118) | The Binding Site Group , Ltd. | 2015-05-26 |
| LUMINA 24 (K140386) | Rogers Sciences, Inc. | 2015-05-26 |
| LAGIS ENDOSCOPIC INSTRUMENTS DISPOSABLE GRASPER (K141902) | Lagis Enterprises Co, Ltd. | 2015-05-26 |
| Centricity Universal Viewer (K150420) | GE Healthcare | 2015-05-26 |
| Sickbay Clinical Platform (K143304) | Medical Informatics Corp | 2015-05-26 |
| Acryfree Denture Base Material and Biosens Denture Base Material (K150454) | Perflex | 2015-05-26 |
| Versatex Monofilament Mesh (K150091) | Sofradim Production | 2015-05-26 |
| Biomet Microfixation RibFix Blu Thoracic Fixation System (K151173) | Biomet Microfixation | 2015-05-26 |
| Oral7 Moisturizing Gel, Oral7 Moisturizing Mouthwash, Oral7 Moisturizing Mouth Spray, Oral7 Toothpaste (K142549) | J.C.E.C. Company, Inc. (Doing Business AS Fountain Health CA | 2015-05-26 |
| MicroTaper Needle Introducer Set (K151076) | Summit Access, LLC | 2015-05-22 |
| Hemoglobin A1c Assay, Hemoglobin A1c Calibrators, Hemoglobin A1c Controls (K140654) | Abbott Laboratories | 2015-05-22 |
| Cautery Tip Cleaner (K151222) | Key Surgical, Inc. | 2015-05-22 |
| Stryker Maestro Air Motors (K150801) | Stryker Corporation | 2015-05-22 |
| Penumbra System ACE (K142458) | Penumbra, Inc. | 2015-05-22 |
| CARDIOCHEK PLUS TEST SYSTEM, CARDIOCHEK HOME TEST SYSTEM (K140068) | Polymer Technology Systems, Inc. | 2015-05-22 |
| DualCap (K142806) | Catheter Connections, Inc. | 2015-05-22 |
| Bausch + Lomb Injector System (K151102) | Bausch & Lomb, Inc. | 2015-05-22 |
| VentriPoint Medical System (K150628) | Ventripoint, Inc. | 2015-05-22 |
| Scrambler Therapy MC-5 A Device (K142666) | Delta International Services & Logistics S.R.L | 2015-05-22 |
| Whisper Pump System (K142385) | Wound RX Medical, LLC | 2015-05-22 |
| Rachel's Remedy (K150139) | Rachel'S Remedies, LLC | 2015-05-22 |
| CalcaNail Orthopedic Arthrodesis Nail (K150471) | Fournitures Hospitalieres Industrie | 2015-05-22 |
| Response 5.5/6.0 Spine System (K150600) | OrthoPediatrics Corp. | 2015-05-22 |
| APEX-DL Spine System (K143683) | Spinecraft, LLC | 2015-05-22 |
| Somnowell Mandibular Advancement Appliance (MAA) (K150941) | Somnowell , Ltd. | 2015-05-22 |
| Marrow Cellution Bone Marrow Aspiration Needle (K150563) | Ranfac, Corp. | 2015-05-22 |
| Fine Structure Analysis(fineSA) (K150069) | Acuitas Medical , Ltd. | 2015-05-22 |
| CalcaNail Orthopedic Nail (K150463) | Fournitures Hospitalieres Industrie | 2015-05-22 |
| Battalion Universal Spacer System (K143740) | Alphatec Spine, Inc. | 2015-05-22 |
| LipoFilter - Hospital Pack, LipoFilter - Clinic Pack (K150779) | Microaire Surgical Instruments, LLC | 2015-05-22 |
| SPINEDESIGN Spine Surgery Planning (Software Application) (K142648) | Medtronic Sofamor Danek USA, Inc. | 2015-05-22 |
| Darlinghurst Vented, Darlinghurst NV-AAV (K143603) | Resmed, Ltd. | 2015-05-21 |
| PlasmaBlade UPPP and Suction Coagulator (K150297) | Medtronic Advanced Energy | 2015-05-21 |
| InvisionECG System (K143436) | Invisionheart, Inc. | 2015-05-21 |
| Retina Workplace (K150467) | Carl Zeiss Meditec, AG | 2015-05-21 |
| SmartGownTM surgical gown (K150151) | Cardinal Health 200, Inc. | 2015-05-21 |
| Intelli-Ox (K143060) | Air Liquide Healthcare | 2015-05-21 |
| Milagro / Milagro Advance Interference Screw (K143660) | Depuy Mitek, A Johnson & Johnson Company | 2015-05-21 |
| LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges, LUMIPULSE G CA 125II Calibrators (K142895) | Fujirebio Diagnostics,Inc. | 2015-05-21 |
| Vital-Port Vascular Access System Power Injectable Port (K150733) | Cook Incorporated | 2015-05-21 |
| Erchonia Zerona 6 headed scanner EZ6 (K150446) | Erchonia Corporation | 2015-05-21 |
| SAGIPLAN, SAGIPLAN PROSTATE MODULE ADD ON, SAGIPLAN INCLUDING PROSTATE MODULE (K141900) | Eckert & Ziegler Bebig GmbH | 2015-05-20 |
| E-App (K142719) | Gc Medtech, LLC | 2015-05-20 |
| cobas Cdiff Test (K142422) | Roche Molecular Systems, Inc. | 2015-05-20 |
| TANAKA ZIRCOLOR COLORING LIQUID, TANAKA ZIRCOLOR DIPPING LIQUID AND TANAKA ENAMEL ZR BLOCKS (K140491) | Tanaka Dental | 2015-05-20 |
| Mentor MemoryShape Resterilizable Gel Breast Implant Sizer STERILE (K151055) | Mentor Worldwide, LLC | 2015-05-20 |
| Dose Calculator (K150848) | Sun Nuclear Corporation | 2015-05-20 |
| StatStrip Xpress Glucose Hospital Meter System (K150461) | Nova Biomedical Corporation | 2015-05-20 |
| RAPIDFRET ORAL FLUID ASSAY FOR AMPHETAMINE, RAPIDFRET ORAL FLUID AMPHETAMINE CALIBRATOR SET, RAPIDFRET ORAL FLUID AMPHETAMINE CONTROL SET (K141748) | Biophor Diagnostics, Inc. | 2015-05-20 |
| Reprocessed Cordless Ultrasonic Dissection Device (K143562) | Sterilmed, Inc. | 2015-05-20 |
| Immunalysis Opiates Urine Enzyme Immunoassay, Immunalysis Opiates Urine Calibrators 300, Immunalysis Opiates Urine Calibrators 2000, Immunalysis Multi-Drug Controls (K143502) | Immunalysis Corporation | 2015-05-20 |
| K-Y BRAND TOUCH All-in-one Warming Caressing Creme and Personal Lubricant (K143511) | Reckitt Benckiser | 2015-05-20 |
| Zimmer Persona Personalized Knee System (K150090) | Zimmer, Inc. | 2015-05-20 |
| BIOFOAM Bone Wedge (K142724) | Wrightmedicaltechnologyinc | 2015-05-20 |
| TULA Iontophoresis System with Earset (K150453) | Acclarent, Inc. | 2015-05-20 |
| U&U Bowie-Dick Test Pack (K143629) | U&U Medical Technology Co, Ltd. | 2015-05-19 |
| ELITECROSS Support Catheter (K150187) | Cordis Corporation, A Johnson & Johnson Company | 2015-05-19 |
| SUPERCHECK PLUS BLOOD GLUCOSE MONITORING SYSTEM, SUPER CHECK PLUS MULTI BLOOD GLUCOSE MONITORING SYSTEM (K141351) | Biotest Medical Corp. | 2015-05-19 |
| GMX Series Medical Air/Oxygen Blender (K142291) | Gentec (Shanghai) Corporation | 2015-05-19 |
| ASTRA SPINE SYSTEM (K150417) | Spinecraft, LLC | 2015-05-19 |
| ELM PTA Balloon Dilatation Catheter (K143561) | O'Connell Regulatory Consultants, Inc. | 2015-05-19 |
| Lucent; Lucent Ti-Bond Systems (K150061) | Spinal Elements, Inc. | 2015-05-19 |
| MiniMed Connect kit, MiniMed Connect uploader, MiniMed Connect app, CareLink Connect (CareLink Personal) (K151236) | Medtronic Minimed, Inc. | 2015-05-19 |
| RETeval Visual Electrodiagnostic Device (K142567) | Lkc Technologies, Inc. | 2015-05-19 |
| syngo.CT Dental (K150785) | Siemens Medical Solutions USA, Inc. | 2015-05-18 |
| HEINE BETA 200, HEINE BETA 200 S, HEINE K 180 (K142486) | Heine Optotechnik GmbH & Co. KG | 2015-05-18 |
| Endopath ETS-Flex45 Endoscopic Articulating Linear Cutter, Endopath ETS-Flex45 No-Knife Articulating Linear Stapler (K150026) | Ethicon Endo-Surgery, LLC | 2015-05-18 |
| BioFlo Midline Catheter (K150407) | Navilyst Medical, Inc. | 2015-05-15 |
| Propeller System (K142516) | Reciprocal Labs Corporation | 2015-05-15 |
| Flexicare Heated Wire Breathing Systems (K150900) | Flexicare Medical, Ltd. | 2015-05-15 |
| ZONARE ZS3 Diagnostic Ultrasound System (K151175) | Zonare Medical Systems, Inc. | 2015-05-15 |
| Centurion POCT System (K150822) | Orthofix, Inc. | 2015-05-15 |
| Brainscope Ahead 200 (K143643) | Brainscope Company, Inc. | 2015-05-15 |
| JuggerStitch Meniscal Repair Device (K150424) | Biomet Manufacturing Corp | 2015-05-15 |
| ANSISTIM (K141168) | Dyansys, Inc. | 2015-05-15 |
| Rebel 3DKNEE System (K143242) | Encore Medical L.P. | 2015-05-15 |
| Chi Lites Orthodontic Sapphire Bracket (K142729) | Progressive Technology, Inc. | 2015-05-15 |
| Adaptive Motion Correction (AMC), CSMC-001A and 4D Airways (K143294) | Toshibamedical Systems Corporation | 2015-05-15 |
| Arthrex RetroFusion Screw (K151078) | Arthrex, Inc. | 2015-05-15 |
| .decimal Astroid Dosimetry App (K150547) | .Decimal, Inc. | 2015-05-15 |
| IS4000 da Vinci EndoWrist Instruments (K150284) | Intuitive Surgical, Inc. | 2015-05-15 |
| CLINISCANSM EEG (K141883) | Picofemto, LLC | 2015-05-15 |
| SculpSure (K150230) | Cynosure, Inc. | 2015-05-15 |
| Interbody Fusion (IBF)/Vertebral Body Replacement(VBR) System (K150521) | Rti Surgical, Inc. Dba Rti Biologics | 2015-05-15 |
| Active Breathing Coordinator (K151097) | Aktina Medical Corporation | 2015-05-15 |
| Datalys Multi-Parameter Patient Monitor (K150691) | Lutech Industries, Inc. | 2015-05-15 |
| Rhondium One-Visit-Crown(OVC) (K143694) | Rhondium, Ltd. | 2015-05-15 |
| Minhua Disposable Blood Pressure Cuff (K143728) | Suzhou Minhua Medical Apparatus | 2015-05-15 |
| T.A.G. Dental Implant System (K143326) | T.A.G. Medical Products Corporation, Ltd. | 2015-05-14 |