| Spectra Optia Apheresis System, Spectra Optia Exchange Set (with AC Connection), Spectra Optia AC Connection Adapter (K151368) | Terumo Bct | 2015-09-11 |
| CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer System (K150619) | Orthofix, Inc. | 2015-09-11 |
| Varian Cleaning Caps, Varian Leak Stop Buttons, Varian Leak Stop Channel Marker Sets (K152018) | Varian Medical Systems, Inc. | 2015-09-11 |
| CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector (K143359) | Lifewatch Technologies , Ltd. | 2015-09-11 |
| 23ga Chandelier Illuminator, 25ga Chandelier Illuminator (K151604) | Peregrine Surgical , Ltd. | 2015-09-11 |
| Amendia Interbody Fusion Devices (K151322) | Amendia, Inc. | 2015-09-10 |
| JUSHA-C23C LCD Monitor (K151861) | Nanjing Jusha Display Technology Co., Ltd. | 2015-09-10 |
| Luggie Super (K151944) | Freerider Corporation | 2015-09-10 |
| Ligaclip 10mm M/L Endoscopic Rotating Multiple Clip Applier (K150840) | Ethicon Endo-Surgery, LLC | 2015-09-10 |
| ML24000 UVA-1 Phototherapy Cabinet (K151795) | Daavlin Distributing Co. | 2015-09-10 |
| HS AMICA DEVICES FAMILY (K150112) | H.S Hospital Service S.P.A | 2015-09-10 |
| Zone, ZoneFree, Zone A1 (K151526) | Sybron Dental Specialties | 2015-09-10 |
| SONON Ultrasound Imaging System (Model: SONON 300C) (K151339) | Healcerion Co., Ltd. | 2015-09-10 |
| Xenco Medical Cervical Interbody System (Argus) (K152302) | Xenco Medical, LLC | 2015-09-10 |
| Keeler Slit Lamp (K151394) | Keeler Limited | 2015-09-10 |
| ViZion DR + Wireless (K152279) | Viztek, LLC | 2015-09-10 |
| Sutter Bipolar Forceps-Calvian (K150959) | Sutter Medizintechnik GmbH | 2015-09-10 |
| Quill Polypropylene Knotless Tissue-Closure Device, Variable Loop Design (K151112) | Angiotech | 2015-09-10 |
| Romeo posterior osteosynthesis system (K151695) | Spineart | 2015-09-10 |
| JUSHA-C43 LCD Monitor (K151972) | Nanjing Jusha Display Technology Co., Ltd. | 2015-09-10 |
| Valleylab FT10 Electrosurgical Platform (K151649) | Covidien | 2015-09-10 |
| Stat Profile Prime ABG Analyzer System (K151982) | Nova Biomedical Corporation | 2015-09-10 |
| NuVasive CoRoent Lumbar System (K151472) | Nu Vasive, Incorporated | 2015-09-10 |
| Cryocare CS-3 Surgical System version 5 (K151968) | Healthtronics | 2015-09-09 |
| TGM Biolox delta Ceramic Heads (K150576) | Tgm Medical, Inc. | 2015-09-09 |
| NFANT Feeding Solution (K143507) | Nfant Labs, LLC | 2015-09-09 |
| VAPRO PLUS POCKET Intermittent Catheter (K152268) | Hollister Incorporated | 2015-09-09 |
| Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Cocaine Test (Strip, Cassette, Cup, Dip Card), Healgen Methamphetamine Test (Strip, Cassette, Cup, Dip Card) (K152269) | Healgen Scientific,, LLC | 2015-09-09 |
| SECURE-LOOP (K151601) | Xiros, Ltd. | 2015-09-09 |
| U&U Sterilization Pouch and Roll (K143637) | U&U Medical Technology Co, Ltd. | 2015-09-09 |
| PAXgene Blood DNA Tube (K142821) | Preanalytix GmbH | 2015-09-09 |
| S-scan (K151668) | Esaote, S.p.A. | 2015-09-08 |
| LigaSure Curved, Small Jaw, Open Sealer/Divider (K152286) | Covidien | 2015-09-08 |
| CAREVIEW 1800R (K141488) | Careray Digital Medical System Co., Ltd. | 2015-09-08 |
| Fully Automatic Electronic Blood Pressure Monitor (K151460) | Andon Health Co, Ltd. | 2015-09-08 |
| On Call Express Pro Blood Glucose Monitoring System (K151595) | ACON Laboratories, Inc. | 2015-09-05 |
| TOTAL COMPRESSION PLATING (TCP) SYSTEM (K151442) | Wrightmedicaltechnologyinc | 2015-09-04 |
| PRO-TOE Hammertoe Fixation System (K151838) | Wrightmedicaltechnologyinc | 2015-09-04 |
| Xenco Medical Pedicle Screw System (K151733) | Xenco Medical, LLC | 2015-09-04 |
| Arcus Staple System (K151160) | Nextremity Solutions, Inc. | 2015-09-04 |
| Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) (K143653) | Nanosphere, Inc. | 2015-09-04 |
| Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators (K152176) | Immunalysis Corporation | 2015-09-04 |
| Navigated XIA 4.5 Polyaxial Screwdriver (K143597) | Stryker Corporate | 2015-09-04 |
| PIEZOSURGERY WHITE (K151248) | Mectron S.P.A. | 2015-09-04 |
| Pyrenees Cervical Plate System (K152015) | K2m, Inc. | 2015-09-04 |
| Synthetic Bone Graft (TriPore HA, TriPore BP90, TriPore BP15) (K150064) | Orthogem, Ltd. | 2015-09-04 |
| Phoenix Thera-Lase System (K151521) | Phoenix Thera-Lase Systems, LLC | 2015-09-04 |
| Volcano Visions PV .018 Digital IVUS Catheter (K150442) | Volcano Corporation | 2015-09-04 |
| ab medica irrigation/suction gravity system (K151822) | Ab Medica Sas | 2015-09-04 |
| JuggerKnot Soft Anchors (K150768) | Biomet Manufacturing Corp | 2015-09-04 |
| CrossTIE Intraosseous Fixation System (K151270) | Crossroads Extremity Systems, LLC | 2015-09-04 |
| PUREWAY SHARPS COLLECTOR 1.2 GALLON, PUREWAY SHARPS COLLECTOR 2 GALLON, PUREWAY SHARPS COLLECTOR 3 GALLON (K151249) | Pureway Compliance, Inc. | 2015-09-04 |
| NuVasive PEEK Corpectomy Railed System (K151538) | Nu Vasive, Incorporated | 2015-09-04 |
| Art-line Single channel blood pressure system, Art-line Double channel blood pressure system, Art-line Triple channel blood pressure system, IAP Monitoring Set with Disposable Transducer (K151040) | Biometrix , Ltd. | 2015-09-04 |
| SIC 8000 (K150852) | Cosmo Technologies, Ltd. | 2015-09-03 |
| SpeqRT (K152250) | Signostics Limited | 2015-09-03 |
| Ebony PTA .014 RX Pheripheral Dilatation Catheter (K152230) | Natec Medical | 2015-09-03 |
| Peristeen Anal Irrigation System (K140310) | Coloplast A/S | 2015-09-03 |
| Exactech® Novation® Crown Cup® (K141960) | Exactech, Inc. | 2015-09-03 |
| Benefix Interspinous Fixation System (K143631) | U&I Corporation | 2015-09-03 |
| SUMMIT SI OCT Spinal Fixation System, MOUNTAINEER OCT Spinal System (K151885) | Depuy Synthes, Inc. | 2015-09-03 |
| MH01 (K152220) | Quanta System Spa | 2015-09-03 |
| REDAPT¿ Revision Femoral System (K151902) | Smith & Nephew, Inc. | 2015-09-03 |
| Exactech Optetrak Logic Enhanced Assembly (K152170) | Exactech, Inc. | 2015-09-03 |
| NuVasive PEEK Corpectomy System (K151167) | Nu Vasive, Incorporated | 2015-09-03 |
| Lotus Posterior Cervical/Thoracic Spinal System (K151705) | Spinal Elements, Inc. | 2015-09-03 |
| S12 Digital Color Doppler Ultrasound System (K152396) | Sonoscape Medical Corp. | 2015-09-03 |
| Klassic HD Hip System (K151440) | Total Joint Orthopedics, Inc. | 2015-09-03 |
| OPUS 5100 Diagnostic Doppler Ultrasound System (K142982) | Chang Gung Medical Technology Co., Ltd. | 2015-09-03 |
| Genesys Spine Apache Cervical Interbody Fusion System (K150812) | Genesys Spine | 2015-09-03 |
| Model 206 Electrometer/Dosimeter (K150265) | Cnmc Company Incorporated | 2015-09-03 |
| Leksell GammaPlan (K151666) | Elekta Instrument AB | 2015-09-03 |
| TRUCLEAR Operative Hysteroscope 5C and Sheath 5C (K152143) | Smith & Nephew, Inc. | 2015-09-02 |
| CleanSmart Wound Cleanser (K142592) | Simple Science, LLC | 2015-09-02 |
| TempTraq TT-100 (K143267) | Blue Spark Technologies, Inc. | 2015-09-02 |
| Fortress Pedicular Fixation System (K152148) | Spineology, Inc. | 2015-09-02 |
| DirectInject (K143661) | Stryker | 2015-09-02 |
| Microlife Upper Arm Automatic Digital Blood Pressure Monitor (K151869) | Microlife Intellectual Property GmbH, Switzerland | 2015-09-02 |
| FACT Medical Imaging Sysytem (K143586) | Dexin Medical Imaging Technology Co., Ltd. | 2015-09-02 |
| COMPACT INTUITIV Multiple-Use Pack (K151783) | Abbott Medical Optics, Inc. | 2015-09-02 |
| HAMILTON-T1,HAMILTON-C1 (K140939) | Hamilton Medical AG | 2015-09-02 |
| The Belmont Hyperthermia Pump (K152208) | Belmont Instrument Corporation | 2015-09-02 |
| Infinity CentralStation Wide (K151860) | Draeger Medical Systems, Inc. | 2015-09-02 |
| Panorama Patient Monitoring Network (K150082) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015-09-02 |
| BD Single Use, Hypodermic Syringe (K151766) | Becton, Dickinson and Company | 2015-09-02 |
| V Series Monitoring System (including V12 and V21 Monitors) (K150352) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015-09-02 |
| Cardinal Health NPWT PRO HC (K150124) | Cardinalhealth | 2015-09-02 |
| BOX DICOM Viewer (K151957) | Box, Inc. | 2015-09-01 |
| TRAUS SUS10 (K151171) | Saeshin Precision Co., Ltd. | 2015-09-01 |
| Dynarex Eye Cups (K151575) | Dynarex Corporation | 2015-09-01 |
| HyaloGYN Vaginal Hydrating Gel (K150883) | Fidia Farmaceutici S.P.A. | 2015-09-01 |
| CIRRUS HD-OCT (K150977) | Carl Zeiss Meditec, Inc. | 2015-09-01 |
| NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and Pulse Slicing Module (K151473) | Focus Medical, LLC | 2015-09-01 |
| FibroScan (K150239) | Echosens | 2015-09-01 |
| Biogel PI Micro Indicator Underglove (K150146) | Molnlycke Health Care Us, LLC | 2015-08-31 |
| Integra Total Ankle Replacement System (K151459) | Ascension Orthopedics | 2015-08-31 |
| Dental Implant OKTAGON Bone Level (K143539) | Hager& Meisinger GmbH | 2015-08-31 |
| EarlySense Central Display Station (CDS) (K151006) | Earlysense, Ltd. | 2015-08-31 |
| Sniper Spine System (K152174) | Spine Wave, Inc. | 2015-08-31 |
| Vitality Spinal Fixation System (K150896) | Zimmer Spine, Inc. | 2015-08-31 |