| VERIFY STEAM Integrating Indicator (K152630) | STERIS Corporation | 2016-05-12 |
| LSFG-NAVI (K153239) | Softcare Co., Ltd. | 2016-05-12 |
| Cardinal Health Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating and Tested for Use with Chemotherapy Drugs (Yellow) (K153316) | Cardinal Health, Inc. | 2016-05-12 |
| Genteel Lancing Device (K153670) | Genteel, LLC | 2016-05-12 |
| Laser Helmet LH40-EVO (K161046) | Theradome, Inc. | 2016-05-12 |
| Venous Assist System (K150980) | Daesung Maref Co., Ltd. | 2016-05-12 |
| Vericore Gradient Temporary Disc (K152443) | Whip Mix Corporation | 2016-05-11 |
| Slit Lamp Microscope (K152429) | Shanghai Mediworks Precision Instruments Co. , Ltd. | 2016-05-11 |
| Catalyst CSR Shoulder System (K152825) | Catalyst Orthoscience, LLC | 2016-05-11 |
| Biodesign Otologic Repair Graft (K161000) | Cook Biotech Incorporated | 2016-05-11 |
| Reprocessed Livewire Steerable Diagnostic EP Catheter (K160242) | Innovative Health, LLC | 2016-05-10 |
| Vanguard XP Knee System (K153657) | Biomet, Inc. | 2016-05-10 |
| Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level 3, Amplichek I, MiniPak (K152679) | Bio-Rad Laboratories | 2016-05-10 |
| Reprocessed Polaris X Steerable Diagnostic EP Catheter (K160303) | Innovative Health, LLC | 2016-05-10 |
| FiberTak DR (K160319) | Arthrex, Inc. | 2016-05-10 |
| LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx (TiNbN) coating (K152431) | Waldemar Link GmbH & Co. KG | 2016-05-09 |
| True HD 3MOS Camera System (K161017) | Conmed Corporation | 2016-05-09 |
| IBS Implant System (K153350) | Innobiosurg Co., Ltd. | 2016-05-09 |
| Diagnostic Station DS20 (K152043) | Schiller AG | 2016-05-06 |
| Achieve ST Mapping Catheter, Catheter Connecting Cable (K153139) | Medtronic, Inc. | 2016-05-06 |
| TOUAREG CloseFit™ UNP 2.75mmD (K153111) | Adin Dental Implants Systems , Ltd. | 2016-05-06 |
| Qora AIM Stool Management Kit, Qora Aeon Stool Management Kit, Qora Arida Stool Management Kit (K153506) | Consure Medical Pvt , Ltd. | 2016-05-06 |
| Spectralis HRA + OCT and variants (e.g.s below), Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT ith Multicolor (K152205) | Heidelberg Engineering GmbH | 2016-05-06 |
| Digital Blood Pressure Monitor (K152415) | Suzhou Sunspirit Co., Ltd. | 2016-05-06 |
| NeoFuse HA Enhanced PLIF/TLIF (K153615) | Ht Medical, LLC | 2016-05-06 |
| FREMAP ELECTRODE (K152769) | Ad-Tech Medical Instrument Corporation | 2016-05-06 |
| EarlySense Insight Sytem (K152911) | Earlysense, Ltd. | 2016-05-06 |
| TD-1035 Thermometer (K152680) | Taidoc Technology Corporation | 2016-05-06 |
| Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW Technology (K160740) | Surgical Instrument Service and Savings, Inc. | 2016-05-06 |
| Pulp Canal Sealer, Pulp Canal Sealer EWT (K152956) | Sybron Dental Specialties | 2016-05-06 |
| Monopolar single-use HF cable (K160053) | Olympus Winter & Ibe GmbH | 2016-05-06 |
| Sydney IVF Blastocyst Cryopreservation Kit, Sydney IVF Blastocyst Thawing Kit (K152717) | William A. Cook Australia Pty. , Ltd. | 2016-05-06 |
| INVISION Total Ankle Revision System (K153008) | Wrightmedicaltechnologyinc | 2016-05-06 |
| HC Spinal System (K151362) | Hung Chun Bio-S Co., Ltd. | 2016-05-05 |
| Cervical Interbody Fusion System (K160324) | Evolution Spine, LLC | 2016-05-05 |
| HydroMARK Breast Biopsy Site Marker (K161021) | Devicor Medical Products, Inc. | 2016-05-05 |
| Cogent Hemodynamic Monitoring System (K152006) | Icu Medical, Inc. | 2016-05-05 |
| Electronic Pulse Stimulator (K153520) | Jkh Health Co., Ltd. | 2016-05-05 |
| LOGIQ P9 and LOGIQ P7 (K161047) | GE Healthcare | 2016-05-05 |
| Certex Spinal Fixation System (K160428) | X-Spine Systems, Inc. | 2016-05-05 |
| ERBE ESU Model VIO dV with Accessories (K150364) | Erbe Elektromedizin GmbH | 2016-05-05 |
| Philips Efficia CMS200 Central Monitoring System (K160951) | Philips Medical Systems | 2016-05-05 |
| Enovare Ultrasound System (K153620) | Oreon Technologies, Inc. | 2016-05-05 |
| Sydney IVF Cryopreservation Kit, Sydney IVF Thawing Kit (K152682) | Willian A. Cook Australia Pty, Ltd. | 2016-05-05 |
| Alma Diode Tabletop Laser (K160952) | Alma, Ltd. | 2016-05-05 |
| Flip Button Suture Anchor (K153585) | First Ray, LLC | 2016-05-05 |
| PeriFlux6000 (K152930) | Perimed AB | 2016-05-05 |
| Vented Vial Adapter Transfer Device - 13mm (K160503) | Medimop Medical Projects, Ltd. | 2016-05-04 |
| Xenco Medical Pedicle Screw System (K160986) | Xenco Medical, LLC | 2016-05-04 |
| 6200 Ultrasound System and 6250 Ultrasound System (K153277) | Esaote, S.p.A. | 2016-05-04 |
| Soehendra Stent Retriever (K161203) | Wilson-Cook Medical, Inc. | 2016-05-04 |
| Yarlap II (K160773) | International Trade Group, Inc. | 2016-05-04 |
| Certus 140 2.45GHz Ablation System (K160936) | Neuwave Medical, Inc. | 2016-05-04 |
| SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIF (K153783) | Spinevision S.A. | 2016-05-04 |
| GastriSail Gastric Positioning System 40 Fr/CH (13.3mm) (K160654) | Covidien, LLC | 2016-05-04 |
| Precision Spine Interspinous Plate System (K160568) | Precision Spine, Inc. | 2016-05-04 |
| Electrosurgical Generator ESG-200 (K160639) | Olympus Winter & Ibe GmbH | 2016-05-04 |
| Vit Kit-Freeze Oocytes, Embryos and PN zygotes Vitrification Freeze Kit, Vit Kit-Thaw Oocytes, Embryos and PN zygotes Vitrification Thaw Kit (K160006) | Irvine Scientific | 2016-05-04 |
| ENZA Zero-Profile Anterior Interbody Fusion (K153720) | Camber Spine Technologies | 2016-05-03 |
| Swan Ganz Catheters (K160084) | Edwards Lifesciences, LLC | 2016-05-03 |
| HAMILTON-H900, HAMILTON-BC8022, HAMILTON-BC4022, HAMILTON-BC8010, HAMILTON-BC4010 (K152029) | Hamilton Medical AG | 2016-05-03 |
| Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device (K160845) | Boston Scientific Corporation | 2016-05-03 |
| SERFAS 90-S Electrosurgical Probe (K160050) | Stryker Corporation | 2016-05-03 |
| STROPP (Single Tunnel Repair of Plantar Plate) (K160118) | Crossroads Extremity Systems, LLC | 2016-05-03 |
| UCP COMPACT DRUG TESTS (K152908) | Ucp Biosciences, Inc. | 2016-05-03 |
| FLEX Monoclonal Rabbitt Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use (Link); FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636, Ready-to-Use (Link) (K160922) | Dako North America, Inc. | 2016-05-03 |
| AirFit N20 (K153673) | Resmed, Ltd. | 2016-05-02 |
| HEX tanning booth (K152336) | J & B Products Ltd Dba Hex Tanning | 2016-05-02 |
| AIR OPTIX plus HydraGlyde, AIR OPTIX plus HydraGlyde for Astigmatism, AIR OPTIX plus HydraGlyde Multifocal, AIR OPTIX plus HydraGlyde Multifocal Toric (K160609) | Alcon Laboratories, Inc. | 2016-05-02 |
| Medline ReNewal Reprocessed LigaSure Impact Open Sealer/Divider (K153745) | Surgical Instrument Service and Savings Inc.(Dba Medline Ren | 2016-05-02 |
| Green Laser Photocoagulator GYC-500 (K152603) | Nidek Co., Ltd. | 2016-05-02 |
| Standard Clamp (K153358) | Standard Bariatrics | 2016-05-02 |
| TRINITY (K160357) | Koelis | 2016-05-02 |
| MX50T(MX50TQS) (K160354) | Wide Corporation | 2016-05-02 |
| BTI Dental Implant System UnicCa (K151391) | B.T.I. Biotechnology Institute, Sl. | 2016-05-02 |
| Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs (K151390) | Maxter Glove Manufacturing Sdn Bhd | 2016-05-02 |
| EndoFLIP (K160725) | Crospon, Ltd. | 2016-05-01 |
| EsophyX® Z Device with SerosaFuse Fasteners and Accessories (K160960) | Endogastric Solutions, Inc. | 2016-05-01 |
| TBS iNsight (K152299) | Medimaps Group SA | 2016-04-29 |
| OsteoBullet Compression Screw (K160304) | Phalanx Innovations | 2016-04-29 |
| Crosstella OTW (K160004) | KANEKA Corporation | 2016-04-29 |
| Blue Sky Bio Zygomatic Implant System (K153064) | Blue Sky Bio, LLC | 2016-04-29 |
| REVIVAL(TM) Modular Revision Hip Stem (K152903) | Corin USA | 2016-04-29 |
| Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft (K160869) | Cook Biotech Incorporated | 2016-04-29 |
| da Vinci Xi Surgical System (K152892) | Intuitive Surgical | 2016-04-29 |
| Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavian Delivery Kit (K160866) | C.R. Bard, Inc. | 2016-04-29 |
| Patient Monitor (K152552) | Edan Instruments, Inc. | 2016-04-29 |
| Alphatec Navigation Instruments (K153603) | Alphatec Spine, Inc. | 2016-04-29 |
| T-32;T-40;T-44;T-52;T-72;TT-50 (K152412) | Tanses Technologies, Inc. | 2016-04-29 |
| Besmed PEEP Valve (K160112) | Besmed Health Business Corp | 2016-04-29 |
| Mobius3D (K153014) | Mobius Medical Systems, LP | 2016-04-29 |
| Dyna-Vision Telemonitoring System (K152973) | Techmedic Development International B.V. | 2016-04-29 |
| Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible) (K152619) | Prosurg, Inc. | 2016-04-29 |
| Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) & Bencox Bone Plug (K152084) | Corentec Co., Ltd. | 2016-04-29 |
| Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control System (K152223) | Oxyheal Medical Systems, Inc. | 2016-04-29 |
| MC-Subtalar(TM) II (K160548) | Merete Medical GmbH | 2016-04-29 |
| Bi-Blade Vitrectomy Cutter (K153168) | Medical Instrument Development Laboratories | 2016-04-29 |
| Crosperio OTW (K160013) | KANEKA Corporation | 2016-04-29 |
| ARCHITECT ROMA (K151502) | Fujirebio Diagnostics,Inc. | 2016-04-28 |
| BRILLIANT EVERGLOW (K152927) | Coltene/Whaledent AG | 2016-04-28 |