| Visaris Avanse (K150725) | Visaris D.O.O. Belgrade | 2015-06-08 |
| BD Veritorâ„¢ System Flu A+B Assay (K151301) | Becton, Dickinson and Company | 2015-06-08 |
| Ensizor Endoscopic Scissors (K150939) | Slater Endoscopy, LLC | 2015-06-08 |
| VIDAS FT4 (K132058) | Biomerieux S.A. | 2015-06-08 |
| smARTrack Feeding Tube System (K142327) | Art Healthcare , Ltd. | 2015-06-08 |
| ZX2 Laser System (K150466) | Lzr7, Inc. | 2015-06-08 |
| MicroCross Catheter (K151082) | Roxwood Medical, Inc. | 2015-06-07 |
| DPZ Pedicular Fixation System (K150294) | Osteomed Implantes, Ltda | 2015-06-05 |
| Freedom Spinal Cord Stimulator System (K150517) | Stimwave Technologies Incorporated | 2015-06-05 |
| Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) (K143715) | Better Plastic Co., Ltd. | 2015-06-05 |
| Metallic Locking Bone Plate and Screw System (K143002) | Changzhou Dingjian Medical Appliance Co., Ltd. | 2015-06-05 |
| Phasix ST Mesh (K143380) | C.R. Bard, Inc. | 2015-06-05 |
| IMED-Z FLUID STATUS MONITOR (K142503) | Intersection Medical, Inc. | 2015-06-05 |
| MUSE System (K151001) | Medigus , Ltd. | 2015-06-05 |
| TI-OSS (K140021) | Chiyewon | 2015-06-05 |
| FreeStyle Lite Blood Glucose Monitoring System (K150332) | Abbott Laboratories | 2015-06-05 |
| HumaPen Luxura (K142518) | Eli Lilly and Company | 2015-06-05 |
| Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalysis cTHC Urine Calibrators, Immunalysis cTHC Urine Control Set (K151203) | Immunalysis Corporation | 2015-06-05 |
| Chariot Guiding Sheath (K150186) | Boston Scientific Corp | 2015-06-05 |
| MCL 31 Dermablate (K150140) | Asclepion Laser Technologies GmbH | 2015-06-05 |
| Ez3D-i/E3 (K150761) | Ewoosoft Co., Ltd. | 2015-06-05 |
| Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter (JACC) with Sustain Technology (K150109) | Arrow International (A Subsidiary of Teleflex, Inc.) | 2015-06-05 |
| COGNIVUE (DEN130033) | Cerebral Assessment Systems, Inc. | 2015-06-05 |
| FreeStyle Freedom Lite Blood Glucose Monitoring System (K150531) | Abbott Laboratories | 2015-06-05 |
| Ultrasound System SONIMAGE HS1 (K151060) | Konica Minolta, Inc. | 2015-06-05 |
| Tritium Sternal Cable Plate System (K150581) | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | 2015-06-04 |
| Sure Lok Mini Posterior Cervical/Upper Thoracic System (K150851) | Precision Spine, Inc. | 2015-06-04 |
| Ebony PTA 0.014'' over the wire Catheter and Ebony PTA 0.018 over the wire Catheter (K143041) | Natec Medical , Ltd. | 2015-06-04 |
| NxStage System One (K150472) | Nxstage Medical, Inc. | 2015-06-04 |
| Collage (K150976) | Anatomage, Inc. | 2015-06-04 |
| ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMS (K150552) | Globus Medical, Inc. | 2015-06-04 |
| CreoDent Solidex Customized Abutment (K150012) | Creodent Prosthetics, Ltd. | 2015-06-04 |
| Alevicyn SG Antipruritic Gel (K143590) | Oculus Innovative Sciences | 2015-06-04 |
| AssureTech Secobarbital Strip, AssureTech Oxycodone Strip, AssureTech Secobarbital/Oxycodone Panel Dip, AssureTech Secobarbital/Oxycodone Quick Cup, AssureTech Secobarbital/Oxycodone Turn Key-Split Cup (K151211) | Assure Tech. Co., Ltd. | 2015-06-04 |
| ToeTac Hammertoe Fixation System (K150443) | Restore Surgical, LLC Dba Instratek | 2015-06-04 |
| INTRAGen (K142833) | Jeisys Medical, Inc. | 2015-06-04 |
| Remington Medical Inc. Tuohy Epidural Needles (K150266) | Remington Medical, Inc. | 2015-06-04 |
| VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit 31, VITROS Chemistry Products %A1c Performance Verifiers I and II (K142595) | Ortho Clinical Diagnostics | 2015-06-04 |
| Fixtemp Cement (K142446) | Exacta Dental Direct, Inc. | 2015-06-04 |
| WIRION (K143570) | Gardia Medical | 2015-06-04 |
| MR Core Software (K151115) | Vital Images, Inc. | 2015-06-03 |
| Mercury Spinal System (K151215) | Spinal Elements, Inc. | 2015-06-03 |
| ANAX OCT Spinal System (K150570) | U&I Corporation | 2015-06-03 |
| GE333 Blood Glucose Monitoring System (K143387) | Bionime Coporation | 2015-06-03 |
| Pulse Oximeter, Models PC-66A; PC-66B; PC-66C;PC-60B1; PC-60B5; PC-60D; PC-60D2; PC-60E; PC-60N; POD-1; POD-2; POD-3; PC-68A; PC-68B; PC-68C; POD- 1W; and POD-60NW-1 (K150093) | Shenzhen Creative Industry Co., Ltd. | 2015-06-03 |
| ACCU-CHEK Connect Diabetes Management App (K150910) | Roche Diabetes Care, Inc. | 2015-06-03 |
| DISPOSABLE PRE-GELLED SURFACE ELECTRODE (K142159) | Rochester Electro Medical, Inc. | 2015-06-03 |
| FibroScan (K150949) | Echosens | 2015-06-03 |
| AOS Clavicle Intramedullary Device (K143204) | Advanced Orthopaedic Solutions, Inc. | 2015-06-03 |
| SPB SKIN EMULSION (K141637) | Biotd S.A. | 2015-06-03 |
| Cardio-TriTest (K143432) | Cardio-Phoenix, Inc. | 2015-06-03 |
| Sonic Surgeon 310L, Sonic Surgeon 600L and Sonic Surgeon 800L (K150076) | Dong IL Technology , Ltd. | 2015-06-02 |
| Fiber Disks and Blocks (TRINIA) (K143524) | Bicon, LLC | 2015-06-02 |
| Everyway Facial MENS (K142794) | Everyway Medical Instruments Co.,Ltd | 2015-06-02 |
| PleuraFlow System (K150042) | Clearflow, Inc. | 2015-06-02 |
| MICRODENT GENIUS IMPLANT SYSTEM (K141188) | Implant Microdent | 2015-06-02 |
| Safe'n'Sound Staked Passive Delivery System - Plajex version (K150562) | Nemera | 2015-06-02 |
| Injection Needle (K150434) | Micro-Tech (Nanjing) Co., Ltd. | 2015-06-02 |
| cobas HSV 1 and 2 Test (K150617) | Roche Molecular Systems, Inc. | 2015-06-01 |
| POWER-TRIALYSIS SLIM-CATH SHORT-TERM DIALYSIS CATHETER (K141531) | C.R. Bard, Inc. | 2015-06-01 |
| PROBEAT-V (K151132) | Hitachi, Ltd., Health Care Company | 2015-06-01 |
| VX120 Ophthalmic Diagnostic Device (K143086) | Luneau Sas | 2015-06-01 |
| ICIS View (K143397) | Agfa Healthcare N.V. | 2015-06-01 |
| Reactor(TM) Trocar and Sleeve (K150549) | Sharp Medical Prducts, LLC | 2015-06-01 |
| Roosin Silver Calcium Alginate Dressing (Prescription), Roosin Alginate Dressing with Preservative (OTC) (K143335) | Roosin Medical Devices Co., Ltd. | 2015-06-01 |
| Occlusion Balloon Catheter (K142692) | Embolx, Inc. | 2015-05-31 |
| Optilite IgG4 Kit (K150526) | The Binding Site Group , Ltd. | 2015-05-30 |
| SmartTENS (K143430) | Easy Med Instrument Co., Ltd. | 2015-05-29 |
| Various Brands of Ultraviolet Lamps (K150778) | Cosmedico Light, Inc. | 2015-05-29 |
| opti-Toe (K142478) | Graham Medical Technologies, LLC (D.B.A.Gramedica) | 2015-05-29 |
| STAT PROFILE PRIME CCS ANALYZER SYSTEM, STAT PROFILE PRIME AUTO QC CARTRIDGE CCS, STAT PROFILE PRIME AMPULED CONTROL ABG/CCS, STAT PROFILE PRIME CALIBRTOR CARTRIDGE CCS/CCS COMP, NOVA LINEARITY STANDARD SET A (K141907) | Nova Biomedical Corporation | 2015-05-29 |
| EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit Connector (K150679) | Boston Scientific Corp | 2015-05-29 |
| ITST Intertrochanteric/Subtrochanteric Fixation System (K143321) | Zimmer, Inc. | 2015-05-29 |
| Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets (K143263) | Covidien | 2015-05-29 |
| SP-1PSpecular Microscope (K142417) | Topcon Corporation | 2015-05-29 |
| Signia Loading Unit, Tri-Staple 2.0 Cartridge (K151163) | Covidien, LLC | 2015-05-29 |
| Exactech Optetrak Logic CC (K150890) | Exactech, Inc. | 2015-05-29 |
| Columbus Total Knee System, Columbus Revision Knee System, EnduRo Knee System (K150544) | Aesculap Implant Systems, LLC | 2015-05-29 |
| Piccolo Composite Plate System (K143496) | CarboFix Orthopedics , Ltd. | 2015-05-29 |
| Instru-Safe Instrument Protection System (K142768) | Summit Medical, Inc. | 2015-05-29 |
| Prime Adaptive Ultrasonic Scalpel System (K150271) | Endoprime, Inc. | 2015-05-29 |
| MAGEC 2 Spinal Bracing and Distraction System (K150885) | Ellipse Technologies, Incorporated | 2015-05-29 |
| Azure Anterior Cervical Plate System (K143028) | Orthofix, Inc. | 2015-05-29 |
| Para-Fix C&S Medium (K150887) | Medical Chemical Corporation | 2015-05-29 |
| URISCAN OPTIMA (K141874) | Yd Diagnostics Corp. | 2015-05-28 |
| TD-Wand (K150824) | Tdm Surgitech, Inc. | 2015-05-28 |
| Vaginal Tactile Imager (K142355) | Advanced Tactile Imaging, Inc. | 2015-05-28 |
| ViMove (K142494) | Dorsavi, Ltd. | 2015-05-28 |
| Imed Technology Intravascular Administration Set, Imed Technology Extension Set (K150513) | Imed Technology, Inc. | 2015-05-28 |
| SMR Modular Glenoid (K143256) | Lima Corporate S.P.A. | 2015-05-28 |
| Captiva Spine FuselOX Cervical IBF System (K142586) | Captiva Spine | 2015-05-28 |
| LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Calibrators and LZI Oral Fluid Cannabinoids Controls (K141320) | Lin-Zhi International, Inc. | 2015-05-28 |
| Ascendant TM Cervical Spacer System (K150130) | Exactech, Inc. | 2015-05-28 |
| AEU-7000L-70V IMPLANT/ENDODONTIC DENTAL SYSTEM (LIGHTED VERSION) (K150129) | Aseptico, Inc. | 2015-05-28 |
| PTA 14 Balloon Dilatation Catheter OTW (K142954) | Texasmedical Technologies, Inc. | 2015-05-28 |
| Mandible External Fixator - MR Conditional (K143285) | Synthes USA Products, LLC | 2015-05-28 |
| Heavy Double Flexible Tipped Wire Guide (K150802) | Cook Incorporated | 2015-05-28 |
| 21.3 inch (54cm) Color LCD Monitor CCL210 (CL21210) (K151134) | Jvckenwood Corporation | 2015-05-27 |
| Medtronic Patient Asistant (K150117) | Medtronic, Inc. | 2015-05-27 |
| Synapse Transcutaneous Electrical Stimulation Device (K143198) | Synapse Electroceutical Limited | 2015-05-27 |