| Range/Denali/Mesa Spinal System (K171832) | K2m, Inc. | 2017-09-14 |
| MediClear PreOp (K163556) | Covalontechnologies, Inc. | 2017-09-14 |
| 3D Echo (K172513) | Jointvue, LLC | 2017-09-14 |
| BePOD® Foot Screws (K163148) | Fournitures Hospitalieres Industrie | 2017-09-14 |
| Clarius Ultrasound System (K172385) | Clarius Mobile Health Corp. | 2017-09-14 |
| HORIZON Therapy System (K171051) | Magstim Company, Ltd. | 2017-09-13 |
| NeuViz Prime Multi-slice CT Scanner System (K171201) | Neusoft Medical Systems Co., Ltd. | 2017-09-13 |
| AnemoCheck (K163215) | Sanguina, LLC | 2017-09-13 |
| Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software (K171664) | Bio-Rad Laboratories, Inc. | 2017-09-13 |
| Pollogen Legend+ System (K171359) | Pollogen, Ltd. | 2017-09-13 |
| FibroScan 430 Mini+ (K172142) | Echosens | 2017-09-13 |
| PASCAL Synthesis Twinstar Ophthalmic Scanning Laser System (K170409) | Topcon Medical Laser Systems, Inc. (Tmls) | 2017-09-12 |
| CAPI 3 Hb A1c (K171537) | Sebia | 2017-09-12 |
| cobas Cdiff Nucleic acid test for use on the cobas Liat System (K171770) | Roche Molecular Systems, Inc. | 2017-09-12 |
| Medifine Pen Needle 3 Bevel, Medifine Pen Needle Quinta 5 Bevel (K171144) | Medbio, LLC | 2017-09-12 |
| Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System (K171233) | Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. | 2017-09-12 |
| tremoFlo C-100 Airwave Oscillometry System (K170185) | Thorasys Thoracic Medical Systems, Inc. | 2017-09-12 |
| da Vinci Si Single-Site Instruments and Accessories, da Vinci Xi Single-Site Instruments and Accessories (K170875) | Intuitive Surgical, Inc. | 2017-09-12 |
| NEO Pedicle Screw System™ (K171582) | Neo Medical SA | 2017-09-12 |
| AIR-FLOW PLUS Prophylaxis powder (K171189) | E.M.S Electro Medical Systems S.A | 2017-09-11 |
| Navina Classic System (K170487) | Dentsply Sirona | 2017-09-11 |
| Electronic Caries Detector (K170822) | Ortek Therapeutics, Inc. | 2017-09-11 |
| Tri Auto ZX2 (K170275) | J. Morita USA, Inc. | 2017-09-11 |
| da Vinci Xi EndoWrist Instruments and Accessories (K170645) | Intuitive Surgical, Inc. | 2017-09-11 |
| INVISION Total Ankle Revision System (K171067) | Wrightmedicaltechnologyinc | 2017-09-11 |
| da Vinci S/Si EndoWrist Instruments and Accessories, Harmonic ACE Curved Shears (5mm & 8mm) (K170644) | Intuitive Surgical, Inc. | 2017-09-11 |
| TN-Brush (K170596) | Genoss Co., Ltd. | 2017-09-11 |
| Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow Biopsy/Aspiration Needle, Jamshidi Evolve Bone Marrow Biopsy/Aspiration Needle (K171531) | Care Fusion | 2017-09-11 |
| Sterile NS System (K170368) | Jeil Medical Corporation | 2017-09-11 |
| Prelude Pursuit Splittable Sheath Introducer (K172117) | Merit Medical Systems, Inc. | 2017-09-11 |
| Clear Vinyl Powder-free Patient Examination Gloves (K171317) | Shandong Zhi Hong Medical Products, Co. , Ltd. | 2017-09-11 |
| All-in-One Health Monitor, PC-303 (K170047) | Shenzhen Creative Industry Co., Ltd. | 2017-09-09 |
| CuffLink Implant System (K171725) | Conmed Corporation | 2017-09-08 |
| The Locking Pediatric Osteotomy Plate (LolliPOP) System (K170704) | Pega Medical, Inc. | 2017-09-08 |
| 014 Hydrophilic Coated PTA Balloon Dilatation Catheter (K171251) | Creagh Medical | 2017-09-08 |
| Powder Free Nitrile Examination Glove (K171667) | Professional Latex Sdn Bhd | 2017-09-08 |
| Luer-Jack Slip 3 ml, Luer-Jack Slip 5 ml, Luer-Jack Slip 20 ml, Luer-Jack Lock 10 ml (K171805) | Conceptomed AS | 2017-09-08 |
| Medline Hemo-Force DVT Compression Sleeve (K170415) | Medline Industries, Inc. | 2017-09-08 |
| hemochroma PLUS System (K163465) | Immunostics Inc., | 2017-09-08 |
| HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls (K170854) | Instrumentation Laboratory CO | 2017-09-08 |
| BM.IRIS (K171648) | Bluecore Co., Ltd. | 2017-09-08 |
| Footmotion Plating System (K171510) | Newclip Technics | 2017-09-08 |
| Nanova Sealant (K171330) | Nanova Biomaterials, Inc. | 2017-09-08 |
| BePOD® EZ Weil Screws (K163710) | Fournitures Hospitalieres Industrie | 2017-09-08 |
| QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EP (K170032) | Fysicon BV | 2017-09-08 |
| Sonic Block Tuohy, Sonic Block Quincke, Sonic Block Chiba, Sonic Block Crawford (K163292) | Spectra Medical Devices | 2017-09-08 |
| APTUS(R) Wrist 2.5 System (K172170) | Medartis AG | 2017-09-08 |
| ALN Optional Vena Cava Filter - Femoral Approach, ALN Optional Vena Cava Filter - Jugular Approach, ALN Optional Vena Cava Filter - Brachial Approach, ALN Optional Vena Cava Filter - Femoral Approach with Hook (K163699) | Aln Implants Chirurgicaux | 2017-09-08 |
| Indego (K171334) | Parker Hannifin Corporation | 2017-09-08 |
| Posterior Spine Truss System (PSTS) Interbody Fusion Device (K171351) | 4Web, Inc. | 2017-09-08 |
| Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone Synergy Cervical Interbody Fusion System (Slate) (K171893) | Bluestone Synergy | 2017-09-08 |
| Minimally Invasive Sealer (MIS) Flex, Minimally Invasive Sealer (MIS) Flex Mini (K170381) | Medtronic Advanced Energy | 2017-09-07 |
| NICO BrainPath (K172433) | Nico Corporation | 2017-09-07 |
| Reliance Cervical IBF System (K172489) | Reliance Medical Systems, LLC | 2017-09-07 |
| NeuroQuant (K170981) | Cortechs Labs, Inc. | 2017-09-07 |
| FuckWater (K171730) | Non-Friction Products, Inc. | 2017-09-07 |
| T-Rex Standalone ALIF (K170855) | Siats, LLC | 2017-09-07 |
| S4 Screw System™ (K162171) | Subchondral Solutions | 2017-09-07 |
| Implantium II (K171126) | Dentium Co., Ltd. | 2017-09-07 |
| XableCath Support Catheter (K170041) | Xablecath, Inc. | 2017-09-07 |
| Cranial Drill Bits and Accessories (K170442) | Ad-Tech Medical Instrument Corporation | 2017-09-07 |
| MicroSTAAR Injector System Cartridges (K172375) | STAAR Surgical Company | 2017-09-06 |
| QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 Controls (K163538) | Inova Diagnostics, Inc. | 2017-09-06 |
| Central Monitoring System (K171178) | Edan Instruments, Inc. | 2017-09-06 |
| Poseidon Ultrasound System (K163510) | Butterfly Network, Inc. | 2017-09-06 |
| QuadraSphere Microspheres (K172372) | Biosphere Medical, S.A. | 2017-09-06 |
| Katalyst Mark 1 Muscle Stimulation System (K171035) | Katalyst, Inc. | 2017-09-06 |
| Dentis Dental Implant System (K171027) | Dentis Co., Ltd. | 2017-09-06 |
| Tritanium C Anterior Cervical Cage (K171496) | Stryker Spine | 2017-09-06 |
| The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS, JLN-2317AS and JLN-2320AS) (K161586) | Shenzhen Homed Medical Device Co., Ltd. | 2017-09-06 |
| Steerable Guide Catheter (K172394) | Abbott Vascular | 2017-09-06 |
| FluidSmart (K172048) | Thermedx, LLC | 2017-09-05 |
| Relieva SpinPlus Nav Balloon Sinuplasty System (K171687) | Acclarent, Inc. | 2017-09-05 |
| Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2) (K163464) | Bmc Medical., Ltd. | 2017-09-05 |
| QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3) Controls (K163525) | Inova Diagnostics, Inc. | 2017-09-05 |
| NaviENT (K163439) | Claronav, Inc. | 2017-09-01 |
| PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0 (K170210) | Given Imaging , Ltd. | 2017-09-01 |
| Senographe Pristina (K163302) | GE Healthcare | 2017-09-01 |
| Arthrex Mesh Plate System (K170547) | Arthrex, Inc. | 2017-09-01 |
| Prizma (K170181) | G-Medical Innovations , Ltd. | 2017-09-01 |
| GrindCare System (K163448) | Sunstar Suisse S.A. | 2017-09-01 |
| Epilaser (K170970) | Epilady 2000, LLC | 2017-09-01 |
| RhythmView Workstation (K171583) | Abbott Electrophysiology | 2017-09-01 |
| OMNIBotics Knee System (K163338) | Omnllife Science, Inc. | 2017-09-01 |
| Carefusion NeutraClear Needle-free connector (EL-NC1000) (K171117) | Cair Lgl | 2017-09-01 |
| CustomizedBone Service (K171507) | Fin-Ceramica Faenza S.P.A. | 2017-09-01 |
| BIOPHOTAS CELLUMA3 (K171323) | Biophotas, Inc. | 2017-09-01 |
| ExsoMed ITN Cannulated Screw System (K171558) | Exsomed Holdings Company, LLC | 2017-09-01 |
| Emprint SX Ablation Platform and Accessories (K171358) | Coviden, LLC | 2017-09-01 |
| CAPRI Corpectomy Cage System (K171704) | K2m | 2017-08-31 |
| SHOFU MZ Primer Plus (K172106) | Shofu Dental Corporation | 2017-08-31 |
| Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D AutoClave® Automatic Sterilizer (K163337) | Midmark Corporation | 2017-08-31 |
| Atellica IM Ferritin Assay (K171642) | Siemens Healthcare Diagnostics, Inc. | 2017-08-31 |
| NLZ Motor System (K163402) | Nakanishi, Inc. | 2017-08-31 |
| Internal Octa Implant System (K170031) | Ebi, Inc. | 2017-08-31 |
| Orthopantomograph OP300 (K163423) | Palodex Group OY | 2017-08-31 |
| Latitude EV Total Elbow Arthroplasty (K171010) | Tornier, Inc. | 2017-08-31 |
| Additional VIPER PRIME™ screws with fenestrations (K171570) | Medos International SARL | 2017-08-31 |
| Medical Video Endoscope System (K172098) | Zhuhai Pusen Medical Technology Co., Ltd. | 2017-08-31 |
| Kelowna GYN and Crook Prostate Templates (K162533) | Varian Medical Systems, Inc. | 2017-08-31 |