| Merge PACS (K173475) | Merge Healthcare Incorporated | 2017-12-08 |
| InMode PLUS System (K172302) | Inmode MD , Ltd. | 2017-12-08 |
| Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color Doppler Ultrasound Imaging System (K173000) | Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) | 2017-12-07 |
| NuVasive® VersaTie™ System (K173117) | Nuvasive, Inc. | 2017-12-07 |
| gel-e Bandage (K172010) | Gel-E, Inc. (Formerly Remedium Technologies, Inc.) | 2017-12-07 |
| Cystoscope 4.0mm autoclavable 0° WL 302mm; Hysteroscope 4.0mm autoclavable 0° WL 302mm; Cysto-Urethroscope Sheath 19 Fr.; Bridge for 17-25 Fr. Cysto-Urethroscope Sheath (K171336) | Henke-Sass, Wolf GmbH | 2017-12-07 |
| Lilium a-200E (K170046) | Lilium Otsuka Co., Ltd. | 2017-12-07 |
| NeuViz 16 Essence Multi-slice CT Scanner System (K171198) | Neusoft Medical Systems Co., Ltd. | 2017-12-07 |
| ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System (K173458) | Orthofix Srl | 2017-12-07 |
| Craniomaxillofacial Distraction System (CMFD) (K170818) | Synthes USA Products, LLC | 2017-12-07 |
| Lunderquist Extra Stiff Wire Guide (K171513) | William Cook Europe Aps | 2017-12-07 |
| Q-Switched Nd:YAG Laser System (K172908) | Ami, Inc. | 2017-12-07 |
| Portex Blue Line Ultra Paediatric Tracheosomy Tube (K170720) | Smiths Medical Asd, Inc. | 2017-12-07 |
| MicroScan Dried Gram-Negative MIC/Combo Panels with Ciprofloxacin-S (0.004 – 8 µg/mL) (K172912) | Beckman Coulter, Inc. | 2017-12-07 |
| MasterLoc Stem: Lateralized Plus (K173267) | Medacta International S.A. | 2017-12-07 |
| gammaCore-2 (K172270) | Eletrocore, LLC | 2017-12-07 |
| Single Use Electrosurgical Snare SD-400 (K172734) | Olympus Medical Systems Corp. | 2017-12-07 |
| Equipment Pouch (K172578) | Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd | 2017-12-07 |
| wettrust D2care (K170797) | Wettrust Korea Co., Ltd. | 2017-12-06 |
| OrthoPediatrics Wrist Fusion Plate (K172425) | Orthopediatrics, Inc. | 2017-12-06 |
| Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion System (K173153) | Nu Vasive, Incorporated | 2017-12-06 |
| 091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cm (K172468) | Inneuroco, Inc. | 2017-12-06 |
| Boundary Anterior Lumbar Buttress Plate (K173091) | Nvision Biomedical Technologies, LLC | 2017-12-06 |
| C3 Wave System (K170934) | Medical Components, Inc (Dba Medcomp_ | 2017-12-06 |
| BEAUTIFIL Flow Plus X (K172530) | Shofu Dental Corporation | 2017-12-06 |
| OxyPure Color Silicone Hydrogel Soft Contact Lenses (K171447) | Visco Vision, Inc. | 2017-12-05 |
| Vivaer ARC Stylus (K172529) | Aerin Medical, Inc. | 2017-12-05 |
| Arisstos™ Spinal System (K173126) | Ingenium Spine | 2017-12-05 |
| Renamel Microfill (K172707) | Cosmedent, Inc. | 2017-12-05 |
| Disposable Circular Stapler (K172561) | Changzhou Kangdi Medical Stapler Co., Ltd. | 2017-12-05 |
| SYSTEMS INTEGRATION ENDOALPHA MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-4 Software Version 1 (K172618) | Olympus Medical Systems Corp. | 2017-12-05 |
| P20 Series Digital Color Doppler Ultrasound System (K172993) | Sonoscape Medical Corp. | 2017-12-05 |
| Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc (K173538) | Alcon Laboratories, Inc. | 2017-12-04 |
| PhotoFix Decellularized Bovine Pericardium (K172085) | Cryolife, Inc. | 2017-12-04 |
| PowerDot PD-01M (K172876) | Smartmissimo Technologies Pte, Ltd. | 2017-12-04 |
| Panther Fusion AdV/hMPV/RV Assay (K172629) | Hologic, Inc. | 2017-12-04 |
| SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica; SeaSpine Spacer System -Hollywood, Hollywood VI, Ventura, Pacifica; SeaSpine Vu e·POD System (K173260) | SeaSpine Orthopedics Corporation | 2017-12-04 |
| ClotTriever Thrombectomy System, ClotTriever Catheter, ClotTriever Sheath (K173470) | Inari Medical | 2017-12-04 |
| ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay (K171771) | Siemens Healthcare Diagnostics, Inc. | 2017-12-04 |
| Velofix™ TLIF Cage (K172419) | U&I Corporation | 2017-12-04 |
| EZFluence (K171352) | Radformation, Inc. | 2017-12-01 |
| ACIF (K173148) | Coligne AG | 2017-12-01 |
| Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Meropenem/Vaborbactam in the Dilution Range of 0.008/8 - 18/8 ug/mL (K173209) | Thermo Fisher Scientific | 2017-12-01 |
| LightWalker Laser System Family (K172819) | Fotona D.O.O. | 2017-12-01 |
| MR Conditional Cup Electrode, MR Conditional Webb Electrode (K172503) | Rhythmlink International, LLC | 2017-12-01 |
| MicroScan Dried Gram Negative MIC/Combo Panels with Ceftolozane/tazobactam (0.25/4 - 16/4 ug/mL) (K172255) | Beckman Coulter, Inc. | 2017-12-01 |
| IR Type Implant System (K171185) | Biotem Co., Ltd. | 2017-12-01 |
| DUS-6000 Digital Ultrasonic Diagnostic Imaging System (K172931) | Advanced Instrumentations, Inc. | 2017-12-01 |
| Octane aspiration system (K173266) | Vascular Solutions, Inc. | 2017-12-01 |
| Alevicyn SG Antimicrobial Gel (K171935) | Sonoma Pharmaceuticals, Inc. | 2017-12-01 |
| PRECICE System (K173129) | Nuvasive Specialized Orthopedics, Inc. | 2017-12-01 |
| S.I.N. Implant System (K170392) | S.I.N. – Sistema DE Implante Nacional S.A. | 2017-12-01 |
| Straumann n!ce Glass Ceramic A14 Blocks (K171773) | Institut Straumann AG | 2017-12-01 |
| ARIX Humerus System (K172008) | Jeil Medical Corporation | 2017-12-01 |
| P10 Series Digital Color Doppler Ultrasound System (K173058) | Sonoscape Medical Corp. | 2017-12-01 |
| CuRAS Nd:YAG Laser (K173038) | Ilooda Co,., Ltd. | 2017-12-01 |
| CrossBow Fascial Closure System, CrossBow Fascial Closure System with Adaptor (K172666) | Sutureease, Inc. | 2017-12-01 |
| Altus Spine Interbody Fusion System (K170553) | Altus Partners, LLC | 2017-12-01 |
| TiLock Modular Spinal System (K172469) | Genesys Spine | 2017-11-30 |
| Birmingham Hip (BH) Dual Mobility Insert (K171934) | Smith & Nephew, Inc. | 2017-11-30 |
| Zimmer Trabecular Metal Reverse Shoulder System, Mini Glenoid (K172767) | Zimmer, Inc. | 2017-11-30 |
| Foot Drop System (Model XFT-2001D) (K162718) | Shenzhen Xft Medical Limited | 2017-11-30 |
| Solanas® Posterior Stabilization System (K173522) | Alphatec Spine, Inc. | 2017-11-30 |
| Endophys Pressure Sensing Sheath Kit- 8F (K173399) | Endophys Holdings, LLC | 2017-11-30 |
| Atlantis Abutment for MIS Implant (K172225) | Dentsply Sirona | 2017-11-30 |
| Graft Delivery, DePuy Synthes (K173385) | Micromedics, Inc. (D/B/A Nordson Medical) | 2017-11-30 |
| NexSite HD, Hemodialysis Step Tip Catheter (60cm) (K171571) | Marvao Medical Devices, Ltd. | 2017-11-30 |
| Fortis and Hana Anterior Cervical Plate System (K173099) | Huvexel Co. , Ltd. | 2017-11-30 |
| CryOmega Flexx (K172769) | Cryoconcepts LP | 2017-11-30 |
| Contact Lens Case, Model: A-1, B-1 (K172925) | P L Overseas Limited | 2017-11-30 |
| FIXIT Threaded Anchor System (K170868) | S.B.M Sas Science For Bio Materials | 2017-11-30 |
| Disposable Linear Stapler, Disposable Linear Cutter (K172538) | Changzhou Kangdi Medical Stapler Co., Ltd. | 2017-11-30 |
| Infrared thermometer (K171578) | Shenzhen Aeon Technology Co., Ltd. | 2017-11-30 |
| HeRO Graft (K172637) | Merit Medical Systems, Inc. | 2017-11-30 |
| ReliefBand 1.5 (K173233) | Reliefband Technologies | 2017-11-30 |
| Destiknee™ Total Knee System (K172936) | Meril Healthcare Pvt. , Ltd. | 2017-11-30 |
| s-Clean TiN Coating Abutments (K171694) | Dentis Co., Ltd. | 2017-11-29 |
| Lucent® (K170235) | Spinal Elements, Inc. | 2017-11-29 |
| HIVOX OTC Electrical Stimulator (K171803) | Hivox Biotek, Inc. | 2017-11-29 |
| M-Vizion Femoral Revision System (K170690) | Medacta International S.A. | 2017-11-29 |
| NobelDesign, DTX Studio Design (K171466) | Nobel Biocare AB | 2017-11-29 |
| Arlington PLIF/TLIF Cage (K172020) | Signature Orthopaedics Pty, Ltd. | 2017-11-29 |
| DESCRIBE PFD Patch (K172689) | Merz North America, Inc. | 2017-11-29 |
| ICONN Square 2.5MM Suture Anchor (K172491) | Iconn Orthopedics, LLC | 2017-11-29 |
| Collision Check (K171350) | Radformation, Inc. | 2017-11-29 |
| Brisbane ALIF Device, Gladstone ALIF Device (K172019) | Signature Orthopaedics Pty, Ltd. | 2017-11-29 |
| Quingo Classic Power Scooter S1301, Quingo Flyte Power Scooter S551, Quingo Toura Power Scooter 5350 (K170634) | Advanced Vehicle Concepts , Ltd. | 2017-11-29 |
| One Mum Pumpset (K172067) | Ardo Medical AG | 2017-11-29 |
| Suction Irrigation Set (K172794) | Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd | 2017-11-29 |
| Epic Pro 940 (K172771) | Biolase, Inc. | 2017-11-29 |
| GeneSTAT.MDx Coccidioides Assay (DEN170041) | Dxna, LLC | 2017-11-29 |
| Meridian PM (K170053) | The Center For Craniofacial & Dental Sleep Medicine | 2017-11-28 |
| DuoFLEX Coil Suite (K173290) | Mr Instruments, Inc. | 2017-11-28 |
| DIAZIR (K161652) | Zxtgy (Beijing) Technology Co., Ltd. | 2017-11-28 |
| PIT’Stop® implant (K170688) | In2bones Sas | 2017-11-28 |
| Ankle Fusion Plating System (K173121) | In2bones Sas | 2017-11-28 |
| Cefaly Dual (K173006) | Cefaly Technology | 2017-11-28 |
| Portable Nebulizer (K170916) | Microbase Technology Corporation | 2017-11-28 |
| Orange Non Sterile Powder Free Nitrile Examination Gloves (K172642) | Central Medicare Sdn Bhd | 2017-11-28 |
| TOKUYAMA UNIVERSAL BOND (K171226) | Tokuyama Dental Corporation | 2017-11-28 |