| Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle (K173184) | Boston Scientific | 2017-10-27 |
| Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray) (K172028) | Gebauer Company | 2017-10-27 |
| ASPIRE Cristalle (K173132) | Fujifilm Medical Systems U.S.A, Inc. | 2017-10-27 |
| ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay (K172133) | Axis-Shield Diagnostics, Ltd. | 2017-10-27 |
| Skylife (K170585) | Neolight, LLC | 2017-10-27 |
| Abbott Architect Free T4 (K173122) | Abbott Laboratories | 2017-10-27 |
| Trocar (K172038) | Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd | 2017-10-27 |
| Healing Cap Multi-Unit Titanium (K171142) | Nobel Biocare AB | 2017-10-26 |
| NuVasive® Modulus TLIF Interbody System (K172341) | Nu Vasive, Incorporated | 2017-10-26 |
| SeaSpine Ventura NanoMetalene System (K173022) | SeaSpine Orthopedics Corporation | 2017-10-26 |
| Cocoon Portable Handheld X-Ray System (K173046) | Dexcowin Co., Ltd. | 2017-10-26 |
| OrthoVision (K173094) | Ewoosoft Co., Ltd. | 2017-10-26 |
| Omnia Medical VBR (K172323) | Omnia Medical, LLC | 2017-10-26 |
| EPI K Console (K172994) | Moria SA | 2017-10-26 |
| Rhapsody H-30 Holmium Laser System (K172325) | Cook Incorporated | 2017-10-26 |
| Intra-Lock Bone Fixation System (K171831) | Intra-Lock International, Inc. | 2017-10-26 |
| Celerity ECG Cable Accessory Pack (K171931) | Medcomp (Medical Components, Inc.) | 2017-10-26 |
| SILC® Fixation System (K172417) | Globus Medical, Inc. | 2017-10-26 |
| Cortina™ Lumbar Cage System (K171914) | Neurostructures, Inc. | 2017-10-25 |
| Treace Medical Concepts (TMC) Compression Screw System (K172617) | Treace Medical Concepts, Inc. | 2017-10-25 |
| VIPER PRIME™ Screws, VIPER PRIME™ Screws with Fenestrations, EXPEDIUM® Verse Screws with Fenestrations (K173095) | Medos International SARL | 2017-10-25 |
| CosmoLock Pedicle Screw System (K172808) | Kalitec Direct, LLC | 2017-10-25 |
| Gel-Bead (K171946) | Vascular Solutions, Inc. | 2017-10-25 |
| iTotal Family Reusable Instrument Tray (K170226) | Conformis, Inc. | 2017-10-25 |
| SunCHECK (K170307) | Sun Nuclear Corporation | 2017-10-25 |
| CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large) (K173242) | Aziyo Biologics, Inc. | 2017-10-25 |
| Emit II Plus Cocaine Metabolite Assay (K170293) | Siemens Healthcare Diagnostics, Inc. | 2017-10-25 |
| Affinity Fusion Oxygenator with Balance Biosurface, Affinity Fusion Oxygenator with Cardiotomy/Venous Reservoir and Balance Biosurface, Affinity Fusion Oxygenator with Cortiva Biosurface, Affinity Fusion Oxygenator with Cortiva BioActive Surface & Cardiotomy/Venous Reservoir (K172626) | Medtronic, Inc. | 2017-10-25 |
| Smart Photon Micro-current Device, Model: EP-300 (K162652) | Li-Tek Electronic Technology Corporation | 2017-10-25 |
| 3880 MRI Patient Monitoring System (K172200) | Iradimed Corporation | 2017-10-25 |
| Colorado Therapeutics Xenograft Implant (K172937) | Colorado Therapeutics, LLC | 2017-10-25 |
| M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic Ultrasound (K172970) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2017-10-25 |
| AIR OPTIX COLORS, AIR OPTIX COLORS Toric, AIR OPTIX COLORS Multifocal (K172600) | Alcon Laboratories, Inc. | 2017-10-25 |
| Advance Medical Designs, Inc. Sterile Ultrasound Gel (K163050) | Advance Medical Designs, Inc. | 2017-10-25 |
| CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software v4.2 Installation Kit (K172455) | Volcano Corporation | 2017-10-25 |
| Automatic Blood Pressure Monitor Model LD-562U, LD-588U & LD-533U (K170454) | Honsun (Nantong) Co., Ltd. | 2017-10-25 |
| DentureID Microchip (K170423) | Cmp Industries, LLC | 2017-10-25 |
| Ortus™ Expandable Lumbar Interbody Fusion System (K172334) | Atlas Spine, Inc. | 2017-10-25 |
| CleanCision Wound Retraction and Protection System (K172132) | Prescient Surgical, Inc. | 2017-10-25 |
| AtriClip LAA Exclusion System with Preloaded PRO·V Clip (K173031) | AtriCure, Inc. | 2017-10-25 |
| SmartLinx Vitals Plus NIBP Module, SmartLinx Vitals Plus License for Spot Monitoring Mode, SmartLinx Vitals Plus Alarm Hub, SmartLinx Vitals Plus License for Advanced Monitoring Mode, Covidien FILAC 3000 - Temperature Module (K171751) | Capsule Technologie Sas | 2017-10-24 |
| Dynamic Coronary Roadmap 2.0 (K172307) | Philips Medical Systems Nederland B.V. | 2017-10-24 |
| ENFLU 18 (enflufocon A) Daily Wear Contact Lens (K171575) | Contamac, Ltd. | 2017-10-24 |
| UTS Stem (K172251) | United Orthopedic Corporation | 2017-10-24 |
| Alinity c ICT Sample Diluent (K170320) | Abbott Laboratories | 2017-10-24 |
| ClearLumen II Peripheral Thrombectomy System (K172000) | Walk Vascular, LLC | 2017-10-24 |
| Nexus DR Digital X-ray Imaging System (with PaxScan 4343RC and PaxScan 4343Rv3) (K172951) | Varex Imaging Corporation | 2017-10-24 |
| G3™ Active Plate® Miniature System (K171293) | Genesis Fracture Care, Inc. | 2017-10-23 |
| BeneLife Premium Facial Treatment Pack, Model: QZ0701A (K171647) | Infinitus (China) Company , Ltd. | 2017-10-23 |
| STERILE VINYL EXAMINATION GLOVES, Powder Free (K170612) | Primus Gloves Pvt Limited | 2017-10-23 |
| M-ARS ACL: Anatomic Ribbon Surgery System (K171640) | Medacta International S.A. | 2017-10-23 |
| Reprocessed Inquiry Steerable Diagnostic EP Catheter (K171277) | Innovative Health, LLC | 2017-10-23 |
| Acapella Cervical Spacer System (K171489) | Choicespine, LP | 2017-10-23 |
| KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw Set (K171938) | Medtronic | 2017-10-23 |
| IRENE Cannulated Screw System (K170056) | Tianjin Zhengtian Medical Instrument Co., Ltd. | 2017-10-23 |
| AnyPlus® Spinal Fixation System (K172546) | GS Medical Co., Ltd. | 2017-10-23 |
| gi-4000 Electrosurgical Generator (K172805) | United States Endoscopy Group, Inc. | 2017-10-23 |
| ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System (K173063) | Acist Medical Systems, Inc. | 2017-10-23 |
| Alinity i Total ß-hCG Reagent Kit, Alinity i System (K170317) | Abbott Laboratories | 2017-10-23 |
| Liberty Anterior Cervical Plate (K172585) | Valorus Spine | 2017-10-23 |
| Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 mg/mL. (K172542) | Liofilchem s.r.l. | 2017-10-23 |
| Lyme B. burgdorferi (IgM) MarStripe Test (K172254) | Trinity Biotech | 2017-10-23 |
| Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D Technology (K172343) | Rti Surgical, Inc. | 2017-10-23 |
| MECRON Cannulated Screw System (K172213) | Merete GmbH | 2017-10-23 |
| TruWave Disposable Pressure Transducer (K171996) | Edwards Lifesciences, LLC | 2017-10-23 |
| Monosyn Quick Synthetic Absorbable Surgical Suture (K171001) | Aesculap, Inc. | 2017-10-23 |
| Panther Fusion Paraflu Assay (K172282) | Hologic, Inc. | 2017-10-23 |
| BR-FHUS Viewer 1.0 (K171709) | Taihao Medical, Inc. | 2017-10-20 |
| ClearPoint System (K171257) | Mri Interventions, Inc. | 2017-10-20 |
| FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture (K172149) | M/s. Meril Endo Surgery Private Limited. | 2017-10-20 |
| Servator H SALF solution-1000 ml PVC free bags, Servator H SALF solution-2000 ml PVC free bags (K170150) | S.A.L.F. Spa | 2017-10-20 |
| Finessis Zero Flexylon Powder Free Sterile White Surgical Glove (K171987) | Lucenxia Prescience AG | 2017-10-20 |
| MyKnee PPS-Pin Positioners (K170106) | Medacta International S.A. | 2017-10-20 |
| DASH 3 ENFit Syringe, DASH 3 Eccentric ENFit Syringe, DASH 3 Plus ENFit Syringe, DASH 3 Plus Eccentric ENFit Syringe, DASH 3 ENFit Low Dose Tip Syringe (K170371) | Intervene Group Limited | 2017-10-20 |
| Heraeus TMW Guidewire (K173052) | Heraeus Medical Components, LLC | 2017-10-20 |
| GingiDent Gingival Retraction Paste (K162662) | Pac-Dent International, Inc. | 2017-10-20 |
| OCTAVIUS I, OCTAVIUS II, OCTAVIUS III, OCTAVIUS 4D (K160405) | Ptw-Freiburg Physikalisch-Technische-Werkstaetten | 2017-10-20 |
| Quantra (K163623) | Hologic, Inc. | 2017-10-20 |
| Sofia Lyme FIA, Sofia Lyme Control Set (K163713) | Quidel Corporation | 2017-10-20 |
| GSI Novus (K172403) | Grason-Stadler, Inc. | 2017-10-20 |
| SafeSept Transseptal Guidewire (K170671) | Pressure Products Medical Device Manufacturing, LLC | 2017-10-20 |
| Ultimate Contour, Ultimate Contour Mini (K171052) | CAO Group, Inc. | 2017-10-20 |
| GuideLiner V3 Catheter (K172090) | Vascular Solutions, Inc. | 2017-10-20 |
| Discovery XR656 HD (K172869) | Ge Hualun Medical Systems Co. , Ltd. | 2017-10-20 |
| Adani MammoScan (K172027) | Adani | 2017-10-20 |
| D'Vill Introducer (K171206) | NuMED, Inc. | 2017-10-20 |
| TREFOIL System (K172352) | Nobel Biocare AB | 2017-10-20 |
| NeuroBlate System (K172881) | Monteris Medical, | 2017-10-20 |
| Accuro (K171594) | Rivanna Medical, LLC | 2017-10-20 |
| audifon Tinnitus-Module (K171243) | Audiofon USA, Inc. | 2017-10-19 |
| Premium Plus Prophy Air Motor (K170261) | Premium Plus International Limited | 2017-10-19 |
| ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM (K170316) | Abbott Laboratories | 2017-10-19 |
| PuRE PMMA Disc (K172281) | Quest Dental USA Corp. | 2017-10-19 |
| VICTUS Femtosecond Laser Platform (K171014) | Technolas Perfect Vision GmbH | 2017-10-19 |
| Medrobotics Flex Robotic System (K170453) | Medrobotics Corporation | 2017-10-19 |
| EsophyX Z, EsophyX2 HD (K172811) | Endogastric Solutions, Inc. | 2017-10-19 |
| RPM Reinforced PTFE Mesh (K171774) | Osteogenics Biomedical, Inc. | 2017-10-19 |
| Amplatz Renal Dilator Set, Catheter for Use with Amplatz Renal Dilator Set, Amplatz Dilator, Amplatz Renal Introducer, Amplatz Radiopaque TFE Sheath, Clear Amplatz Sheath with Radiopaque Stripe (K172527) | Cook Incorporated | 2017-10-19 |
| GRI-FILL PERISTALTIC SET (K162216) | Laboratorios Grifols, S.A. | 2017-10-19 |
| 065 Zenith, 074 Zenith (K171672) | Inneuroco, Inc. | 2017-10-19 |