| QUANTIEN Measurement System (K172182) | St. Jude Medical (Now Part of the Abbott Medical) | 2017-08-18 |
| SnoreRx (K170825) | Apnea Sciences Corporation | 2017-08-18 |
| QEVO System with KINEVO 900 (K170667) | Carl Zeiss Meditec, AG | 2017-08-18 |
| ID-FISH Plasmodium Genus Test Kit, ID-FISH Plasmodium falciparum and P. vivax Combo Test Kit (DEN160025) | Id-Fish Technology, Inc. | 2017-08-18 |
| ExsoMed ArcPhix and ExsoMed ArrowPhix (K171407) | Exsomed Holding Company, LLC | 2017-08-18 |
| 3DMetal Tibial Cones (K170149) | Medacta International S.A. | 2017-08-18 |
| ARK Methotrexate Assay (K163359) | Ark Diagnostics, Inc. | 2017-08-18 |
| Optum TeleHealth Application (K171406) | United Health Group, Inc. | 2017-08-18 |
| Diazyme DZ-Lite Total beta-hCG Test System (K163418) | Diazyme Laboratories | 2017-08-18 |
| ScannerSide DoseCheck (K171261) | Right Dose, Inc. | 2017-08-18 |
| Relievant Medsystems RF Generator (K171143) | Relievant Medsystems | 2017-08-18 |
| EMBA Hourglass Peripheral Embolization Device (K171845) | Emba Medical Limited | 2017-08-18 |
| Sterile Polyisoprene Powder Free Surgical Gloves, Tested for Use With Chemotherapy Drugs (K171898) | Better Care Plastic Technology Co., Ltd. | 2017-08-18 |
| Duo Lumbar Interbody Fusion Device (K171660) | Spineology, Inc. | 2017-08-18 |
| Supria True64 (K171738) | Hitachi Healthcare Americas Corporation | 2017-08-18 |
| StarWalker (K171227) | Fotona D.O.O. | 2017-08-18 |
| Zip 4 Skin Closure Device (K170003) | Zipline Medical, Inc. | 2017-08-18 |
| OmniTom (K171183) | Neurologica Corporation | 2017-08-18 |
| Medline UNITE® Snap-Off Screws (K170782) | Medline Industries, Inc. | 2017-08-18 |
| CT Syringe for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), CT Syringe Dual Pack for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), Single Fascia and Ram Tip, Dual Fascia and Ram Tip (K170431) | Coeur, Inc. | 2017-08-18 |
| s LDL-EX SEIKEN (K161679) | Denka Seiken Co., Ltd. | 2017-08-18 |
| UroLift System (UL500) (K172359) | Neotract, Inc. | 2017-08-18 |
| Acclarix AX4 Diagnostic Ultrasound System (K171900) | Edan Instruments, Inc. | 2017-08-18 |
| ACIST RXi Mini System (K172216) | Acist Medical Systems, Inc. | 2017-08-18 |
| Sequential Circulator SC-2004FC-OC (K171793) | Bio Compression Systems, Inc. | 2017-08-17 |
| Rocket Indwelling Pleural Catheter (IPC) Insertion Kit (K163321) | Rocket Medical Plc | 2017-08-17 |
| Zimmon Needle Knife Papillotome (K171993) | Wilson-Cook Medical Inc./Cook Endoscopy | 2017-08-17 |
| Dentium NR Line CAD/CAM Abutments (K170384) | Dentium Co., Ltd. | 2017-08-17 |
| IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class) (K163500) | Ion Beam Applications S.A. | 2017-08-17 |
| SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0 (K163339) | Spectralmd, Inc. | 2017-08-17 |
| BD Intima II PLUS Closed IV Catheter System (K172204) | Becton, Dickinson and Company | 2017-08-17 |
| Q-Fix Suture Anchor (K172165) | ArthroCare Corporation | 2017-08-17 |
| CARESCAPE Respiratory MOdules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX and accessories (K171028) | GE Healthcare Finland Oy | 2017-08-17 |
| Ureteral Dilators and Percutaneous Nephrostomy Dilators (K170531) | Coloplast Corp. | 2017-08-17 |
| Creo Medical Electrosurgical System including Speedboat RS2 Surgical Accessory (K171983) | Creo Medical, Ltd. | 2017-08-17 |
| ARIX Ankle Fibula Hook Plate System (K170979) | Jeil Medical Corporation | 2017-08-17 |
| Allerhope Allergy Skin Tester (K162917) | Procare Industrial Co., Limited | 2017-08-17 |
| U Deliver Bolink ENFit Enteral Feeding Sets (K170555) | U Deliver Medical, LLC | 2017-08-17 |
| DeRoyal Laprador Specimen Retrieval System (K171475) | Deroyal Industries, Inc. | 2017-08-17 |
| OMNI Anseris Hip Stem (K171156) | Omnilife Science | 2017-08-17 |
| Advanced Perfusion System 1 (K172220) | Terumo Cardiovascular Systems Corporation | 2017-08-17 |
| CapSure® PS System (K172175) | Spine Wave, Inc. | 2017-08-16 |
| Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B) (K171950) | Visionary Optics, LLC | 2017-08-16 |
| Medacta Anatomic Shoulder Prosthesis (K170910) | Medacta International S.A. | 2017-08-16 |
| PROPHECY INVISION Pre-operative Navigation System (K170968) | Wrightmedicaltechnologyinc | 2017-08-16 |
| Clear Blue Digi LED Curing Light (K172426) | Promident, LLC | 2017-08-16 |
| SHOFU RESIN GLAZE (K163568) | Shofu Dental Corporation | 2017-08-16 |
| GLUCOCARD W Blood Glucose Monitoring System (K170064) | Arkray Factory, Inc. | 2017-08-16 |
| ACUSON S3000 S2000 S1000 Diagnostic Ultrasound Systems (K172162) | Siemens Healthcare | 2017-08-16 |
| EXCELSIUS GPS (K171651) | Globus Medical, Inc. | 2017-08-16 |
| ECG multi leads and IP-SET trunk cable, Monobloc ECG cable, SpO2 sensors and IBP transducers interface cable, ECG leadwire for INTEGRAL PROCESS trunk cables, ECG leadwire for original truk cables (K162768) | Integral Process Sas | 2017-08-16 |
| ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound System (K172374) | Siemens Medical Solutions USA, Inc. | 2017-08-15 |
| Carefusion NeutraClear multi-fuse Extension Set with needle-free connector(s) (K171118) | Cair Lgl | 2017-08-15 |
| Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap Shield (K171162) | Prestige Ameritech | 2017-08-15 |
| Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM) (K163570) | Carolina Liquid Chemistries Corporation | 2017-08-15 |
| Aisys CS2 (K170872) | Datex-Ohmeda, Inc. | 2017-08-15 |
| Eclipse Treatment Planning System (K172163) | Varian Medical Systems, Inc. | 2017-08-15 |
| PANA SPRAY Plus (K163483) | Nakanishi, Inc. | 2017-08-15 |
| Rapid Tox Cup II (K170222) | American Bio Medica Corp. | 2017-08-15 |
| Artemis Neuro Evacuation Device (K171332) | Penumbra, Inc. | 2017-08-14 |
| 3M Comply Hydrogen Peroxide Chemical Indicator 1248 (K170321) | 3M Company | 2017-08-14 |
| ATLANTIS suprastructures (K163398) | Dentsply Sirona | 2017-08-14 |
| ARIX Foot System (2.3/2.8) (K170780) | Jeil Medical Corporation | 2017-08-14 |
| EASYWELL TENS System TENS and Heat, EASYWELL TENS System TENS only (K163166) | Easywell Biomedicals, Inc. | 2017-08-11 |
| SOZO (K172122) | ImpediMed Limited | 2017-08-11 |
| xTAG CYP2D6 Kit v3 (K170492) | Luminex Molecular Diagnostics, Inc. | 2017-08-11 |
| TalarLift STS (K170624) | Fusion Orthopedics, LLC | 2017-08-11 |
| ShurFit 2C Lumbar Interbody Fusion System (K171657) | Precision Spine, Inc. | 2017-08-11 |
| NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10cm), NovoSorb BTM Wound Dressing (10cm x 20cm), NovoSorb BTM Wound Dressing (20cm x 40cm) (K172140) | Polynovo Biomaterials Pty, Ltd. | 2017-08-11 |
| Paonan Armstrong Posterior Spinal Fixation System (K161225) | Paonan Biotech Co., Ltd. | 2017-08-11 |
| Breathe Technologies Life2000™ Ventilation System (K170037) | Breathe Technologies | 2017-08-11 |
| Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway Exchange Catheter, and Cook Airway Exchange Catheter - Extra Firm With Soft Tip (K162729) | Cook Incorporated | 2017-08-11 |
| GenetiSure Dx Postnatal Assay (K163367) | Agilent Technologies, Inc. | 2017-08-11 |
| Silk'n Infinity (K171433) | Home Skinovations , Ltd. | 2017-08-11 |
| NOOSA Anterior Lumbar Plate System;NAMBUCCA Anterior Lumbar Plate System; CAIRNS Anterior Lumbar Plate System (K163625) | Signature Orthopaedics Pty, Ltd. | 2017-08-11 |
| ADVIA 2120i, ADVIA 2120 (K162977) | Siemens Healthcare Diagnostics | 2017-08-11 |
| Diacap Pro Dialyzer (K170574) | B. Braun Avitum AG | 2017-08-11 |
| 3M™ VFlex™ Health Care Particulate Respirator and Surgical Mask , Models 1804/1804S (K171116) | 3M Healthcare | 2017-08-10 |
| Grandio blocs (K171200) | Voco GmbH | 2017-08-10 |
| LENSAR Laser System – fs 3D (LLS-fs 3D) (K171337) | Lensar, Inc. | 2017-08-10 |
| SmartUs EXT-1M/3M (K163121) | Telemed | 2017-08-10 |
| Zimmer Natural Nail System (K172114) | Zimmer, Inc. | 2017-08-10 |
| OEC Elite (K171565) | Ge Oec Medical Systems, Inc. | 2017-08-10 |
| Peak Left Ventricular Vent Cannula, 20 Fr.; Peak Left Ventricular Vent Cannula, 18 Fr; Peak Left Ventricular Vent Cannula, 16 Fr (K170488) | Surge Cardiovascular | 2017-08-10 |
| MegaVac Mechanical Thrombectomy System (K171493) | Capture Vascular, Inc. | 2017-08-10 |
| HAART 200 Aortic Annuloplasty Device 19mm, HAART 200 Aortic Annuloplasty Device 21mm, HAART 200 Aortic Annuloplasty Device 23mm, HAART 200 Aortic Annuloplasty Device 25mm (K171431) | Biostable Science & Engineering, Inc. | 2017-08-10 |
| CKS Plus Knee System (K163167) | Consensus Orthopedics, Inc. | 2017-08-09 |
| WS80A Diagnostic Ultrasound System (K171070) | Samsung Medison Co., Ltd. | 2017-08-09 |
| Epic Biliary Endoscopic Stent System (K171809) | Boston Scientific Corporation | 2017-08-09 |
| Powered Wheelchair DYW30A(D09) (K170787) | Nanjing Jin Bai HE Medical Apparatus Co., Ltd. | 2017-08-09 |
| M22 and ResurFx Systems (K170060) | Lumenis, Ltd. | 2017-08-09 |
| StimSox(TM) System (K171071) | Stimmed, LLC | 2017-08-09 |
| CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza B Lineage Genotyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/H5 Subtyping Kit (K172091) | Centers for Disease Control and Prevention | 2017-08-09 |
| DAILIES AquaComfort Plus (sphere), DAILIES AquaComfort Plus Toric, DAILIES AquaComfort Plus Multifocal (K172066) | Alcon Laboratories, Inc. | 2017-08-09 |
| Fraxis (K172096) | Ilooda Co,., Ltd. | 2017-08-09 |
| Reperen Surgical Mesh (K170134) | Iconlab, Inc. | 2017-08-09 |
| INTRACEPT Intraosseous Nerve Ablation System (K170827) | Relievant Medsystems | 2017-08-09 |
| iC-GPC Assay TM for use on the iC-SystemTM (K163390) | Icubate, Inc. | 2017-08-08 |
| Renovis S141 Lumbar Interbody Fusion System (K170888) | Renovis Surgical Technologies | 2017-08-08 |
| Delight, Delight ortho, B&Lite S (K170529) | Dentall Co., Ltd. | 2017-08-08 |