| PowerLoc MAX Power-Injectable Infusion Set and SafeStep Huber Needle Set (K171735) | C.R. Bard, Inc. | 2017-08-08 |
| MiniMAX (K170845) | Medacta International S.A. | 2017-08-08 |
| AxoGen Nerve Cap (K163446) | Axogen Corporation | 2017-08-08 |
| DESS Dental Smart Solutions (K170588) | Terrats Medical SL | 2017-08-08 |
| AFIAS iFOB with AFIAS-50 (K163225) | Immunostics Inc., | 2017-08-08 |
| Styptin, Hemogin-L, Hemodettes, and GingiGEL Aluminum Chloride Impregnated Retraction Cord/Materials (K162948) | Kerr Corporation | 2017-08-08 |
| ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISA (K163133) | Immco Diagnostics, Inc. | 2017-08-08 |
| EVOLUTION Revision CCK System (K171389) | Microport Orthopedics, Inc. | 2017-08-08 |
| YUKON OCT Spinal System (K171444) | K2m, Inc. | 2017-08-08 |
| Delta III Lithotripter (K172084) | Dornier Medtech America, Inc. | 2017-08-08 |
| JAZZ Passer Band (K171881) | Implanet, S.A. | 2017-08-08 |
| Supplemental Instrument Trays (K170939) | Nuvasive Specialized Orthopedics, Incorporated | 2017-08-08 |
| TruMatch CMF Titanium 3D Printed Implant System (K170272) | Materialise NV | 2017-08-08 |
| HS40 Diagnostic Ultrasound System (K172129) | Samsung Medison Co., Ltd. | 2017-08-08 |
| GA-B, GA-C, GA-E, GA-I, GA-S, GA-W3A, GA-F3A, GA-IL, GA-SL, GA-W3B, GA-F1A (K171707) | Gowoonsesang Cosmetics Co., Ltd. | 2017-08-08 |
| Ahmed Glaucoma Valve Model FP8 (K171451) | New World Medical, Inc. | 2017-08-08 |
| dpl SpectraLite (K171386) | Led Technologies, Inc. | 2017-08-07 |
| InMode Diolaze XL (K170738) | Inmode MD , Ltd. | 2017-08-07 |
| Anterior Spine Truss System (STS) Interbody Fusion Device (K170851) | 4Web, Inc. | 2017-08-07 |
| Merit Syringe (K171362) | Merit Medical Systems, Inc. | 2017-08-07 |
| Epix Electrosurgical Probe with Smoke Evacuation (K171684) | Applied Medical Resources Corporation | 2017-08-07 |
| FuzeFix Screw System (K170038) | Fusion Orthopedics, LLC | 2017-08-07 |
| Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect Platinum Vena Cava Filter Set for Jugular Vein Approach, Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach (K171712) | William Cook Europe Aps | 2017-08-07 |
| REVEAL Bulk (K171147) | Bisco, Inc. | 2017-08-04 |
| Maestro Microcatheter (K172081) | Merit Medical Systems, Inc. | 2017-08-04 |
| ECHO-3-22: Echotip Ultra and EUSN-1, EUSN-3: Echotip Ultrasound Needle (K171596) | Wilson-Cook Medical, Inc. | 2017-08-04 |
| Cellvizio 100 Series Systems with Confocal Miniprobes (K171345) | Mauna Kea Technologies | 2017-08-04 |
| Nucleoss Tpure Implant System (K160850) | Sanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti | 2017-08-04 |
| Life Essence Universal Porcelain System (K163251) | Blue Sky Bio | 2017-08-04 |
| Premier (K170861) | Shandong Weigao Orthopaedic Device Co., Ltd. | 2017-08-04 |
| Glucommander (K152300) | Glytec, LLC | 2017-08-04 |
| Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory Kit, Charger Kit (K171366) | Stimwave Technologies Inc., Dba Stimq, LLC | 2017-08-04 |
| Hi-Dow Wireless TENS/EMS System (Model HD-5N) (K163393) | Hi-Dow International, Inc. | 2017-08-04 |
| CADence System (K170928) | Aum Cardiovascular, Inc. | 2017-08-03 |
| eCareManager 4.1 (K171322) | Visicu, Inc. | 2017-08-03 |
| Everyway OTC EMS, Model EV-805 (K162744) | Everyway Medical Instrument Co., Ltd. | 2017-08-03 |
| U-Lite EXP (K171164) | Sonoscanner | 2017-08-03 |
| Medrobotics Flex Robotic System (K172036) | Medrobotics Corporation | 2017-08-03 |
| Clarity Reveal (K171356) | Ceevra, Inc. | 2017-08-03 |
| The TiBow Expandable Spacer System (K170919) | Life Spine, Inc. | 2017-08-03 |
| dpl II Panel (K171390) | Led Technologies, Inc. | 2017-08-03 |
| CATHTONG II PICC Catheter (K172039) | L&Z Us, Inc. | 2017-08-03 |
| Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems (K171456) | Choicespine | 2017-08-03 |
| Medline ReNewal Reprocessed Stryker Neptune 2 Manifolds (K161358) | Surgical Instrument Service and Savings, Inc. | 2017-08-03 |
| Arzzt 3.5 / 4.5 Small & Large Fragments System (K162507) | Truemed Group, LLC | 2017-08-03 |
| Hearing Healthcare Pro (K171038) | Db Diagnostic Systems, Inc. | 2017-08-02 |
| truSculpt (K172004) | Cutera, Inc. | 2017-08-02 |
| Accutorr 7/VS-900 Vital Signs Monitor (K170712) | Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. | 2017-08-02 |
| M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System (K171595) | Medacta International S.A. | 2017-08-02 |
| AUTOCON III 400 (K171717) | KARL STORZ Endoscopy-America, Inc. | 2017-08-02 |
| Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card (K163704) | Healgen Scientific,, LLC | 2017-08-02 |
| Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle (K170651) | Yangzhou Medline Industry, Co., Ltd. | 2017-08-02 |
| Skyn Original Polyisoprene Lubricated Male Condom - Flavored (K171172) | Ansell Healthcare Products, LLC | 2017-08-02 |
| 731 Series Ventilators (K162832) | ZOLL Medical Corporation | 2017-08-02 |
| M.U.S.T. MINI Posterior Cervical Screws System (K171369) | Medacta International S.A. | 2017-08-01 |
| AED Sinuscope (K170285) | National Advanced Endoscopy Devices, Inc. | 2017-08-01 |
| Trojan Supra Lubricated Polyurethane Male Condom (K171639) | Church & Dwight Co., Inc. | 2017-08-01 |
| BP5S Wireless Blood Pressure Monitor (K171062) | Andon Health Co, Ltd. | 2017-08-01 |
| Liofilchem MIC Test Strip (MTS)- Delafloxacin 0.002 - 32 µg/mL (K171906) | Liofilchem s.r.l. | 2017-08-01 |
| DD cubeX2 HS (K170885) | Dental Direkt GmbH | 2017-08-01 |
| M.U.S.T. Combined Set Screws (K171758) | Medacta International S.A. | 2017-08-01 |
| The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.0005 – 8 ug/mL (K171870) | Thermo Fisher Scientific | 2017-08-01 |
| Zirconia Dental Ceramics (K170894) | Chengdu Besmile Biotechnology Co., Ltd. | 2017-08-01 |
| HEXA100 (hexafocon A) Daily Wear Contact Lenses (K171077) | Contamac, Ltd. | 2017-08-01 |
| Advanced RBC Application (K171315) | CellaVision AB | 2017-08-01 |
| Calix-C Cervical Interbody Spacer (K171075) | X-Spine Systems, Inc. | 2017-08-01 |
| 14Fr Colon Decompression Set, Macon Colon Decompression Set (K171619) | Cook Ireland, Ltd. | 2017-08-01 |
| HardyDisk AST Delafloxacin 5 µg (DLX5) (K171975) | Hardy Diagnostics | 2017-08-01 |
| Q-Switched Nd:YAG Laser System (K171079) | Ids, Ltd. | 2017-08-01 |
| LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L (K170565) | Lifewatch Services, Inc. | 2017-08-01 |
| Litho 60 (K172025) | Quanta System Spa | 2017-07-31 |
| NuBODY Skin Toning Device (K171588) | Carol Cole Company Dba Nuface | 2017-07-31 |
| Performer Introducer (K171999) | Cook Incorporated | 2017-07-31 |
| Nasal Pancreatic Drainage Set (K171623) | Cook Ireland, Ltd. | 2017-07-31 |
| Scanmate Flex (K171301) | Dgh Technology, Inc. | 2017-07-31 |
| bellavista 1000 (K163127) | Imtmedical AG | 2017-07-31 |
| Electronic Blood Pressure Monitor (K161845) | Shenzhen Pango Electronic Co., Ltd. | 2017-07-31 |
| Carefusion NeutraClear Needle-free connector (K171132) | Cair Lgl | 2017-07-31 |
| Xingyu Nitrile Powder Free Patient Examination Gloves, White color (K171615) | Shandong Xingyu Gloves Co., Ltd. | 2017-07-31 |
| WEGO-PTFE (K170842) | Foosin Medical Supplies Inc., Ltd. | 2017-07-31 |
| Youha electric breast pump (K163136) | Ningbo Youhe Electrical Appliance Technology Co., Ltd. | 2017-07-31 |
| Obturys (K170207) | Itena Clinical | 2017-07-31 |
| Bronchi and Gastrointestinal Cytology Brush (K171607) | Wilson-Cook Medical Inc./Cook Endoscopy | 2017-07-31 |
| Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range (K171040) | Koelis | 2017-07-31 |
| Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRAD Chemical Indicator, Tyvek Heat-Seal Pouches with STERRAD Chemical Indicator (K163598) | Advanced Sterilization Products | 2017-07-31 |
| cobas HbA1c Test, cobas b 101 system (K163633) | Roche Diagnostics Operations | 2017-07-28 |
| Otowave 302 Portable Tympanometer (K171265) | Amplivox, Ltd. | 2017-07-28 |
| Wheelchair (K163352) | Kunshan Hi-Fortune Health Products Co., Ltd. | 2017-07-28 |
| da Vinci Xi Surgical System, da Vinci Si Surgical System, da Vinci X Surgical System (K171699) | Intuitive Surgical, Inc. | 2017-07-28 |
| NovaPACS (K171754) | Novarad Corporation | 2017-07-28 |
| ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG Antibody ELISA (K163177) | Immco Diagnostics, Inc. | 2017-07-28 |
| Smart Stitching Software System, Image Processing, Radiological (K163048) | Osko, Inc. | 2017-07-28 |
| AXS Offset Delivery Assist Catheter (K163259) | Stryker Neurovascular | 2017-07-28 |
| Discovery Pico, Discovery Pico Plus (K171945) | Quanta System Spa | 2017-07-28 |
| TUBETECH IV Administration Set (K162951) | Douglas Medical Products, Inc. | 2017-07-28 |
| Williams Cystoscopic Injection Needle (K171602) | Cook Incorporated | 2017-07-28 |
| Biomet Knee Joint Replacement Prostheses (K171054) | Biomet, Inc. | 2017-07-28 |
| Photodynamic Therapy Device (K170187) | Uvbiotek, LLC | 2017-07-28 |
| Lumipulse G TSH-III Immunoreaction Cartridges (K171103) | Fujirebio Diagnostics,Inc. | 2017-07-28 |
| VitalBeam (K172013) | Varian Medical Systems, Inc. | 2017-07-28 |