FDA 510(k) Decisions During September, 2017  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K171351 09/08/2017 Posterior Spine Truss System (PSTS) Interbody Fusion Device 4Web, Inc. Jessee Hunt
K162482 09/15/2017 A.B. DENTAL DEVICES Dental Implants System A. B. Dental Device Ltd. Gabi Krauss
K170183 09/27/2017 Cetus system, Cetus probe A.R.C. Laser GmbH Angela Thyzel
K171941 09/27/2017 FreeStyle Precision Neo Blood Glucose Test Strips Abbott Diabetes Care Inc. Danielle Tayor
K171583 09/01/2017 RhythmView Workstation Abbott Electrophysiology Dennis Pozzo
K172394 09/06/2017 Steerable Guide Catheter Abbott Vascular Makena Mc Gowan
K171687 09/05/2017 Relieva SpinPlus Nav Balloon Sinuplasty System Acclarent, Inc. James Patrick Garvey II
K171176 09/15/2017 M-CATH Microcatheter Acrostak (Schweiz) AG Carmen Herraez
K170442 09/07/2017 Cranial Drill Bits and Accessories Ad-Tech Medical Instrument Corporation Lisa Theama
K170505 09/29/2017 SecurePortIV Catheter Securement Adhesive Adhezion Biomedical, LLC Richard G. Jones
K171792 09/29/2017 Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit Alere Scarborough, Inc. Angela Drysdale
K163699 09/08/2017 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 ALN Implants Chirurgicaux Alain Nigon
K163664 09/18/2017 Health-e-Connect System with IDA ALR TECHNOLOGIES SIDNEY CHAN
K171876 09/20/2017 Ceramill Zolid HT+ white Amann Girrbach AG Debora Engel
K172479 09/14/2017 Amsel Occluder Device Amsel Medical Raanan Miller
K170231 09/15/2017 iHealth Align Gluco-Monitoring System (BG1); iHealth Wireless Smart Gluco-Monitoring System (BG5)á Andon health Co., Ltd Yi Liu
K172486 09/21/2017 Anexa Wound Flush, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 120 mL cup, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 100mL bottle, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chlo Anexa Biomedical, Inc. Lenny Budloo
K172314 09/20/2017 Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) Art Optical Contact Lens Inc Mike Johnson
K172612 09/28/2017 FiberTak DX Arthex, Inc Ivette Galmez
K170547 09/01/2017 Arthrex Mesh Plate System Arthrex, Inc. Ivette Galmez
K171953 09/14/2017 Bard Mission Disposable Core Biopsy Instrument Bard Peripheral Vascular, Inc. Susan Sheffield
K172544 09/22/2017 IV Fat Emulsion Administration Sets Baxter Healthcare Corporation Jill M. Laack
K172506 09/17/2017 BD Cathena Safety IV Catheter Becton, Dickinson and Company Henry Boland
K171664 09/13/2017 Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software Bio-Rad Laboratories, Inc. Sweta Patel
K172150 09/15/2017 Etest Ceftazidime/Avibactam (CZA) (0.016 - 256 ug/mL) bioMerieux, Inc Cherece L. Jones
K170013 09/21/2017 Eztetic BellaTek Encode Healing Abutments BIOMET 3I KRUPAL PATEL
K171323 09/01/2017 BIOPHOTAS CELLUMA3 Biophotas Inc PATRICK JOHNSON
K163627 09/14/2017 Shotel Ankle Arthrodesis Nail System BioPro, Inc. Dave Mrak
K172372 09/06/2017 QuadraSphere Microspheres Biosphere Medical, S.A. Alix Fonlladosa
K171822 09/20/2017 NuvoMed Wireless Blood Glucose Monitoring System (Model BGM-6/0352) Biotest Medical Corporation Fred Lee
K171785 09/15/2017 WowGoHealth Blood Glucose Monitoring System Biotest Medical Corporation Fred Lee
K171648 09/08/2017 BM.IRIS Bluecore Co.,Ltd. Bill Choi
K171893 09/08/2017 Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone Synergy Cervical Interbody Fusion System (Slate) Bluestone Synergy Lisa Peterson
K163464 09/05/2017 Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2) BMC MEDICAL.,LTD. Jiang Huiqi
K170816 09/26/2017 Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature Correction, Elements TRAM Brainlab AG Rainer Birkenbach
K171922 09/28/2017 Anatotemp Anatomic Dental Implant Healing Abutment Buckeye Medical Technologies LLC Terry B. Philibin
K163510 09/06/2017 Poseidon Ultrasound System BUTTERFLY NETWORK, INC. BRIAN SAWIN
K172571 09/22/2017 ULTRASCORE Focused Force PTA Balloon C.R. Bard Jonathan Holmes
K172247 09/20/2017 Magic3 Go Intermittent Urinary Catheter C.R. Bard, Inc. Nancy Underwood
K172397 09/29/2017 Sherlock 3CG Tip Positioning System Stylet C.R. Bard, Inc. Mona Shahrebani
K171117 09/01/2017 Carefusion NeutraClear Needle-free connector (EL-NC1000) Cair L.G.L Delphine Molinari
K172064 09/15/2017 Ti-Diagon Oblique TLIF Camber Spine Technologies Daniel Pontecorvo
K171986 09/22/2017 Sterling Supreme Diode Laser CAO Group, Inc. Robert K. Larsen
K171499 09/22/2017 Occlusion Detection Dressing Kit Cardinal Health Beth Foster
K171531 09/11/2017 Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow Biopsy/Aspiration Needle, Jamshidi Evolve Bone Marrow Biopsy/Aspiration Needle CareFusion Tamara Brey
K172015 09/26/2017 POWDER FREE NITRILE EXAMINATION GLOVES, BLUE (COLORED) Careglove Global Sdn Bhd Lim Kwee Shyan
K172581 09/26/2017 CareView 1800Cw X-ray Flat Panel Detectors CareRay Digital Medical System Co., Ltd. Xu Wei
K171408 09/29/2017 Carbon Monoxide Breath Sensor System (COBSS) Carrot Sense, Inc. Daniel J. Balbierz
K171446 09/15/2017 Cefaly Acute CEFALY Technology Jean-Yves Mignolet
K172126 09/25/2017 Xpert Xpress Strep A Cepheid Yi-Ping Lin
K171442 09/25/2017 Exofin Fusion Skin Closure System Chemence Medical, Inc. Kenneth Broadley
K171686 09/15/2017 Choice Spine HawkeyeÖ Vertebral Body Replacement (VBR) System Choice Spine Kim Finch
K172385 09/14/2017 Clarius Ultrasound System Clarius Mobile Health Corp. Abhijit Ahir
K163439 09/01/2017 NaviENT ClaroNav Inc. Ahmad Kolahi
K171862 09/25/2017 GALAXY G3 Mini Microcoil Delivery System Codman & Shurtleff, Inc Yoon Hee Beatty
K171541 09/20/2017 Powder Free Nitrile Examination Gloves (Orange) Comfort Rubber Gloves Industries Sdn. Bhd. Chan Yew Men
K171805 09/08/2017 Luer-Jack Slip 3 ml, Luer-Jack Slip 5 ml, Luer-Jack Slip 20 ml, Luer-Jack Lock 10 ml ConceptoMed AS Marit Martinsen
K171725 09/08/2017 CuffLink Implant System CONMED Corporation Dionne Sanders
K162956 09/22/2017 NOWCARDIO SYSTEM CONTEX INTERNATIONAL TECHNOLOGIES (CANADA), INC. RICARDO RODRIGUEZ
K170323 09/14/2017 Entuit Start Initial Placement Gastrostomy Set Cook Incorporated Erum B. Nasir
K170020 09/28/2017 Peel-Away Introducer Set Cook Incorporated Colin Jacob
K171685 09/29/2017 Med4 Elite Cool Systems, Inc. (dba Game Ready) Natalie Kennel
K170981 09/07/2017 NeuroQuant CorTechs Labs, Inc Kora Marinkovic
K163556 09/14/2017 MediClear PreOp COVALON TECHNOLOGIES, INC. KIM CROOKS
K171358 09/01/2017 Emprint SX Ablation Platform and Accessories Coviden llc Patti Arndt
K170166 09/29/2017 CARESORB-Polyglactin 910 Surgical Suture, CARESORB-Polyglactin 910 (fast absorbing) Surgical Suture CPT Sutures Co., Ltd. Khoa Do
K171251 09/08/2017 014 Hydrophilic Coated PTA Balloon Dilatation Catheter Creagh Medical Shane Costello
K170810 09/27/2017 CRYOFOS CRYOFOS Medical Gmbh Gerlinde Hornung-Stehling
K171992 09/26/2017 Sculpsure Cynosure, Inc Amy Tannenbaum
K171262 09/22/2017 TempSure Cynosure, Inc Amy Tannenbaum
K171027 09/06/2017 Dentis Dental Implant System Dentis Co.,Ltd. Sun Chul Shin
K171126 09/07/2017 Implantium II Dentium Co., Ltd. Yoon Spyoon
K170487 09/11/2017 Navina Classic System Dentsply Sirona Karl Nittinger
K171161 09/25/2017 Dimensional Bioceramics Calcium Sulfate Device (DB-CSD) Dimensional Bioceramics LLC David Delaney
K172481 09/14/2017 IntelliCart System Dornoch Medical Systems Larry Smith
K171189 09/11/2017 AIR-FLOW PLUS Prophylaxis powder E.M.S. Electro Medical Systems S.A. Suzanne Fassio-Hardy
K172142 09/13/2017 FibroScan 430 Mini+ Echosens Karine Bonenfant
K172196 09/19/2017 ECOMÖ Cardiac Output Monitoring System ECOM Medical, Inc Guy Lowery
K172380 09/29/2017 U2 Diagnostic Ultrasound System Edan Instruments Inc Alice Yang
K171178 09/06/2017 Central Monitoring System Edan Instruments, Inc. Alice Yang
K171943 09/25/2017 Electrocardiograph Edan Instruments, Inc. Alice Yang
K171123 09/15/2017 Leksell Vantage Stereotactic System Elekta Instrument AB Matilda Forsberg
K170970 09/01/2017 Epilaser Epilady 2000 LLC Joseph Miller
K171519 09/15/2017 FLXfitÖ Expanding Orthopedics, Inc. Ofer Bokobza
K171558 09/01/2017 ExsoMed ITN Cannulated Screw System Exsomed Holdings Company, LLC Richard Kovach
K163209 09/14/2017 Fiagon Navigation System FIAGON GMBH Dirk Mucha
K171507 09/01/2017 CustomizedBone Service Fin-ceramica faenza spa Marina Monticelli
K163710 09/08/2017 BePOD« EZ Weil Screws Fournitures Hospitalieres Industrie Patricia Donnard
K163148 09/14/2017 BePOD« Foot Screws Fournitures Hospitalieres Industrie Patricia Donnard
K171652 09/15/2017 Fresenius Liberty Select Cycler Fresenius Medical Care Renal Therapies Group, LLC Denise Oppermann
K171463 09/29/2017 ASPIRE Bellus II FUJIFILM Medical Systems U.S.A., Inc. Jyh-Shyan Lin
K170032 09/08/2017 QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EP Fysicon BV C.W.A (Eric) Van Antwerpen
K170181 09/01/2017 Prizma G-Medical Innovations Ltd. N. Epstein
K163302 09/01/2017 Senographe Pristina GE Healthcare Camille Vidal
K172342 09/29/2017 Voluson E6, Voluson E8, Voluson E10 GE Healthcare Bryan Behn
K170498 09/28/2017 Gems Oocyte Retrieval Buffer ORB-20, ORB-50 Genea Biomedx Pty Ltd Kea Dent
K170596 09/11/2017 TN-Brush GENOSS Co. Ltd. Hyeyoung Moon
K170210 09/01/2017 PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0 Given Imaging Ltd. Hilla Debby
K170157 09/25/2017 INDEPENDENCE« Spacers Globus Medical Inc. Kelly J. Baker
K163611 09/19/2017 Pain Therapy Device Guangzhou Xinbo Electronic Co., Ltd. Sammy Li
K171440 09/29/2017 Berkeley VC-10 Vacuum Curettage System Gyrus ACMI Christina Flores
K163283 09/20/2017 HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010 HAMILTON MEDICAL AG Steffen Boden
K171599 09/22/2017 WiTouch Pro, WiTouch, Neubac Hollywog LLC Michael Treas
K172566 09/20/2017 Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices Hologic, Inc. Catherine Sanford
K171963 09/26/2017 Panther Fusion Flu A/B/RSV Assay, Panther Fusion Universal Fluids Kit, Panther Fusion Assay Fluids I-S Kit, Panther Fusion Specimen Lysis Tubes Hologic, Inc. Ron Domingo
K163465 09/08/2017 hemochroma PLUS System IMMUNOSTICS, INC. ANTOINETTE PRUSIK
K163577 09/25/2017 Ecofit« Hip System Implantcast GmbH Juliane Hoeppner
K163525 09/05/2017 QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3) Controls Inova Diagnostics, Inc. Peter Martis
K163538 09/06/2017 QUANTA Flash« LKM-1 Reagents, QUANTA Flash« LKM-1 Calibrators, QUANTA Flash« LKM-1 Controls INOVA DIAGNOSTICS, INC. ROGER ALBESA
K162848 09/22/2017 Straumann CARES Golden Ti/TiN Abutments INSTITUT STRAUMANN AG Christopher Klaczyk
K170854 09/08/2017 HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls Instrumentation Laboratory Co. Carol Marble
K172595 09/28/2017 CUSA Excel+ Ultrasonic Surgical Aspirator System Integra LifeSciences Corporation Alexandra Wells
K163326 09/29/2017 SmartEP INTELLIGENT HEARING SYSTEMS Edward Miskiel
K171632 09/19/2017 da Vinci Xi Surgical System Intuitive Surgical, Inc Brandon Hansen
K170641 09/21/2017 da Vinci S/Si Endoscopes, da Vinci Xi Endoscopes Intuitive Surgical, Inc. Kunal Gunjal
K170644 09/11/2017 da Vinci S/Si EndoWrist Instruments and Accessories, Harmonic ACE Curved Shears (5mm & 8mm) Intuitive Surgical, Inc. Kunal Gunjal
K170875 09/12/2017 da Vinci Si Single-Site Instruments and Accessories, da Vinci Xi Single-Site Instruments and Accessories Intuitive Surgical, Inc. Manjunath Bisalehalli
K170645 09/11/2017 da Vinci Xi EndoWrist Instruments and Accessories Intuitive Surgical, Inc. Kunal Gunjal
K170640 09/17/2017 Endoscope Sterilization Tray Intuitive Surgical, Inc. Kunal Gunjal
K170879 09/21/2017 IS4000 Stapler 45 Instrument and its Reusable Accessories, IS4000 EndoWrist Stapler 30 Instrument, IS3000 Stapler 45 Instrument and its Reusable Accessories Intuitive Surgical, Inc. Kunal Gunjal
K163270 09/25/2017 ISEN-Goggles with Data Viewer ISENT TECH & TRADING COMPANY,LTD. MARTIN LIU
K170275 09/11/2017 Tri Auto ZX2 J. MORITA USA, INC. KEISUKE MORI
K170705 09/21/2017 ARIX Wrist System Jeil Medical Corporation Ji won SONG
K170368 09/11/2017 Sterile NS System Jeil Medical Corporation Seungyong Lee
K172513 09/14/2017 3D Echo JointVue LLC Mohamed R. Mahfouz
K163518 09/19/2017 Digital Thermometer JOYTECH HEALTHCARE CO., LTD Ren Yunhua
K170262 09/28/2017 Digital Thermometer K-Jump Health Co., Ltd. JM Lin
K171832 09/14/2017 Range/Denali/Mesa Spinal System K2M, Inc. Nancy Giezen
K172086 09/22/2017 MatiraÖ Anterior Cervical System Kalitec Direct, LLC Keith Cannan
K171035 09/06/2017 Katalyst Mark 1 Muscle Stimulation System Katalyst Inc. Amish Patel
K170286 09/18/2017 Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens, Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens for ASTIGMATISM, Largan (hioxifilcon A) Daily Wear Soft (Hydrophilic) Contact Lens for PRESBYOPIA Largan Medical Co. Ltd. Amy Tien
K161434 09/28/2017 Photon Vibrating massage Facial Aesthetic Device (Model: UI-200) LI-TEK ELECTRONICS TECHNOLOGIES BARRY YUAN
K172109 09/27/2017 Liofilchem MIC Test Strip (MTS), Erythromycin 0.016 - 256 ?g/mL Liofilchem s. r. l. Fabio Brocco
K170179 09/18/2017 LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity Lumenis Ltd. Amaya De Levie
K172659 09/28/2017 MEGASORB - Natural absorbable Polyglycolic Acid Surgical Suture, MITSU - Absorbable Polyglactin 910 Surgical Sutures, MITSU FST - Absorbable Polyglactin 910 Surgical Suture, FILAXYN - Absorbable Polydioxanone Surgical (PDS), FILAPRON - Absorbable poly(gly M/s. Meril Endo Surgery Private Limited Umesh Sharma
K171051 09/13/2017 HORIZON Therapy System Magstim Company Ltd. Tom Campbell
K172219 09/21/2017 Mako Total Knee Application MAKO Surgical Corp. Karen Ariemma
K170168 09/14/2017 Masimo Rad-97 and Accessories MASIMO CORPORATION MARGUERITE THOMLINSON
K172522 09/15/2017 Mazor X Mazor Robotics Ltd. Shiran Conforti
K172587 09/18/2017 Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markers Medacta International SA Stefano Baj
K172170 09/08/2017 APTUS(R) Wrist 2.5 System Medartis AG Andrea Schweizer
K171144 09/12/2017 Medifine Pen Needle 3 Bevel, Medifine Pen Needle Quinta 5 Bevel Medbio LLC. Jatin Rajani
K170838 09/15/2017 Medentika CAD/CAM TiBases Medentika GmbH Gerhard Polzer
K170002 09/19/2017 Medline Blood Collection Set Medline Industries, Inc. Matt Clausen
K170415 09/08/2017 Medline Hemo-Force DVT Compression Sleeve Medline Industries, Inc. Matt Clausen
K170937 09/14/2017 VIPER PRIME navigated inserter Medos International, SARL Karen Sylvia
K170381 09/07/2017 Minimally Invasive Sealer (MIS) Flex, Minimally Invasive Sealer (MIS) Flex Mini Medtronic Advanced Energy Heather Valley
K172199 09/19/2017 ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium Medtronic Sofamor Danek Justin O'Connor
K171107 09/26/2017 CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal System Medtronic Sofamor Danek USA, Inc. Julie Bassett
K172117 09/11/2017 Prelude Pursuit Splittable Sheath Introducer Merit Medical Systems, Inc. Jacquelyn Huyghue
K172309 09/29/2017 Endoscopic Ultrasound Aspiration Needle Micro-Tech (Nanjing) CO.,Ltd. Becky Li
K163442 09/28/2017 Single Use Micro Electrode (Brass with gold plated shaft); Single Use Micro Electrode (Stainless Steel shaft) Modern Medical Equipment Manufacturing Limited Thomas Tsz Fung Chan
K171964 09/19/2017 LigaMetrics Suture Anchors Mortise Medical LLC Robert Hoy
K171330 09/08/2017 Nanova Sealant Nanova Biomaterials Inc Andrew C. Ritts
K163674 09/22/2017 Exsens Personal Lubricant - Pure Aqua, Exsens Personal Lubricant - Aloe Vera, Exsens Personal Lubricant - Fresh Mint, Exsens Personal Lubricant - Candy Apple, Exsens Personal Lubricant - Raspberry NEO COSMETIQUE NATHALIE VERNIN
K171582 09/12/2017 NEO Pedicle Screw SystemÖ Neo Medical S.A. Jonas Larsson
K171201 09/13/2017 NeuViz Prime Multi-slice CT Scanner System Neusoft Medical Systems Co., Ltd. Shao Xiancheng
K171510 09/08/2017 Footmotion Plating System Newclip Technics Gaelle Lussori
K172433 09/07/2017 NICO BrainPath NICO Corporation Sean Spence
K171730 09/07/2017 FuckWater Non-Friction Products Inc. Marc Barrette
K172628 09/25/2017 PRECICE System NuVasive Specialized Orthopedics, Inc. Cora Sim
K171633 09/28/2017 NuVasive TLX Interbody System NuVasive, Incorporated Cynthia Adams
K171894 09/28/2017 NuVasive« PreceptÖ Spinal System NuVasive, Incorporated Marysa Loustalot
K171232 09/21/2017 PeriView FLEX Olympus Surgical Technologies America Mary Anne Patella
K171965 09/28/2017 Resection Electrodes with HF cable Olympus Winter & Ibe GmbH Jan-Oliver Upmeier
K163338 09/01/2017 OMNIBotics Knee System OMNllife Science Inc. Daniel Decruppe
K170822 09/11/2017 Electronic Caries Detector Ortek Therapeutics, Inc. Mitchell Goldberg
K163433 09/18/2017 VITROS Chemistry Products GLU Slides Ortho Clinical Diagnostics Darlene J. Phillips
K171211 09/27/2017 OIC External Fixation System Orthopaedic Implant Company Douglas Fulton
K171334 09/08/2017 Indego Parker Hannifin Corporation Achilleas Dorotheou
DEN160018 09/14/2017 reSet PEAR THERAPEUTICS, INC. NANDINI MURTHY
K171936 09/27/2017 Peerbridge Cor(TM) System Peerbridge Health INc. Arthur A. Bertolero
K170704 09/08/2017 The Locking Pediatric Osteotomy Plate (LolliPOP) System Pega Medical Inc. Ariel R. Dujovne
K163614 09/20/2017 PENTAX Medical ED34-i10T, Video Duodenoscope PENTAX Medical Kanchana Iyer
K171184 09/21/2017 Persyst Mobile App Persyst Development Corporation Dari Darabbeigi
K170527 09/15/2017 Phoenix Clinical ICON Phoenix Technology Group, Inc. dba Phoenix Clinical Christopher A. Henderson
K171359 09/13/2017 Pollogen Legend+ System Pollogen Ltd. Ilana Dessow Lironne
K171667 09/08/2017 Powder Free Nitrile Examination Glove Professional Latex Sdn Bhd Yoon Lim Kok
K172279 09/20/2017 PMT Posterior Fixation System Providence Medical Technology, Inc. Edward Liou
K163590 09/15/2017 Psychemedics Microplate EIA for Benzodiazepines in Hair Psychemedics Corporation Virginia Hill
K171215 09/27/2017 QiF Blood and Fluid Warmer Quality In Flow Ltd. Neta Sherman
K163462 09/21/2017 AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX Radiometer Medical ApS Per Pape Thomsen
K172489 09/07/2017 Reliance Cervical IBF System Reliance Medical Systems, LLC Bret M. Berry
K163666 09/15/2017 neuro inspire Rensihaw plc Roberto Liddi
K171212 09/28/2017 AirFit N20 ResMed Ltd Kim Kuan LEE
K171770 09/12/2017 cobas Cdiff Nucleic acid test for use on the cobas Liat System Roche Molecular Systems, Inc. Clare Santulli
K161719 09/21/2017 Salter Labs Bubble Humidifier SALTER LABS MARA CALER
K163215 09/13/2017 AnemoCheck SANGUINA, LLC ERIKA TYBURSKI
K171661 09/27/2017 Scopis Extended Instrument Set EM Scopis GmbH Christopher ?zbek
K171537 09/12/2017 CAPI 3 Hb A1c Sebia Karen Aderson
K171726 09/25/2017 LapBag Sejong Medical Co., Ltd. Yoojung Choi
K171378 09/14/2017 Non-Sterile, Single use, Powder-free examination glove tested for use with Chemotherapy drugs SEMPERIT INVESTMENTS ASIA PTE. LTD. Clemens Eichler
K171317 09/11/2017 Clear Vinyl Powder-free Patient Examination Gloves Shandong Zhi Hong Medical Products, Co. Ltd. Jennifer Guo
K171460 09/24/2017 Powder-free Clear Vinyl Patient Examination Gloves Shandong Zhiwei Medical Products, Co. Ltd. Carrie Wu
K163422 09/18/2017 Shanghai Sanyou PEEK Cage System SHANGHAI SANYOU MEDICAL CO, LTD David Fan
K170047 09/09/2017 All-in-One Health Monitor, PC-303 Shenzhen Creative Industry Co., Ltd. Jia Wang
K163135 09/19/2017 Finger Pulse Oximeter SHENZHEN FITFAITH TECHNOLOGY CO.,LTD Yuan Junfeng
K161586 09/06/2017 The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS, JLN-2317AS and JLN-2320AS) SHENZHEN HOMED MEDICAL DEVICE CO., LTD Shengming Shi
K171891 09/21/2017 ZS3 Ultrasound System, z.one pro Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., Ltd Zhai Pei
K171233 09/12/2017 Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd Zhai Pei
K170855 09/07/2017 T-Rex Standalone ALIF SIATS, LLC Robert Compton
K172519 09/15/2017 PICO Single Use Negative Pressure Wound Therapy System Smith & Nephew Medical Limited Samantha Neilson
K172521 09/20/2017 PICO Single Use Negative Pressure Wound Therapy System Smith & Nephew Medical Limited Samantha Neilson
K172545 09/22/2017 SERI Contour Sofregen Medical, Inc. Anh Hoang
K170758 09/22/2017 Thermage FLX System and Accessories Solta Medical Melissa Thomas
K172082 09/21/2017 S60 Series Digital Color Doppler Ultrasound System Sonoscape Medical Corp. Toki Wu
K163292 09/08/2017 Sonic Block Tuohy, Sonic Block Quincke, Sonic Block Chiba, Sonic Block Crawford SPECTRA MEDICAL DEVICES SCOTT HENDERSON
K172101 09/26/2017 ROMEO« 2 Posterior Osteosynthesis System Spineart Franck Pennesi
K172065 09/29/2017 SCARLET AC-T SPINEART Franck PENNESI
K163407 09/29/2017 Confirm Rx Insertable Cardiac Monitor (ICM) System St. Jude Medical, Inc. Jennifer Dunham
K172375 09/06/2017 MicroSTAAR Injector System Cartridges STAAR Surgical Company Kate Ueda
K170956 09/22/2017 SYSTEM 1E Liquid Chemical Sterilant Processing System STERIS Corporation Tricia Cregger
K171728 09/28/2017 MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mm Sterngold Dental, LLC Maria Rao
K171840 09/15/2017 Stryker Consolidated Operating Room Equipment (CORE) 2 Console Stryker Corporation Nicholas Werner
K171496 09/06/2017 Tritanium C Anterior Cervical Cage STRYKER SPINE Deborah Cynamon
K162171 09/07/2017 S4 Screw SystemÖ SUBCHONDRAL SOLUTIONS SHERYL MCCOY
K163448 09/01/2017 GrindCare System SUNSTAR SUISSE S.A. Olivier Ducamp
K163455 09/28/2017 SurgiCube SURGICUBE INTERNATIONAL B.V. GER VIJFVINKEL
K170802 09/28/2017 TRAUMACEMÖ V+ Injectable Bone Cement Synthes (USA) Products, LLC Christopher J. Medberry
K171309 09/29/2017 BR-FHUS Navigation 1.0 TaiHao Medical Inc. Hsin Hung Lai
K170482 09/27/2017 Spider Frame External Fixation System TASARIMMED TIBBI MAMULLER SANAYI VE TICARET A.S Sumru Alperen
K170118 09/21/2017 Scanostics UTI Check Application Test System Teco Diagnostics Ling Koh
K170417 09/15/2017 Glidewire GT Terumo Corporation Monika McDole-Russell
K172501 09/21/2017 iNSitu Total Hip System Theken Companies, LLC Dale Davison
K171829 09/21/2017 EndoNaut Therenva SAS Matthis HAMY
K172048 09/05/2017 FluidSmart THERMEDX, LLC Homer Gregory
K171795 09/29/2017 Thommen Implant System Thommen Medical AG Daniel Snetivy
K170185 09/12/2017 tremoFlo C-100 Airwave Oscillometry System THORASYS Thoracic Medical Systems, Inc. Sebastien Jutras
K172299 09/19/2017 Accordion Piccolo Stone Management Device THS International, Inc. d/b/a Accordion Medical David Quigley
K170985 09/25/2017 Urbanek Device TMJ Services, LLC Anthony Urbanek
K170409 09/12/2017 PASCAL Synthesis Twinstar Ophthalmic Scanning Laser System Topcon Medical Laser Systems, Inc. (TMLS) Sweta Srivastava
K171303 09/22/2017 Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664 University of Texas Medical School at Houston, Texas K. Lance Gould
K172356 09/15/2017 BladderScan Prime PLUS System Verathon Incorporated Swapna Chirala
K170162 09/26/2017 Vesco Medical Nasoenteric Feeding Tubes Vesco Medical, LLC Chris O'Keefe
K170378 09/14/2017 AirLife Adult Heated Wire BiPAP/NIV Circuit Vyaire Medical Sharon Nichols
K172420 09/29/2017 Sterile Powder Free Nitrile Surgical Glove, White Colored. Tested for Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim Wear Safe (Malaysia) Sdn. Bhd. Cho Sow Fong
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