FDA 510(k) Decisions During November, 2019  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K190190 11/01/2019 WV1 Endoscope 270Surgical Ltd Avi Levy
K192937 11/16/2019 3M Comply Hydrogen Peroxide Chemical Indicator 3M Company Mary Fretland
K191236 11/22/2019 3MÖ AttestÖ Steam Chemical Integrators 3M Company Mary Fretland
K192992 11/05/2019 Suglue 3 3M Deutschland GMBH Desi W. Soegiarto
K191911 11/27/2019 3Shape Splint Design 3Shape A/S Shreyosi Chakraborty
K190119 11/01/2019 Foryou NPWT Dressing Kit 4L Health Co., Ltd. Jackie Jian
K192140 11/05/2019 7D Surgical System 7D Surgical Inc. Daniel Ziskind
K192945 11/27/2019 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application 7D Surgical Inc. Daniel Zisind
K192019 11/08/2019 Dragonfly OpStarÖ Imaging Catheter, AptiVueÖ Software version E.5.1 Abbott Medical Richard DeMello
K192769 11/18/2019 Impella CP Introducer Abiomed, Inc. Robert Stewart
K193041 11/22/2019 Hemochron Signature Elite Accriva Diagnostics, Inc. Brian James
K191734 11/22/2019 MatriStem UBM Pericardial Patch Acell, Inc. Michelle Huettner
K191047 11/05/2019 ADI TiDAL Osteotomy Wedge Additive Device, Inc. (ADI) d/b/a restor3d Nathan Evans
K192266 11/21/2019 M. Blue Adjustable Shunt System Aesculap, Inc. Kathy A Racosky
K191650 11/01/2019 LEGION System Alcon Research, LLC Nickerson Hill
K190590 11/25/2019 Allwin Ovum Pickup Needles (ACE Single Lumen Ovum Pickup Needle, OVUMPICK Double Lumen Ovum Pickup Needle, ACE-FL Single Lumen Ovum Pickup Needle with Flushing Line, ACE-M Manual Single Lumen Ovum Pickup Needle) Allwin Medical Devices, Inc. Digish Mehta
K191292 11/05/2019 Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) Anhui Powerguard Technology Co.,Ltd Nike Dai
K190998 11/08/2019 BA Pit & Fissure Sealant Apex Dental Materials, Inc. Scott Lamerand
K190331 11/22/2019 Applied Medical Laparoscopic Linear Cutter Applied Medical Resources Corporation Aditi Iyengar
K192238 11/12/2019 AC3 Series Intra-Aortic Balloon Pump (IABP) Arrow International, Teleflex Deb Fleetham
K191651 11/06/2019 Arthrex Nano SwiveLock Suture Anchor Arthrex Inc. Rebecca R. Homan
K191426 11/26/2019 FiberTak Button Arthrex Inc. Ivette Galmez
K192782 11/29/2019 ASAHI CROSSWALK Peripheral Support Catheter Asahi Intecc Co., Ltd. Yasuyuki Kawuhara
K191464 11/21/2019 Asahi PTCA Guide Wire Asahi SION Series Asahi Intecc Co., LTD. Yasuyuki Kawahara
K192125 11/04/2019 Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen AtriCure, Inc Johnathon McElwee
K190816 11/19/2019 Vial Adapter ?20 mm , Vial Adapter ?13 mm Avenir Performance Europeenne Medical (APEM) Fatoumata Dao
K190855 11/01/2019 BD Acute Central Line Bard Access Systems, Inc. (Bard has joined BD) Sean J. Loring
K192948 11/07/2019 EleVation Breast Biopsy Driver, EleVation Breast Biopsy Probe - 10G, EleVation Breast Biopsy Probe - 14G Bard Peripheral Vascular, Inc. Meghan McKelvey
K192271 11/26/2019 Access PCT, Access PCT Calibrators Beckman Coulter, Inc. Jennifer Bennett
K192355 11/14/2019 MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32ug/mL) Beckman Coulter, Inc. Elaine Duncan
K192519 11/27/2019 Multi-modality workstation Beijing Superlaser Technology Co., Ltd. Shi Shuang
K191304 11/04/2019 EthanZir Zirconia Besorah Dental Solutions NZ Limited Jobin Jose
K192738 11/26/2019 ETEST Delafloxacin (DFX) (0.002-32 ?g/mL) BioMerieux SA Sophie Quiblier
K182463 11/06/2019 Silicone Foley Catheter Biosensors International Pte Ltd Lor Yen Yin
K192480 11/21/2019 Torpedo Gelatin Foam Biosphere Medical, S.A. Alix Fonlladosa
K192996 11/21/2019 Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool Biotronik, Inc Jon Brumbaugh
K182917 11/18/2019 FluoroCal Bisco, Inc Ryan Hobson
K192403 11/08/2019 VK100 Percutaneous Vertebral Augmentation System BONWRx Ltd Ralph W. Carmichael
K192438 11/27/2019 Rhythmia HDxTM Mapping System Boston Scientific Corporation Lee Margolin
K190760 11/23/2019 Cadwell Bolt Software Cadwell Industries, Inc. Emily Whitehead
K192632 11/07/2019 DIGITAL RADIOGRAPHY CXDI-702C Wireless, DIGITAL RADIOGRAPHY CXDI-402C Wireless Canon, Inc. Yamazaki Tatsuya
K190923 11/07/2019 Salem Sump Dual Lumen Stomach Tube with ENFit Connection Cardinal Health Alexis Erazo
K190330 11/04/2019 DRX-Evolution/Plus with Dual Energy Carestream Health, Inc. Carolyn Wagner
K192871 11/07/2019 B. anthracis Real-time PCR Assay Centers for Disease Control and Prevention Yon Yu
K192113 11/15/2019 DRSplus CenterVue SpA Roberto Gabriotti
K183666 11/14/2019 EBA One Nailing System CITIEFFE S.r.l. Stefano Pullega
K192168 11/04/2019 Idys ALIF ZP 3DTi CLARIANCE, SAS Fadwa Bahr
K190868 11/05/2019 Cleerly Labs Cleerly Inc Kimberly Elmore
K191921 11/15/2019 Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical Instruments Cochlear Americas Chinda Hemmavanh
K191237 11/08/2019 CERENOVUS Large Bore Catheter Codman & Shurtleff, Inc. Kirsten Franco
K192198 11/06/2019 Conformis Hip System Conformis, Inc. Paul Smolenski
DEN180062 11/20/2019 EchoTip Insight Portosystemic Pressure Gradient Measuring System Cook Ireland Ltd. Jane Kennedy
K190143 11/04/2019 LARS AC Band Device Corin USA Lucinda Gerber
K192643 11/19/2019 Dannik Laparoscopic Suction Irrigation System Dannik Olga Haberlad
K191361 11/07/2019 DemeDIOX Barbed Absorbable Surgical Suture DemeTECH Corporation Tracy Chadwrick
K191634 11/04/2019 Scan Abutments and Comfort Caps Dentium Co., Ltd. Byung-sun Kim
K183465 11/02/2019 Allcem, Allcem Core Dentscare LTDA Roberta Uyara
K190977 11/22/2019 Navina Smart System, Navina Classic System Dentsply Sirona Karl Nittinger
K191865 11/20/2019 SmartLite Pro Modular LED Curing Light Dentsply Sirona Karl Nittinger
K190344 11/01/2019 DePuy Corail AMT Hip Prosthesis DePuy (Ireland) Kathy Harris
K192946 11/26/2019 DePuy Corail AMT Hip Prosthesis DePuy Orthopaedics, Inc. Kathy Harris
K182301 11/08/2019 PFC SIGMA Knee System DePuy Orthopaedics, Inc. Kathy Harris
K192919 11/26/2019 Pinnacle Duofix HA Acetabular Cup Prosthesis DePuy Orthopaedics, Inc. Kathy Harris
K192376 11/26/2019 Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack DiaSorin Molecular LLC Sharon Young
K190544 11/01/2019 XIHPOSÖ ZFUZEÖ Interbody Fusion System DiFusion Technologies Derrick Johns
K190955 11/27/2019 Hypotension Decision Assist Directed Systems Ltd Mark S. Leaning
K192573 11/19/2019 Dolphin Medical Imaging USB Ultrasound System Dolphin Medical Imaging, LLC Brian S. Heaney
K190312 11/15/2019 Dornier Ureteral Stent Dornier MedTech America Inc. John Hoffer
K190571 11/07/2019 StoneBite and StoneBite scan Dreve Dentamid GmbH Reiner Altmann
K193017 11/22/2019 EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP DRTECH Corporation Shin Dongwook
K193031 11/22/2019 EXPD 4343P, EXPD 3643P DRTECH Corporation Dongwook Shin
K192791 11/27/2019 Diagnostic Ultrasound System Edan Instruments, Inc. Stella Guo
K192242 11/22/2019 Synergy Platform, Synergy, Infinity, VersaHD Elekta Limited Irina Proutski
K191564 11/07/2019 Progenikine Concentrating System 25 mL System Emcyte Corporation Patrick Pennie
K190439 11/21/2019 EngageÖ Partial Knee System Engage UNI, LLC Nicholas Slater
K192661 11/10/2019 LATERA Absorbable Nasal Implant System Entellus Medical, Inc. (Aka Stryker ENT) Karen E. Peterson
K192079 11/27/2019 EOSedge EOS imaging Bernard Ismael
K190189 11/01/2019 MDT2 BLE Self-Monitoring Blood Glucose System EPS Bio Technology Corp. Cynthia Hung
K192157 11/22/2019 6450 Ultrasound system Esaote, S.p.A. Piet DeJong
K192842 11/15/2019 HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High Eurotrol B.V. Elisanne Biemans
K192592 11/21/2019 Axis Plating System Extremity Medical, LLC. Brian Smekal
K191673 11/27/2019 Upper Arm Blood Pressure Monitor Famidoc Technology Company Limited Leon Cao
K191987 11/27/2019 Orapeutic Forward Science Brian Pikkula
K192150 11/13/2019 AMICUS Separator System Fresenius Kabi AG Aunica Jones
K192932 11/12/2019 FDR D-EVO III flat panel detector system FUJIFILM Corporation Randy Vader
K192440 11/01/2019 FDR SE Lite Fujifilm Corporation Randy Vader
K192664 11/20/2019 FUJIFILM Endoscope Model EC-760Z-V/L FUJIFILM Corporation Randy Vader
K192323 11/18/2019 PolyLock Small Bone Plating System Fusion Orthopedics, LLC Eli Jacobson
K192026 11/26/2019 Peridot Intervertebral body fusion System GBS Commonwealth Co., Ltd. Jimmy Kim
K192260 11/22/2019 everX Flow GC America Inc. Mark Heiss
K192819 11/08/2019 OEC Elite GE OEC Medical Systems, Inc. Kenny M Bello
K192269 11/19/2019 TwinScan 808/755 Laser System GME German Medical Engineering GmbH Stefan Schulze
K182672 11/15/2019 ROSA Bracket GNI Co., LTD Duk Soo Kim
K190872 11/07/2019 BioGenesis Fertility Lubricant Good Clean Love, Inc. Wendy Strgar
K192915 11/13/2019 GMA 2.0 Pedicle Screw System Grafton Medical Alliance James Henry
K191570 11/13/2019 Infrared Thermometer Model MD-H30 Guangzhou Berrcom Medical Device Co., Ltd. Zhigang Du
K192232 11/08/2019 Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (White) Hartalega NGC Sdn. Bhd. Kuan Mun Leong
K191502 11/26/2019 Heraeus Peripheral Guidewire Heraeus Medical Components, LLC Chelsea Pioske
K191016 11/01/2019 COPAL exchange G Hip and Knee Spacers Heraeus Medical GmbH Ljuba Jitaau
K191110 11/14/2019 HeraBEATÖ US HeraMED Ltd. Dganit Litinsky
K191201 11/15/2019 EM SA Implant System Hiossen, Inc. Peter Lee
K192264 11/08/2019 HIVOX Spopad EMS SP-911, SP-921 Hivox Biotek Inc. Marx Lee
K191477 11/13/2019 AEON-C Stand Alone System Huvexel Co., Ltd Sung Kyu Hur
K190268 11/06/2019 Hydrofera Blue READY - Border Hydrofera, LLC Sean Anderson
K192109 11/05/2019 KOALA IB Lab GmbH Richard Ljuhar
K190397 11/15/2019 Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA Immunalysis Corporation Yang Yang
K190529 11/25/2019 SOZO ImpediMed Limited Catherine Kingsford
K192105 11/29/2019 Innonix Antiviral Child's Face Mask Innonix Technologies Limited Tommy Lui
K192049 11/08/2019 Oryx Cervical Plate System Innovasis, Inc. Marshall McCarty
K192843 11/22/2019 INNOVITA HCG Pregnancy Rapid Test Strip, INNOVITA HCG Pregnancy Rapid Test Cassette, INNOVITA HCG Pregnancy Rapid Test Midstream Innovita (Tangshan) Biological Technology Co., Ltd Leo Lee
K190512 11/22/2019 SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare Intelligent Endoscopy Melissa Clark
K191280 11/14/2019 E-100 Electrosurgical Generator, SynchroSeal Intuitive Surgical, Inc. Melissa Gonzalez
K192367 11/26/2019 Ion Endoluminal System Intuitive Surgical, Inc. Jennifer Siu
K192289 11/15/2019 IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit IRRAS USA, Ltd. Vinny Podichetty
K192417 11/26/2019 ARIX Cannulated Screw System Jeil Medical Corporation Sejin Ryu
K191972 11/12/2019 ARIX Wrist System Jeil Medical Corporation Ahhyeon Woo
K190958 11/09/2019 Neodent Implant System JJGC Industria e Comercio de Materiais Dentarios S.A. Mariana Soares Hartmann
K182732 11/18/2019 JTL-250-01 Jointechlabs, Inc. Thomas Lawson
K183393 11/18/2019 Digital Thermometer Joytech Healthcare Co.,Ltd Ren Yunhua
K192329 11/25/2019 Blue Latex Examination Powder Free Gloves JR Engineering & Medical Technologies (M) SDN.BHD. Ganesan Surbramaniam
K192911 11/14/2019 Brainlab Compatible K2M Navigation Instruments K2M, Inc. Oonagh Lahiff
K182712 11/23/2019 DEXIS CariVu 3-in-1 by KaVo Kaltenbach & Voigt GmbH Stefan Trampler
K190697 11/22/2019 PREVENA PLUS Incision Management System (No Ag); PREVENA PLUS DUO Incision Management System (No Ag) KCI USA, Inc. Patricia Lopez
K191527 11/08/2019 Visalys CemCore, Visalys Cem Core Try In Paste Kettenbach GmbH & Co. KG Katja Simon
K183598 11/15/2019 KeyPrint KeySplint Soft Keystone Industries Negar Movahed
K191028 11/22/2019 KLS Martin Individual Patient Solutions KLS-Martin L.P. Jennifer Damato
K191754 11/22/2019 Hair Growth System Kunshan Bella Optical technology Co., Ltd. Wu Xuefeng
K191980 11/18/2019 CLEARFIL MAJESTY ES Flow Kuraray Noritake Dental Inc. Yasujiro Ohara
K190721 11/14/2019 LongBow Ti Life Spine Inc. Angela Batker
K190911 11/26/2019 Physica KR Liner and SMR Reverse Humeral Liner LimaCorporate Roberto Gabetta
K191746 11/22/2019 SMR TT Augmented Glenoid System Limacorporate S.p.A Michela Zanotto
K191622 11/01/2019 Delta Multihole TT Pro Acetabular System Limacorporate S.p.A. Roberto Gabetta
K192299 11/21/2019 LZI Cotinine II Enzyme Immunoassay Lin-Zhi International, Inc. Bernice Lin
K191161 11/12/2019 xTAG Gastrointestinal Pathogen Panel (GPP) Luminex Molecular Diagnostics, Inc. Tina Ip
K191160 11/04/2019 xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) Luminex Molecular Diagnostics, Inc. Tina Ip
K192331 11/12/2019 LaseMD LEO Laser System Lutronic Global James Childs
K192126 11/22/2019 AMIStem-P Short Neck Medacta International SA Stefano Baj
K192297 11/08/2019 APTUS Wrist Arthrodesis Plates Medartis AG Andrea Kiefer-Schweizer
K192891 11/07/2019 Laparoscope Lens Shield Device (LENS) Medeon Biodesign, Inc Tsung-Yu Hsieh
K191026 11/07/2019 MEDIP PRO MEDICALIP Co., Ltd Yoon Bo Chung
K192508 11/22/2019 Medsynapse Ris Pacs & Medsynapse VNA Medsynaptic Private Ltd Ashish Dhawad
K191851 11/25/2019 VS3-IR Medtronic Alex Chanin
K191597 11/01/2019 Stealth Autoguide System, Midas Rex Legend Depth Stop System Medtronic Navigation, Inc. Jason Woehrle
K192336 11/22/2019 Navigated Anterolateral Disc Prep Instruments Medtronic Sofamor Danek USA, INC. Parwinder Singh
K192347 11/14/2019 ST Internal Implant System Megagen Implant Co. Ltd You Jung Kim
K192907 11/26/2019 Advocate PTA Catheter Merit Medical Systems Inc. Mark Mullaney
K192625 11/21/2019 PG Pro Microcatheter MicroVention, Inc., A Terumo Group Company Ganesh Balachandar
K182929 11/06/2019 BIO-RAY A-1 Anchor Screw System Microware Precision Co., Ltd. Harrison Du
K190334 11/01/2019 MIMOSA Imager MIMOSA Diagnostics Inc Yuan Fang
K191701 11/15/2019 Arcus Head Fixation Frame MRI Interventions, Inc. Pete Piferi
K191278 11/19/2019 RSI-MRI+ MultiModal Imaging Services Corporation (dba HealthLytix) Stephen Kosnosky
K190661 11/09/2019 Omics Core NantHealth, Inc. Aleece Nolasco
K192186 11/29/2019 I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal Portable Assessment System - Nysragmograph Neurolign USA, LLC Aura Kullmann
K192764 11/26/2019 NeuroOne Cortical Electrode NeuroOne, Inc. Debra Kridner
K192248 11/25/2019 CortinaÖ [MAX] Lumbar Cage System NeuroStructures, Inc. Moti Altarac
K192153 11/07/2019 Portux CAD/CAM Disc New Stetic S.A. Juan David Jaramillo G.
K192045 11/15/2019 Ophthalmic Yag Laser System YC-200 Nidek Co., Ltd. Tsutomu Sunada
K190494 11/25/2019 Infant Incubator Ningbo David Medical Device Co.,Ltd Lin Dingyu
K191032 11/27/2019 fMRI Hardware System NordicNeurolab AS Chandana Gurung Bhandari
K192174 11/15/2019 SPY Portable Handheld Imaging (SPY-PHI) System Novadaq Technologies ULC. (now a part of Stryker) Agatha Szeliga
K192469 11/13/2019 Nox Sleep System Nox Medical Kolburn E Ottosdottir
K192181 11/07/2019 PRECICE Plating System NuVasive Specialized Orthopedics, Inc. Madison Heffron
K191974 11/03/2019 NuVasive AttraX Putty NuVasive, Incorporated Jessica LeBlanc
K192582 11/13/2019 NuVasive CoRoent Small Interlock System NuVasive, Incorporated Jessica LeBlanc
K191230 11/08/2019 Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves O & M Halyard, Inc. Steve Dowdlley
K181839 11/21/2019 CVS Health Dry Mouth Spray, OraLabs Dry Mouth Spray OraLabs, Inc. Gary Schlatter
K190003 11/06/2019 Vivid Aligners Orthodent Laboratory, Inc. Michael Wright
K192080 11/05/2019 iASSIST Knee System Orthosoft Inc. (d/b/a Zimmer CAS) Eduardo Mendoza
K190608 11/04/2019 Mei Ceramic Bracket Orthosun Co., Ltd. Ju-Sung Lee
K192379 11/27/2019 Hi-Fatigue G Bone Cement OSARTIS GmbH Volker Stirnal
K190811 11/27/2019 Optimus NEURO System - Sterile Kit Osteonic Co., Ltd Choi Se Young
K171899 11/22/2019 Revitalair 430F Oxavita S.R.L. Eduardo Northing
K192824 11/02/2019 Parcus Knotless AP Suture Anchors Parcus Medical, LLC Paul Vagts
K192964 11/22/2019 Parcus Synd-EZ SS Parcus Medical, LLC Paul Vagts
K191103 11/22/2019 Parkell Desensitizer Gel Parkell, Inc. David Mott
K193036 11/22/2019 C2 CryoBalloon EndoGrip PENTAX Medical, A Division of PENTAX of America, Inc. Gurvinder Singh Nanda
K191282 11/08/2019 PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family PENTAX of America, Inc. William Goeller
K192245 11/15/2019 Pentax Medical Video Duodenoscope ED34-i10T2 PENTAX of America, Inc. William Goeller
K190799 11/12/2019 PENTAX Medical Video Upper GI Scopes (EG Family) PENTAX of America, Inc. William Goeller
K192955 11/20/2019 Penumbra LP Coil System Penumbra, Inc. Anush Puvvada
K190335 11/06/2019 GSP Neonatal Total Galactose kit PerkinElmer Inc. Brian Ciccariello
K190710 11/29/2019 EliA SymphonyS Immunoassay Phadia AB Carina Magnusson
K182979 11/19/2019 IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient Monitors MX700, MX800, IntelliVue Patient Monitors MP5, MP5SC, Multi-Measurement Module X3 Philips Medizin Systeme Boeblingen GmbH Markus Stacha
K192396 11/26/2019 Streamline MIS Spinal Fixation System Pioneer Surgical Technology, Inc. Michael Mach
K191976 11/13/2019 Piper GO-IO Intraosseous Infusion System Piper Access, LLC Jacob Lee
K190541 11/05/2019 MTS225 and MTS300 Multiple Tray Sterilization Systems PMBS, LLC Michele E. Mauzerall
K191903 11/22/2019 BruxZir GT (Gum Tissue) Color Prismatik Dentalcraft, Inc. Mythili Reguraman
K192858 11/05/2019 A1AT Genotyping Test Progenika Biopharma S.A., A Grifols Company Diego Tejedor
K183018 11/01/2019 VPro5 Propel Orthodontics LLC Bryce Way
K191959 11/08/2019 QuantX Breast MRI Biopsy Guidance Plugin Qlarity Imaging Robert Tomek
K190797 11/18/2019 Reedgyn disposable hysteroscope (Model RH-2S-01 and Model RH-2D-01) Reed Medical (Zhejiang) Co., Ltd. Lu Zhong Zhong
K192270 11/22/2019 LEva Pelvic Digital Health System Renovia Inc. Gina Prochilo-Cawston
K191693 11/01/2019 BC-5 Reveallux, Corp Justin D Linn
K181845 11/25/2019 Pivot System Sterilization case RP Medical, Inc. Jim Barley
K182892 11/26/2019 TRAUS Dental Handpieces Saeshin Precision Co., Ltd. Choi Jong Woo
K191488 11/21/2019 SAM IO Intraosseous Access System SAM« Medical Products, Inc. Jeff Lipps
K181953 11/20/2019 SDS1.2 dental implant SDS Swiss Dental Solutions AG Martin Chares
K193040 11/30/2019 Resorbable Mesh Device SeaSpine Orthopedics Corporation Caryn Sailor
K192095 11/01/2019 CAPI 3 Immunotyping, Capillarys 3 Tera Sebia Karen Anderson
K192936 11/15/2019 Soltus 500 Sedecal., SA. Ma Luisa Gomez de Aguero
K192118 11/08/2019 CRP Vario Sentinel CH, Spa Patricia Dupe
K190225 11/05/2019 TAP Blood Collection Device Seventh Sense Biosystems, Inc. Tim Richards
K192672 11/20/2019 uPMR 790 Shanghai United Imaging Healthcare Co., Ltd Xin Gao
K192432 11/08/2019 IPL Home Use Hair Removal Device Model(s): D-1128, D-1103, D-1119, D-1129, D-1130 Shenzhen Bosidin Technology Co., Ltd. Wang Jiaoyan
K191428 11/27/2019 ECG Cable Shenzhen Changke Connect Electronics Co., Ltd. Yahui Zhou
K192087 11/01/2019 Combo Electrotherapy Device Shenzhen Roundwhale Technology Co., Ltd. Kevin Zhang
K192365 11/29/2019 Shoulder Innovations Total Shoulder System Shoulder Innovations Inc Don Running
K192777 11/22/2019 ADVIA Centaur CA 15-3 assay Siemens Healthcare Diagnostics, Inc. Anoop Joy
K192788 11/25/2019 ADVIA Centaur Cortisol (COR) Siemens Healthcare Diagnostics, Inc. Ian Thompson
K192061 11/21/2019 SOMATOM Go Platform û SOMATOM go.Now, go.Up, go.All, go.Top, go.Sim, go.Open Pro, Scan & GO Siemens Medical Solutions USA, Inc. Alaine Medio
K191891 11/06/2019 SOMATOM X.cite Siemens Medical Solutions USA, Inc. Tabitha Estes
K190898 11/01/2019 Sight OLO Sight Diagnostics Ltd. Sarah Levy
K190577 11/27/2019 World Knee Total Knee Systems Signature Orthopaedics Pty Ltd. Declan Brazil
K192603 11/22/2019 Spes Medica Subdermal Needle Electrodes Spes Medica S.r.l. Giorgio Facco
K190478 11/14/2019 Reprocessed ViewFlexÖ Xtra ICE Catheter Sterilmed, Inc. Jan Flegeau
K191466 11/07/2019 SandShark Injectable Anchor (SIA) System Stimwave Technologies Inc. Elizabeth Greene
K192292 11/19/2019 L10 LED Light Source with AIM, L11 LED Light Source with AIM, AIM SafeLight Cable Stryker April Malmborg
K192207 11/22/2019 Trevo NXT ProVue Retriever Stryker Rhoda M Santos
K192122 11/22/2019 Trevo Trak 21 Microcatheter Stryker Rhoda Santos
K192675 11/22/2019 VariAx Foot Stryker GmbH Jemin Dedania
K193034 11/29/2019 AXS Infinity LS Plus Long Sheath Stryker Neurovascular Shivani H Patel
K181993 11/01/2019 STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R) Sturdy Industrial Co., Ltd Wolfgang Huang
K190144 11/05/2019 MucoPEG SunBio, Inc. Sun S. Kim
K191784 11/15/2019 Gabriel Feeding Tube with Balloon, and EnFit Connector Syncro Medical Innovations, Inc. Sabry Gabriel
K192327 11/07/2019 DePuy Synthes 2.4mm LCP Straight Wrist Plate, Sterile Synthes (USA) Products LLC Thomas Shea
K192745 11/26/2019 DePuy Synthes Trauma Screws Synthes (USA) Products LLC / DePuy Orthopaedics Inc Keith Knapp
K190391 11/15/2019 TDM Plate and Screw Systems TDM Co. Ltd. Yougdae Kim
K191247 11/15/2019 SmartSPACE Shoulder System TechMah Medical LLC Mohamed R. Mahfouz
K191312 11/01/2019 Perfect PFE TensCare Ltd. Andrew Brown
K191986 11/10/2019 DESS Dental Smart Solutions Terrats Medical SL Roger Terrats
K192729 11/06/2019 Sensititre 18-24 Hour MIC or Breakpoint Susceptibility System with Lefamulin in the dilution range of 0.008-16ug/ml Thermo Fisher Scientific Cynthia Knapp
K191914 11/06/2019 Thermo Scientific Sensititre ARIS HiQ System Thermo Fisher Scientific Cynthia Knapp
K191918 11/06/2019 Thermo Scientific Sensititre ARIS HiQ System Thermo Fisher Scientific Cynthia Knapp
K191075 11/22/2019 Healy TimeWaver Production GmbH Martin Wittmann
K191961 11/26/2019 OrthoGold Tissue Regeneration Technologies John Warlick
K192792 11/20/2019 TranS1 AxiaLIF Plus System TranS1 Kristen Allen
K192877 11/22/2019 Senhance Surgical System TransEnterix, Inc. Kaitlyn Alexander
K192117 11/01/2019 Small VBRÖ ulrich GmbH & Co. KG Christoph Ulrich
K191171 11/13/2019 EchoGo Core Ultromics Ltd Melissa Clark
K192124 11/21/2019 Canady Plasma SMART XL-1000 Electrosurgical Generator with Accessories US Medical Innovations, LLC David Hinds
K192278 11/01/2019 Luminelle DTx Hysteroscopy System, Luminelle Dx 360 Rotatable Disposable Sheath (Diagnostic) UVision360 Inc. Allison London Brown
K192204 11/19/2019 Sensuva Strawberry Personal Lubricant, Sensuva Apple Candy Personal Lubricant, Sensuva Butter Rum Personal Lubricant, Sensuva Orange Creamsicle Personal Lubricant, Sensuva Salted Caramel Personal Lubricant, Valencia Naturals Inc. Louie Goryoka
K192968 11/12/2019 IDENTIFY Varian Medical Systems, Inc. Peter J Coronado
K192935 11/15/2019 CAPERE Thrombectomy System Vascular Medcure, Inc. Jeffrey P DuMontelle
K191497 11/01/2019 NextDent Denture 3D+ Vertex-Dental BV Loes Vloet-Emonts
K190013 11/04/2019 WellDoc BlueStar WellDoc, Inc. Caroline York
K192908 11/14/2019 Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes Wilson-Cook Medical, Inc Tiffanny A. Thomas
K192202 11/12/2019 Clear21 World Class Technology Corporation Alan Kozlowski
K192320 11/26/2019 HealthCXR Zebra Medical Vision, Ltd. Flair Bar
K190497 11/20/2019 Ziehm 8000 Ziehm Imaging GmbH Steve Seeman
K192236 11/05/2019 Fitmore Hip Stem Zimmer GmbH Roberto Tommasini
K192940 11/15/2019 CoolTone Zimmer MedizinSysteme GmbH Ute Hauss
K183457 11/05/2019 Zimmer Biomet 12/14 CoCr Femoral Head and Freedom Head Zimmer, Inc. Rebecca Nofiz
K190518 11/22/2019 Color Liquid, Vita Liquid Zirkonzahn srl Julian Steger
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