FDA 510(k) Decisions During June, 2019  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K182785 06/19/2019 LOQTEQ VA Foot Plates 2.5 aap Implantate AG Annesha Lahiri
K191175 06/27/2019 ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System ACIST Medical Systems, Inc. Angela Johnson
K191038 06/12/2019 On Call Express Voice Blood Glucose Monitoring System ACON Laboratories, Inc. Qiyi Xie
K182573 06/07/2019 Hailie Sensor Adherium (NZ) Ltd Chris Mander
K182638 06/19/2019 Hailie Sensor Adherium (NZ) Ltd Chris Mander
K182159 06/13/2019 Strome-Blitzer Cytology Balloon ADN International LLC Marshall Strome
K191185 06/03/2019 Solanas« Posterior OCT Fixation System Alphatec Spine Ruby Zheng
K172232 06/12/2019 LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS 600 AMS Diagnostics Samuel Burgos
K183535 06/04/2019 Fully Automatic Electronic Blood Pressure Monitor Andon Health Co., Ltd. Liu Yi
K183385 06/18/2019 NanoKnife System Angiodynamics Troy Roberts
K190095 06/20/2019 Powder-Free Clear Vinyl Patient Examination Gloves Anhui Intco Medical Products Co. Ltd Jacken Cai
K190585 06/05/2019 Biocode Gastrointestinal Pathogen Panel (GPP) Applied Biocode, Inc. Robert Di Tullio
K183595 06/21/2019 Aqua Medical RF Vapor System Aqua Medical, Inc. Lloyd Mencinger
K183229 06/07/2019 Argen Clear Aligner Argen Corporation Paul Cascone
K190117 06/13/2019 Fiberoptix IAB Arrow International, Inc. Niyati Boghani
K190101 06/28/2019 UltraFlex IAB Arrow International, Inc. Niyati Boghani
K191226 06/11/2019 Arthrex SwiveLock Suture Anchor Arthrex Inc. David L. Rogers
K182844 06/22/2019 ASAHI SASUKE Asahi Intecc Co., Ltd. Yasuyuki Kawahara
K191340 06/04/2019 CORTRAK* 2 Equilateral Enteral Access System Avanos Medical, Inc. Monica King
K182416 06/11/2019 NOVA Minimally Invasive System BAUI Biotech CO., LTD. Herman Jhan
K183649 06/07/2019 Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology Cable Baylis Medical Company Inc. Meghal Khakhar
K183632 06/07/2019 Diagnostic Fixed Electrophysiology Lumen Catheter , Diagnostic Electrophysiology Cable Baylis Medical Company Inc. Meghal Khakhar
K190251 06/28/2019 RecoveryRx BioElectronics Corporation Sree N Koneru
K190616 06/06/2019 VITEK 2 AST-Gram Positive Dalbavancin (<= 0.015 - >= 1 ?g/mL) bioMerieux, Inc. Cherece L. Jones
K190576 06/05/2019 WalterLorenz Surgical Assist Arm Scope Holder Biomet Microfixation Lauren Jasper
K190564 06/02/2019 Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring System GM700SB Bionime Corporation Shane Chou
K183578 06/18/2019 Torpedo Gelatin Foam Biosphere Medical, S.A. Alix Fonlladosa
K191223 06/28/2019 NAVIO Blue Belt Technologies, Inc. Amy Winegarden
K191285 06/11/2019 Spine & Trauma Navigation Brainlab AG Julia Mehltretter
K191331 06/12/2019 Life Sensor Cardiac Monitor BraveHeart Wireless, Inc. Balaji Sudabattula
K190784 06/25/2019 BUHLMANN fCAL turbo BUHLMANN Laboratories AG Laura Zurbrugg
K190185 06/12/2019 Phasix ST Mesh with Open Positioning System C.R. Bard, Inc. Shirin Mate
K183046 06/12/2019 Aquilion ONE (TSX-305A/6) V8.9 with AiCE Canon Medical Systems Corporation Paul Biggins
K190505 06/05/2019 Low Dose Lung Screening Option Canon Medical Systems Corporation Paul Biggins
K191128 06/26/2019 Vantage Titan 3T, MRT-3010, V2.5 Canon Medical Systems Corporation Paul Biggins
K191194 06/25/2019 CLARUS Carl Zeiss Meditec, Inc Saurabh Jamkhindikar
K183195 06/14/2019 VIVO Catheter Precision, Inc. Steve Adler
K190106 06/24/2019 Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire ; Tracking Pad ; Guidewire Handle Centerline Biomedical, Inc. Vikash Goel
K190475 06/28/2019 Delivery Catheter SSPC1, Delivery Catheter SSPC2, Delivery Catheter SSPC3, Delivery Catheter SSPC4 CenterPoint Systems Marybeth Gamber
K182683 06/27/2019 Z-Robot Patient Positioning System Chinan Biomedical Technology, Inc. James Chinan Chen
K191263 06/06/2019 Idys ALIF TiVac Clariance SAS Fadwa Bahr
K183460 06/13/2019 ClariCT.AI ClariPI Inc. Hyun-Sook Park
K190597 06/21/2019 BRILLIANT EverGlow Flow Coltene/Whaledent AG Wolfgang Dorner
K190080 06/27/2019 Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black) Comfort Rubber Gloves Industries Sdn. Bhd. Chan Yew Men
K190516 06/28/2019 MicroLink All-Suture Button Fixation System (Radiolucent) CONMED Corporation Diana L. Nader-Martone
K190582 06/28/2019 MicroLink All-Suture Button Fixation System (Radiopaque) CONMED Corporation Diana L. Nader-Martone
K182832 06/26/2019 Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor Set Cook Incorporated Kotei Aoki
K191485 06/26/2019 Deflectable Brush Biopsy Set Cook Incorporated Irasema Rivera
K182695 06/17/2019 Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter Cook Incorporated Chelsea Woods
K191291 06/12/2019 Wallace Dual Lumen Oocyte Recovery System CooperSurgical, Inc. Christine Kupchick
K190016 06/12/2019 Lateral Plate System CoreLink, LLC Steven Mounts
K183114 06/05/2019 Corin BiPolar-i Corin USA Limited Homer Trieu
K183533 06/04/2019 Unity Total Knee System Corin USA Limited Lucinda Gerber
K191335 06/06/2019 Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags Corinth MedTech, Inc. Sandeep Saboo
K191341 06/13/2019 Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags Corinth MedTech, Inc. Sandeep Saboo
K190750 06/21/2019 DePuy Synthes Plates and Screws Portfolio DePuy Synthes Quinn McCarthy
K191450 06/28/2019 Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System and Dexcom Pro Q Continuous Glucose Monitoring System Dexcom, Inc. Emily Chung
K182625 06/03/2019 Diapex Plus Diadent Group International Myung sub Kim
K191166 06/26/2019 DigniCap Delta Dignitana Inc. William Cronin
K182742 06/20/2019 DB-CMF Dimensional Bioceramics, LLC Duran N. Yetkinler
K180511 06/12/2019 eon Dominion Aesthetic Technologies, Inc. Ahmed Mohammed
K191209 06/18/2019 Aneroid Type Blood Pressure Kit Dongguan Mars Medical Products Co., Ltd Lily Liao
K181965 06/13/2019 Restore Toothpaste Dr. Collins, Inc. Jiahe Li
K190583 06/27/2019 DynaFlex DynaFlex Matthew Malabey
K191089 06/13/2019 Edwards Pressure Cable Edwards LifeSciences, LLC Anne Lo
K190130 06/21/2019 The ClearSight finger cuffs Edwards Lifesciences, LLC Christine J. Chun
K190299 06/26/2019 Elos Accurate« Customized Abutment Elos Medtech Pinol A/S Tina Friis Poulsen
K190057 06/07/2019 DJO Acetabular System Encore Medical, L.P. Teffany Hutto
K182145 06/07/2019 t?n« ultrasonic tips product family Engineered Endodontics Mark Fiorina
K191387 06/14/2019 ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube Envizion Medical Ltd. Doron Besser
K191438 06/27/2019 ERBEFLO 2 Endo Quick Connect Pentax Scope Port Connector Erbe USA, Inc. John Tartal
K190572 06/01/2019 Erchonia FX-635 Erchonia Corporation Steven Shanks
K191072 06/10/2019 7410 Ultrasound System (MyLabSigma) Esaote S.p.A. Piet De Jong
K183183 06/27/2019 VICRYL Polyglactin 910 Sterile Synthetic Absorbable Surgical Suture, PDS II Polydioxanone Sterile Synthetic Absorbable Surgical Suture, PDS Plus Antibacterial Polydioxanone Sterile Synthetic Absorbable Surgical Suture Ethicon, Inc. Stephanie Saati
K183021 06/28/2019 ClearEndoclip Finemedix Co., Ltd. Heon-sik Lee
K182658 06/19/2019 Bioliner Five Star Orthodontic Lab & Supply Andrew Loch
K191388 06/21/2019 FloPatch (FP110) Flosonics Medical (r/a 1929803 Ontario Corp.) Joe Eibl
K183032 06/24/2019 FUJIFILM Double Balloon Endoscope EI580BT FUJIFILM Corporation Randy Vader Vader
K190152 06/21/2019 Vit Kit- Freeze NX and Vit Kit- Warm NX FUJIFILM Irvine Scientific, Inc. Jayme Yamaguchi-Owens
K183564 06/13/2019 Electrosurgical Generator Fulwell LLC Xi Chen
K190216 06/09/2019 SpaceFlex Knee G21 S.R.L Filippo Foroni
K190443 06/24/2019 MMSphere Galactic Beauty, LLC Ellen Marmur
K190762 06/19/2019 The JASPER Spinal Fixation System II GBS Commonwealth Co., Ltd. Jimmy Kim
K190754 06/23/2019 Orthoss(R) Geistlich Pharma AG Marco Steiner
K183354 06/20/2019 Powder Free Blue Nitrile Examination Gloves Tested for use with 32 Chemotherapy Drugs and Fentanyl Citrate GX Corporation SDN BHD Khon Pu Foo
K183389 06/28/2019 Polyisoprene Powder Free Surgical Glove, Polyisoprene Powder Free Surgical Underglove Hartalega NGC Sdn. Bhd. Kuan Leong
K190133 06/13/2019 Full Automatic (NIBP) Blood Pressure Monitor-HL158UB Health & Life Co., Ltd. JS Hsu
K190804 06/05/2019 HydroCision TenJet Device HydroCision, Inc. Mark J. Lewis
K190545 06/20/2019 VADER« one Pedicle System MIS and LightMore« Pedicle System 6.0 icotec ag Marina Hess
K190341 06/28/2019 iC-GN iC-Cassette for use on the iC-System iCubate, Inc. Carter Wells
K191310 06/10/2019 Insight Essentials DRF Digital Imaging System Imaging Engineering, LLC George Jachode
K190121 06/17/2019 IDS SHBG Immunodiagnostic Systems Ltd. Mick Henderson
K191368 06/17/2019 FlowTriever Retrieval/Aspiration System Inari Medical Eben Gordon
K183450 06/20/2019 EmBody System InMode MD Ltd. Amit Goren
K182139 06/21/2019 AXTi Titanium Stand-Alone ALIF System Innovasis, Inc. Marshall McCarty
K190684 06/17/2019 LxHA PEEK Lateral IBF System Innovasis, Inc. Marshall McCarty
K183064 06/28/2019 TxTi IBF System Innovasis, Inc. Marshall McCarty
DEN180057 06/07/2019 IB-Stim Innovative Health Solutions (IHS), Inc. Tom Carrico
K190785 06/25/2019 Reprocessed PentaRay Nav eco High-Density Mapping Catheter Innovative Health, LLC. Amanda Babcock
K190097 06/26/2019 Straumann CARES Screw-Retained Bridges and Bars Institut Straumann AG Gordon Dodds
K190654 06/28/2019 Straumann CI RD Ceramic Healing Caps Institut Straumann AG Pierre-Yves Calinon
K190360 06/21/2019 LineSiderÖ Spinal System Integrity Implants, Inc Lauren Kamer
K190220 06/10/2019 Vista FS, Vista FS Liquid Inter-Med / Vista Dental Products Alex Johnson
K191043 06/06/2019 da Vinci Handheld Camera Intuitive Surgical, Inc. Manjunath Bisalehalli
K183559 06/05/2019 WatchPAT ONE Itamar Medical, Ltd. Koby Sheffy
K183311 06/07/2019 Ivenix Infusion System (IIS) Ivenix, Inc. John J. Sokolowski
K182656 06/11/2019 JAMBRO Single Core A Sterilization wrap Jiangsu Zhande Medical Supplies Co., Ltd Chanjuan Xu
K191151 06/21/2019 JKH Stimulator Plus JKH USA, LLC Bill Quanqin Dai
K190573 06/04/2019 KOWA DR-1a Kowa Company, Ltd. Nariaki Morita
K183624 06/20/2019 Kubtec Mozart (Xpert42) KUB Technologies, Inc. Chester Lowe
K182749 06/12/2019 Lansinoh Signature Pro Double Electric Breast Pump, Lansinoh Smartpump Double Electric Breast Pump Lansinoh Laboratories Saglik Gerecleri Tasarim San. Tic. Ltd Lindsay Ewers
K190782 06/27/2019 FlexGard Cut-Resistant Glove Liners LDI Corporation Lou LaMarca
K183513 06/13/2019 XenoSure Dura Biologic Patch LeMaitre Vascular Inc. Xiang Zhang
K191005 06/13/2019 ProLift« Expandable System Life Spine Inc. Angela Batker
K183262 06/21/2019 EsoCheck CCD Cell Collection Device Lucid Diagnostics, Inc. Lishan Aklog
K183566 06/14/2019 CLARITY II Laser System Lutronic Corporation James Childs
K182429 06/07/2019 Masimo O3 Regional Oximeter System Masimo Corporation Sindura Penubarthi
K190874 06/05/2019 Materialise Mimics Enlight Materialise N.V. Mieke Janssen
K190892 06/04/2019 MectaScrew PEEK Interference Screw Medacta International SA Stefano Baj
K183219 06/14/2019 Trio-CT Triple Lumen Catheter Medical Components Inc. (dba MedComp) Courtney Nix
K181260 06/21/2019 MiiS Horus Scope DPT 100 Medimaging Integrated Solution Inc. (MiiS) Chih-Lu Hsu
K183431 06/14/2019 Medline Digital Rectal Thermometer Sheath Medline Industries, Inc. Dinah Rincones
K183335 06/12/2019 Medline Poly-Cath Red Polymer Urethral Catheter Medline Industries, Inc. Dinah Rincones
K191483 06/28/2019 HEALIX ADVANCE Anchor with DYNA+TAPE Sutures Medos International SARL Ashley Goncalo
K190096 06/26/2019 R2GATE MegaGen Implant Co., Ltd. HyeJin Jung
K180952 06/07/2019 Ceramic Bracket MEM Dental Technology Co., Ltd Anita Chen
K190503 06/07/2019 CeraSeal Meta Biomed Co., Ltd. Suk Song Oh
K191307 06/05/2019 Palm Bladder Scanner - PBSV5.1 Mianyang Meike Electronic Equipment Co., Ltd. Wenjun Zhao
K191172 06/20/2019 Cepheid Xpert MRSA NxG Control Panel Microbiologics, Inc. Tina Sobania
K191168 06/25/2019 Cepheid Xpert SA Nasal Complete Control Panel Microbiologics, Inc. Tina Sobania
K182519 06/07/2019 Miha Bodytec II Miha Bodytec Gmbh Juergen Decker
K190115 06/19/2019 MHD TENS MingHuangDa Electronic Co., Ltd Zhang Guixiang
K182524 06/17/2019 GALILEO Spine Alignment Monitoring System MiRus, LLC Jordan Bauman
K190618 06/06/2019 RIGEL PEEK Anterior Cervical Interbody Fusion System MiRus, LLC Jordan Bauman
K190568 06/06/2019 ComPAS2 (Computerized Pulmonary Analysis System) Morgan Scientific, Inc. Deborah Cornish
K190414 06/14/2019 Moss Gastrostomy Tube, Moss Nasal Tube û Mark IV Moss Tubes, Inc. Michael Moss
K183602 06/27/2019 SwimCount Sperm Quality Test MotilityCount ApS Jacob Mollenbach
K191220 06/06/2019 Pure Vu System Motus GI Medical Technologies Ltd. Ravit Peled
K191400 06/21/2019 Voyager Trajectory Array Guide (V-TAG) MRI Interventions, Inc. Pete Piferi
K171304 06/24/2019 Maxxi Rip Sensor Neurovirtual USA, INC. Eduardo Faria
K191064 06/12/2019 Argon Handset New Deantronics Taiwan Ltd Jane Liu
K182851 06/26/2019 SkyBreeze Zero Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs O & M Halyard, Inc. Angela L. Bunn
K182713 06/11/2019 Scoreflex PTA Scoring Balloon Catheter OrbusNeich Medical Trading, Inc. John Pazienza
K191316 06/07/2019 VITROS XT Chemistry Products ALB-TP Slides Ortho-Clinical Diagnostics, Inc. Darlene Phillips
K190388 06/07/2019 RIVAL View Plating Systems and Reduce Fracture Plating Systems Orthofix Srl Gianluca Ricadona
K183220 06/21/2019 OrthoScan TAU Mini C-Arm Orthoscan, Inc. Richard Westrich
K190595 06/05/2019 Signature ONE System Orthosoft Inc. (d/b/a Zimmer CAS) Paul Hardy
K190663 06/17/2019 Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6 Pajunk GmbH Medizintechnologie Christian G. H. Quass
K183580 06/20/2019 Panthera Dental Milled Bars Panthera Dental Inc. Martine Fortin
K182285 06/20/2019 PK High Tibial Osteotomy Correction System Paonan Biotech Co., Ltd. Vivi Tsai
K190667 06/13/2019 Sonopet iQ Sterilization Tray Paragon Medical Rebecca Walker
K190245 06/04/2019 PDS Barbed Suture, PDO MAXX Threads PDO MAX, Inc. Giovanna McCarthy
K183691 06/12/2019 PENTAX Medical ENT Video Imaging System PENTAX of America, Inc. William Goeller
K190010 06/16/2019 Penumbra System Reperfusion Catheter JET 7 Penumbra, Inc. Micaela Victoria
K190017 06/27/2019 LiverMultiScan (LMSv3) Perspectum Diagnostics Ltd Jaco Jacobs
K190913 06/18/2019 QLAB Advanced Quantification Software 13 Philips Healthcare Arti Arvind
K190461 06/04/2019 Achieva 1.5T, 3.0T and Intera 1.5T MR Systems Philips Medical Systems Nederland B.V. Jan van de Kerkhof
K182503 06/03/2019 Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors Physio-Control, Inc. Chelsea Cullen
K182774 06/19/2019 STOP U (Packed Black USA), STOP U (Packed White USA) Pollogen Ltd. Einat Shammai
K181514 06/13/2019 SeraQuest HSV Type 2 Specific IgG Quest International, Inc. Steve Andrus
K182719 06/19/2019 Quidel Triage TOX Drug Screen, 94600; Quidel Triage« MeterPro Quidel Cardiovascular Inc. Rachael S. Williamson
K190177 06/12/2019 J-Type Marrow Biopsy Needle,T-Type Marrow Biopsy Needle,Tweezer Bone Marrow Biopsy Needle, Ranfac Corporation Eric Kreuz
K190387 06/19/2019 RayStation RaySearch Laboratories AB (publ) David Hedfors
K182960 06/21/2019 ReliefBand ReliefBand Technologies LLC Barbara Whitman
K190122 06/20/2019 Renovis A200 PS Knee System as part of the Renovis A200 Knee System Renovis Surgical Technologies Anthony Debenedictis
K190889 06/19/2019 Republic Spine Restore Cervical Interbody Fusion System Republic Spine, L.L.C. James Doulgeris
K190337 06/03/2019 ReWalk Restore ReWalk Robotics Ltd. Ofir Koren
K180671 06/05/2019 MINE RHT Co., Ltd Joon-Ho Oh
K182733 06/27/2019 Rochal Bioshield Silicone Film Rochal Industries, LLC William J. Coulston
K190927 06/24/2019 Oscillometric Blood Pressure Monitor Rudolf Riester GmbH Vivi Ding
K191115 06/12/2019 RS85 Diagnostic Ultrasound System Samsung Medison Co., Ltd Ji Yea Lee
K191055 06/12/2019 HS40 Diagnostic Ultrasound System Samsung Medison Co., Ltd. Scully Kim
K182703 06/19/2019 EntericBio Dx Assay Serosep, Ltd. David Clancy
K190938 06/26/2019 Photodynamic Therapy System Shanghai Apolo Medical Technology Co., Ltd. Felix Li
K190936 06/17/2019 Q-Switched Nd: YAG Laser System Shanghai Apolo Medical Technology Co., Ltd. Felix Li
K183170 06/24/2019 uWS-CT Shanghai United Imaging Healthcare Co., Ltd. Xin Gao
K190700 06/14/2019 ELECTRODES PAD Shenzhen Bestpad Technology Development Co., Ltd Junwei Xu
K190228 06/13/2019 Transcranial Doppler Ultrasound System Shenzhen Delica Medical Equipment Co., Ltd. Yolanda Lan
K182667 06/18/2019 Med-link Temperature Probes Shenzhen Med-link Electronics Tech Co., Ltd. Baihan Feng
K190578 06/27/2019 SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Edge Plus, SOMATOM Definition AS/AS+, SOMATOM Confidence Siemens Medical Solutions USA Inc. Kimberly Mangum
K191418 06/19/2019 Multix Fusion Max Siemens Medical Solutions USA, Inc. Martin Rajchel
K191299 06/14/2019 Silhouette Featherlift / Silhouette Lift Silhouette Lift Inc. Anthony DiBernardo
K182608 06/13/2019 Oyster ACIF Cage Silony Medical GmbH Bircan Tasdelen
K191231 06/07/2019 Andorate Auxiliary Water Connector, Andorate Valves Set Smartdata Suzhou Co., Ltd Cindy Ye
K190336 06/20/2019 Soniquence Bipolar Electrodes Soniquence, LLC Suzanne Lucas
K183630 06/10/2019 SPINEART Navigation Instrument System Spineart SA Franck Pennesi
K190662 06/17/2019 MRI Compatibility for Existing Straumann Dental Implant Systems Straumann USA LLC Loretta Kushner-Mooney
K190172 06/14/2019 Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments Stryker David Colao
K190696 06/28/2019 Stryker Surgeon iD Mandible Recon Plate Stryker Zainab Amini
K190779 06/25/2019 Trevo XP ProVue Retriever Stryker Rhoda M. Santos
K191049 06/18/2019 Stryker MIS and Footed Attachments Stryker Corporation Paminder Khurmi
K183104 06/10/2019 Mini Cannulated Headed and Headless Screw Set Stryker GmbH Sanja Jahr
K191271 06/11/2019 T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws System, IMN Instruments System Stryker Trauma Gmbh Heike Gustke
K181672 06/28/2019 SureTouch Mobile Pressure Mapping System Sure Inc. David Ables
K190052 06/25/2019 Radio Frequency Ablation System Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. Guofang Ma
K191036 06/13/2019 SyMRI SyntheticMR AB Maria Almesaker
K190579 06/04/2019 TD-4183 Blood Glucose Monitoring System TaiDoc Technology Corporation Sophia Wu
K191207 06/25/2019 Guardian Angel Rx GA2001 Digital Vital Sign Monitoring System Taiwan Aulisa Medical Devices Technologies, Inc. Paul Liu
K191456 06/20/2019 Campylobacter Quik Chek Techlab, Inc Donna Link
K191442 06/20/2019 Campylobacter Chek Techlab, Inc. Donna Link
K191268 06/11/2019 Force Fiber Suture Teleflex Medical Incorporated Andrea Curria
K191465 06/27/2019 Human IgM Kit for use on SPAPlus The Binding Site Group Ltd. Natasha Verhaak
K182493 06/18/2019 Bovine Pericardial Tissue Patch Tisgenx Kris Kupumbati
K190521 06/12/2019 Aequalis Ascend Flex Shoulder System Tornier SAS Lamia Askri
K191318 06/14/2019 AEQUALIS FLEX REVIVE Shoulder System Tornier, Inc. Katie Molland
K183363 06/13/2019 Treace Medical Concepts (TMC) Snap-Off Screw System Treace Medical Concepts, Inc. Rachel Osbeck
K182650 06/10/2019 Arzzt Distal Radius and Ulna System Truemed Group LLC Nina Galeana Rodriguez
K183263 06/14/2019 UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope UNiPACK Medical Corporation Joe Pomparelli
K190827 06/06/2019 Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath Rigid UVision360 Inc. Allison London Brown
K190743 06/25/2019 Venus Bliss Venus Concept USA Inc. Yoni Iger
K183692 06/12/2019 Avid IF2 Vision Quest Industries Inc./ dba VQ OrthoCare Mohamed Ouerghi
K190916 06/07/2019 VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20 VitalConnect, Inc. Cynthia Merrell
K190422 06/12/2019 Viveve System 2.0 Viveve Medical Suzon Lommel
K182704 06/25/2019 WishBone Guided Growth System WishBone Medical Gary Barnett
K183620 06/06/2019 PROSTEP TBC Implant System Wright Medical Technology, Inc. Michael Mullins
K182411 06/24/2019 Scooter, Model: R-100 Yongkang Dingchang Industry & Trade Co., LTD. Cheng Chen
K190424 06/13/2019 HealthICH Zebra Medical Vision Ltd. Flair Bar
K190051 06/07/2019 TD Clip Zephyr Sleep Technologies, Inc. Sabina Bruehlmann
K190068 06/04/2019 Vanguard XP Knee System Zimmer Inc. Charles Neitzel
K190814 06/10/2019 AccuFill Bone Substitute Material Zimmer Knee Creations David l. Nichols
K182963 06/21/2019 emFieldPro Zimmer MedizinSysteme GmbH Ute Hauss


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