| 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 |
| K182638 |
06/19/2019 |
Hailie Sensor |
Adherium (NZ) Ltd |
Chris Mander |
| K182573 |
06/07/2019 |
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 FR |
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 |
tⁿn« 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 |
