| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K181748 |
09/12/2018 |
Magnesium |
Abbott Laboratories |
Mark Littlefield |
| K181563 |
09/26/2018 |
The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology |
Access Scientific, LLC |
Martina Nguyen |
| K182243 |
09/18/2018 |
The CVC WAND Safety Introducer with Valved Peelable Sheath |
Access Scientific, LLC |
Martina Nguyen |
| K181124 |
09/28/2018 |
Acessa ProVu System |
Acessa Health, Inc. |
Brian J. Bergeron |
| DEN170080 |
09/28/2018 |
Adaptive Biotechnologies clonoSEQ Assay |
Adaptive Biotechnologies Corporation |
B. Melina Cimler |
| K182226 |
09/11/2018 |
AirStrip RPM InvisionHeart Adapter |
AirStrip Technologies, Inc. |
Kirk Johnson |
| K171947 |
09/21/2018 |
SOLOASSIST II |
AKTORmed GmbH |
Andreas Mohr |
| K180366 |
09/20/2018 |
EndoTool SubQ |
Al Pacheco and Associates |
Al Pacheco |
| K182053 |
09/07/2018 |
UltravisionÖ Visual Field Clearing System |
Alesi Surgical Ltd. |
David Broderick |
| K181980 |
09/25/2018 |
OsseoScrew System |
Alphatec Spine, Inc. |
Jeremy Markovich |
| K181277 |
09/28/2018 |
E-CUBE 12 |
Alpinion Medical Systems Co., Ltd. |
Boyeon Cho |
| K181423 |
09/07/2018 |
AMSure Sterile Water, and Sterile Normal Saline for Wound Flush |
Amsino International Inc. |
Jane Gao |
| K173665 |
09/05/2018 |
AMSafe Sure-Lok Needle-Free Connector |
Amsino International, Inc. |
Cathy Hong |
| K181814 |
09/04/2018 |
AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water |
Amsino International, Inc. |
Cathy Hong |
| K182147 |
09/07/2018 |
CTXX85 |
Analogic Corporation |
Karen Provencher |
| K181926 |
09/21/2018 |
InVivo Web Viewer |
Anatomage Inc. |
Changxin Xu |
| DEN180044 |
09/11/2018 |
ECG App |
Apple Inc |
Donna-Bea Tillman |
| DEN180042 |
09/11/2018 |
Irregular Rhythm Notification Feature |
Apple Inc |
Donna-Bea Tillman |
| K180041 |
09/28/2018 |
BioCode Gastrointestinal Pathogen Panel (GPP) |
Applied Biocode, Inc. |
Robert Di Tullio |
| K182039 |
09/28/2018 |
Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid Inlay |
Arthrex Inc. |
Courtney Smith |
| K181769 |
09/21/2018 |
Arthrex FiberTak Suture Anchor |
Arthrex, Inc. |
David L. Rogers |
| K181665 |
09/21/2018 |
BD Phoenix Automated Microbiology System - BD Phoenix CPO detect - GN |
Becton,Dickinson and Company |
Monica E. Giguere |
| K181821 |
09/13/2018 |
MOSS VRS Spinal System |
Biedermann Motech GmbH & Co. KG |
Gerd Federle |
| K181006 |
09/21/2018 |
BB-613 Watch Oximeter |
Bio-Beat Technologies Ltd. |
Johanan May |
| K181337 |
09/18/2018 |
Sypher Spacer System |
Biogennix, LLC |
Tim Bumbalough |
| K180998 |
09/28/2018 |
BioHorizons CAD/CAM Bars |
BioHorizons Implant Systems, Inc. |
Michael Davis |
| K181611 |
09/24/2018 |
Comprehensive Reverse Shoulder System |
Biomet Manufacturing Corp |
Dalene Binkley |
| K181021 |
09/27/2018 |
EmboCube Embolization Gelatin |
Biosphere Medical, S.A. |
Alix Fonlladosa |
| K180068 |
09/28/2018 |
ORISE Gel |
Boston Scientific |
Thomas Hirte |
| K180144 |
09/21/2018 |
Agile Esophageal Stent System |
Boston Scientific Corporation |
Kayla Mackey |
| K182315 |
09/26/2018 |
Magic Torque DLVR Guidewire |
Boston Scientific Corporation |
Andrea Dance |
| K182275 |
09/13/2018 |
Seal Single Use Biopsy Valve |
Boston Scientific Corporation |
Andrew Akers |
| K180781 |
09/19/2018 |
Bard Vertus Foley Catheter |
C. R. Bard, Inc. |
Sharon Lambert |
| K173910 |
09/14/2018 |
Impress SFS System |
Cable Fix Medical LLC |
Carey Bryant |
| K181466 |
09/01/2018 |
Cadwell Zenith System |
Cadwell Industries, Inc. |
Alison Hull |
| K182415 |
09/28/2018 |
Alphenix, INFX-8000F/B, V8.0 |
Canon Medical Systems Corporation |
Paul Biggins |
| K181415 |
09/10/2018 |
XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0 |
Canon Medical Systems Corporation |
Paul Biggins |
| K182223 |
09/14/2018 |
Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A |
Canon Medical Systems USA |
Paul Biggins |
| K181229 |
09/19/2018 |
TirboLOX-C Cervical IBFD |
Captiva Spine, Inc. |
Jackie Ferro |
| K182377 |
09/27/2018 |
CarboClear« Pedicle Screw System |
CarboFix Orthopedics Ltd. |
Hila Wachsler-Avrahami |
| DEN070001 |
09/21/2018 |
NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR PRIMER AND PROBE SET |
CENTERS FOR DISEASE CONTROL AND PREVENTION |
HYE-JOO KIM |
| K181205 |
09/20/2018 |
Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set |
Centers for Disease Control and Prevention |
Yon Yu |
| K181995 |
09/20/2018 |
Chiral Surgical Pedicle Screw System |
Chiral Surgical |
Andy Choi |
| K173893 |
09/06/2018 |
Trabis |
coLigne, AG |
Robert Lange |
| K181811 |
09/07/2018 |
ReTrace Ureteral Access Sheath |
Coloplast A/S |
Cori Ragan |
| K173822 |
09/11/2018 |
Anchor Tissue Retrieval System by CONMED |
Conmed Corporation |
Rachelle D Fitzgerald |
| K181128 |
09/06/2018 |
Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin System) |
Contego Medical, LLC |
Elizabeth Saylors |
| K180182 |
09/14/2018 |
Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Catheter |
Cook Incorporated |
Samuel Engelman |
| K180029 |
09/21/2018 |
Malecot Nephrostomy Catheter/Stent Set |
Cook Incorporated |
Minjin Choi |
| K180216 |
09/28/2018 |
Seidmon Antegrade AQ Stent Set |
Cook Incorporated |
Rebecca Odulio (Li-Chun-Liu) |
| K180053 |
09/13/2018 |
Sof-Flex Ureteral Stent Set |
Cook Incorporated |
Minjin Choi |
| K181061 |
09/07/2018 |
Corin Optimized Positioning System (OPS) Femoral |
Corin USA |
Lucinda Gerber |
| K173141 |
09/19/2018 |
CSM Submerged3-L Implant System |
CSM Implant |
Sung Am Cho |
| K181721 |
09/17/2018 |
Ceracell Ortho Foam |
curasan AG |
Gregor Thomas |
| K181476 |
09/28/2018 |
Prime&Bond active Universal Adhesive |
Dentsply Sirona |
Karl Nittinger |
| K173960 |
09/21/2018 |
DePuy Corail AMT Hip Prosthesis |
DePuy France S.A.S. |
David Holzwarth |
| K182214 |
09/14/2018 |
DizzyDoctor System 1.0.0 |
DizzyDoctor Systems, LLC |
Ian Purcell |
| K181066 |
09/26/2018 |
Powder Free Nitrile Examination Glove (Blue) with Low Dermatitis claim and with tested for Use with Chemotherapy Drugs Claims |
ECO Medi Glove Sdn Bhd |
Suresh Kumar |
| K181510 |
09/04/2018 |
ECHOLASER X4 |
El.En Electronic Engineering Spa |
Paolo Peruzzi |
| K182138 |
09/05/2018 |
Precise Treatment System; Synergy platform; Synergy; Infinity; VersaHD |
Eleckta Limited |
Andrew Hedges |
| K181653 |
09/18/2018 |
Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed |
Ethicon Endo-Surgery, LLC |
Sigfrido Delgado |
| K181652 |
09/28/2018 |
Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable Suture |
Ethicon, Inc. |
Donna Marshall |
| K181707 |
09/26/2018 |
Everyway Wireless TENS & EMS Unit |
Everyway Medical Instruments Co., Ltd. |
Paul Hung |
| K181532 |
09/04/2018 |
Exactech Alteon Monobloc Revision Stem |
Exactech, Inc. |
Zach Sharrah |
| K181794 |
09/28/2018 |
Truliant Porous Femoral Components |
Exactech, Inc. |
Patrick Hughes |
| K181620 |
09/18/2018 |
Endoscopic Linear Cutting Staplers and Loading Units for Single Use |
Ezisurg (Suzhou) Medical Co., Ltd. |
Renjing Tian |
| K181773 |
09/25/2018 |
Synapse 3D Optional Tools |
FUJIFILM Corporation |
Randy Vader |
| K181783 |
09/20/2018 |
LOGIQ P9; LOGIQ P7 |
GE Healthcare |
Bryan Behn |
| K173830 |
09/18/2018 |
MAC VU360 Resting ECG Analysis System |
GE Medical Systems Information Technologies, Inc. |
Marcella Entwisle |
| K182234 |
09/06/2018 |
Optima XR240amx |
GE Medical Systems, LLC |
Chris Paulik |
| K181558 |
09/06/2018 |
Sofclear Enhance (methafilcon A) Daily Wear Contact Lens, Sofclear Colors (methafilcon A) Daily Wear Contact Lens, Sofclear Comfort (methafilcon A) Daily Wear Contact Lens |
Gelflex Laboratories |
David Masel |
| K173982 |
09/19/2018 |
FORTIFY Corpectomy Spacers |
Globus Medical Inc. |
Lori Burns |
| K181034 |
09/21/2018 |
Pocket Colposcope System |
Hadleigh Health Technologies, LLC |
Robert Miros |
| K182357 |
09/26/2018 |
HardyDisk AST Eravacycline 20╡g (ERV20) |
Hardy Diagnostics |
Anna Klavins |
| K181692 |
09/25/2018 |
5cm Tag Applicator, 7cm Tag Applicator, 10 cm Tag Applicator, 5 cm Tag Applicator (10 pack), 7cm Tag Applicator (10 pack), 10cm Tag Applicator (10 pack), LOCalizer Surgical Probe, LOCalizer Surgical Probe (5 pack) |
Health Beacons, Inc. |
Nancy Confrey |
| K182043 |
09/21/2018 |
Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored) |
Hebei Titans Hongsen Medical Technology Co., LTD. |
ShaoZhang Nan |
| K181594 |
09/13/2018 |
Spectralis HRA+OCT and variants with OCT Angiography Module |
Heidelberg Engineering GmbH |
Christoph Schoess |
| K182260 |
09/17/2018 |
PALACOS MV |
Heraeus Medical GmbH |
Ute Greiner |
| K173676 |
09/14/2018 |
A-FIT |
HIRONIC Co., Ltd. |
Sangwon Hwang |
| K181734 |
09/19/2018 |
Beurer IPL 8500 device/ IPL VelvetSkin Pro |
Home Well Trading LTD |
Martin Gurovich |
| K181874 |
09/14/2018 |
MX40 Mobile Digital X-ray System |
Huestis Machine Corporation |
Frederick M. Correira |
| K182196 |
09/11/2018 |
Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-Steth |
Imediplus, Inc. |
Moriah Hsieh |
| K182402 |
09/27/2018 |
CoLink View Plating System |
In2Bones USA, LLC |
Christine Scifert |
| K182325 |
09/26/2018 |
InMode RF System |
Inmode MD Ltd. |
Amit Goren |
| K181397 |
09/27/2018 |
DualX |
Innovasive, Inc. |
Andy Choi |
| K180964 |
09/28/2018 |
Endoscope Sterilization Tray |
Intuitive Surgical, Inc. |
Kunal Gunjal |
| K181662 |
09/05/2018 |
Iridex TruFocus LIO Premiere |
Iridex Corporation |
Edward J. Sinclair |
| K180714 |
09/24/2018 |
Probe Covers for Thermometers |
K-jump Health Co., Ltd. |
JM Lin |
| K181199 |
09/20/2018 |
Katalyst Mark 1 Muscle Stimulation System Model 2 |
Katalyst Inc. |
Bjoern Woltermann |
| K172957 |
09/28/2018 |
Kawasumi Laboratories Blood Drawing Kit (BDK) System |
Kawasumi Laboratories, Inc. |
Takayuki Nakajima |
| K181878 |
09/05/2018 |
Kiierr 272 Laser, Kiierr 148 Laser |
Kiierr International, LLC |
Michael Anderson |
| K181241 |
09/13/2018 |
KLS Martin Individual Patient Solutions (IPS) Planning System |
KLS-Martin L.P. |
Jennifer Damato |
| K182153 |
09/06/2018 |
Ultrasound System SONIMAGE HS1 |
KONICA MINOLTA, INC. |
Tsutomu Fukui |
| K181380 |
09/11/2018 |
LnK Lumbar Interbody Fusion Cage System |
L&K BIOMED Co., Ltd. |
Jihyeon Seo |
| K173926 |
09/14/2018 |
DORADOnova MR3T |
LAP GmbH Laser Applikationen |
Martin Pfabel |
| K181537 |
09/07/2018 |
GLOW800 |
Leica Microsystems (Schweiz) AG |
Georges Hakim |
| K180894 |
09/19/2018 |
Magnetic Surgical System |
Levita Magnetics International Corp. |
Alberto Rodrigues-Navarro |
| K181167 |
09/02/2018 |
Upcera Glaze Paste, Glaze Powder, and Glaze Liquid |
Liaoning Upcera Co., Ltd |
Charles Shen |
| K180215 |
09/13/2018 |
DYNA-LINK ELITE Stand-Alone Anterior Lumbar System |
Life Spine Inc. |
Randy Lewis |
| K173883 |
09/07/2018 |
External Fixation System |
Life Spine Inc. |
Randy Lewis |
| K173827 |
09/14/2018 |
LightScalpel |
LightScalpel LLC |
David Walters |
| K181889 |
09/13/2018 |
MTS Penicillin 0.002- 32 ╡g/mL |
Liofilchem s. r. l. |
Fabio Brocco |
| K173976 |
09/05/2018 |
Masimo Acoustic Respiration Sensors, infant and neonate |
Masimo Corporation |
Karina Simpson |
| K180973 |
09/28/2018 |
Libertas Hip Replacement System |
Maxx Orthopedics, Inc |
Corey Perine |
| K181789 |
09/21/2018 |
VeriSuite |
MedCom GmbH |
Johannes Messow |
| K170702 |
09/07/2018 |
mediCAD 4.0 |
mediCAD Hectec Gmbh |
Claas-Fabian Luers |
| K181591 |
09/26/2018 |
Fixated Asfora BULLET CAGE« (FABC) |
Medical Designs, LLC |
Kristi Vondra |
| K181568 |
09/11/2018 |
IPL Salon Hair Reduction System |
Medical Device Branch of Zhangzhou Easepal Industrial Co.,Lt |
Bruce Wu |
| K181726 |
09/20/2018 |
Medline Patient Cables and Lead Wires |
Medline Industries, Inc. |
Dinah Rincones |
| K182079 |
09/07/2018 |
Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic Mask |
MEDTEC Inc. dba CIVCO Medical Solutions |
Alena Newgren |
| K180933 |
09/17/2018 |
DenTek Ultimate Dental Guard |
Medtech Products Inc. |
Mary Beth Fritz |
| K180875 |
09/14/2018 |
POLY REJUV |
Medtek Skincare, LLC |
Gary Richardson |
| K181328 |
09/19/2018 |
T2 STRATOSPHEREÖ Expandable Corpectomy System |
Medtronic Sofamor Danek, USA Inc. |
Kanesha Hines |
| K182335 |
09/25/2018 |
CPX 4 Breast Tissue Expander with Smooth Surface |
Mentor Worldwide LLC |
Martin Sprunck |
| K182290 |
09/25/2018 |
IBM iConnect Access |
Merge Healthcare Incorporated |
Tracey Fox |
| K181200 |
09/21/2018 |
AEROmini Tracheobronchial Stent System |
Merit Medical Systems, Inc |
David Thomas |
| K180871 |
09/14/2018 |
Portable Nebulizer |
MicroBase Technology Corporation |
Molly Hsieh |
| K181598 |
09/14/2018 |
Prime E-CLASS XLPE Liner |
MicroPort Orthopedics Inc. |
Sarah Evonne Stroupe |
| K173898 |
09/20/2018 |
MicroPort Orthopedics Total Hip Systems MR Labeling |
MicroPort Orthopedics Inc. (MPO) |
Usman Rashid |
| K171904 |
09/18/2018 |
Tandry Locking Plate System |
Microware Precision Co., Ltd. |
Harrison Du |
| K173765 |
09/04/2018 |
Surveyor Patient Monitor |
Mortara Instrument, Inc. |
Manisha Gokuli |
| K180778 |
09/07/2018 |
Exceed Microneedling Device |
MT.DERM GmbH |
Anderas Pachten |
| K182263 |
09/07/2018 |
RetCam 3 ; RetCam Shuttle ; RetCam Portable |
Natus Medical Incorporated |
Brian R. Ackley |
| K181078 |
09/10/2018 |
The Sex Gel |
Necessaire, Inc. |
Randi Christiansen Stanley |
| K181702 |
09/21/2018 |
Tranquil-L Interbody System |
Nexus Spine, LLC |
Jared Crocker |
| K182340 |
09/20/2018 |
NICO Myriad |
NICO Corporation |
Sean Spence |
| K181075 |
09/27/2018 |
PureSet Tray |
Nobel Biocare AB |
Charlemagne Chua |
| K180340 |
09/26/2018 |
Stat Profile Prime Plus Analyzer System |
Nova Biomedical Corporation |
Adam Heroux |
| K172418 |
09/21/2018 |
OpenSight |
Novarad Corporation |
Doug Merrill |
| K181991 |
09/26/2018 |
NxStage Connected Health System |
NxStage Medical, Inc |
Christina Marabella |
| K182317 |
09/24/2018 |
AMADEO M-DR mini, AMADEO M-AX mini |
OEHM UND REHBEIN GMBH |
Markus Brueggmann |
| K181270 |
09/07/2018 |
Disposable SpO2 Sensors, Reusable SpO2 Sensors |
Orantech Inc. |
Yunxi Xiong |
| K180241 |
09/28/2018 |
Orthocaps Twinaligner |
Ortho Caps GmbH |
Wajeeh Khan |
| K181390 |
09/18/2018 |
Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine System |
OrthoPediatrics, Corp |
Mark Fox |
| K181449 |
09/19/2018 |
Ortoma Treatment Solution - OTS |
Ortoma AB |
Linus Bystrom |
| K182286 |
09/19/2018 |
Oh'Care Lite Smart Blood Glucose Monitoring System |
OSANG Healthcare Co., Ltd. |
Jin Ho An |
| K181236 |
09/13/2018 |
HySil Impression Materials |
OSSTEM IMPLANT CO LTD |
Jungmin Yoo |
| K181975 |
09/27/2018 |
Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30╡g) MEV30 |
Oxoid Limited (Part of Thermo Fisher Scientific) |
Philip Brame |
| K182148 |
09/07/2018 |
SILVERBACK Gorilla Plating System |
Paragon 28, Inc. |
Eric Lintula |
| K181616 |
09/21/2018 |
PSM 3-Way Silicone Foley Catheter |
Pathway, LLC |
David Stroup |
| K181424 |
09/25/2018 |
PeDIA |
PeDIA, LLC |
Diane Miller |
| K181102 |
09/15/2018 |
ThermaCare Quick Therapy TENS |
Pfizer Inc. |
Nicola Romano |
| K181311 |
09/07/2018 |
Philips Hemodynamic Application R1.0 |
Philips Medical Systems Nederlands B.V. |
Owen Callaghan |
| K173941 |
09/10/2018 |
IntelliSpace Perinatal Rev.K.00 |
Philips Medizin Systeme Boeblingen GmbH |
Christoph Krause |
| K181314 |
09/04/2018 |
IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue Microstream Extension |
Philips Medizin Systeme Boeblingen GmbH |
Stefan Breuer |
| K181904 |
09/25/2018 |
5 FR Dual Lumen Piper PICC |
Piper Access LLC |
Jay Muse |
| K181576 |
09/13/2018 |
Planmeca Viso |
Planmeca Oy |
Lars Moring |
| K181305 |
09/20/2018 |
OralTox Oral fluid Drug Test |
Premier Biotech, Inc. |
Jacqueline Gale |
| K182157 |
09/18/2018 |
BioSign Flu A+B |
Princeton BioMeditech Corp. |
Kyung-ah Kim |
| K182144 |
09/07/2018 |
Bi-Flex Evo |
Promepla Sam |
Alexandre Bareille |
| K181455 |
09/10/2018 |
ProSun sunlamp products, Luxura sunlamp products |
ProSun International LLC |
Tom Henkemans |
| K180893 |
09/19/2018 |
IHM Technology Bandage |
Protege Biomedical |
Mike Corcoran |
| K181000 |
09/13/2018 |
SelectFlex 072 Neurovascular Access System |
Q'Apel |
Ken Peartree |
| K173872 |
09/28/2018 |
FibriCheck |
Qompium nv |
Jo Van der Auwera |
| K182213 |
09/14/2018 |
QT Ultrasound Breast Scanner - 1 |
QT Ultrasound LLC |
Mark W. Lenox |
| K181632 |
09/17/2018 |
Venacure 1470 Pro |
Quanta System Spa |
Francesco Dell'Antonio |
| K180369 |
09/14/2018 |
Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe) |
Relievant Medsystems |
Alex DiNello |
| K181655 |
09/11/2018 |
Renovis S180 Lateral Lumbar Interbody Fusion System |
Renovis Surgical Technologies |
Anthony Debenedictis |
| K181320 |
09/18/2018 |
Caprolon |
Resorba Medical GmbH |
Helen Topping |
| K181771 |
09/28/2018 |
RightEye Vision System |
RightEye, LLC |
Adam Gross |
| K181233 |
09/18/2018 |
Elecsys FT4 III |
Roche Diagnostics |
Reanna Toney |
| K182370 |
09/27/2018 |
Acculoc Total Knee System |
RootLoc Co., Ltd. |
Jungsun Ha |
| K181518 |
09/06/2018 |
Sebacia Microparticles |
Sebacia, Inc. |
Todd J. Meyer |
| K173833 |
09/27/2018 |
CRP Vario |
SENTINEL CH. SpA |
Patricia Dupe |
| K180177 |
09/13/2018 |
Guidewire |
Shanghai Kindly Medical Instruments Co., Ltd. |
Xu Jianhai |
| K180178 |
09/10/2018 |
Introducer Set |
Shanghai Kindly Medical Instruments Co., Ltd. |
Xu Jianhai |
| K173813 |
09/07/2018 |
IPL Hair Removal Device Joy Version |
Shen Zhen CosBeauty Co., Ltd |
Nicole Hu |
| K172834 |
09/06/2018 |
Dual output digital therapy massager |
Shenzhen OSTO Technology Co., Ltd. |
Li Yang |
| K181688 |
09/07/2018 |
R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator |
Shenzhen Roundwhale Technology Co., Ltd. |
Kevin Zhang |
| K180803 |
09/26/2018 |
BeautiBond Universal |
Shofu Dental Corporation |
Mauro Malzyner |
| K181795 |
09/25/2018 |
AST Model MA012 and MS019 Rehab Wheelchair |
Sichuan AST Medical Equipment Co., Ltd. |
Johnson Van |
| K181525 |
09/07/2018 |
INNOVANCE Free PS Ag |
Siemens Healthcare Diagnostics Products GmbH |
Petra Dissmann |
| K182208 |
09/07/2018 |
syngo.via View&GO (Version VA10A) |
Siemens Healthcare GmbH |
Elango Alampalayam Rangappan |
| K173127 |
09/25/2018 |
skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent Kit) |
Skyla Corporation H.S.P.B. |
Cindy Lu |
| K181366 |
09/24/2018 |
REDAPT Porous Acetabular Shell |
Smith & Nephew, Inc. |
Bryan Cowell |
| K181746 |
09/28/2018 |
MICRORAPTOR Knotless Suture Anchor |
Smith and Nephew, Inc. |
Katherine Marcaccio |
| K173921 |
09/05/2018 |
HD-500 Video Endoscope System |
Sonoscape Medical Corp. |
Toki Wu |
| K180465 |
09/06/2018 |
Provata Implant System |
Southern Implants (Pty) Ltd |
Lauranda G. Breytenbach |
| K180728 |
09/06/2018 |
Spinal Elements Cerclage System |
Spinal Elements Inc |
Julie Lamothe |
| K182345 |
09/21/2018 |
Spineology Navigation Instruments |
Spineology Inc |
Karen Roche |
| K181608 |
09/27/2018 |
Disposable Standard Clamp |
Standard Bariatrics |
Alison Sathe |
| K181249 |
09/04/2018 |
EUSRA RF Electrode |
STARmed Co., Ltd. |
Jun-Young Jung |
| K180981 |
09/19/2018 |
Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit |
Stimwave Technologies Incorporated |
Elizabeth Greene |
| K181504 |
09/11/2018 |
Stryker Pediatric Mandibular Distractor 2 |
Stryker |
Gregory Gohl |
| K181742 |
09/27/2018 |
ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA) |
Stryker GmbH |
Tina Mornak |
| K173871 |
09/17/2018 |
CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres |
Suzhou Hengrui Callisyn Biomedical Co., Ltd. |
Xiao Chen |
| K173424 |
09/12/2018 |
BioSphere Flex |
Synergy Biomedical |
Mark Borden |
| K180916 |
09/24/2018 |
iNtuition-T1 Mapping and T2/T2* Mapping |
TeraRecon Inc., |
Megha Jain |
| K180489 |
09/21/2018 |
TEVADAPTOR Closed Drug Reconstitution and Transfer System |
Teva Medical Ltd., Migada Plant |
Nadav Reuben |
| K182376 |
09/28/2018 |
Harmony |
Topcon Medical Systems, Inc. |
James Lorkowski |
| K181420 |
09/20/2018 |
Aequalis Flex Revive Shoulder System |
Tornier, Inc. |
Laurie Lewandowski |
| K181088 |
09/28/2018 |
TSP Crosser Transseptal Access System |
Transseptal Solutions Ltd. |
Mary P. LeGraw |
| K182206 |
09/13/2018 |
RiX70 DC |
Trident s.r.l |
Giorgio Rizzo |
| K171532 |
09/11/2018 |
TruBase S |
TruAbutment Inc. |
Brandon Kim |
| K182055 |
09/10/2018 |
SECULOKÖ ACP System |
U&i Corporation |
Kwang-Eun Song |
| K181211 |
09/10/2018 |
Human Tecar HCR 1002 |
UNIBELL S.r.l |
Mario Scerri |
| K182258 |
09/21/2018 |
AquaShield System CO2 ; AquaShield System CO2 - PENTAX ; AquaShield System CO2 - Fujifilm |
United States Endoscopy Group, Inc. |
Carroll L. Martin |
| K182232 |
09/11/2018 |
Octane Mechanical Thrombectomy System |
Vascular Solutions, Inc. |
Iroquois Ledbeter |
| K181349 |
09/19/2018 |
Vexillum (olifilcon B) with Tangible Polymers Silicone Hydrogel Soft Contact Lens; Daily Breeze (olifilcon B) Silicone Hydrogel Soft Contact Lens |
Visco Vision Inc |
Evan Huang |
| K182230 |
09/07/2018 |
Multi Modality Viewer |
Vital Images, Inc. |
Fei Li |
| K182310 |
09/21/2018 |
Volpara Imaging Software |
Volpara Health Technologies Limited |
Ralph Highnam |
| K173568 |
09/04/2018 |
NeoBase 2 Non-derivatized MSMS Kit |
Wallac Oy, Subsidiary of PerkinElmer, Inc. |
Brian Carney |
| K180338 |
09/21/2018 |
Cellulize |
Ward Photonics LLC |
Terry Ward |
| K172450 |
09/13/2018 |
TENS device-HeadaTerm, eEspress |
WAT Medical Technology (Ningbo) Co., Ltd |
Rodney Zhang |
| K181255 |
09/12/2018 |
PRODENSE Bone Graft Substitute |
Wright Medical Technology, Inc. |
Rachel Roberts |
| K173933 |
09/13/2018 |
Sorrento Bioglass Bone Graft Substitute |
Xenco Medical, LLC |
gustavo Prado |
| K182080 |
09/19/2018 |
Scope Antifogging System |
Xodus Medical, Inc. |
Paul Lloyd |
