| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K171003 |
04/04/2017 |
3M Attest Rapid Readout Biological Indicator, 3M Attest Auto-reader |
3M Company |
Hilary B. Hovde |
| K171116 |
04/14/2017 |
3MÖ VFlexÖ Health Care Particulate Respirator and Surgical Mask , Models 1804/1804S |
3M Health Care |
Linda Johnsen |
| K171225 |
04/26/2017 |
Sorbact Wound Dressing-Ribbon Gauze |
ABIGO Medical AB |
Annica Corbe |
| K171086 |
04/12/2017 |
Accuray Precision Treatment Planning System |
Accuray Incorporated |
Shweta Kaushik |
| K171176 |
04/21/2017 |
M-CATH Microcatheter |
Acrostak (Schweiz) AG |
Carmen Herraez |
| K171254 |
04/28/2017 |
LeEject 2 Dental Syringe and Needle System |
Advanced Technology and Capital, Inc. |
Alexander Lee |
| K171001 |
04/04/2017 |
Monosyn Quick Synthetic Absorbable Surgical Suture |
Aesculap, Inc. |
Kathy A. Racosky |
| K171256 |
04/28/2017 |
Quingo Flyte Mobility Scooter |
Agile Distributors LLC |
Steven Mahaffy |
| K171148 |
04/19/2017 |
Aleo BME Liquid Bandage |
Aleo BME Inc. |
Chao Liu |
| K171041 |
04/07/2017 |
SilverSeal |
Alliqua BioMedical, Inc |
Johanna Reinert |
| K171242 |
04/27/2017 |
Alma LipoFlow System |
Alma Lasers Inc. |
Rekha Anand |
| K171037 |
04/06/2017 |
PoreStar Patient Specific Implant |
Anatomics Pty Ltd |
Joanne Flatley |
| K171062 |
04/10/2017 |
BP5S Wireless Blood Pressure Monitor |
Andon Health Co., Ltd. |
Liu Yi |
| K171172 |
04/21/2017 |
Skyn Original Polyisoprene Lubricated Male Condom - Flavored |
Ansell Healthcare Products LLC. |
Robert Mahler |
| K171231 |
04/27/2017 |
Endoform Topical Matrix |
Aroa Biosurgery |
Tina OÆBrien |
| K171146 |
04/19/2017 |
Arrow Seldinger Arterial Catheterization Device 18 ga., Arrow Seldinger Arterial Catheterization Device 20 ga., Arrow Seldinger Arterial Catheterization Device 22 ga., Arrow Seldinger Arterial Catheterization Device 24 ga. |
Arrow International, Inc. (Subsidiary of Telelflex Inc.) |
Fallon Young |
| K171020 |
04/05/2017 |
Arthrex Knotless SutureTak Anchor |
Arthrex Inc. |
David L Rogers |
| K171141 |
04/18/2017 |
Arthrex SwiveLock Anchors |
Arthrex Inc. |
David L. Rogers |
| K170978 |
04/03/2017 |
Embrace Neonatal MRI System |
Aspect Imaging Ltd. |
Israel Citron |
| K171039 |
04/06/2017 |
Assut Filbloc Permanent Sutures |
Assut Europe S.p.A. |
Gloria Aggio |
| K171250 |
04/28/2017 |
BRIDALVEIL Occipital Cervical Thoracic System |
Astura Medical |
Troy Taylor |
| K171243 |
04/28/2017 |
audifon Tinnitus-Module |
audiofon USA Inc. |
Jane E. Perrone |
| K170987 |
04/03/2017 |
Captus Vascular Retrieval System |
Avantec Vascular Corporation |
Nicholas deBeer |
| K170989 |
04/03/2017 |
Dymaxeon Spine System |
Back 2 Basics Direct, LLC |
Mitchell Bass |
| K170974 |
04/03/2017 |
BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical configurations), BD FACSuite Clinical Software, BD Multitest 6-Color Assays, BD Multitest 4-Color Assays, BD Multitest 6-Color TBNK |
Becton, Dickinson and Company |
Li Zhou |
| K171047 |
04/07/2017 |
Sterile Polyisoprene Powder Free Surgical Gloves |
Better Care Plastic Technology Co.,Ltd. |
Zhu Chunyan |
| K171026 |
04/05/2017 |
Mytens Model: BW-TSX |
Bewell Connect Corp. |
Jacob Chen |
| K171061 |
04/10/2017 |
MRSASelect II |
Bio-Rad |
Sylvie Fernez |
| K171054 |
04/10/2017 |
Biomet Knee Joint Replacement Prostheses |
Biomet, Inc |
Jason Heckaman |
| K170997 |
04/03/2017 |
CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath |
Biosense Webster, Inc. |
John Jimenez |
| K171185 |
04/24/2017 |
IR Type Implant System |
Biotem Co., Ltd. |
Hong Koo Yeo |
| K171179 |
04/24/2017 |
BR Type Implant System |
Biotem Co.,Ltd. |
Hong Koo Yeo |
| K171147 |
04/19/2017 |
REVEAL Bulk |
Bisco, Inc. |
Ryan Hobson |
| DEN170021 |
04/03/2017 |
SEM Scanner (Model 200) |
Bruin Biometrics, LLC |
Ya-Chen Tonar |
| K171139 |
04/18/2017 |
LaparoLight Veress Needle |
Buffalo Filter, LLC |
Kyrylo Shvetsov |
| K171118 |
04/14/2017 |
Carefusion NeutraClear multi-fuse Extension Set with needle-free connector(s) |
Cair L.G.L |
Delphine Molinari |
| K171117 |
04/14/2017 |
Carefusion NeutraClear Needle-free connector (EL-NC1000) |
Cair L.G.L |
Delphine Molinari |
| K171132 |
04/17/2017 |
Carefusion NeutraClear Needle-free connector |
CAIR LGL |
Delphine Molinari |
| K171194 |
04/24/2017 |
AS-10, CXDI-401RF |
Canon, Inc. |
Shinji Mori |
| K171099 |
04/13/2017 |
EON Portable Reverse Osmosis Water Purification System |
Cantel |
Mike Halliday |
| K171052 |
04/10/2017 |
Ultimate Contour, Ultimate Contour Mini |
CAO Group, Inc. |
Robert K. Larsen |
| K171007 |
04/04/2017 |
Fluorescence Mode |
Carl Zeiss Suzhou Co., Ltd. |
Huang XiaoDong |
| K171186 |
04/24/2017 |
Cerebrotech CMS-5000 |
Cerebrotech Medical Systems |
Dawnel Scott |
| K171245 |
04/28/2017 |
Presygen/si-1 |
Christie Medical Holdings, Inc. |
Salwa Rezk |
| K170983 |
04/03/2017 |
NIOX VERO |
Circassia AB |
Susanne Parks |
| K171088 |
04/12/2017 |
Cochlear Baha SoundArc |
Cochlear Americas |
Beth Murray |
| K171008 |
04/04/2017 |
Anorganic Bone Mineral with Collagen in Delivery Applicator |
Collagen Matrix, Inc. |
Danielle Lindner |
| K171043 |
04/07/2017 |
Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters |
Coloplast Corp |
Cori Ragan |
| K171077 |
04/11/2017 |
HEXA100 (hexafocon A) Daily Wear Contact Lenses |
CONTAMAC Ltd. |
Rob McGregor |
| K171017 |
04/05/2017 |
Convaid Flyer FL12, FL13, FL14, FL15 and FL16; Convaid Flyer transit FL12T, FL13T, FL14T, FL15T and FL16T |
Convaid Products llc. |
Donald Griggs |
| K171199 |
04/24/2017 |
AVIEW |
Coreline Soft Co., Ltd. |
Hye Yi Park |
| K170981 |
04/03/2017 |
NeuroQuant |
CorTechs Labs, Inc |
Kora Marinkovic |
| K171066 |
04/10/2017 |
BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider |
Covidien, llc |
Sharon McDermott |
| K171251 |
04/28/2017 |
014 Hydrophilic Coated PTA Balloon Dilatation Catheter |
Creagh Medical |
Shane Costello |
| K171087 |
04/12/2017 |
AXON IR Heat Lamp |
Crystal Medtech, LLC |
Nelson Marquina |
| K171024 |
04/05/2017 |
ShockPulse-SE Lithotripsy System |
Cybersonics, Inc. |
Samradni Patil |
| K171111 |
04/14/2017 |
Sculpsure |
Cynosure, Inc |
Amy Tannenbaum |
| K171038 |
04/06/2017 |
Hearing Healthcare Pro |
dB Diagnostic Systems, Inc. |
Steven Levine |
| K171027 |
04/05/2017 |
Dentis Dental Implant System |
Dentis Co.,Ltd. |
Sun Chul Shin |
| K171126 |
04/17/2017 |
Implantium II |
Dentium Co., Ltd. |
Yoon Spyoon |
| K171115 |
04/14/2017 |
3D Endo Software |
Dentsply Sirona |
Karl Nittinger |
| K171122 |
04/17/2017 |
CEREC Ortho Software |
Dentsply Sirona |
Karl J. Nittinger |
| K171015 |
04/04/2017 |
Citryte |
Di-Chem, Inc. |
Keith Buchholz |
| K171161 |
04/20/2017 |
Dimensional Bioceramics Calcium Sulfate Device (DB-CSD) |
Dimensional Bioceramics LLC |
David Delaney |
| K171137 |
04/17/2017 |
EVS 2430W, EVS 2430GW |
DRTECH Corporation |
Choul-Woo Shin |
| K171004 |
04/04/2017 |
Hintermann Series H2 Total Ankle System |
Dt MedTech LLC |
Shawn T Huxel |
| K171189 |
04/24/2017 |
AIR-FLOW PLUS Prophylaxis powder |
E.M.S. Electro Medical Systems S.A. |
Suzanne Fassio-Hardy |
| K171174 |
04/21/2017 |
PERIO-FLOW nozzle |
E.M.S. Electro Medical Systems S.A. |
Suzanne Fassio-Hardy |
| K171178 |
04/21/2017 |
Central Monitoring System |
Edan Instruments, Inc. |
Alice Yang |
| K170995 |
04/03/2017 |
Electrocardiograph |
Edan Instruments, Inc. |
Alice Yang |
| K171123 |
04/17/2017 |
Leksell Vantage Stereotactic System |
Elekta Instrument AB |
Matilda Forsberg |
| K171247 |
04/28/2017 |
epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test |
Epocal Inc. |
Jennifer Armstrong |
| K171045 |
04/07/2017 |
Exactech« TruliantÖ Line Extensions |
Exactech, Inc. |
Patrick Hughes |
| K171056 |
04/10/2017 |
WAVE Clinical Platform |
Excel Medical Electronics, LLC |
Lance Burton |
| K171018 |
04/05/2017 |
Axis Charcot Fixation System, 4.5 to 8.5mm Screw System |
Extremity Medical, LLC. |
Brian Smekal |
| K171193 |
04/24/2017 |
Certa Catheter |
Ferrosan Medical Devices SP. Z O.O. |
Elzbieta Porebska-Guillemant |
| K171163 |
04/20/2017 |
Contact Lens Case Round Glasses |
FiftyTwoWays Ltd |
Jos Reinders |
| K171227 |
04/26/2017 |
StarWalker |
Fotona d.o.o. |
Stojan Trost |
| K171096 |
04/13/2017 |
Fujifilm Diathermic Slitter (FlushKnife) |
FUJIFILM Medical Systems U.S.A., Inc. |
Jeffrey Wan |
| K171207 |
04/25/2017 |
FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M |
FUJIFILM Medical Systems U.S.A., Inc. |
Jeffrey Wan |
| K171103 |
04/13/2017 |
Lumipulse G TSH-III Immunoreaction Cartridges |
Fujirebio Diagnostics, Inc. |
Stacey Dolan |
| K171013 |
04/04/2017 |
Revolution ACT |
GE Hangwei Medical Systems, Co., Ltd. |
Wang Xing |
| K171028 |
04/05/2017 |
CARESCAPE Respiratory MOdules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX and accessories |
GE Healthcare Finland OY |
Anna Pehrsson |
| K171128 |
04/17/2017 |
SIGNA Premier |
GE Medical Systems, LLC |
Mary A. Mayka |
| K171050 |
04/07/2017 |
Geistlich Fibro-Gide |
Geistlich Pharma AG |
Marco Steiner |
| K171191 |
04/24/2017 |
Hexagen Derm |
Global Health Solutions, LLC |
Bradley Burnam |
| K171108 |
04/14/2017 |
AUTOBAHN Nailing System |
Globus Medical Inc. |
Kelly J. Baker |
| K171049 |
04/07/2017 |
Real Time Image Gating System for Proton Beam Therapy Systems |
Hitachi, Ltd. Healthcare |
Tomoyuki Seino |
| K170988 |
04/03/2017 |
DropSafe Safety Pen Needle |
HTL-Strefa S.A. |
Aleksandra Prazmowska-Wilanowska |
| K171241 |
04/27/2017 |
Pulse Oximeter |
Hunan Accurate Bio-Medical Technology Co., Ltd. |
Zhou Le |
| K171079 |
04/11/2017 |
Q-Switched Nd:YAG Laser System |
IDS, Ltd. |
C. J. Park |
| K171169 |
04/21/2017 |
Aquarius 8600 1417TG and Aquarius 8600 1717TG |
Imaging Dynamics Company Ltd. |
Nicole Wherry |
| K171175 |
04/21/2017 |
Aquarius 8600 1417WC |
Imaging Dynamics Company Ltd. |
Nicole Wherry |
| K170993 |
04/03/2017 |
QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Flash Calprotectin Extraction Buffer |
Inova Diagnostics, Inc. |
Roger Albesa |
| K171092 |
04/12/2017 |
XiniWave II Model ECS322P |
International Trade Group, Inc. |
Brent C. Reider |
| K171083 |
04/11/2017 |
iChemVELOCITY Automated Urine Chemistry System |
Iris Diagnostics, a Division of Iris International Inc |
Nancy Nadler |
| K171224 |
04/26/2017 |
Arctic Sperm Cryopreservation Medium |
Irvine Scientific Sales Co., Inc. |
Jayme Yamaguchi-Owens |
| K171102 |
04/13/2017 |
Ives MR Conditional Cup Electrode |
Ives EGG Solutions |
John Ives |
| K171012 |
04/04/2017 |
Veraview X800 |
J.Morita USA, Inc. |
Keisuke Mori |
| K170979 |
04/03/2017 |
ARIX Ankle Fibula Hook Plate System |
Jeil Medical Corporation |
Sejin RYU |
| K171097 |
04/13/2017 |
MOJAVE Expandable Interbody System |
K2M, Inc. |
Nancy Giezen |
| K171238 |
04/27/2017 |
KARL STORZ ICG Imaging System |
Karl Storz Endoscopy- America, Inc. |
Winkie Wong |
| K171035 |
04/06/2017 |
Katalyst Mark 1 Muscle Stimulation System |
Katalyst Inc. |
Amish Patel |
| K171040 |
04/06/2017 |
Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range |
Koelis |
Laetitia GERVAIS |
| K171171 |
04/21/2017 |
KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs (Blue, Black) |
Koon Seng Sdn. Bhd. |
Koon Seng Sdn. Bhd. |
| K170986 |
04/03/2017 |
KATANA Zirconia Block |
Kuraray Noritake Dental Inc. |
Yasujiro Ohara |
| K170984 |
04/03/2017 |
LG BEAUTY LED MASK |
LG Electronics |
Jooyong Kim |
| K171136 |
04/17/2017 |
LIA Pregnancy Test |
LIA Diagnostics |
Anna Couturier |
| K171113 |
04/14/2017 |
LiNA OperaScope with HDMI cable and on-board LCD-single unit, LiNA OperaScope with HDMI cable and on-board LCD-6 units, LiNA OperaScope Recording Module |
LiNA Medical ApS |
Natalia Szychulska |
| K171135 |
04/17/2017 |
Lipogems System |
Lipogems International SpA |
Carlo Russo |
| K171188 |
04/24/2017 |
Ossler Exam Scope |
LR Med Inc |
Prashant Deshpande |
| K171009 |
04/04/2017 |
LASEMD Laser System |
Lutronic Corporation |
Jhung Won Vojir |
| K171051 |
04/10/2017 |
HORIZON Therapy System |
Magstim Company Ltd. |
Tom Campbell |
| K171121 |
04/17/2017 |
Masimo Root Monitoring System and Accessories |
Masimo Corporation |
Marguerite Thomlinson |
| K171131 |
04/17/2017 |
MHC Standard and NRFit Tip Syringes |
Mazza Healthcare, LLC. |
Michael A. Mazza |
| K171129 |
04/17/2017 |
CO Check Pro, CO Screen |
MD Diagnostics Limited |
Glen Hillsley |
| K171170 |
04/21/2017 |
M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional Screws |
Medacta International SA |
Stefano Baj |
| K171058 |
04/10/2017 |
Medacta Shoulder System: Threaded Glenoid Baseplate |
Medacta International SA |
Stefano Baj |
| K171144 |
04/19/2017 |
Medifine Pen Needle 3 Bevel, Medifine Pen Needle Quinta 5 Bevel |
Medbio LLC. |
Jatin Rajani |
| K171237 |
04/27/2017 |
FMS VUE II Fluid Management and Tissue Debridement System |
Medos International SARL |
Tatyana Korsunsky |
| K171114 |
04/14/2017 |
HEALIX ADVANCE KNOTLESS Anchor |
Medos International SARL |
Julie Vafides |
| K171253 |
04/28/2017 |
Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Pacing Lead, Streamline 6495 Bipolar Temporary Myocardial Pacing Lead, Streamline 6500 Unipolar Temporary Myocardial Pacing Lead |
Medtronic |
Debra Taitague |
| K171031 |
04/06/2017 |
CRESCENTÖ Spinal System |
Medtronic Sofamor Danek |
Ankit K. Shah |
| K171107 |
04/14/2017 |
CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal System |
Medtronic Sofamor Danek USA, Inc. |
Julie Bassett |
| K171109 |
04/14/2017 |
Praxiject 0.9% NaCl |
MedXL Inc. |
Premala Premanathan |
| K171068 |
04/10/2017 |
OrthoView 7.2 |
Meridian Technique Ltd |
Barbara March |
| K171150 |
04/19/2017 |
AW-100 |
Micron Corporation |
Takashi Terui |
| K171181 |
04/24/2017 |
PROCOTYL« PRIME E-CLASSÖ XLPE Liner |
MicroPort Orthopedics, Inc. |
Sarah Evonne Stroupe |
| K171255 |
04/28/2017 |
Monteris Medical NeuroBlate System |
Monteris Medical, Inc. |
David H. Mueller |
| K171257 |
04/28/2017 |
ClearPoint System |
MRI Interventions, Inc. |
Pete Piferi |
| K171155 |
04/20/2017 |
Surgical Angle Handpiece, Surgical Straight Handpiece |
Nakanishi Inc. |
Kimihiko Satoh |
| K171183 |
04/24/2017 |
OmniTom |
NeuroLogica Corporation, |
Ninad Gujar |
| K171085 |
04/12/2017 |
GMR40 |
NeuroLogica Corporation, a Subsidiary of |
Ninad Gujar |
| K171112 |
04/14/2017 |
Trifore(tm) Cervical Plating System |
NeuroStructures, Inc. |
Kathleen Wong |
| K171198 |
04/24/2017 |
NeuViz 16 Essence Multi-slice CT Scanner System |
Neusoft Medical Systems Co., Ltd. |
Shao Xiancheng |
| K171201 |
04/24/2017 |
NeuViz Prime Multi-slice CT Scanner System |
Neusoft Medical Systems Co., Ltd. |
Shao Xiancheng |
| K171022 |
04/05/2017 |
Ablation Confirmation |
NeuWave Medical, Inc. |
Dan Kosednar |
| K171140 |
04/18/2017 |
Matrixx System |
Nexxt Spine LLC |
Andy Elsbury |
| K171124 |
04/17/2017 |
Nihon Kohden Wireless Input Unit WEE-1200 |
Nihon Kohden Corporation |
Tom Bento |
| K171244 |
04/28/2017 |
Physiotrace |
NimbleHeart, Inc. |
Sonal Tambe |
| K171142 |
04/18/2017 |
Healing Cap Multi-Unit Titanium |
Nobel Biocare AB |
Charlemagne Chua |
| K171059 |
04/10/2017 |
Nova StatSensor Creatinine Hospital Meter System |
Nova Biomedical Corporation |
Paul W. MacDonald |
| K171130 |
04/17/2017 |
Nucleus Image Management System |
NucleusHealth, LLC |
Linda Moore |
| K171206 |
04/25/2017 |
D'Vill Introducer |
NuMED, Inc. |
Nichelle LaFlesh |
| K171158 |
04/20/2017 |
Single Use Electrosurgical knife |
Olympus Medical Systems Corp. |
Toshiyuki Nakajima |
| K171232 |
04/27/2017 |
PeriView FLEX |
Olympus Surgical Technologies America |
Mary Anne Patella |
| K171156 |
04/20/2017 |
OMNI Anseris Hip Stem |
OMNIlife science |
Christina Rovaldi |
| K171167 |
04/21/2017 |
Prodigio Stain Powder |
OperArt LLC |
Domenico Cascione |
| K171168 |
04/21/2017 |
VITROS Immunodiagnostic Products Insulin Calibrators |
Ortho Clinical Diagnostics |
Bradley P. Boyer |
| K171249 |
04/28/2017 |
EntradaÖ hip stem |
Ortho Development Corporation |
Drew Weaver |
| K171082 |
04/11/2017 |
Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline Fixation Screw, Phoenix CDX MIS Spinal Fixation System, Firebird NXG Spinal Fixation System |
Orthofix Inc. |
Jacki Koch |
| K171211 |
04/25/2017 |
OIC External Fixation System |
Orthopaedic Implant Company |
Douglas Fulton |
| K171173 |
04/21/2017 |
OrthoPediatrics Titanium PediPlates« System |
OrthoPediatrics, Corp. |
Adam Cargill |
| K170972 |
04/03/2017 |
Apex Tibial Nailing System |
OrthoXel |
Aisling O'Sullivan |
| K171217 |
04/26/2017 |
DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Reduction System |
Osprey Medical, Inc. |
Melanie Hess |
| K171011 |
04/04/2017 |
PENTAX Medical VIVIDEO ENT Videoscope Solution |
Pentax Medical |
James W. Monroe |
| K171184 |
04/24/2017 |
Persyst Mobile App |
Persyst Development Corporation |
Dari Darabbeigi |
| K171055 |
04/10/2017 |
Philips BlueControl |
Philips Electronics Nederland B.V. |
Gaozhen Hang |
| K171157 |
04/20/2017 |
PolyDev Soft Contact Lenses |
Polydev Ltd. |
John Mulvihill |
| K171162 |
04/20/2017 |
Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap Shield |
Prestige Ameritech |
Rex Reese |
| DEN170024 |
04/17/2017 |
AQUABEAM System |
PROCEPT BioRobotics Corporation |
Michael Nketiah |
| K171133 |
04/17/2017 |
Qfix« Abdominal/Thoracic Motion Control System,Qfix« SBRT Solution and Accessories |
Qfix |
Alexandra Nicole Low |
| K171215 |
04/25/2017 |
QiF Blood and Fluid Warmer |
Quality In Flow Ltd. |
Neta Sherman |
| DEN170022 |
04/07/2017 |
QuantX |
Quantitative Insights, Inc |
Robert Tomek |
| K171229 |
04/27/2017 |
DELL UP3017 with QUBYX PerfectLum bundle |
Qubyx Software Technologies Inc. |
Marc Leppla |
| K170996 |
04/03/2017 |
Wingman 14C Crossing Catheter |
ReFlow Medical, Inc. |
Rebecca K. Pine |
| K171143 |
04/18/2017 |
Relievant Medsystems RF Generator |
Relievant Medsystems |
Alex DiNello |
| K171212 |
04/25/2017 |
AirFit N20 |
ResMed Ltd |
Kim Kuan LEE |
| K171235 |
04/27/2017 |
OmniCap |
Respirion, Inc. |
Ed Fadel |
| K171081 |
04/11/2017 |
Guider Catheter Introducer |
Rhythm Xience, Inc. (RXI) |
James Hassett |
| K171060 |
04/10/2017 |
OrthoButton AL |
Riverpoint Medical |
Nathan Cook |
| K171080 |
04/11/2017 |
ALP IFCC Gen.2 |
Roche Diagnostics Operations (RDO) |
Patrick Stimart |
| K171182 |
04/24/2017 |
ri-former Predictive Thermometer |
Rudolf Riester GmbH |
Artur Pfister |
| K171119 |
04/14/2017 |
GM85 |
Samsung Electronics Co.,Ltd. |
Chulsin Kim |
| K171048 |
04/07/2017 |
RS80A Diagnostic Ultrasound System |
Samsung Medison Co., Ltd. |
Ji Yea Lee |
| K171070 |
04/10/2017 |
WS80A Diagnostic Ultrasound System |
Samsung Medison Co., Ltd. |
Emily Woo |
| K171230 |
04/27/2017 |
My Dose Coach |
Sanofi |
Robert Ezzell |
| K171093 |
04/12/2017 |
STERILE NITRILE PATIENT EXAMINATION GLOVES, POWDERFREE |
Sanrea Healthcare Products Pvt Ltd |
JOSE PAUL M. |
| K171165 |
04/20/2017 |
SmartByte Device |
Scientific Intake |
Marc Gibeley |
| DEN170023 |
04/17/2017 |
ThermoNeuroModulation Device, TNM Device |
Scion NeuroStim, LLC |
Robert Black |
| K171046 |
04/07/2017 |
SeaSpine Cambria System |
SeaSpine Orthopedics Corporation |
Gina Flores |
| K171214 |
04/25/2017 |
Infrared Thermometer |
Shenzhen Brav Electronic Technologies Co., Ltd. |
Aaron Wan |
| K171034 |
04/06/2017 |
M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic Ultrasound System, M8 Elite Diagnostic Ultrasound System |
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. |
Ma Chao |
| K171233 |
04/27/2017 |
Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System |
Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd |
Zhai Pei |
| K171072 |
04/10/2017 |
N Latex Cystatin C; N Protein Standard UY |
Siemens Healthcare Diagnostics Products GmbH |
Christine Perkins |
| K171053 |
04/10/2017 |
syngo Dynamics Version VA30 |
Siemens Healthcare GmbH |
Lauren Bentley |
| K170992 |
04/03/2017 |
AcuNav V 10F Ultrasound Catheter |
Siemens Medical Solutions USA, Inc |
Shelly Pearce |
| K171005 |
04/04/2017 |
Silhouette Featherlift |
Silhouette Lift Inc. |
Anthony DiBernardo |
| K171073 |
04/11/2017 |
Smith & Nephew, Inc. REDAPT Augments |
Smith & Nephew, Inc. |
Kim Phan |
| K170977 |
04/03/2017 |
SURESHOT Distal Targeting System V4.0 Trauma Interface |
Smith & Nephew, Inc. |
Allison Chan |
| K170982 |
04/03/2017 |
CADD«- Solis Ambulatory Infusion Pump with Wireless Communication; CADD«-Solis Infusion Pump, Model 2110; PharmGuard« Administrator Medication Safety Software; CADD« Administration Sets; Wireless Communication Module (CM) |
Smiths Medical ADS, Inc. |
Breanna Fautsch |
| K171098 |
04/13/2017 |
AXIS Image Management System |
Sonomed, Inc. |
Mark Wallace |
| K171164 |
04/20/2017 |
U-Lite EXP |
Sonoscanner |
Bruno Richard |
| K170999 |
04/03/2017 |
P50 Series Digital Color Doppler Ultrasound System |
SONOSCAPE MEDICAL CORP. |
Toki Wu |
| K171000 |
04/03/2017 |
P60 Series Digital Color Doppler Ultrasound System |
SONOSCAPE MEDICAL CORP. |
Toki Wu |
| K171151 |
04/20/2017 |
ACRONÖ TLIF System |
SpineMED Ges.m.b.H |
Andreas Bernegger |
| K170990 |
04/03/2017 |
Active Needle Endoscopic Treatment (ANET) Electrosurgical Applicator |
Spiration, Inc. |
Cheryl Frederick |
| K171228 |
04/26/2017 |
Fiji Anchor |
SportWelding GmbH |
Joerg Mayer |
| K171071 |
04/10/2017 |
StimSox(TM) System |
StimMed, LLC |
Peter G. Demakos |
| K171152 |
04/20/2017 |
Stryker Universal Neuro III System AXS Screw |
Stryker |
Jonathan Schell |
| K171149 |
04/19/2017 |
Altrix Temperature Management Wraps |
Stryker Medical |
Brian Orwat |
| K171105 |
04/13/2017 |
AIXPLORER« & AIXPLORER« Ultimate Ultrasound Systems |
Supersonic Imagine |
Laurence HERMITTE |
| K171019 |
04/05/2017 |
ScioCardio ECG Transmitter |
Synergen Technology Labs LLC |
Sunil Konda |
| K171125 |
04/17/2017 |
Tangible Hydrogel w/ Hydra-PEG (etafilcon A) Soft (Hydrophilic) Daily Wear Contact Lens |
Tangible Science LLC |
Vic McCray |
| K171078 |
04/11/2017 |
TRI-COMBO PARASITE SCREEN |
Techlab, Inc. |
Donna T. Link |
| K171014 |
04/04/2017 |
VICTUS Femtosecond Laser Platform |
Technolas Perfect Vision GmbH |
Friedrich Moritz |
| K170975 |
04/03/2017 |
Televere Digital Imaging System |
Televere Systems |
Randell Quaal |
| K171213 |
04/25/2017 |
One Touch Condom with Benzocaine |
Thai Nippon Rubber Industry Public Company Limited |
Pisut Chanwatarungkull (Pete) |
| K171234 |
04/27/2017 |
Mistral-Air Warming Unit |
The Surgical Company International BV (as The 37Company) |
Kees van Hassel |
| K171094 |
04/12/2017 |
Thermi Reusable Non-invasive RF Electrode |
ThermGen, L.L.C |
Suzanne Cheang |
| K170985 |
04/03/2017 |
Urbanek Device |
TMJ Services, LLC |
Anthony Urbanek |
| K171226 |
04/26/2017 |
TOKUYAMA UNIVERSAL BOND |
Tokuyama Dental Corporation |
Fumia Takahashi |
| K171010 |
04/04/2017 |
Latitude EV Total Elbow Arthroplasty |
Tornier Inc. |
Renee Stoffel |
| K171222 |
04/26/2017 |
Vitrea Software Toshiba Package; VSTP-001A |
Toshiba Medical Systems Corporation |
Paul Biggins |
| K171120 |
04/14/2017 |
Senhance Surgical Robotic System |
TransEnterix, Inc. |
Stephanie Fitts |
| K171239 |
04/27/2017 |
TULA Tube Delivery System |
Tusker Medical |
Pavan Sethi |
| K171021 |
04/05/2017 |
JO AgapΘ Personal Lubricant |
United Consortium |
Stephanie Morris |
| K171138 |
04/18/2017 |
Nexus DR Digital X-ray Imaging System |
Varex Imaging Corporation |
Catherine Mulcahy |
| K171029 |
04/06/2017 |
eCareCoordinator |
Visicu Inc. |
Daniel R. Plonski |
| K171208 |
04/25/2017 |
Trans-anal Introducer |
Visionsense Ltd. |
Alex Chanin |
| K170973 |
04/03/2017 |
VitalWatch Software User Interface |
VitalConnect, Inc. |
Kevin Potgieter |
| K171200 |
04/24/2017 |
Grandio blocs |
VOCO GmbH |
M. Th. Plaumann |
| K171223 |
04/26/2017 |
Quantum TTC Biliary Balloon Dilator |
Wilson-Cook Medical, Inc |
Tiffanny A. Thomas |
| K171067 |
04/10/2017 |
INVISION Total Ankle Revision System |
Wright Medical Technology, Inc. |
Val Myles |
| K171044 |
04/07/2017 |
Climax Personal Lubricant |
WSM Investment LLC, dba Topco Sales |
Adrian Mendoza |
| K171075 |
04/11/2017 |
Calix-C Cervical Interbody Spacer |
X-Spine Systems, Inc. |
Kriss Andersson |
| K171104 |
04/13/2017 |
Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Blue, Cobalt Blue) |
YTY INDUSTRY (MANJUNG) SDN BHD |
Punitha Samy |
| K171101 |
04/13/2017 |
Closed Male Luer |
Yukon Medical |
Todd Korogi |
| K171069 |
04/10/2017 |
ZELTIQ CoolSculpting System |
ZELTIQ Aesthetics, Inc. |
Shruti Jayakumar |
| K171076 |
04/11/2017 |
Medical Video Endoscope System |
Zhuhai Pusen Medical Technology Co., Ltd. |
Wang ChangShen |
| K171197 |
04/24/2017 |
Zuga Dental Implant System |
Zuga Medical, Inc. |
Chan Wang |
