| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K170321 |
08/14/2017 |
3M Comply Hydrogen Peroxide Chemical Indicator 1248 |
3M COMPANY |
NADIA BATTAH |
| K171116 |
08/10/2017 |
3MÖ VFlexÖ Health Care Particulate Respirator and Surgical Mask , Models 1804/1804S |
3M Health Care |
Linda Johnsen |
| K170851 |
08/07/2017 |
Anterior Spine Truss System (STS) Interbody Fusion Device |
4Web, Inc. |
Jessee Hunt |
| K163342 |
08/22/2017 |
i-STAT Hematocrit test with i-STAT Alinity System |
Abbott Laboratories |
Tamara McCaw |
| K172073 |
08/25/2017 |
Hi-Torque Command 18 Guide Wire |
Abbott Vascular |
Kathyrene Logrono |
| K171225 |
08/21/2017 |
Sorbact Wound Dressing-Ribbon Gauze |
ABIGO Medical AB |
Annica Corbe |
| K172216 |
08/18/2017 |
ACIST RXi Mini System |
ACIST Medical Systems, Inc. |
Amber Luker |
| K163485 |
08/30/2017 |
SmartTouch |
Adherium (NZ) Ltd |
CHRIS MANDER |
| K172055 |
08/31/2017 |
DUS-7000 Digital Color Doppler Ultrasound System |
Advanced Instrumentations, Inc |
Jorge Millan |
| K163367 |
08/11/2017 |
GenetiSure Dx Postnatal Assay |
Agilent Technologies, Inc. |
Lois Nakayama |
| K171299 |
08/24/2017 |
Fixone Biocomposite Anchor |
AJU Pharm Co.,Ltd. |
Kim Jung Gil |
| K172066 |
08/09/2017 |
DAILIES AquaComfort Plus (sphere), DAILIES AquaComfort Plus Toric, DAILIES AquaComfort Plus Multifocal |
Alcon Laboratories, Inc. |
Sherri Lakota |
| K171041 |
08/22/2017 |
SilverSeal |
Alliqua BioMedical, Inc |
Johanna Reinert |
| K171329 |
08/29/2017 |
Altus Spine Titanium Interbody Fusion System |
Altus Partners, LLC |
Claudia Hill |
| K170222 |
08/15/2017 |
Rapid Tox Cup II |
AMERICAN BIO MEDICA CORP. |
MELISSA WATERHOUSE |
| K172002 |
08/25/2017 |
Catalys Precision Laser System |
AMO Manufacturing USA, LLC |
Anita Xavier |
| K171062 |
08/01/2017 |
BP5S Wireless Blood Pressure Monitor |
Andon Health Co., Ltd. |
Liu Yi |
| K171921 |
08/24/2017 |
VenaCure EVLT NeverTouch Procedure Kit |
AngioDynamics, Inc. |
Hans Kjolhede |
| K171172 |
08/02/2017 |
Skyn Original Polyisoprene Lubricated Male Condom - Flavored |
Ansell Healthcare Products LLC. |
Robert Mahler |
| K170825 |
08/18/2017 |
SnoreRx |
Apnea Sciences Corporation |
James Fallon |
| K171684 |
08/07/2017 |
Epix Electrosurgical Probe with Smoke Evacuation |
Applied Medical Resources Corporation |
Aditi Iyengar |
| K163359 |
08/18/2017 |
ARK Methotrexate Assay |
ARK Diagnostics, Inc. |
Cherry Mun |
| K170599 |
08/31/2017 |
SureFlo EVD Catheter |
Arkis BioSciences Inc. |
Joseph Howell |
| K170064 |
08/16/2017 |
GLUCOCARD W Blood Glucose Monitoring System |
ARKRAY FACTORY, INC. |
KAZUYA YORIMITSU |
| K172033 |
08/31/2017 |
Pirouette High Pressure (HP) |
ArraVasc Ltd |
Carmel Doherty |
| K172165 |
08/17/2017 |
Q-Fix Suture Anchor |
ArthroCare Corporation |
Laura Kasperowicz |
| K171039 |
08/29/2017 |
Assut Filbloc Permanent Sutures |
Assut Europe S.p.A. |
Gloria Aggio |
| K170928 |
08/03/2017 |
CADence System |
AUM Cardiovascular, Inc. |
Marie Johnson |
| K170987 |
08/28/2017 |
Captus Vascular Retrieval System |
Avantec Vascular Corporation |
Nicholas deBeer |
| K163446 |
08/08/2017 |
AxoGen Nerve Cap |
AxoGen Corporation |
Mark L. Friedman |
| K170574 |
08/11/2017 |
Diacap Pro Dialyzer |
B. Braun Avitum AG |
Giuliana Gavioli |
| K172204 |
08/17/2017 |
BD Intima II PLUS Closed IV Catheter System |
Becton, Dickinson and Company |
Henry Boland |
| K171898 |
08/18/2017 |
Sterile Polyisoprene Powder Free Surgical Gloves, Tested for Use With Chemotherapy Drugs |
Better Care Plastic Technology Co., Ltd |
Zhu Chunyan |
| K171793 |
08/17/2017 |
Sequential Circulator SC-2004FC-OC |
Bio Compression Systems, Inc. |
Barbara J. Whitman |
| K171985 |
08/30/2017 |
Astroglide O Oil Personal Lubricant & Massage Oil |
BioFilm Inc. |
Richard Hines |
| K171540 |
08/30/2017 |
Refobacin Bone Cement R |
Biomet Inc. |
Heidi Busz |
| K171431 |
08/10/2017 |
HAART 200 Aortic Annuloplasty Device 19mm, HAART 200 Aortic Annuloplasty Device 21mm, HAART 200 Aortic Annuloplasty Device 23mm, HAART 200 Aortic Annuloplasty Device 25mm |
BioStable Science & Engineering, Inc. |
Julie Thomas |
| K171147 |
08/04/2017 |
REVEAL Bulk |
Bisco, Inc. |
Ryan Hobson |
| K163251 |
08/04/2017 |
Life Essence Universal Porcelain System |
BLUE SKY BIO |
ALBERT ZICKMANN |
| K171809 |
08/09/2017 |
Epic Biliary Endoscopic Stent System |
Boston Scientific Corporation |
Thomas Hirte |
| K171452 |
08/21/2017 |
MAMBA and MAMBA FLEX Microcatheters |
Boston Scientific Corporation |
Sherry Kollmann |
| K170750 |
08/24/2017 |
RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review |
Brainlab AG |
Rainer Birkenbach |
| K170037 |
08/11/2017 |
Breathe Technologies Life2000Ö Ventilation System |
Breathe Technologies |
Samir Ahmad |
| K160378 |
08/25/2017 |
BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS) |
BRH Medical Ltd. |
Kevin Bentley |
| K171735 |
08/08/2017 |
PowerLoc MAX Power-Injectable Infusion Set and SafeStep Huber Needle Set |
C.R. Bard, Inc. |
Jeremy Tidwell |
| K171487 |
08/25/2017 |
Sirius MRI Marker NS |
C4 Imaging, LLC |
Andrew Bright |
| K171118 |
08/15/2017 |
Carefusion NeutraClear multi-fuse Extension Set with needle-free connector(s) |
Cair L.G.L |
Delphine Molinari |
| K171493 |
08/10/2017 |
MegaVac Mechanical Thrombectomy System |
Capture Vascular, Inc. |
Aaron Call |
| K172227 |
08/23/2017 |
Endoscopic Injection Needle |
Carbon Medical Technologies, Inc. |
Andrew J. Adams |
| K170667 |
08/18/2017 |
QEVO System with KINEVO 900 |
Carl Zeiss Meditec AG |
Christian Muenster |
| K163570 |
08/15/2017 |
Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM) |
Carolina Liquid Chemistries Corporation |
Mica A. Welsh |
| K171356 |
08/03/2017 |
Clarity Reveal |
Ceevra, Inc. |
Russ Yoshinaka |
| K171315 |
08/01/2017 |
Advanced RBC Application |
Cella Vision AB |
Cella Vision AB |
| K172091 |
08/09/2017 |
CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza B Lineage Genotyping Kit, |
Centers for Disease Control and Prevention |
Yon Yu |
| K171459 |
08/21/2017 |
Ceribell Instant EEG Headband |
Ceribell, Inc. |
Josef Parvizi |
| K170894 |
08/01/2017 |
Zirconia Dental Ceramics |
CHENGDU BESMILE BIOTECHNOLOGY CO.,LTD. |
Moushan Liu |
| K171456 |
08/03/2017 |
ThunderboltÖ Minimally Invasive and LancerÖ Open Pedicle Screw Systems |
Choice Spine |
Kim Finch |
| K171639 |
08/01/2017 |
Trojan Supra Lubricated Polyurethane Male Condom |
Church & Dwight Co., Inc. |
Lisa Burns |
| K170431 |
08/18/2017 |
CT Syringe for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), CT Syringe Dual Pack for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), Single Fascia and Ram Tip, Dual Fascia and Ram Tip |
Coeur, Inc. |
Priscilla Clinner |
| K170531 |
08/17/2017 |
Ureteral Dilators and Percutaneous Nephrostomy Dilators |
Coloplast Corp |
Cori Ragan |
| K171592 |
08/29/2017 |
CrossFTÖ Knotless Biocomposite Suture Anchor with Disposable Driver |
ConMed Corporation |
Diana L. Nader-Martone |
| K163167 |
08/09/2017 |
CKS Plus Knee System |
CONSENSUS ORTHOPEDICS, INC. |
ZAC JOHNSON |
| K171077 |
08/01/2017 |
HEXA100 (hexafocon A) Daily Wear Contact Lenses |
CONTAMAC Ltd. |
Rob McGregor |
| K162729 |
08/11/2017 |
Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway Exchange Catheter, and Cook Airway Exchange Catheter - Extra Firm With Soft Tip |
COOK INCORPORATED |
KOTEI AOKI |
| K171897 |
08/21/2017 |
Approach CTO Microwire Guide |
Cook Incorporated |
Jennifer Allman |
| K171853 |
08/24/2017 |
Liver Access and Biopsy Sets |
Cook Incorporated |
David Lehr |
| K170010 |
08/28/2017 |
Salle Intraoperative Pyeloplasty Stent Set |
COOK INCORPORATED |
MINJIN CHOI |
| K171619 |
08/01/2017 |
14Fr Colon Decompression Set, Macon Colon Decompression Set |
Cook Ireland Ltd |
Laura Graham |
| K163385 |
08/29/2017 |
Cortex Dental Implant System |
Cortex Dental Implants Industries Ltd. |
Michal Yeger |
| K171983 |
08/17/2017 |
Creo Medical Electrosurgical System including Speedboat RS2 Surgical Accessory |
Creo Medical Ltd |
Keith Penny |
| K172049 |
08/30/2017 |
CryoIQ DERM, CryoIQ PRO, CryoIQ EquiMED |
Cry IQ AB |
Stefan Skafte |
| K171626 |
08/30/2017 |
truFreeze System |
CSA Medical, Inc. |
Sherrie Coval-Goldsmith |
| K172004 |
08/02/2017 |
truSculpt |
Cutera, Inc. |
Bradley Renton |
| K171024 |
08/21/2017 |
ShockPulse-SE Lithotripsy System |
Cybersonics, Inc. |
Samradni Patil |
| K170872 |
08/15/2017 |
Aisys CS2 |
Datex-Ohmeda, Inc. |
Michelle Huettner |
| K171038 |
08/02/2017 |
Hearing Healthcare Pro |
dB Diagnostic Systems, Inc. |
Steven Levine |
| K161679 |
08/18/2017 |
s LDL-EX SEIKEN |
DENKA SEIKEN CO., LTD. |
Takayoshi Ishii |
| K170885 |
08/01/2017 |
DD cubeX2 HS |
Dental Direkt GmbH |
Uwe Greitens |
| K170529 |
08/08/2017 |
Delight, Delight ortho, B&Lite S |
DENTALL Co., Ltd. |
Jonghyuk Lee |
| K170384 |
08/17/2017 |
Dentium NR Line CAD/CAM Abutments |
Dentium Co., Ltd. |
Sangpil Yoon |
| K163398 |
08/14/2017 |
ATLANTIS suprastructures |
Dentsply Sirona |
Karl Nittinger |
| K171475 |
08/17/2017 |
DeRoyal Laprador Specimen Retrieval System |
DeRoyal Industries, Inc. |
Sarah Bennett |
| K171561 |
08/28/2017 |
Dextera MicroCutter 30 Blue Reload, Dextera MicroCutter 30 Curved Tip Blue Reload, Dextera MicroCutter 30 White Reload, Dextera MicroCutter 30 Curved Tip White Reload |
Dextera Surgical Inc. |
Greg Watson |
| K163418 |
08/18/2017 |
Diazyme DZ-Lite Total beta-hCG Test System |
Diazyme Laboratories |
Abhijit Datta |
| K172084 |
08/08/2017 |
Delta III Lithotripter |
Dornier MedTech America, Inc. |
John Hoffer |
| K163166 |
08/11/2017 |
EASYWELL TENS System TENS and Heat, EASYWELL TENS System TENS only |
EASYWELL BIOMEDICALS, INC. |
ARTHUR CHEN |
| K170031 |
08/31/2017 |
Internal Octa Implant System |
EBI Inc. |
Mi Sook Kim |
| K171900 |
08/18/2017 |
Acclarix AX4 Diagnostic Ultrasound System |
Edan Instruments, Inc |
Crystal Cai |
| K171845 |
08/18/2017 |
EMBA Hourglass Peripheral Embolization Device |
EMBA Medical Limited |
Veronica Reott |
| K162744 |
08/03/2017 |
Everyway OTC EMS, Model EV-805 |
EVERYWAY MEDICAL INSTRUMENT CO., LTD. |
PAUL HUNG |
| K172364 |
08/22/2017 |
EzDent-i / E2 / Prora View |
Ewoo Soft Co., Ltd. |
Young Seok Kim |
| K170911 |
08/22/2017 |
NEOCERA Advanced Barrier Cream |
EXELTIS USA Dermatology, LLC |
Babu Lad |
| K171407 |
08/18/2017 |
ExsoMed ArcPhix and ExsoMed ArrowPhix |
ExsoMed Holding Company, LLC |
Richard L. Kovach |
| K171865 |
08/24/2017 |
F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer Monitoring |
Farus, LLC |
Rahul Singh |
| K170367 |
08/24/2017 |
Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Large, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Medium, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Small, Nivairo |
Fisher and Paykel Healthcare Limited |
Danica Tung |
| K171227 |
08/18/2017 |
StarWalker |
Fotona d.o.o. |
Stojan Trost |
| K170038 |
08/07/2017 |
FuzeFix Screw System |
Fusion Orthopedics, LLC |
Adam Cundiff |
| K170624 |
08/11/2017 |
TalarLift STS |
Fusion Orthopedics, LLC |
Adam Cundiff |
| K172214 |
08/23/2017 |
Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters |
G-21 s.r.l. |
Maurizio Foroni |
| K171028 |
08/17/2017 |
CARESCAPE Respiratory MOdules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX and accessories |
GE Healthcare Finland OY |
Anna Pehrsson |
| K171565 |
08/10/2017 |
OEC Elite |
GE OEC Medical Systems, Inc. |
Rachel Schandel |
| K171523 |
08/22/2017 |
Monopolar Single Use Laparoscopic Instrument |
Getsch+Hiller Medizintechnik GmbH |
Werner Hiller |
| K171191 |
08/25/2017 |
Hexagen Derm |
Global Health Solutions, LLC |
Bradley Burnam |
| K171651 |
08/16/2017 |
EXCELSIUS GPS |
Globus Medical Inc. |
Kelly J. Baker |
| K152300 |
08/04/2017 |
Glucommander |
GLYTEC, LLC |
JULIE GLENDRANGE |
| K171707 |
08/08/2017 |
GA-B, GA-C, GA-E, GA-I, GA-S, GA-W3A, GA-F3A, GA-IL, GA-SL, GA-W3B, GA-F1A |
Gowoonsesang Cosmetics Co., Ltd |
Kyeong Tai Ko |
| K171975 |
08/01/2017 |
HardyDisk AST Delafloxacin 5 ╡g (DLX5) |
Hardy Diagnostics |
Rianna Malherbe |
| K163704 |
08/02/2017 |
Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card |
HEALGEN SCIENTIFIC LLC |
Jianqiu Fang |
| K163393 |
08/04/2017 |
Hi-Dow Wireless TENS/EMS System (Model HD-SN) |
Hi-Dow International, Inc. |
Eric Chen |
| K171738 |
08/18/2017 |
Supria True64 |
Hitachi Healthcare Americas Corporation |
Doug Thistlethwaite |
| K171433 |
08/11/2017 |
Silk'n Infinity |
Home Skinovations Ltd. |
Amit Goren |
| K170134 |
08/09/2017 |
Reperen Surgical Mesh |
IconLab Inc. |
Pavel Paul Artemow |
| K171346 |
08/25/2017 |
Sapphire Sets |
ICU Medical |
Andrea Doyle |
| K163390 |
08/08/2017 |
iC-GPC Assay TM for use on the iC-SystemTM |
iCubate, Inc |
Carter Wells |
| DEN160025 |
08/18/2017 |
ID-FISH Plasmodium Genus Test Kit, ID-FISH Plasmodium falciparum and P. vivax Combo Test Kit |
ID-FISH TECHNOLOGY, INC |
JYOTSNA SHAH |
| K171079 |
08/01/2017 |
Q-Switched Nd:YAG Laser System |
IDS, Ltd. |
C. J. Park |
| K172096 |
08/09/2017 |
Fraxis |
Ilooda Co. LTD |
Kathy Maynor |
| K163133 |
08/08/2017 |
ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISA |
IMMCO Diagnostics, Inc. |
Kevin Lawson |
| K163225 |
08/08/2017 |
AFIAS iFOB with AFIAS-50 |
IMMUNOSTICS, INC. |
Antoinette Prusik |
| K172122 |
08/11/2017 |
SOZO |
ImpediMed Limited |
Catherine Kingsford |
| K171881 |
08/08/2017 |
JAZZ Passer Band |
Implanet, S.A. |
Fabienne Larquey Cadiere |
| K170738 |
08/07/2017 |
InMode Diolaze XL |
InMode MD Ltd. |
Amit Goren |
| K162768 |
08/16/2017 |
ECG multi leads and IP-SET trunk cable, Monobloc ECG cable, SpO2 sensors and IBP transducers interface cable, ECG leadwire for INTEGRAL PROCESS trunk cables, ECG leadwire for original truk cables |
INTEGRAL PROCESS SAS |
Virginie S Grondin |
| K163500 |
08/17/2017 |
IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class) |
Ion Beam Applications S.A. |
Anne-Sophie Grell |
| K171224 |
08/31/2017 |
Arctic Sperm Cryopreservation Medium |
Irvine Scientific Sales Co., Inc. |
Jayme Yamaguchi-Owens |
| K163628 |
08/30/2017 |
Idylla Respiratory (IFV-RSV) Panel |
JANSSEN PHARMACEUTICA NV |
SARAH PARSONS |
| K170979 |
08/17/2017 |
ARIX Ankle Fibula Hook Plate System |
Jeil Medical Corporation |
Sejin RYU |
| K170780 |
08/14/2017 |
ARIX Foot System (2.3/2.8) |
Jeil Medical Corporation |
Yein Han |
| K171704 |
08/31/2017 |
CAPRI Corpectomy Cage System |
K2M |
Nancy Giezen |
| K171321 |
08/30/2017 |
K2M Navigation Instruments |
K2M |
Nancy Giezen |
| K172104 |
08/23/2017 |
Ozark(tm) Cervical Plate System |
K2M Inc. |
Nancy Giezen |
| K171444 |
08/08/2017 |
YUKON OCT Spinal System |
K2M, Inc. |
Nancy Giezen |
| K171717 |
08/02/2017 |
AUTOCON III 400 |
KARL STORZ Endoscopy-America, Inc. |
AnnaLisa Smullin |
| K162948 |
08/08/2017 |
Styptin, Hemogin-L, Hemodettes, and GingiGEL Aluminum Chloride Impregnated Retraction Cord/Materials |
KERR CORPORATION |
Jennifer Dzidrums |
| K171716 |
08/25/2017 |
SKR 3000 |
Konica Minolta, Inc. |
Tsutomu Fukui |
| K171563 |
08/24/2017 |
MagnetOs Putty |
Kuros Biosciences B.V. |
Yvonne P. Bovell |
| K172039 |
08/03/2017 |
CATHTONG II PICC Catheter |
L&Z US, Inc. |
Jenella Coutts |
| K171895 |
08/22/2017 |
Grivamax Hair Growth System |
Leana Orders, Inc. |
Leonid Krits |
| K171390 |
08/03/2017 |
dpl II Panel |
LED Technologies, Inc. |
Lloyd Nelson |
| K171386 |
08/07/2017 |
dpl SpectraLite |
LED Technologies, Inc. |
Lloyd Nelson |
| K171337 |
08/10/2017 |
LENSAR Laser System û fs 3D (LLS-fs 3D) |
LENSAR, Inc. |
Keith Peck |
| K170984 |
08/23/2017 |
LG BEAUTY LED MASK |
LG Electronics |
Jooyong Kim |
| K172131 |
08/28/2017 |
2 Hole Lateral Plating System |
Life Spine Inc. |
Randy Lewis |
| K170919 |
08/03/2017 |
The TiBow Expandable Spacer System |
Life Spine Inc. |
Randy Lewis |
| K163647 |
08/25/2017 |
Revolve Envi 600 Advanced Adipose System |
LifeCell Corporation |
Anuja Yardi |
| K170565 |
08/01/2017 |
LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L |
LifeWatch Services, Inc |
Stefanie Martinez-Koenig |
| K171906 |
08/01/2017 |
Liofilchem MIC Test Strip (MTS)- Delafloxacin 0.002 - 32 ╡g/mL |
Liofilchem s. r. l. |
Fabio Brocco |
| K170060 |
08/09/2017 |
M22 and ResurFx Systems |
LUMENIS, LTD. |
Naama Jacoby |
| K170492 |
08/11/2017 |
xTAG CYP2D6 Kit v3 |
Luminex Molecular Diagnostics, Inc. |
Jennifer Grimes |
| K171506 |
08/29/2017 |
Easyscreen |
Maico Diagnostics GmbH |
Amy Yanta |
| K170272 |
08/08/2017 |
TruMatch CMF Titanium 3D Printed Implant System |
Materialise NV |
Lina Ramirez |
| K171345 |
08/04/2017 |
Cellvizio 100 Series Systems with Confocal Miniprobes |
Mauna Kea Technologies |
Veronique Dentan |
| K170149 |
08/18/2017 |
3DMetal Tibial Cones |
Medacta International SA |
Stefano Baj |
| K171758 |
08/01/2017 |
M.U.S.T. Combined Set Screws |
Medacta International SA |
Stefano Baj |
| K171369 |
08/01/2017 |
M.U.S.T. MINI Posterior Cervical Screws System |
Medacta International SA |
Stefano Baj |
| K171595 |
08/02/2017 |
M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System |
Medacta International SA |
Stefano Baj |
| K170910 |
08/16/2017 |
Medacta Anatomic Shoulder Prosthesis |
Medacta International SA |
Stefano Baj |
| K170845 |
08/08/2017 |
MiniMAX |
Medacta International SA |
Stefano Baj |
| K172021 |
08/30/2017 |
LigaPASS |
Medicrea International S.A. |
David Ryan |
| K170782 |
08/18/2017 |
Medline UNITE« Snap-Off Screws |
Medline Industries, Inc. |
Jennifer Mason |
| K171570 |
08/31/2017 |
Additional VIPER PRIMEÖ screws with fenestrations |
Medos International, SARL |
Karen Sylvia |
| K172036 |
08/03/2017 |
Medrobotics Flex Robotic System |
Medrobotics Corporation |
John D. Bonasera |
| K163375 |
08/21/2017 |
INFINITYÖ OCT System |
Medtronic Sofamor Danek USA, Inc. |
Tejas Patel |
| K171526 |
08/21/2017 |
ZeniusÖ, lliadÖ and KoraÖ Spinal Fixation Systems |
Medyssey USA, Inc. |
Shawn Kim |
| K172081 |
08/04/2017 |
Maestro Microcatheter |
Merit Medical Systems, Inc. |
Niloufar Samimi |
| K171362 |
08/07/2017 |
Merit Syringe |
Merit Medical Systems, Inc. |
Cory Marsh |
| K170467 |
08/30/2017 |
Microlife Upper Arm Automatic Digital Blood Pressure Monitor |
Microlife Intellectual Property GmbH |
Gerhard Frick |
| K171389 |
08/08/2017 |
EVOLUTION Revision CCK System |
MicroPort Orthopedics Inc. |
Matt Paul |
| K171181 |
08/28/2017 |
PROCOTYL« PRIME E-CLASSÖ XLPE Liner |
MicroPort Orthopedics, Inc. |
Sarah Evonne Stroupe |
| K163337 |
08/31/2017 |
Midmark and Ritter M9 and M11 UltraClave« Automatic Sterilizers and Ritter M9D AutoClave« Automatic Sterilizer |
Midmark Corporation |
ADAM CLUTTER |
| K170722 |
08/28/2017 |
Moxxly Flow Collection System |
Moxxly, Inc. |
Cara Delzer |
| K170564 |
08/30/2017 |
MyndMove System, MyndMove Functional Electrical Stimulator |
MyndTec Inc |
Alexa Granger |
| K163402 |
08/31/2017 |
NLZ Motor System |
NAKANISHI INC. |
Kimihiko Satoh |
| K163483 |
08/15/2017 |
PANA SPRAY Plus |
NAKANISHI, INC. |
Kimihiko Satoh |
| K170787 |
08/09/2017 |
Powered Wheelchair DYW30A(D09) |
Nanjing Jin Bai He Medical Apparatus Co., Ltd. |
Jen Ke-Min |
| K170285 |
08/01/2017 |
AED Sinuscope |
National Advanced Endoscopy Devices, Inc. |
Gayle Butler |
| K172359 |
08/18/2017 |
UroLift System (UL500) |
NeoTract, Inc. |
Louis-Pierre Marcoux |
| K171183 |
08/18/2017 |
OmniTom |
NeuroLogica Corporation, |
Ninad Gujar |
| K171451 |
08/08/2017 |
Ahmed Glaucoma Valve Model FP8 |
New World Medical, Inc. |
Cristina Avalos |
| K171140 |
08/22/2017 |
Matrixx System |
Nexxt Spine LLC |
Andy Elsbury |
| K171124 |
08/25/2017 |
Nihon Kohden Wireless Input Unit WEE-1200 |
Nihon Kohden Corporation |
Tom Bento |
| K171244 |
08/23/2017 |
Physiotrace |
NimbleHeart, Inc. |
Sonal Tambe |
| K172061 |
08/24/2017 |
PRECICE UNYTE System |
NuVasive Specialized Orthopedics, Inc. |
Cora Sim |
| K171791 |
08/31/2017 |
MAGEC« System |
NuVasive Specialized Orthopedics, Incorporated |
Manthan J. Damani |
| K170939 |
08/08/2017 |
Supplemental Instrument Trays |
NuVasive Specialized Orthopedics, Incorporated |
Cora Sim |
| K170800 |
08/18/2017 |
NuVasive LessRay with Enhanced Tracking |
NuVasive, Incorporated |
Manthan J. Damani |
| K171331 |
08/24/2017 |
NxStage System One |
NxStage Medical, Inc. |
Paul Kravitz |
| K171156 |
08/17/2017 |
OMNI Anseris Hip Stem |
OMNIlife science |
Christina Rovaldi |
| K171249 |
08/24/2017 |
EntradaÖ hip stem |
Ortho Development Corporation |
Drew Weaver |
| K171617 |
08/22/2017 |
OKI Surgical Planning Software |
Ortho Kinematics, Inc. |
Adam Deitz |
| K172327 |
08/25/2017 |
VMAÖ System version 3.0 |
Ortho Kinematics, Inc. |
Adam Deitz |
| K172194 |
08/18/2017 |
Connector System |
Orthofix Inc. |
Jacki Koch |
| K171173 |
08/24/2017 |
OrthoPediatrics Titanium PediPlates« System |
OrthoPediatrics, Corp. |
Adam Cargill |
| K163423 |
08/31/2017 |
Orthopantomograph OP300 |
PaloDEx Group Oy |
Eric Schwandt |
| K161225 |
08/11/2017 |
Paonan Armstrong Posterior Spinal Fixation System |
Paonan Biotech Co., Ltd. |
YI-JHEN TSAI |
| K171332 |
08/14/2017 |
Artemis Neuro Evacuation Device |
Penumbra, Inc. |
Mary Rose |
| K171560 |
08/25/2017 |
OTIS Optical Coherence Tomography System |
Perimeter Medical Imaging, Inc. |
Elizabeth Munro |
| K172139 |
08/18/2017 |
Streamline OCT Occipito-Cervico-Thoracic System |
Pioneer Surgical Technology, Inc. (DBA RTI Surgical, Inc.) |
Sarah Pleaugh |
| K172140 |
08/11/2017 |
NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10cm), NovoSorb BTM Wound Dressing (10cm x 20cm), NovoSorb BTM Wound Dressing (20cm x 40cm) |
PolyNovo Biomaterials Pty Ltd |
Sue Cho |
| K171657 |
08/11/2017 |
ShurFit 2C Lumbar Interbody Fusion System |
Precision Spine, Inc. |
Michael C. Dawson |
| K171162 |
08/15/2017 |
Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap Shield |
Prestige Ameritech |
Rex Reese |
| K162917 |
08/17/2017 |
Allerhope Allergy Skin Tester |
PROCARE INDUSTRIAL CO., LIMITED |
WANG YANHONG |
| K172426 |
08/16/2017 |
Clear Blue Digi LED Curing Light |
Promident LLC |
Gary Kris |
| K171511 |
08/21/2017 |
RIDA GENE Norovirus GI/GII |
R-Biopharm AG |
Andreas Simons |
| K171896 |
08/29/2017 |
Feminine Personal Trainer (FPT) |
Ralston Group |
Russell Ralston |
| K170827 |
08/09/2017 |
INTRACEPT Intraosseous Nerve Ablation System |
Relievant Medsystems |
Alex DiNello |
| K171143 |
08/18/2017 |
Relievant Medsystems RF Generator |
Relievant Medsystems |
Alex DiNello |
| K170888 |
08/08/2017 |
Renovis S141 Lumbar Interbody Fusion System |
Renovis Surgical Technologies |
Anthony DeBenedictis |
| K162613 |
08/31/2017 |
Integrated Catch-up Freedom Syringe Driver Infusion System |
Repro-Med Systems, Inc., DBA RMS Medical Products |
Fred Ma |
| K171261 |
08/18/2017 |
ScannerSide DoseCheck |
Right Dose Inc. |
William Moore |
| K163321 |
08/17/2017 |
Rocket Indwelling Pleural Catheter (IPC) Insertion Kit |
ROCKET MEDICAL PLC |
Tracy Charlton |
| K172129 |
08/08/2017 |
HS40 Diagnostic Ultrasound System |
Samsung Medison Co., Ltd. |
JiYeon Cho |
| K171048 |
08/24/2017 |
RS80A Diagnostic Ultrasound System |
Samsung Medison Co., Ltd. |
Ji Yea Lee |
| K171070 |
08/09/2017 |
WS80A Diagnostic Ultrasound System |
Samsung Medison Co., Ltd. |
Emily Woo |
| K160850 |
08/04/2017 |
Nucleoss Tpure Implant System |
SANLILAR TIBBI CIHAZLAR MED. KIM.SAN.TIC.LTD.STI |
EZGI ERDEM |
| K162543 |
08/28/2017 |
Reverse Pull Adjustable Facemask |
SAWBROS INDUSTRIES PVT.LTD. |
DHRUV SAWHNEY |
| K171741 |
08/29/2017 |
Laport |
Sejong Medical Co., Ltd. |
Yoojung Choi |
| K170136 |
08/25/2017 |
Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs |
SHANDONG FEIYANG PROFESSIONAL GLOVES CO., LTD |
KEN LU |
| K170861 |
08/04/2017 |
Premier |
Shandong Weigao Orthopaedic Device Co., Ltd. |
Han Wang |
| K161298 |
08/25/2017 |
ShenDa Sinuscope |
SHENYANG SHENDA ENDOSCOPE CO., LTD |
GAO FENG |
| K170876 |
08/23/2017 |
Passport Series Patient Monitors(Passport 12m, Passport 17m) |
Shenzhen Mindray Bio-medical Electronics Co., LTD. |
Yanhong Bai |
| K170712 |
08/02/2017 |
Accutorr 7/VS-900 Vital Signs Monitor |
Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. |
Yanhong Bai |
| K172106 |
08/31/2017 |
SHOFU MZ Primer Plus |
Shofu Dental Corporation |
Mauro Malzyner |
| K163568 |
08/16/2017 |
SHOFU RESIN GLAZE |
Shofu Dental Corporation |
Mauro Malzyner |
| K172162 |
08/16/2017 |
ACUSON S3000 S2000 S1000 Diagnostic Ultrasound Systems |
Siemens Healthcare |
Jessica Stenberg |
| K162977 |
08/11/2017 |
ADVIA 2120i, ADVIA 2120 |
SIEMENS HEALTHCARE DIAGNOSTICS |
Gerard Sadrakula |
| K171642 |
08/31/2017 |
Atellica IM Ferritin Assay |
Siemens Healthcare Diagnostics Inc. |
Kira Gordon |
| K162540 |
08/22/2017 |
INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW Controls |
SIEMENS HEALTHCARE DIAGNOSTICS PRODCTS GMBH |
ROSE T MARINELLI |
| K172374 |
08/15/2017 |
ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound System |
Siemens Medical Solutions USA, Inc. |
Shelly Pearce |
| K163625 |
08/11/2017 |
NOOSA Anterior Lumbar Plate System;NAMBUCCA Anterior Lumbar Plate System; CAIRNS Anterior Lumbar Plate System |
Signature Orthopaedics Pty Ltd. |
Declan Brazil |
| K172262 |
08/23/2017 |
EVOS Small Fragment Plating System |
Smith & Nephew, Inc. |
Samantha Staubach |
| K170982 |
08/24/2017 |
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 |
| K171164 |
08/03/2017 |
U-Lite EXP |
Sonoscanner |
Bruno Richard |
| K163339 |
08/17/2017 |
SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0 |
SPECTRALMD, INC. |
J. MICHAEL DIMAIO |
| K172175 |
08/16/2017 |
CapSure« PS System |
Spine Wave, Inc. |
Amy Noccioli |
| K171660 |
08/18/2017 |
Duo Lumbar Interbody Fusion Device |
Spineology Inc. |
Jacqueline A. Hauge |
| K172107 |
08/21/2017 |
ThresholdÖ V2 Pedicular Fixation System, ThresholdÖ Pedicular Fixation System, FortressÖ Pedicular Fixation System, PalisadeÖ Pedicular Fixation System |
Spineology Inc. |
Jacqueline A. Hauge |
| K172182 |
08/18/2017 |
QUANTIEN Measurement System |
St. Jude Medical (now part of the Abbott Medical) |
Julie Dalquist |
| K172207 |
08/25/2017 |
Standard Supreme Sterilization Wrapper |
Standard Textile Co., Inc. |
Bradley J. Bushman |
| K171504 |
08/22/2017 |
VERIFY Assert VH2O2 Self-Contained Biological Indicator |
STERIS Corporation |
Anthony Piotrkowski |
| K171587 |
08/22/2017 |
VERIFY Incubator for Assert VH2O2 Self-Contained Biological Indicator |
Steris Corporation |
Anthony Piotrkowski |
| K171071 |
08/09/2017 |
StimSox(TM) System |
StimMed, LLC |
Peter G. Demakos |
| K171366 |
08/04/2017 |
Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory Kit, Charger Kit |
Stimwave Technologies Inc.,DBA StimQ LLC |
Elizabeth Greene |
| K171465 |
08/24/2017 |
Stryker Self-Punching ICONIX |
Stryker |
Katie Farraro |
| K172367 |
08/22/2017 |
Stryker Integrated Bipolar Cord and Tubing Sets |
Stryker Instruments |
Susanne Galin |
| K162165 |
08/29/2017 |
ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent Pump |
SUMMIT MEDICAL PRODUCTS, INC |
LeVoy Haight |
| K170488 |
08/10/2017 |
Peak Left Ventricular Vent Cannula, 20 Fr.; Peak Left Ventricular Vent Cannula, 18 Fr; Peak Left Ventricular Vent Cannula, 16 Fr |
Surge Cardiovascular |
Rick Shorey |
| K161358 |
08/03/2017 |
Medline ReNewal Reprocessed Stryker Neptune 2 Manifolds |
SURGICAL INSTRUMENT SERVICE AND SAVINGS INC |
BRANDI J. PANTELEON |
| K162943 |
08/29/2017 |
SyMRI |
SyntheticMR AB |
Maria Almesaker |
| K163121 |
08/10/2017 |
SmartUs EXT-1M/3M |
TELEMED |
YURY SOKOLOV |
| K170588 |
08/08/2017 |
DESS Dental Smart Solutions |
Terrats Medical SL |
Roger Terrats |
| K172220 |
08/17/2017 |
Advanced Perfusion System 1 |
Terumo Cardiovascular Systems Corporation |
Bryan K. Hann |
| K171276 |
08/21/2017 |
Sterile Polyisoprene Surgical Powder Free Glove Tested for Use with Chemotherapy Drugs |
TG Medical SDN. BHD. |
Fatima Wati BT Mohamad |
| K171870 |
08/01/2017 |
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.0005 û 8 ug/mL |
Thermo Fisher Scientific |
Cynthia Knapp |
| K172274 |
08/30/2017 |
The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.00025-8╡g/mL |
Thermo Fisher Scientific |
Cynthia Knapp |
| K171010 |
08/31/2017 |
Latitude EV Total Elbow Arthroplasty |
Tornier Inc. |
Renee Stoffel |
| K170958 |
08/29/2017 |
ChitoPulse 9in / 23 cm, ChitoPulse 12in / 30.5 cm, ChitoPulse 15in / 38 cm |
Tricol Biomedical Inc. |
Maire Ni Beilliu |
| K162507 |
08/03/2017 |
Arzzt 3.5 / 4.5 Small & Large Fragments System |
TRUEMED GROUP, LLC |
Jorge Castillo |
| K170555 |
08/17/2017 |
U Deliver Bolink ENFit Enteral Feeding Sets |
U Deliver Medical, LLC |
Brian Johnson |
| K171406 |
08/18/2017 |
Optum TeleHealth Application |
United Health Group Inc. |
Donald J. Matthews |
| K163441 |
08/25/2017 |
Locking Cage, Full XPE Cup |
UNITED ORTHOPEDIC CORPORATION |
GIMPEL CHIEN |
| K162533 |
08/31/2017 |
Kelowna GYN and Crook Prostate Templates |
Varian Medical Systems, Inc |
Peter J. Coronado |
| K172163 |
08/15/2017 |
Eclipse Treatment Planning System |
Varian Medical Systems, Inc. |
Peter J. Coronado |
| K163695 |
08/22/2017 |
Borrelia B31 ViraChip IgM Test Kit |
Viramed Biotech AG |
Martin Kintrup |
| K171322 |
08/03/2017 |
eCareManager 4.1 |
Visicu, Inc. |
Daniel R. Plonski |
| K171950 |
08/16/2017 |
Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B) |
Visionary Optics LLC |
Donald R. Sanders |
| K171200 |
08/10/2017 |
Grandio blocs |
VOCO GmbH |
M. Th. Plaumann |
| K172386 |
08/24/2017 |
1.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy System, 2.4mm X 130cm Phoenix Atherectomy System |
Volcano AtheroMed Inc |
Jean Chnag |
| K171712 |
08/07/2017 |
Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect Platinum Vena Cava Filter Set for Jugular Vein Approach, Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach |
William Cook Europe ApS |
Henriette Stordal Christiansen |
| K171596 |
08/04/2017 |
ECHO-3-22: Echotip Ultra and EUSN-1, EUSN-3: Echotip Ultrasound Needle |
Wilson-Cook Medical Inc. |
Tiffanny A. Thomas |
| K171993 |
08/17/2017 |
Zimmon Needle Knife Papillotome |
Wilson-Cook Medical, Inc. / Cook Endoscopy |
Doris A. Hawks |
| K170642 |
08/22/2017 |
GRAVITYÖ Soft Tissue Repair System |
Wright Medical Technology, Inc. |
Michael Mullins |
| K170968 |
08/16/2017 |
PROPHECY INVISION Pre-operative Navigation System |
Wright Medical Technology, Inc. |
Alayne Melancon |
| K171075 |
08/01/2017 |
Calix-C Cervical Interbody Spacer |
X-Spine Systems, Inc. |
Kriss Andersson |
| K171567 |
08/28/2017 |
IRIX-A Lumbar Integrated Fusion System |
X-Spine Systems, Inc. |
Kriss Andersson |
| K170651 |
08/02/2017 |
Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle |
Yangzhou Medline Industry Co., Ltd. |
Jianzhong Qi |
| K171104 |
08/25/2017 |
Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Blue, Cobalt Blue) |
YTY INDUSTRY (MANJUNG) SDN BHD |
Punitha Samy |
| K172098 |
08/31/2017 |
Medical Video Endoscope System |
Zhuhai Pusen Medical Technology Co., Ltd. |
WANG CHANGSHEN |
| K172114 |
08/10/2017 |
Zimmer Natural Nail System |
Zimmer Inc. |
Dhaval Saraiya |
| K170003 |
08/18/2017 |
Zip 4 Skin Closure Device |
ZipLine Medical, Inc. |
Trish Howell |
| K162832 |
08/02/2017 |
731 Series Ventilators |
ZOLL MEDICAL CORPORATION |
CHUCK KOLIFRATH |
