| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K193110 |
03/13/2020 |
3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E |
3M Health Care |
Andrew Wingen |
| K192272 |
03/17/2020 |
Wolf445nm |
A.R.C. Laser GmbH |
Angela Thyzel |
| K193479 |
03/23/2020 |
Sternal Cable System |
A&E Medical Corporation |
Peter Browne |
| K200306 |
03/06/2020 |
CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula Kit |
Abbott (formerly Thoratec Corporation) |
Bindya Gadhia |
| K193310 |
03/17/2020 |
myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS) |
Abbott (St. Jude Medical) |
Vanessa Powell |
| K191912 |
03/27/2020 |
BiWaze Cough |
ABMRC LLC |
Chad M Boerst |
| K193453 |
03/23/2020 |
TruDi Probe |
Acclarent, Inc. |
Leena Sorathia |
| K193183 |
03/20/2020 |
ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter |
ACIST Medical Systems, Inc. |
Angela Johnson |
| K183570 |
03/09/2020 |
LiquiBand Plus |
Advanced Medical Solutions Limited |
Martin Mitchell |
| K192056 |
03/27/2020 |
JJ Series Container System |
Aesculap, Inc. |
Sierra Mertz |
| K193582 |
03/17/2020 |
SterilContainer S2 System |
Aesculap, Inc. |
Sierra Mertz |
| K193262 |
03/09/2020 |
DR 600 with Tomosynthesis |
Agfa N.V. |
Wim Govaerts |
| K192484 |
03/11/2020 |
Fixone Biocomposite Anchor |
AJU Pharm Co., Ltd. |
Kim Jung Gil |
| K192032 |
03/03/2020 |
Fixone Biocomposite Small Anchor |
AJU Pharm Co., Ltd. |
Lee Gun Tak |
| K200311 |
03/06/2020 |
VersaWrap Tendon Protector |
Alafair Biosciences Inc |
Ben Walthall |
| K193659 |
03/20/2020 |
iTero Element 5D |
Align Technology, Inc. |
Angela M. Frederickson |
| K193256 |
03/02/2020 |
Anjon Bremer Halo System |
Anjon Holdings LLC |
Kenneth A Collins |
| K193612 |
03/12/2020 |
AMT Suture Delivery System |
Applied Medical Technology, Inc. |
Joy Tubero |
| K190129 |
03/11/2020 |
AC5 Topical Gel |
Arch Therapeutics, Inc. |
Terrence Norchi |
| K192437 |
03/25/2020 |
Arterys MICA |
Arterys Inc. |
Sharon Cholowsky |
| K200341 |
03/12/2020 |
Arthrex FiberTak Suture Anchor |
Arthrex Inc. |
Jessica L. Singelais |
| K200433 |
03/17/2020 |
iBalance UKA Tibial Tray Implant |
Arthrex Inc. |
Ivette Galmez |
| K193425 |
03/09/2020 |
Pre-Milled Blank |
Arum Dentistry Co. Ltd |
Hwang-Heung Yeon |
| K192483 |
03/13/2020 |
MeDioStar |
ASCLEPION LASER TECHNOLOGIES GMBH |
Antje Katzer |
| K191566 |
03/06/2020 |
Avinent Surgical Tray |
AVINENT Implant System, S.L.U. |
Anna Cortina |
| K191658 |
03/19/2020 |
IV Sets not made with PVC |
B. Braun Medical Inc. |
Angela J. Caravella |
| K193101 |
03/05/2020 |
Omnifix Low Dead Space Luer Lock Syringe |
B. Braun Medical Inc. |
Tracy Larish |
| K191910 |
03/12/2020 |
SpaceStation MRI |
B. Braun Melsugen AG |
Ullrich Trottier |
| K193482 |
03/13/2020 |
PrisMax System Version 3 |
Baxter Healthcare Corporation |
Christopher Scavotto |
| K193536 |
03/18/2020 |
MicroScan Dried Gram Negative MIC/Combo Panels with Ciprofloxacin (Cp) (0.004 - 8╡g/mL) |
Beckman Coulter, Inc |
Elaine Duncan |
| K193358 |
03/03/2020 |
MicroScan Dried Gram-Negative MIC/Combo Panels with Levofloxacin (Lvx) (0.008-16ug/mL) |
Beckman Coulter, Inc. |
Elaine Duncan |
| K193328 |
03/25/2020 |
IPL + Diode Laser Machine |
Beijing Globalipl Development Co., Ltd. |
Li Ye |
| K193609 |
03/20/2020 |
Q Switched Nd: YAG Laser machine |
Beijing Lead Beauty S & T Co., Ltd |
Jiao Zhang |
| K193519 |
03/18/2020 |
BioFire Blood Culture Identification 2 (BCID2) Panel |
BioFire Diagnostics, LLC |
Kristen Kanack |
| K193487 |
03/30/2020 |
Agilon Strip |
Biogennix, LLC |
Timothy Bumbalough |
| K191657 |
03/20/2020 |
Bioland Blood Glucose Monitoring System |
Bioland Technology Ltd. |
Ke-Min Jen |
| K193486 |
03/16/2020 |
Epic 980 |
Biolase, Inc |
Alicia Mszyca |
| K193572 |
03/13/2020 |
VITEK 2 AST-Gram Negative Imipenem/Relebactam (<=0.25/4 - >=16/4 ╡g/mL) |
BioMerieux, Inc. |
Jolyn Tenllado |
| K193402 |
03/05/2020 |
ALLthread PEEK Suture Anchor |
Biomet Inc. |
Haley Pioch |
| K200262 |
03/04/2020 |
L100 Go System |
Bioness Inc. |
Mercedes Bayani |
| K200482 |
03/27/2020 |
StimRouter Neuromodulation System |
Bioness Inc. |
Sageev George |
| K190495 |
03/16/2020 |
Transferrin |
BioSystems S.A. |
Noelia Gil |
| K192007 |
03/17/2020 |
TheraBase, TheraBase Ca |
Bisco, Inc. |
Diana Vu |
| K193614 |
03/25/2020 |
FINE Osteotomy around the knee |
Bodycad Laboratories, Inc. |
Guy Sevigny |
| K193619 |
03/25/2020 |
Cry-Ac«, Cry-Ac-3«, Cry-Baby |
Brymill Cryogenic Systems |
Paul Sideleau |
| K190527 |
03/05/2020 |
GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters, HemoStar XK Long-Term Hemodialysis Catheters |
C.R. Bard |
Jonathan Holmes |
| K192506 |
03/02/2020 |
Vantage Galan 3T, MRT-3020, V6.0 |
Canon Medical Systems Corporation |
Paul Biggins |
| K192574 |
03/09/2020 |
Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR |
Canon Medical Systems Corporation |
Paul Biggins |
| K193378 |
03/02/2020 |
CarboClear Lumbar Cage System |
CarboFix Orthopedics Ltd. |
Hila Wachsler-Avrahami |
| K193327 |
03/20/2020 |
Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus Full Coverage Gown, Open Back, Cardinal Health ChemoPlus Full Coverage Sleeve |
Cardinal Health 200, LLC |
Caroline Miceli |
| K200198 |
03/18/2020 |
WIRION |
Cardiovascular Systems, Inc |
Erika Huffman |
| K200370 |
03/10/2020 |
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 A/H5 Subtyping Kit |
Centers For Disease Control And Prevention |
Yon Yu |
| K191876 |
03/18/2020 |
PulmoScan |
Cognita Labs, LLC |
Rajoshi Biswas |
| K200028 |
03/04/2020 |
Coronet Soft Tissue Fixation System |
CoNextions Medical |
Matthew Swift |
| K193105 |
03/13/2020 |
iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System, iTotal CR Knee Replacement System, iTotal PS Knee Replacement System |
Conformis, Inc. |
Nancy Giezen |
| K193667 |
03/25/2020 |
Shapiro MD model laser 272 |
Conversion Labs, PR, LLC |
Stefan Galluppi |
| K192697 |
03/05/2020 |
Instinct Plus Endoscopic Clipping Device |
Cook Endoscopy |
Karthik Pillai |
| K191763 |
03/23/2020 |
MyDay (Stenfilcon A) ASPHERE, MyDay (Stenfilcon A) TORIC, MyDay (Stenfilcon A) MULTIFOCAL, MyDay (Stenfilcon A) MULTIFOCAL TORIC |
CooperVision, Inc. |
Marie Dutton |
| K200267 |
03/06/2020 |
LOSPA« ISÖ Spinal Fixation System |
Corentec Co., Ltd. |
Sungwon Yang |
| K192720 |
03/13/2020 |
GIA Stapler with Tri-Staple Technology |
Covidien |
Sarah Tang |
| K193356 |
03/02/2020 |
BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider |
Covidien, LLC |
Juma Hoshino |
| K192905 |
03/19/2020 |
Creo Electrosurgical System with HS1 Hemostasis Accessory |
Creo Medical Ltd. |
Leif Geoghegan |
| K192534 |
03/25/2020 |
CrossBay Endometrial Tissue Sampler (ETS) |
CrossBay Medical |
Piush Vidyarthi |
| K173590 |
03/30/2020 |
System 83 Plus Washer/Disinfector |
Custom Ultrasonics, Inc. |
Mario P. Infanti |
| K193426 |
03/09/2020 |
Elite iQ |
Cynosure LLC |
Michael King |
| K200241 |
03/25/2020 |
TempSure System |
Cynosure LLC |
Kevin O'Connell |
| K193019 |
03/04/2020 |
DANNIK Disposable Monopolar Laparoscopic Instrument |
Dannik |
Olga Haberlad |
| K193144 |
03/30/2020 |
T-Line Hernia Mesh |
Deep Blue Medical Advances, Inc. |
William Perry |
| K193529 |
03/05/2020 |
ATLANTIS Abutment for MIS Conical Connection Implants |
Dentsply Sirona |
Karl Nittinger |
| K193078 |
03/25/2020 |
MIS CONNECT Conical Connection System |
Dentsply Sirona |
Karl Nittinger |
| K193064 |
03/03/2020 |
Atlantis suprastructures |
Dentsply Sirona Inc. |
Karl Nittinger |
| K192510 |
03/20/2020 |
DIAFIL & DIAFIL Capsule |
Diadent Group International |
Kab Sun Lee |
| K192284 |
03/25/2020 |
DiaFil Flow |
Diadent Group International |
Kab Sun Lee |
| K190091 |
03/27/2020 |
Diapaste |
Diadent Group International |
Myung Sub Kim |
| K193532 |
03/02/2020 |
LIAISON Anti-HAV Assay |
DiaSorin Inc. |
John C. Walter |
| K193139 |
03/05/2020 |
ProVecta 3D Prime Ceph |
Durr Dental SE |
Oliver Lange |
| K193518 |
03/26/2020 |
KOSMOS |
EchoNous, Inc. |
Trish Liau |
| K193121 |
03/20/2020 |
GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for use with Chemotherapy Drugs Claims |
ECO Medi Glove SDN BHD |
Suresh Kumar |
| K191031 |
03/06/2020 |
NightOwl |
Ectosense nv |
Bart Van Pee |
| K200258 |
03/09/2020 |
Edwards eSheath Introducer Set |
Edwards Lifesciences |
Vilma Arechiga |
| K200358 |
03/13/2020 |
Fem-Flex II Femoral Arterial Cannula, Fem-Flex II Femoral Venous Cannula, Femoral Venous Cannula, FemTrak Femoral Venous Cannula |
Edwards Lifesciences LLC |
Anna Califato |
| K200499 |
03/29/2020 |
QuickDraw Venous Cannula |
Edwards Lifesciences LLC |
Diem My Nguyen |
| K200485 |
03/23/2020 |
RadiForce RX1270, RadiForce RX1270-AR |
EIZO Corporation |
Hiroaki Hashimoto |
| K191830 |
03/26/2020 |
gammaCore Sapphire |
Electrocore, Inc. |
Mike Romaniw |
| K192951 |
03/26/2020 |
Ellipse Frax 1940 for Ellipse Nordlys and Ellipse Ydun |
Ellipse A/S |
Ole Kofod |
| K191612 |
03/20/2020 |
Encision AEM Monopolar Laparoscopic Instruments and Accessories |
Encision Incorporated |
Denise Baker |
| K192300 |
03/20/2020 |
EnlightenVue Microendoscopy System |
EnlightenVue, Inc. |
Giacomo Basadonna |
| K192413 |
03/31/2020 |
SiteSeal Femoral Compression Device |
Ensite Vacular, LLC |
Tom Reidy |
| K192144 |
03/25/2020 |
STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device |
Ethicon, Inc. |
Eleanor Zhou |
| K192888 |
03/13/2020 |
EzOrtho |
Ewoo Soft Co., Ltd. |
Young Seok Kim |
| K191525 |
03/04/2020 |
KinematX Total Wrist Arthroplasty System |
Extremity Medical, LLC. |
Brian Smekal |
| K200041 |
03/10/2020 |
FlexPointer 1.5 Single Use, FlexTube 3 Single Use |
Fiagon GmbH |
Dirk Mucha |
| K200043 |
03/23/2020 |
Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws; Field Orthopaedics Bony Trauma Extremity System (BTES) Screw Range |
Field Orthopaedics Pty Ltd |
Kieran Leacy |
| K191624 |
03/09/2020 |
F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version |
Fisher & Paykel Healthcare Limited |
Nicholas Yap |
| K191818 |
03/19/2020 |
F&P Optiflow 3S Nasal Cannula (Small, Medium, Large) |
Fisher & Paykel Healthcare Ltd |
Reena Daken |
| K191909 |
03/23/2020 |
HepaShield Bacterial Viral Breathing System Filter |
Flexicare Medical Limited |
Joel Biddle |
| K200337 |
03/24/2020 |
FloPatch (FP120) |
Flosonics Medical (r/a 1929803 Ontario Corp.) |
Andrew Eibl |
| K191550 |
03/04/2020 |
Broncholab |
Fluidda Inc. |
Anjali Nair |
| K192590 |
03/05/2020 |
CURA 778 |
FMI Medical Systems Inc. |
Dazhuang Meng |
| K193661 |
03/25/2020 |
LightWalker Laser System Family |
Fotona d.o.o. |
Marko Berdajs |
| K193656 |
03/27/2020 |
SkyPulse |
Fotona d.o.o. |
Marko Berdajs |
| K193061 |
03/19/2020 |
G3 40 Radiopaque Bone Cement |
G21 S.r.l |
Flilippo Foroni |
| K193059 |
03/19/2020 |
G1 40 Radiopaque Bone Cement |
G21 S.r.l. |
Filippo Foroni |
| K200494 |
03/29/2020 |
CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRES |
GE Healthcare |
Joel Kent |
| K193281 |
03/20/2020 |
Hepatic VCAR |
GE Medical Systems SCS |
Lifeng Wang |
| K193448 |
03/12/2020 |
BioNourish Lubricant |
Good Clean Love, Inc. |
Weny Strgar |
| K200108 |
03/26/2020 |
GEO 1st MTP Joint Arthrodesis Plating System |
Gramercy Extremity Orthopedics, LLC |
Michael P. Simpson |
| K191856 |
03/19/2020 |
Compression Therapy Device |
Guangzhou Longest Science & Technology Co., Ltd. |
Xiaobing Luo |
| K192640 |
03/30/2020 |
Kidro Digital Electric Breast Pump, Dr. Brown's Digital Electric Breast Pump |
Guangzhou Yongyi Industrial Co., Ltd. |
Jian Zhongrong |
| K200263 |
03/12/2020 |
Health Line CT Midline Catheter |
Health Line International Corporation |
Aaron G Faulkner |
| K193367 |
03/12/2020 |
elysion-pro |
High Technology Products SLU |
Sergi Lozano |
| K200436 |
03/23/2020 |
Aptima Combo 2 Assay (Panther) - 250 test kit, Aptima Combo 2 Assay (Tigris) - 250 test kit, Aptima Trichomonas Vaginalis (Panther) - 250 test kit, Aptima Trichomonas Vaginalis (Tigris) - 250 test kit |
Hologic, Inc. |
Jill Wyland |
| K191562 |
03/06/2020 |
Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor |
HORIBA ABX SAS |
Caroline Ferrer |
| K200556 |
03/31/2020 |
AquaFlate Pre-Filled Sterile Water Syringe 10mL |
HR Pharmaceuticals, Inc. |
Colby Wiesman |
| K200406 |
03/18/2020 |
Evolve Breast Pump |
Hygeia II Medical Group, Inc. |
Brett Nakfoor |
| K191709 |
03/05/2020 |
V-STRUT Vertebral Implant |
Hyprevention SAS |
Cecile Vienney |
| K191868 |
03/31/2020 |
iCEWav Neuromonitoring Platform |
iCE Neurosystems, Inc. |
Allen Waziri |
| K192897 |
03/20/2020 |
icotec Cervical Cage |
icotec ag |
Marina Hess |
| K190918 |
03/06/2020 |
SwabTip Male Disinfectant Cap |
ICU Medical |
Nichelle Cato |
| K200396 |
03/06/2020 |
Insight Enhanced DRF Digital Imaging System |
Imaging Engineering, LLC |
George Jachode |
| K200224 |
03/24/2020 |
SEA-LINK Anterior Cervical Plate System |
Indius Medical Technologies Pvt. Ltd. |
Aditya Ingalhalikar |
| K200385 |
03/16/2020 |
CONTINUUM PACS |
Integrated Ophthalmic Systems, Inc. |
Matthew Carnevale |
| K193389 |
03/04/2020 |
Vista Clear |
Inter-Med / Vista Dental Products |
Alex Johnson |
| K193447 |
03/11/2020 |
Vista Dyes |
Inter-Med / Vista Dental Products |
Alex Johnson |
| K193481 |
03/10/2020 |
AeroNOx 2.0 Nitric Oxide Titration & Monitoring System |
International Biomedical |
Amy Pieper |
| K183086 |
03/31/2020 |
da Vinci X and Xi Surgical System |
Intuitive Surgical, Inc |
Brandon Hansen |
| K191583 |
03/06/2020 |
PhotonBlade with Smoke Evacuation |
Invuity Inc. |
Dione Fuller |
| K193087 |
03/31/2020 |
Rapid ICH |
iSchemaView Incorporated |
James Rosa |
| K192852 |
03/28/2020 |
MRI ECG Patient Cable |
Ivy Biomedical Systems, Inc. |
Alejandra Aceves |
| K190509 |
03/04/2020 |
Lubrina 2 |
J. Morita USA, Inc. |
Fujio Zushi |
| K192987 |
03/26/2020 |
Aina HbA1c Monitoring System 2 |
Jana Care, Inc |
Michal Depa |
| K193616 |
03/04/2020 |
ARIX Ankle System |
Jeil Medical Corporation |
Jonghwan Kim |
| K192039 |
03/29/2020 |
Torc Body |
Johari Digital Healthcare Limited |
Pooja Johari |
| K200243 |
03/17/2020 |
ACUVUE (senofilcon A) Soft Contact Lens Multifocal |
Johnson & Johnson Vision Care, Inc. |
Scott Durland |
| K192328 |
03/10/2020 |
JR.MEDIK Latex SurgeonÆs Gloves Powder Free |
JR Engineering & Medical Technologies (M) SDN.BHD. |
Ganesan Subramaniam |
| K190993 |
03/05/2020 |
Kinepict Medical Imaging Tool version v2.2 |
Kinepict Health Ltd |
Lilla Strobel |
| K192979 |
03/11/2020 |
KLS Martin Individual Patient Solutions (IPS) Planning System |
KLS-Martin L.P. |
Jennifer Damato |
| K193311 |
03/25/2020 |
Aluna |
Knox Medical Diagnostics, Inc. |
Charvi Shetty |
| K191558 |
03/26/2020 |
Konan Specular Microscope XVII |
Konan Medical, Inc. |
Tatsuya Kasahara |
| K200328 |
03/11/2020 |
Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System |
Kyocera Medical Technologies, Inc. |
Anthony DeBenedictis |
| K193393 |
03/06/2020 |
BOND Ready-to-Use Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 (Concentrated Liquid Antibody Format). |
Leica Biosystems Newcastle Ltd. |
Matthew West |
| K192925 |
03/13/2020 |
32HL512D |
LG Electronics Inc. |
Jinhwan Jun |
| K200180 |
03/20/2020 |
MTS Omadacycline 0.002 - 32 ug/mL |
Liofilchem s. r. l. |
Fabio Brocco |
| K193446 |
03/10/2020 |
Bare: 808 |
LUVO Medical Technologies, Inc |
Gregory Berzak |
| K193072 |
03/05/2020 |
Lucent : IPL |
LUVO Medical Technologies, Inc. |
Gregory Berzak |
| K191027 |
03/18/2020 |
Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System |
Maquet Critical Care AB |
Kribu Valdre |
| K193560 |
03/20/2020 |
Materialise Shoulder Guide and Models, Materialise SurgiCase Shoulder Planner, Materialise Shoulder Planner, SurgiCase Shoulder Planner, SurgiCase Planner |
Materialise NV |
Veerle Vanderheyden |
| K200548 |
03/27/2020 |
CUBEScan BioCon-1100 |
Mcube Technology Co., Ltd. |
Hye-Ri Choi |
| K200075 |
03/13/2020 |
3DMetal Diaphyseal Femoral Cones |
Medacta International SA |
Stefano Baj |
| K192906 |
03/04/2020 |
Mecta-C Stand Alone |
Medacta International SA |
Stefano Baj |
| K200048 |
03/09/2020 |
MectaLIF Anterior Simple |
Medacta International SA |
Stefano Baj |
| K192967 |
03/25/2020 |
Medacta Shoulder System |
Medacta International, SA |
Stefano Baj |
| K193633 |
03/26/2020 |
APTUS« Ankle Trauma System 2.8/3.5 |
Medartis AG |
Andrea Kiefer-Schweizer |
| K193639 |
03/26/2020 |
APTUS« Foot 2.8-3.5 System |
Medartis AG |
Andrea Kiefer-Schweizer |
| K192753 |
03/17/2020 |
NeuralScan System |
Medeia, Inc. |
Slav Danev |
| K193652 |
03/26/2020 |
AbClose - Port Site Closure Device |
Medeon Biodesign, Inc. |
Tsung-Yu Hsieh |
| K192713 |
03/16/2020 |
Altera Filter and HME/Filter |
Meditera Tibbi Malzeme San. ve Tic. A.S. |
Cenk Kilic Kalkan |
| K191915 |
03/06/2020 |
SensiCare Sterile Power-Free Polymer Coated Polyisoprene Sugical Glove, Coated with Aloe V |
Medline Industries, Inc |
Jennifer Mason |
| K191753 |
03/17/2020 |
Medline Sterile Powder-Free Nitrile Examination Gloves - Green (Tested For Use with Chemotherapy Drugs) |
Medline Industries, Inc. |
Claire Pigman |
| K191638 |
03/12/2020 |
Pointe Scientific Cocaine Metabolite Enzyme Immunoassay |
MedTest Dx |
William Cripps |
| K193579 |
03/24/2020 |
PlasmaBlade X 3.0S LIGHT |
Medtronic Navigation |
Gina Cunsolo |
| K191788 |
03/23/2020 |
CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium, DIVERGENCE-L Anterior/Oblique Lumbar Fusion System |
Medtronic Sofamor Danek, USA Inc. |
Mia Wiggins |
| K200456 |
03/26/2020 |
Becker External Drainage and Monitoring System |
Medtronic, Inc. |
Nancy Hampton |
| K192389 |
03/27/2020 |
TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large) |
Medtronic, Inc. |
Nancy Cameron |
| K193145 |
03/24/2020 |
Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch |
Megadyne Medical Products, Inc. |
Sharon Sussex |
| K191872 |
03/02/2020 |
Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution |
Menicon Co., Ltd. |
Tetsuji Kawai |
| K192817 |
03/13/2020 |
Curian HpSA, Curian Analyzer |
Meridian Bioscience, Inc. |
Cathlena Martinez |
| K191991 |
03/05/2020 |
Ezfil |
Meta Biomed Co., Ltd. |
Suk Song Oh |
| K191680 |
03/20/2020 |
AZUR Vascular Plug |
MicroVention Inc. |
Ganesh Balachander |
| K191869 |
03/13/2020 |
Biogel(R) PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, Biogel(R) PI UltraTouch S Indicator Underglove with a Low Dermatitis Potential Claim |
Molnlycke Health Care, US LLC |
Leonard Stewart |
| K200443 |
03/17/2020 |
EndoTool IV 1.10 |
Monarch Medical Technologies, LLC |
Ann Marie Gaitan |
| K191838 |
03/20/2020 |
Clearform Aligners |
Motor City Lab Works |
Christina Groth |
| K193374 |
03/04/2020 |
TumEase Acupressure Bracelets |
MumEase |
Catherine Varley |
| K193211 |
03/20/2020 |
Nano FortiFix« System |
Nanovis Spine LLC |
Matthew Hedrick |
| K192813 |
03/06/2020 |
Plasma IQ |
Neauvia North America, Inc |
Misty Williams |
| K192162 |
03/13/2020 |
NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Plate |
NeuroVention LLC |
Rohit Khanna |
| K200455 |
03/31/2020 |
Trigger Switch and Cord |
New Deantronics Taiwan, Ltd. |
Jane Liu |
| K192338 |
03/12/2020 |
NEOLab Clear Aligners |
New England Ortho Lab, Inc. |
Olivia Channon |
| K200543 |
03/23/2020 |
NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) System |
Nexxt Spine LLC |
Andy Elsbury |
| K200040 |
03/30/2020 |
Universal Base Conical Connection (CC) |
Nobel Biocare AG |
Bernice Jim |
| K200349 |
03/13/2020 |
Stat Profile Prime Plus Analyzer System |
Nova Biomedical Corporation |
Rachel Gilbert |
| K191749 |
03/26/2020 |
TIGR Matrix Surgical Mesh, TIGR Surgical Mesh |
Novus Scientific AB |
Thomas Engstrom |
| K193593 |
03/25/2020 |
NuVasive 3DP Interfixated ALIF System |
NuVasive, Incorporated |
Jessica LeBlanc |
| K193541 |
03/30/2020 |
NuVasive Cohere Thoracolumbar Interbody System |
NuVasive, Incorporated |
Michelle Cheung |
| K191401 |
03/27/2020 |
PregSense |
Nuvo-Group Ltd. |
Adar Shani |
| K192241 |
03/13/2020 |
Halyard Purple Xtra and Purple Sterile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate |
O & M Haylard, Inc. |
Steven Dowdley |
| K200522 |
03/16/2020 |
AERO CHROME* Breathable Performance Surgical Gowns |
O&M Halyard, Inc |
Kimberly Lewis |
| K192164 |
03/06/2020 |
Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding Device CC-220DR |
Olympus Medical Systems Corp. |
Toshiyuki Nakajima |
| K193517 |
03/18/2020 |
ViziShot 2 FLEX |
Olympus Surgical Technologies America |
Mary Anne Patella |
| K193335 |
03/24/2020 |
Sherlock |
Open Implants, LLC |
Tamara Nazzal |
| K200275 |
03/03/2020 |
OVision Imaging System |
Ophthalmic Labs, Inc. |
Matthew Carnevale |
| K200269 |
03/04/2020 |
Sapphire II PRO |
OrbusNeich Medical Trading Inc. |
John Pazienza |
| K200281 |
03/31/2020 |
The Gecko Spinal System |
Ortho Development Corporation |
Divya Palan |
| K193052 |
03/27/2020 |
HBP6 Settable, Resorbable Hemostatic Bone Paste |
Orthocon, Inc. |
Howard Schrayer |
| K200097 |
03/16/2020 |
Response BandLoc Spinal Fixation |
OrthoPediatrics Corp. |
Jackie Jaskula |
| K193100 |
03/24/2020 |
RESPONSEÖ Spine System, RESPONSEÖ 4.5/5.0 Spine System, RESPONSEÖ 5.5/6.0 Spine System |
OrthoPediatrics, Corp |
Jackie Jaskula |
| K190652 |
03/06/2020 |
OSSIOfiberÖ Hammertoe Fixation System/OSSIOfiberÖ Hammertoe Fixation Implant |
Ossio Ltd. |
Taly Lindner |
| K200741 |
03/31/2020 |
Tablo Hemodialysis System |
Outset Medical, Inc. |
Jennifer Mascioli-Tudor |
| K191716 |
03/23/2020 |
Somryst |
Pear Therapeutics, Inc. |
David Amor |
| K193244 |
03/13/2020 |
Indigo Aspiration System û Lightning Aspiration Tubing |
Penumbra, Inc. |
Micaela Victoria |
| K200304 |
03/06/2020 |
EPIQ Diagnostic Ultrasound System |
Philips Ultrasound, Inc. |
Linda Schulz |
| K193468 |
03/12/2020 |
Tritium Sternal Cable Plate System |
Pioneer Surgical Technology, Inc. (dba RTI Surgical, Inc.) |
Linda Busklein |
| K200278 |
03/31/2020 |
CytoCore |
Praxis Medical, LLC |
John Fisher |
| K192732 |
03/26/2020 |
BodyGuardian Remote Monitoring System |
Preventice Technologies, Inc. |
Charles Rector |
| K193325 |
03/13/2020 |
Avantgarde Faecal Management Systems, Avantgarde Faecal Management System Replacement Pouches |
ProSys International Ltd |
Graham Steer |
| K200363 |
03/11/2020 |
Quidel Triage« TOX Drug Screen, 94600 |
Quidel Cardiovascular Inc. |
Rachael S Williamson |
| K192724 |
03/26/2020 |
Propeller Sensor for Symbicort |
Reciprocal Labs Corporation |
Greg Dunkelberger |
| K190978 |
03/12/2020 |
RefleXion Medical Radiotherapy System |
RefleXion Medical, Inc. |
Kathy OÆShaughnessy |
| K200094 |
03/18/2020 |
speX LP Support Catheter |
Reflow Medical |
Krystal Santiago |
| K193491 |
03/19/2020 |
restor3d Metallic Interference Screw |
restor3D |
Nathan Evans |
| K192815 |
03/09/2020 |
Elecsys BRAHMS PCT |
Roche Diagnostics |
Wes Gerbig |
| K193053 |
03/26/2020 |
Tina-quant Hemoglobin A1cDx Gen.3 |
Roche Diagnostics Operations (RDO) |
Leslie Patterson |
| K183425 |
03/02/2020 |
CARDIOVIT AT-102 G2 |
Schiller AG |
Sabina Standiford |
| K193229 |
03/05/2020 |
Transpara |
ScreenPoint Medical B.V. |
Umar Waqas |
| K193615 |
03/25/2020 |
NorthStarÖ OCT Spinal System |
SeaSpine Orthopedics Corporation |
Alicia McArthur |
| K193418 |
03/13/2020 |
SeaSpine Skipjack System |
SeaSpine Orthopedics Corporation |
Aly Alvarez |
| K193054 |
03/31/2020 |
Sectra Digital Pathology Module |
Sectra AB |
Edoardo Mastrovito |
| K191860 |
03/31/2020 |
Sterile Powder-Free Synthetic Rubber SurgeonÆs Glove with Low Dermatitis Potential |
Semperit Technische Produkte Gesellchaft m.b.H. |
Andreas Woess |
| K191655 |
03/06/2020 |
MEGAFIX« Pedicle Screw Spinal System |
SeohanCare Co., Ltd |
Chae Lynn Song |
| K193200 |
03/27/2020 |
uMR Omega |
Shanghai United Imaging Healthcare Co., Ltd. |
Xin Gao |
| K200036 |
03/20/2020 |
AI-ECG Tracker |
Shenzhen Carewell Electronics Co., Ltd. |
Chang Liu |
| K193629 |
03/25/2020 |
Disposable NIBP Cuff |
Shenzhen Changke Connect Electronics Co., Ltd. |
Yahui Zhou |
| K200069 |
03/13/2020 |
Disposable SpO2 Sensor |
Shenzhen Changke Connect Electronics Co., Ltd. |
Yahui Zhou |
| K190783 |
03/14/2020 |
Health Expert Electronic Stimulator (model: AST-3000L) |
Shenzhen OSTO Technology Company Limited |
Li Yang |
| K193524 |
03/31/2020 |
SI-BONE iFuse Implant System« |
Si-Bone, Inc |
Susan Noriega |
| K192240 |
03/27/2020 |
RAPIDPoint 500e Blood Gas System |
Siemens Healthcare Diagnostics, Inc. |
Lois Parillon |
| K192924 |
03/11/2020 |
MAGNETOM Vida, MAGNETOM Lumina, MAGNETOM Vida Fit |
Siemens Medical Solutions USA Inc. |
Andrew Turner |
| K193267 |
03/16/2020 |
Al-Rad Companion (Musculoskeletal) |
Siemens Medical Solutions USA, Inc. |
Alaine Medio |
| K193089 |
03/20/2020 |
MULTIX Impact |
Siemens Medical Solutions USA, Inc. |
Martin Rajchel |
| K200474 |
03/20/2020 |
Symbia 6.7 |
Siemens Medical Solutions USA, Inc. |
Cynthia Busch |
| K193216 |
03/09/2020 |
syngo.CT Lung CAD |
Siemens Medical Solutions, Inc |
Abhineet Johri |
| K200515 |
03/25/2020 |
syngo.CT Cardiac Planning |
Siemens Medical Soultions USA, Inc. |
Veronica Padharia |
| K200140 |
03/27/2020 |
Silhouette Instalift |
Silhouette Lift Inc. |
Anthony DiBernardo |
| K193558 |
03/18/2020 |
HEALICOIL Knotless Suture Anchors |
Smith & Nephew, Inc. |
Camille Black |
| K200407 |
03/13/2020 |
LEGION Inserts with JRNY Lock |
Smith & Nephew, Inc. |
Konrad Wolfmeyer |
| K200331 |
03/10/2020 |
Rapid Acoustic Pulse Device |
Soliton Inc. |
Leslie Honda |
| K193581 |
03/20/2020 |
Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Lilac, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Orchid, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemot |
Sri Trang Gloves (Thailand) Public Company Limited |
Jarinya Jirojkul |
| K191184 |
03/05/2020 |
ImmuView S pneumoniae and L pneumophila Urinary Antigen Test |
SSI Diagnostica A/S |
Pernille Landsbo Elverdal |
| K193147 |
03/05/2020 |
Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System |
Stereotaxis, Inc. |
Kenneth H. Lock |
| K200310 |
03/06/2020 |
1688 Pendulum 4K Camera Head with Integrated Coupler, 1688 4K Camera Control Unit with Advanced Imaging Modality |
Stryker |
April Malmborg |
| K193136 |
03/26/2020 |
Stryker Customized Mandible Recon Plate Kit |
Stryker |
Zainab Amini |
| K193143 |
03/26/2020 |
Stryker Facial iD Plating System |
Stryker |
Zainab Amini |
| K200493 |
03/21/2020 |
Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgical Togas, Zippered with Peel Away Face Shield, Stryker T7 Surgical Togas, Pullover |
Stryker Corporation |
Corinne Larke-Grass |
| K192818 |
03/31/2020 |
Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal System |
Stryker Corporation |
Kristi Ashton |
| K193366 |
03/20/2020 |
T2 ICF |
Stryker GmbH |
Cindy Leon |
| K191827 |
03/16/2020 |
Sunmed Disposable Angio-Closure Pads |
Sunny Medical Device (Shenzhen) Co.,Ltd. |
James Qi Zhang |
| K191057 |
03/19/2020 |
Park's Pectus System |
TDM Co. Ltd. |
Jung-Wook Choi |
| K193530 |
03/19/2020 |
Deklene MAXX |
Teleflex Medical |
Robin Haden |
| K192490 |
03/30/2020 |
Tevdek II, Silky II Polydek, 'Cottony' II, NextStitch |
Teleflex Medical |
Robin Haden |
| K191705 |
03/16/2020 |
OptikView GUP2103CMI |
The Linden Group Corp |
James Chen |
| K190767 |
03/16/2020 |
AnatomicAligner |
The Methodist Hospital Research Institute d/b/a Houston |
Christina Talley |
| K192854 |
03/25/2020 |
MammoScreen |
Therapixel |
Quentin de Snoeck |
| K193538 |
03/12/2020 |
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 ╡g/ml |
Thermo Fisher Scientific |
Cynthia Knapp |
| K192388 |
03/12/2020 |
SonoVision Ultrasound Imaging System |
Tissue Differentiation Intelligence, LLC |
Christian Zaal |
| K200379 |
03/19/2020 |
Super Sheath |
TOGO MEDIKIT CO., LTD. |
Daisuke Nagamizu |
| K200360 |
03/05/2020 |
TrackX |
Track X Technology, LLC |
David Skwerer |
| K200049 |
03/09/2020 |
Senhance Surgical System |
TransEnterix, Inc. |
Kaitlyn Alexander |
| K200183 |
03/13/2020 |
CS 9600 |
Trophy |
Marie-Pierre Labat-Camy |
| K192810 |
03/11/2020 |
Apollo Suture Anchor System |
Valeris Medical |
Brendan Thies |
| K193108 |
03/26/2020 |
Bonecam Suture Anchor |
Valeris Medical Inc. |
Brendan Thies |
| K200314 |
03/04/2020 |
Capere Thrombectomy System |
Vascular Medcure, Inc. |
Jeffrey P DuMontelle |
| K200418 |
03/18/2020 |
VIVIX-S VW |
Vieworks Co., Ltd. |
Jordin Kim |
| K192008 |
03/25/2020 |
LaserShot M, NaviLase |
Vitrolife GmbH |
Susanne Schweitzer |
| K193658 |
03/18/2020 |
Viz ICH |
Viz.ai, Inc. |
Gregory Ramina |
| K200294 |
03/27/2020 |
GrandioSO Light Flow |
VOCO GmbH |
M Th Plaumann |
| K192886 |
03/26/2020 |
OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip |
Volcano Corporation |
Jenny Fu |
| K200113 |
03/18/2020 |
LINK TrabecuLink Tibial Cones |
Waldemar Link GmbH & Co. KG |
Stefanie Fuchs |
| K200110 |
03/16/2020 |
SANDRO Dual |
WON TECH Co., Ltd. |
Lana Hong |
| K200136 |
03/17/2020 |
Shear Wave Quantificational Ultrasound Diagnostic System |
Wuxi Hisky Medical Technologies Co., Ltd. |
Jinhua Shao |
| K192637 |
03/02/2020 |
High Strength Suture |
Yunyi (Beijing) Medical Device Co., LTD |
Xiaowei Liu |
| K191568 |
03/06/2020 |
sam 2.0 Long Duration Ultrasound System |
ZetrOZ Systems, LLC |
Sabrina Lewis |
| K191900 |
03/27/2020 |
Single Use Grasping Forceps |
Zhejiang Chuangxiang Medical Technology Co., LTD. |
Lucius Long |
| K191735 |
03/20/2020 |
CPT Hip System |
Zimmer Inc |
Caleb Barylski |
| K200151 |
03/17/2020 |
Persona Partial Knee Tibial Cut Guide 5 Deg Left Medial Right Lateral, Persona Partial Knee Tibial Cut Guide 5 Deg Right Medial Left Lateral, Persona Partial Knee 2MM Tibial Recutter Left Medial Right Lateral, Persona Partial Knee 2MM Tibial Recutter Righ |
Zimmer, Inc. |
Pankti Shah |
| K200209 |
03/24/2020 |
Persona Personalized Knee System |
Zimmer, Inc. |
Gregory Foster |
