| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K192937 |
10/18/2019 |
3M Comply Hydrogen Peroxide Chemical Indicator |
3M Company |
Mary Fretland |
| K192961 |
10/22/2019 |
ADH19 |
3M Deutschland GmbH |
Ruediger Franke |
| K192992 |
10/25/2019 |
Suglue 3 |
3M Deutschland GMBH |
Desi W. Soegiarto |
| K192945 |
10/18/2019 |
7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application |
7D Surgical Inc. |
Daniel Zisind |
| K193015 |
10/29/2019 |
HydroPICC (PICC-142) |
Access Vascular, Inc |
Brian Hanley |
| K193041 |
10/31/2019 |
Hemochron Signature Elite |
Accriva Diagnostics, Inc. |
Brian James |
| K192887 |
10/10/2019 |
Revitive Medic Plus, Revitive Advanced 2 |
Actegy, Ltd. |
Lawrence Brookfield |
| K193013 |
10/29/2019 |
AcQMap High Resolution Imaging and Mapping System |
Acutus Medical, Inc. |
Karla Schaffner |
| K192898 |
10/11/2019 |
PneumoLiner |
Advanced Surgical Concepts |
Edward Hyland |
| K192938 |
10/18/2019 |
InvictusÖ Spinal Fixation System |
Alphatec Spine, Inc. |
Cynthia Adams |
| K192944 |
10/18/2019 |
AncestryDNA Factor V Leiden Genetic Health Risk Test |
Ancestry Genomics, Inc. |
Raajdeep Venkatesan |
| K192947 |
10/18/2019 |
AncestryDNA Saliva Collection Kit |
Ancestry Genomics, Inc. |
Raajdeep Venkatesan |
| K192864 |
10/07/2019 |
UNI*FUSE Infusion System with Cooper Wire |
Angiodynamics, Inc. |
Brandon M. Brackett |
| K192912 |
10/15/2019 |
AutoMIStar |
Apollo Medical Imaging Technology Pty. Ltd. |
Qing Yang |
| K192953 |
10/21/2019 |
APTOS Threads û Polypropylene Surgical Sutures |
APTOS, LLC. |
Nikolai Pirtskhalaichvili |
| K192846 |
10/03/2019 |
Argen Clear Aligner, Argen Clear Aligner Premium |
Argen Corporation |
Paul Cascone |
| K192930 |
10/17/2019 |
Dymaxeon Spine System |
Back 2 Basics Direct, LLC |
Lou Keppler |
| K192829 |
10/02/2019 |
Demetra BDEM-01 Dermatoscope |
Barco NV |
Julie Vandecandelaere |
| K192948 |
10/18/2019 |
EleVation Breast Biopsy Driver, EleVation Breast Biopsy Probe - 10G, EleVation Breast Biopsy Probe - 14G |
Bard Peripheral Vascular, Inc. |
Meghan McKelvey |
| K193028 |
10/30/2019 |
MEDRAD Mark 7 Arterion Injection System |
Bayer Medical Care Inc. |
Kelly Frank |
| K192880 |
10/09/2019 |
InferRead Lung CT.AI |
Beijing Infervision Technology Co.,Ltd. |
Xiaoyan Fan |
| K192942 |
10/18/2019 |
ALLthread Titanium Suture Anchor |
Biomet Inc. |
Saveetha Raghupathi |
| K192996 |
10/28/2019 |
Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool |
Biotronik, Inc |
Jon Brumbaugh |
| K192958 |
10/22/2019 |
TwitchView System |
Blink Device Company |
Justin Hulvershorn |
| K192867 |
10/07/2019 |
Apyx Helium Plasma Generator (APYX-200H/P, APYX-JS3/RS3) |
Bovie Medical Corporation dba Apyx Medical Corporation |
Topaz Kirlew |
| K192822 |
10/01/2019 |
Benesta Hysteroscope |
Caldera Medical, Inc. |
Vicki Gail |
| K192828 |
10/02/2019 |
Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System |
Canon Medical Systems Corporation |
Paul Biggins |
| K192832 |
10/02/2019 |
Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i |
Canon Medical Systems Corporation |
Paul Biggins |
| K193021 |
10/30/2019 |
Vantage Orian 1.5T, MRT-1550, V6.0 |
Canon Medical Systems Corporation |
Paul Biggins |
| K192923 |
10/16/2019 |
Vitrea Software Package |
Canon Medical Systems Corporation |
Paul Biggins |
| K192894 |
10/11/2019 |
Vita Flex CR System with LLI |
Carestream Health, Inc. |
Duane Gutowski |
| K192871 |
10/08/2019 |
B. anthracis Real-time PCR Assay |
Centers for Disease Control and Prevention |
Yon Yu |
| K192885 |
10/10/2019 |
C.T.M. Mobility Scooter HS-268 |
Chien Ti Enterprise Co., Ltd. |
Vivian Lo |
| K192939 |
10/18/2019 |
Volumetric Specimen Imager |
Clarix Imaging |
Xiao han |
| K192954 |
10/21/2019 |
Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl |
Comfort Rubber Gloves Industries Sdn. Bhd. |
Ng Kok Howe |
| K192841 |
10/03/2019 |
InPen System |
Companion Medical, Inc. |
Jasper Benke |
| K193042 |
10/31/2019 |
Optimized Positioning System (OPS) ReView |
Corin USA |
Lucinda Gerber |
| K192905 |
10/15/2019 |
Creo Electrosurgical System with HS1 Hemostasis Accessory |
Creo Medical Ltd. |
Leif Geoghegan |
| K193043 |
10/31/2019 |
Critical Alert CommonPath Enterprise |
Critical Alert |
John Elms |
| K192863 |
10/07/2019 |
MONDRIAN Lumbar Interbody Fusion Cage System |
CTL Medical Corporation |
Sean Suh |
| K193019 |
10/29/2019 |
DANNIK Disposable Monopolar Laparoscopic Instrument |
Dannik |
Olga Haberlad |
| K192973 |
10/24/2019 |
densitas densityai |
Densitas, Inc. |
Mo Abdolell |
| K192806 |
10/01/2019 |
DENTCA Crown and Bridge |
Dentca, Inc. |
Jason Lee |
| K192855 |
10/04/2019 |
DELTA XTEND(TM) Reverse Shoulder System |
DePuy (Ireland) |
Ashley Goncalo |
| K192946 |
10/18/2019 |
DePuy Corail AMT Hip Prosthesis |
DePuy Orthopaedics, Inc. |
Kathy Harris |
| K192919 |
10/15/2019 |
Pinnacle Duofix HA Acetabular Cup Prosthesis |
DePuy Orthopaedics, Inc. |
Kathy Harris |
| K193027 |
10/30/2019 |
Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French |
DeRoyal Industries, Inc. |
Sarah Bennett |
| K193005 |
10/28/2019 |
DIMI RRT System |
Dialco Medical Inc. |
Danijela Domljanovic |
| K192847 |
10/03/2019 |
AUTOLIGN |
Diorco Co., Ltd. |
Yongkyu Jin |
| K192830 |
10/02/2019 |
Bright Temporary C&B |
DMP Dental Industry S.A. |
Dimitris Prantsidis |
| K192920 |
10/16/2019 |
Oragene«òDx |
DNA Genotek Inc. |
Austin Udocor |
| K193017 |
10/29/2019 |
EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP |
DRTECH Corporation |
Shin Dongwook |
| K193031 |
10/30/2019 |
EXPD 4343P, EXPD 3643P |
DRTECH Corporation |
Dongwook Shin |
| K192889 |
10/10/2019 |
Neo |
eemagine Medical Imaging Solutions GmbH |
Maarten Van De Velde |
| K192951 |
10/21/2019 |
Ellipse Frax 1940 for Ellipse Nordlys and Ellipse Ydun |
Ellipse A/S |
Ole Kofod |
| K192842 |
10/03/2019 |
HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High |
Eurotrol B.V. |
Elisanne Biemans |
| K192888 |
10/10/2019 |
EzOrtho |
Ewoo Soft Co., Ltd. |
Young Seok Kim |
| K192969 |
10/23/2019 |
Ezra Plexo Software |
Ezra AI Inc. |
David Girard |
| K192928 |
10/17/2019 |
Optiflux Enexa F500 Dialyzer |
Fresenius Medical Care Reanal Therapies Group LLC |
Denise Oppermann |
| K192932 |
10/17/2019 |
FDR D-EVO III flat panel detector system |
FUJIFILM Corporation |
Randy Vader |
| K192918 |
10/15/2019 |
Video Laparoscope, Video Processor, Light Source |
FUJIFILM Corporation |
Randy Vader |
| K192956 |
10/21/2019 |
Auto Positioning |
GE Hangwei Medical Systems, Co., Ltd. |
Yonghui Han |
| K192917 |
10/15/2019 |
ViewPoint 6 |
GE Medical Systems Ultrasound and |
Tracey Ortiz |
| K192819 |
10/01/2019 |
OEC Elite |
GE OEC Medical Systems, Inc. |
Kenny M Bello |
| K192922 |
10/16/2019 |
Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter |
Gentuity, LLC |
David Kolstad |
| K192915 |
10/15/2019 |
GMA 2.0 Pedicle Screw System |
Grafton Medical Alliance |
James Henry |
| K193033 |
10/31/2019 |
GSI Audera Pro |
Grason Stadler |
Brent Nissly |
| K192851 |
10/03/2019 |
OASIS MRI System |
Hitachi Healthcare Americas |
Aaron Pierce |
| K192859 |
10/04/2019 |
CareSens S Clear BT Blood Glucose Monitoring System |
i-SENS, Inc. |
Joon Ho Jung |
| K192962 |
10/22/2019 |
icobrain-ctp |
Icometrix NV |
Dirk Smeets |
| K192897 |
10/11/2019 |
icotec Cervical Cage |
icotec ag |
Marina Hess |
| K193020 |
10/30/2019 |
VenaPro Vascular Therapy System |
Innovamed Health, LLC |
Luke Zeutzius |
| K192998 |
10/28/2019 |
Reprocessed BRK Transseptal Needle |
Innovative Health, LLC. |
Amanda Babcock |
| K192843 |
10/03/2019 |
INNOVITA HCG Pregnancy Rapid Test Strip, INNOVITA HCG Pregnancy Rapid Test Cassette, INNOVITA HCG Pregnancy Rapid Test Midstream |
Innovita (Tangshan) Biological Technology Co., Ltd |
Leo Lee |
| K192893 |
10/11/2019 |
Straumann Ceramic Healing Abutments |
Institut Straumann AG |
Laure Kuhner Borsenberger |
| K192852 |
10/03/2019 |
MRI ECG Patient Cable |
Ivy Biomedical Systems, Inc. |
Alejandra Aceves |
| K192987 |
10/25/2019 |
Aina HbA1c Monitoring System 2 |
Jana Care, Inc |
Michal Depa |
| K193022 |
10/30/2019 |
Retractable Safety Insulin Syringe |
Jiangsu Caina Medical Co.,Ltd. |
Xinyan Ruan |
| K192911 |
10/15/2019 |
Brainlab Compatible K2M Navigation Instruments |
K2M, Inc. |
Oonagh Lahiff |
| K192963 |
10/23/2019 |
Kogent Torus Ultrasonic Aspirator |
Katalyst Surgical, LLC |
Meryl Koch Wilhelm |
| K192845 |
10/03/2019 |
Sperm Freeze, Sperm Fridge |
Kitazato Corporation |
Futoshi Inoue |
| K192979 |
10/24/2019 |
KLS Martin Individual Patient Solutions (IPS) Planning System |
KLS-Martin L.P. |
Jennifer Damato |
| K192966 |
10/23/2019 |
FlowMet |
Laser Associated Sciences, Inc. |
Sean White |
| K192925 |
10/16/2019 |
32HL512D |
LG Electronics Inc. |
Jinhwan Jun |
| K193007 |
10/28/2019 |
LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module |
LiNA Medical ApS |
Jaroslaw Mr?wczynski |
| K192856 |
10/04/2019 |
MT One |
M&T SRL |
Fiorenzo Rossi |
| K192834 |
10/02/2019 |
MECTA Sigma |
Mecta Corporation |
Robin Nicol |
| K192906 |
10/15/2019 |
Mecta-C Stand Alone |
Medacta International SA |
Stefano Baj |
| K192827 |
10/02/2019 |
Quadra-P |
Medacta International SA |
Stefano Baj |
| K192967 |
10/23/2019 |
Medacta Shoulder System |
Medacta International, SA |
Stefano Baj |
| K192984 |
10/25/2019 |
APTUS Clavicle System |
Medartis AG |
Andrea Kiefer-Schweizer |
| K192891 |
10/10/2019 |
Laparoscope Lens Shield Device (LENS) |
Medeon Biodesign, Inc |
Tsung-Yu Hsieh |
| K192807 |
10/01/2019 |
Duo-Flow Side x Side Double Lumen Catheter |
Medical Components Inc. (dba MedComp) |
Courtney Nix |
| K192988 |
10/25/2019 |
Dermasure Green Sterile SyntheticPolychloroprene Powder-Free Surgical Glove Tested for Use |
Medline Industries, Inc. |
Jennifer Mason |
| K192985 |
10/25/2019 |
Medline Glide-On 3G Vinyl Examination Gloves |
Medline Industries, Inc. |
Stephanie Augsburg |
| K192820 |
10/01/2019 |
SensiCare Neoprene Synthetic Polychloroprene Surgical Glove (Tested for Use with Chemotherapy Drugs) |
Medline Industries, Inc. |
Matt Clausen |
| K192804 |
10/01/2019 |
CEREBASE DA Guide Sheath, 95cm, CEREBASE DA Guide Sheath, 90cm, CEREBASE DA Guide Sheath, 80cm, CEREBASE DA Guide Sheath, 70cm |
Medos International SARL |
Michael Liao |
| K193011 |
10/29/2019 |
CD HorizonÖ Fenestrated Screw Set |
Medtronic Sofamor Danek USA, Inc. |
Lee Grant |
| K192817 |
10/01/2019 |
Curian HpSA, Curian Analyzer |
Meridian Bioscience, Inc. |
Cathlena Martinez |
| K192907 |
10/15/2019 |
Advocate PTA Catheter |
Merit Medical Systems Inc. |
Mark Mullaney |
| K192809 |
10/01/2019 |
Dental Handpiece |
Micro-NX Co., Ltd. |
Sojeong Park |
| K192943 |
10/18/2019 |
CEDIA Heroin Metabolite (6-AM) assay |
Microgenics Corporation |
Sharron Penn |
| K192813 |
10/01/2019 |
Plasma IQ |
Neauvia North America, Inc |
Misty Williams |
| K193004 |
10/28/2019 |
Monopolar Cord |
New Deantronics Taiwan Ltd |
Jane Liu |
| K192900 |
10/15/2019 |
H500 Multi-Sensing Oximetry System |
Nonin Medical, Inc. |
Kim E Aves |
| K193016 |
10/29/2019 |
PRECICE Bone Transport System |
NuVasive Specialized Orthopedics, Inc. |
Madison Heffron |
| K193039 |
10/31/2019 |
Single Use Balloon Dilator V (with knife) |
Olympus Medical Systems Corp. |
Toshiyuki Nakajima |
| K193026 |
10/30/2019 |
Visera Elite II Video System Center, Visera Elite II Endoeye 3D |
Olympus Medical Systems Corp. |
Toshiyuki Nakajima |
| K192941 |
10/18/2019 |
HySil Super Fast Impression Materials |
Osstem Implant Co., Ltd. |
Jungmin Yoo |
| K192995 |
10/25/2019 |
OsteoRemedies Hip Spacer System |
OsteoRemedies, LLC |
Eric Stookey |
| K192994 |
10/25/2019 |
Paragon 28 APEX 3D Total Ankle Replacement System |
Paragon 28, Inc. |
Eric Lintula |
| K192824 |
10/02/2019 |
Parcus Knotless AP Suture Anchors |
Parcus Medical, LLC |
Paul Vagts |
| K192964 |
10/23/2019 |
Parcus Synd-EZ SS |
Parcus Medical, LLC |
Paul Vagts |
| K193036 |
10/31/2019 |
C2 CryoBalloon EndoGrip |
PENTAX Medical, A Division of PENTAX of America, Inc. |
Gurvinder Singh Nanda |
| K192981 |
10/24/2019 |
Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12 |
Penumbra, Inc |
Teri Nguyen |
| K192833 |
10/02/2019 |
Indigo Aspiration System |
Penumbra, Inc. |
Teri Nguyen |
| K192955 |
10/21/2019 |
Penumbra LP Coil System |
Penumbra, Inc. |
Anush Puvvada |
| K192875 |
10/08/2019 |
Philips Biosensor BX100 |
Philips Medical Systems |
Suzanne Goodman |
| K192914 |
10/15/2019 |
Stimuplex Onvision System |
Philips Medical Systems Nederland B.V. |
Gert de Vries |
| K192869 |
10/07/2019 |
SherpaPak Lung Preservation System , SherpaPak Liver Transport System |
Pragonix Technologies |
Lisa Anderson |
| K192858 |
10/04/2019 |
A1AT Genotyping Test |
Progenika Biopharma S.A., A Grifols Company |
Diego Tejedor |
| K193009 |
10/28/2019 |
Promisemed Heel Blood Lancet |
Promisemed Hangzhou Meditech Co., Ltd. |
Zearou Yang |
| K192990 |
10/25/2019 |
Litho Evo |
Quanta System spa |
Francesco Dell'Antonio |
| K192850 |
10/03/2019 |
Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22 |
Qura S.r.l. |
Raffaella Tommasini |
| K193032 |
10/31/2019 |
KY Grosz Liquid |
RB Health (US) LLC |
Elizabeth Viguerie |
| K192982 |
10/25/2019 |
KY Grosz UltraGel |
RB Health (US) LLC |
Elizabeth Viguerie |
| K193012 |
10/29/2019 |
speX Support Catheter |
ReFlow Medical |
Krystal Santiago |
| K192815 |
10/01/2019 |
Elecsys BRAHMS PCT |
Roche Diagnostics |
Wes Gerbig |
| K192926 |
10/16/2019 |
RxSight Insertion Device |
RxSight, Inc. |
Maureen O'Connell |
| K192903 |
10/15/2019 |
RS85 Diagnostic Ultrasound System |
Samsung Medison Co., Ltd |
Ji Yea Lee |
| K192910 |
10/15/2019 |
STATClave G4 Chamber Autoclave |
SciCan Ltd. |
Teresa Boyce |
| K193040 |
10/31/2019 |
Resorbable Mesh Device |
SeaSpine Orthopedics Corporation |
Caryn Sailor |
| K192936 |
10/18/2019 |
Soltus 500 |
Sedecal., SA. |
Ma Luisa Gomez de Aguero |
| K192890 |
10/10/2019 |
SentEP |
SentiAR, Inc |
Berk Tas |
| K193001 |
10/28/2019 |
Albumin BCP |
Sentinel CH. SpA |
Patricia Dupe |
| K192972 |
10/24/2019 |
Patient Monitor |
Shenzhen Mindray Bio-medical Electronics Co., LTD. |
Yanhong Bai |
| K192924 |
10/16/2019 |
MAGNETOM Vida, MAGNETOM Lumina, MAGNETOM Vida Fit |
Siemens Medical Solutions USA Inc. |
Andrew Turner |
| K192835 |
10/02/2019 |
ACUSON NX3 Diagnostic Ultrasound System / ACUSON NX3 Elite Diagnostic Ultrasound System |
Siemens Medical Solutions, USA, Inc. |
Hyunjung Lee |
| K192883 |
10/10/2019 |
Spartan Hip Stem |
Signature Orthopaedics Pty Ltd. |
Declan Brazil |
| K192866 |
10/07/2019 |
Chemfort CSTD |
Simplivia Healthcare Ltd. |
Itsik Shmueli |
| K192876 |
10/08/2019 |
INTELLIO Tablet Application |
Smith & Nephew |
Janice Haselton |
| K193029 |
10/30/2019 |
CONQUEST FN |
Smith & Nephew, Inc. |
Thomas Fearnley |
| K193003 |
10/28/2019 |
NemoCast |
Software Nemotec S.L. |
Carlos Arias |
| K192873 |
10/08/2019 |
SX-One MicroKnife |
Sonex Health, Inc. |
Aaron Keenan |
| K192838 |
10/03/2019 |
Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure |
Spectrum Medical Ltd |
Colleen Powell |
| K192993 |
10/25/2019 |
SCARLET AL-T |
Spineart |
Franck Pennesi |
| K192952 |
10/21/2019 |
Spire Health Remote Patient Monitoring System |
Spire, Inc. d/b/a Spire Health |
Joanne Hollenbach |
| K192929 |
10/17/2019 |
SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 |
STERIS Corporation |
Jennifer Nalepka |
| K192818 |
10/01/2019 |
Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal System |
Stryker Corporation |
Kristi Ashton |
| K193034 |
10/31/2019 |
AXS Infinity LS Plus Long Sheath |
Stryker Neurovascular |
Shivani H Patel |
| K193018 |
10/29/2019 |
Surgical Direct Hand-held Laparoscopic Instruments |
Surgical Direct, Inc. |
David Murray |
| K192854 |
10/04/2019 |
MammoScreen |
Therapixel |
Quentin de Snoeck |
| K193024 |
10/30/2019 |
Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint, Susceptibility System with Lefamulin in the dilution range of 0.008-16ug/mL |
Thermo Fisher Scientific |
Cynthia Knapp |
| K193006 |
10/28/2019 |
MagVenture TMS Therapy û for treatment of OCD, MagVenture TMS Therapy system |
Tonica Elektronik A/S |
Sanne Barsballe Jessen |
| K192877 |
10/08/2019 |
Senhance Surgical System |
TransEnterix, Inc. |
Kaitlyn Alexander |
| K192974 |
10/24/2019 |
Tyber Medical Trauma Screw |
Tyber Medical LLC |
Mark Schenk |
| K192975 |
10/24/2019 |
Tyber Medical Trauma Screws |
Tyber Medical LLC |
Mark Schenk |
| K192872 |
10/08/2019 |
ulrichINJECT CT Motion |
ulrich GmbH & Co. KG |
Sven Erdmann |
| K192810 |
10/01/2019 |
Apollo Suture Anchor System |
Valeris Medical |
Brendan Thies |
| K192968 |
10/23/2019 |
IDENTIFY |
Varian Medical Systems, Inc. |
Peter J Coronado |
| K192935 |
10/17/2019 |
CAPERE Thrombectomy System |
Vascular Medcure, Inc. |
Jeffrey P DuMontelle |
| K192991 |
10/25/2019 |
Vesco Medical Extension Feeding Set |
Vesco Medical LLC |
Chris O'Keefe |
| K192957 |
10/21/2019 |
VivaChek Blood Glucose and B-Ketone Monitoring System |
Vivachek Biotech (Hangzhou) Co., Ltd |
Mark Qian |
| K192886 |
10/10/2019 |
OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip |
Volcano Corporation |
Jenny Fu |
| K192908 |
10/15/2019 |
Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes |
Wilson-Cook Medical, Inc |
Tiffanny A. Thomas |
| K192901 |
10/15/2019 |
HealthVCF |
Zebra Medical Vision Ltd. |
Flair Bar |
| K193030 |
10/30/2019 |
Avenir Muller Stem, Avenir Cemented Hip Stem |
Zimmer GmbH |
Roberto Tommasini |
| K192940 |
10/18/2019 |
CoolTone |
Zimmer MedizinSysteme GmbH |
Ute Hauss |
