| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K221885 |
06/29/2022 |
23andMe Personal Genome Service (PGS) Pharmacogenetic Reports |
23andMe, Inc. |
Marianna Frendo |
| K221695 |
06/10/2022 |
3M Filtek Supreme Flowable Restorative |
3M Company ESPE Dental Products |
Regina Feferman-Savvateev |
| K221585 |
06/01/2022 |
3M V.A.C. Veraflo Cleanse Choice Dressing Kit, 3M Veraflo Cleanse Choice Complete Dressing Kit |
3M Health Care Business Group |
Margaret Marsh |
| K221664 |
06/08/2022 |
CLEARinse CTS Specimen Collection and Transport System |
Aardvark Medical, Inc. |
Steven Bacich |
| K221750 |
06/16/2022 |
CPS AIM Universal II Slittable Inner Catheter |
Abbott Medical |
Indira Verdekel |
| K221796 |
06/21/2022 |
Cyware 4H and Cysart 4H |
Abys Medical |
Arnaud Destainville |
| K221901 |
06/30/2022 |
EleGARD |
AdvancedCPR Solutions LLC |
Philip Faris |
| K221719 |
06/13/2022 |
ABTross ALIF Expandable Cage System |
Aegis Spine, Inc. |
KiHyang Kim |
| K221907 |
06/30/2022 |
RhinAer« Stylus (FG1393) |
Aerin Medical Inc. |
Shannon Scott |
| K221574 |
06/01/2022 |
LUDWIG Electrosurgical Device |
Aesthetics Biomedical |
Lawrence A. Rheins |
| K221913 |
06/30/2022 |
Arm Blood Pressure Monitor |
Alicn Medical Shenzhen,Inc |
Fang Meisong |
| K221637 |
06/06/2022 |
Surgical Gown (Sterile); Surgical Gown (Non-sterile) |
Allmed Medical (Hubei) Protective Products Co., Ltd |
Vince Tian |
| K221821 |
06/23/2022 |
ATEC IOM Accessory Instruments |
Alphatec Spine, Inc. |
Sandy Gill |
| K221576 |
06/01/2022 |
Ameda Pearl Electric Breast Pump |
Ameda, Inc. |
Sean Pettibone |
| K221883 |
06/29/2022 |
Solero Microwave Tissue Ablation (MTA) System and Accessories |
AngioDynamics, Inc. |
Kasey E Newcomb |
| K221590 |
06/02/2022 |
NaviCam Small Bowel Capsule Endoscopy System |
ANKON Technologies Co., Ltd. |
Si Feng Wang |
| K221608 |
06/03/2022 |
NaviCam Capsule Endoscope System with NaviCam Stomach Capsule and NaviCam Tether, NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule and NaviCam Tether |
AnX Robotica Corp |
Tim Thomas |
| K221830 |
06/23/2022 |
Apyx One Console |
Apyx Medical Corporation |
David Ceretti |
| K221841 |
06/24/2022 |
EOlife« |
ARCHEON |
Valentine OQDA |
| K221711 |
06/13/2022 |
AccuICAS |
ArteryFlow Technology Co., Ltd. |
Jianping Xiang |
| K221742 |
06/15/2022 |
CONNEQT PULSE |
Atcor Medical |
Toni Hofhine |
| K221759 |
06/17/2022 |
Cornisol |
Aurolab |
Krishna Kumar |
| K221787 |
06/21/2022 |
Auxein's DHS/DCS Plate System |
Auxein Medical Private Limited |
Rahul Luthra |
| K221624 |
06/06/2022 |
Avenda Health AI Prostate Cancer Planning Software |
Avenda Health, Inc. |
Brittany Berry-Pusey |
| K221716 |
06/13/2022 |
CINA |
AVICENNA.AI |
Stephane Berger |
| K221815 |
06/22/2022 |
Electrosurgical Pencil (OBS-Db, OBS-Dr, OBS-Dc, OBS-Df, OBS-Di, OBS-De); Electrosurgical Pencil (OBS-Dt, OBS-Dd, OBS-Ds, OBS-Dl, OBS-Da) |
Baisheng Medical Co., Ltd. |
Xi Chen |
| K221826 |
06/23/2022 |
BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30) |
Becton Dickinson, and Company |
Kamisha Gray |
| K221897 |
06/30/2022 |
Hydrozid Precise |
BIBAWO Medical A/S |
Sandra Larsen |
| K221789 |
06/21/2022 |
IRIS Pi Q switched Nd YAG laser |
Bio-Med USA Inc |
Young Chi |
| K221856 |
06/27/2022 |
BIOMONITOR IIIm, BIOMONITOR III |
BIOTRONIK, Inc. |
Jon Brumbaugh |
| K221845 |
06/24/2022 |
Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G |
Blue Sky Bio, LLC |
Albert Zickmann |
| K221810 |
06/22/2022 |
LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device |
Bonraybio Co., LTD. |
Clare Huang |
| K221618 |
06/03/2022 |
Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma, Alignment System Spine, Alignment Software Spine, Cirq Arm System |
Brainlab AG |
Chiara Cunico |
| K221865 |
06/27/2022 |
BTL-094 |
BTL Industries Inc. |
David Chmel |
| K221601 |
06/02/2022 |
MS-39 |
C.S.O. S.r.l. |
Gilda Mura |
| K221879 |
06/28/2022 |
Patient Monitor, models LM-8, LM-10, LM-12 and LM-15 |
CAF Medical Solutions Inc. |
Oscar Arriaga Yamin |
| K221616 |
06/03/2022 |
Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17 |
CAF Medical Solutions Inc. |
Oscar Arriaga Yamin |
| K221620 |
06/03/2022 |
Digital Radiography CXDI-Elite, Digital Radiography E1 |
Canon Inc. |
Akira Hirai |
| K221876 |
06/28/2022 |
Digital Radiography CXDI-Pro, Digital Radiography D1 |
Canon Inc. |
Akira Hirai |
| K221603 |
06/02/2022 |
Kangaroo OMNIÖ Enteral Feeding Pump (385400 );Kangaroo OMNIÖ Feeding Set 500ml (B5FD );Kangaroo OMNIÖ ENtelliSet 500ml (E5FD );Kangaroo OMNIÖ Feeding Set 1000ml (B10FD );Kangaroo OMNIÖ ENtelliSet 1000ml (E10FD );Kangaroo OMNIÖ ENPlus Spike Set (BSPFD ) |
Cardinal Health LLC |
Varela Fredy |
| K221640 |
06/06/2022 |
AlloMap Heart Molecular Expression Testing |
CareDx, Inc. |
Camilla Lu |
| K221908 |
06/30/2022 |
JO CUMPLAY Personal Lubricant |
CC Wellness LLC |
Marlent Perez |
| K221834 |
06/23/2022 |
Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set |
Centers For Disease Control And Prevention |
Julie Villanueva, PhD |
| K221658 |
06/08/2022 |
Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set |
Centers for Disease Control and Prevention |
Julie Villanueva, PhD |
| K221848 |
06/24/2022 |
prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments |
Centinel Spine LLC |
Jessica Staub |
| K221668 |
06/08/2022 |
Dental Impression Material |
Chemoment Materials Co.,ltd |
Mabel Lu |
| K221606 |
06/02/2022 |
Absorbable Cranial Flap Fixation System |
Chendu MedArt Medical Scientific Co., Ltd. |
Huaping Ran |
| K221906 |
06/30/2022 |
TROJAN Fire & Ice lubricated male natural rubber latex condom |
Church & Dwight Co., Inc. |
Supreet Sahota-Bhatti |
| K221708 |
06/13/2022 |
CIMILRE Free-T2 Plus |
Cimilre Co., Ltd. |
Not Provided |
| K221823 |
06/23/2022 |
Cionic Neural Sleeve NS-100 |
CIONIC |
Mihai Ionescu |
| K221824 |
06/23/2022 |
OpClear Platform (CU3 DI3), OpClear Control Unit with Footswitch (CS-CU33), OpClear Disposable Procedure Kits (CS-10-00-300, CS-10-30-300, CS-10-00-315, CS-10-30-315, CS-10-00-330, CS-10-30-330, CS-05-00-290, CS-05-30-290), Contd from 3 above: CS-05-00-30 |
Cipher Surgical Limited |
Justin Buch |
| K221735 |
06/15/2022 |
Mineral Collagen Composite Bioactive Moldable |
Collagen Matrix, Inc. |
Peggy Hansen |
| K221874 |
06/28/2022 |
Altis Single Incision Sling System |
Coloplast A/S |
Gayatri Ghadge |
| K221661 |
06/08/2022 |
Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S) |
Compression Works Inc |
John Croushorn |
| K221914 |
06/30/2022 |
Catapult Guide Sheath |
Contract Medical International GmbH |
Juliana Vaz Nuernberger |
| K221593 |
06/02/2022 |
Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus |
ConvaTec, Inc. |
Courtney Smith |
| K221761 |
06/17/2022 |
Solea |
Convergent Dental, Inc. |
Jhung Vojir |
| K221832 |
06/23/2022 |
SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation Catheter |
Cordis US Corp. |
Luis Davila |
| K221592 |
06/02/2022 |
AVIEW Lung Nodule CAD |
Coreline Soft Co.,Ltd. |
Hyeyi Park |
| K221776 |
06/21/2022 |
NextGen Pedicle Screw System |
CoreLink, LLC |
Steven Mounts |
| K221771 |
06/21/2022 |
EEA Circular Stapler with Tri-Staple Technology |
Covidien |
Leo Chan |
| K221629 |
06/06/2022 |
Tri-StapleÖ 2.0 Black Circular Reloads (for use with SigniaÖ Circular Adapters) |
Covidien |
Katherine Y. Choi |
| K221672 |
06/09/2022 |
Creo Electrosurgical System with NP1 Instrument |
Creo Medical Ltd. |
Tiffany Powell |
| K221851 |
06/27/2022 |
Lumina-PTFE Titanium |
Criteria Industria e Comercio de Produtos Medicinais |
Andre Hamar Braga |
| K221636 |
06/06/2022 |
EMPHASYS Acetabular System |
DePuy Ireland UC |
Elaine Pears |
| K221809 |
06/22/2022 |
DePuy Synthes 3.5mm Intrapelvic Acetabular System |
DePuy Synthes |
Alyssa Bryan |
| K221587 |
06/01/2022 |
DHX-70H, XTG-70H |
DIGIMED Co., Ltd. |
Youngbae Kwon |
| K221903 |
06/30/2022 |
Delta III Pro |
Dornier MedTech America, Inc |
John Hoffer |
| K221676 |
06/09/2022 |
Exsalta |
DRW Medical |
Dan Tatum |
| K221836 |
06/23/2022 |
Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus |
DrΣgerwerk AG & Co. KGaA |
Luise Lang |
| K221698 |
06/13/2022 |
Eargo 5 , Eargo 6 |
Eargo, Inc. |
Monica Barrett |
| K221833 |
06/23/2022 |
HemoSphere Advanced Monitor, HemoSphere ClearSight Module |
Edwards Life Sciences LLC |
Varad Raghuwanshi |
| K221704 |
06/13/2022 |
HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion Index (GHI) |
Edwards Lifesciences, LLC |
Michelle Ducca |
| K221873 |
06/28/2022 |
NeoGen PSR System |
Energist Limited |
Graham Booth |
| K221790 |
06/21/2022 |
HARMONIC 700 Shears |
Ethicon Endo-Surgery, LLC |
Nathan Anderson |
| K221744 |
06/16/2022 |
STRATAFIXÖ Spiral MONOCRYLÖ Plus Knotless Tissue Control Device |
Ethicon, Inc. |
Jenny Wang |
| K221747 |
06/16/2022 |
Nitrile Patient Examination Gloves Tested For Use With Chemotherapy Drugs |
Fitone Latex Products Co., Ltd. Guangdong |
Christine Ou |
| K221712 |
06/13/2022 |
Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm) |
Fotona d.o.o. |
Marko Berdajs |
| K221677 |
06/09/2022 |
Synapse 3D Base Tools v6.6 |
FUJIFILM Corporation |
Randy Vader |
| K221619 |
06/03/2022 |
ECHELON Oval V6.2 MRI System |
Fujifilm Healthcare Corporation |
Randy Vader |
| K221774 |
06/21/2022 |
Garmin ECG App |
Garmin International, Inc. |
Travis Johnson |
| K221680 |
06/09/2022 |
Xeleris V Processing and Review System |
GE Healthcare |
George Mashour |
| K221904 |
06/30/2022 |
EK12 V2 Algorithm |
GE Medical Systems Information Technologies, Inc. |
Shlomi Deler |
| K221891 |
06/29/2022 |
UNO Negative Pressure Wound Therapy System |
Genadyne Biotechnologies, Inc |
Andrew Goh |
| K221888 |
06/29/2022 |
Genadyne Hybrid Foam Dressings |
Genadyne Biotechnologies, Inc. |
Saiken Ho |
| K221737 |
06/15/2022 |
InstaFill Graft Delivery System, SIGNIFY Bioactive |
Globus Medical Inc. |
Jennifer Antonacci |
| K221894 |
06/30/2022 |
Lumbar Expandable lnterbody Spacers -Additional Indications/Implants |
Globus Medical Inc. |
Kelly Baker |
| K221623 |
06/06/2022 |
FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nm |
GME German Medical Engineering GmbH |
Dietmar Fischer |
| K221877 |
06/28/2022 |
Powder-Free Nitrile Examination Glove, Non-Sterile |
GoodGloves Industries Sdn Bhd |
Yee Kam Lin |
| K221687 |
06/10/2022 |
Pegasus-X Expandable PLIF System |
GS Medical Co. Ltd. |
Sam Camp |
| K221887 |
06/29/2022 |
Nitrile Examination Glove, Pink Color; Nitrile Examination Glove, Black Color, Nitrile Examination Glove, White Color |
Guangdong Kingfa Sci. & Tech. Co., Ltd. |
Xiaoge Yu |
| K221861 |
06/27/2022 |
FloNavi Endoscopic Fluorescence Imaging System |
Guangdong OptoMedic Technologies, Inc. |
Jane Guo |
| K221781 |
06/21/2022 |
Image Processing Unit, Model: OPTO-CAM104K, Camera Head, Model: OPTO-CHD104KH |
Guangdong OptoMedic Technologies, Inc. |
Jane Guo |
| K221748 |
06/16/2022 |
Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves |
Guilin HBM Health Protections, Inc. |
Pu Lei |
| K221722 |
06/14/2022 |
Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US) |
Haemonetics Corporation |
Ergang Alexis |
| K221713 |
06/13/2022 |
Polypectomy Snare |
Hangzhou AGS MedTech Co., Ltd. |
Jiayuan Zhang |
| K221718 |
06/13/2022 |
Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs (Natural) |
Hartalega NGC SDN BHD |
Kuan Mun Leong |
| K221871 |
06/28/2022 |
Healstone Accurate (TM) Drug of Abuse Urine Test Cup, Healstone Accurate (TM) Drug of Abuse Urine Test Cup Rx |
Healstone Biotech Inc |
Bryan Fang |
| K221839 |
06/24/2022 |
Lancet |
Hebei Xinle Sci&Tech Co., Ltd |
Jianxun Tian |
| K221805 |
06/22/2022 |
AccurSound Electronic Stethoscope AS-101 |
Heroic Faith International Ltd. |
Yuan-Ren Cheng |
| K221767 |
06/17/2022 |
Surgical Sutures with or without Needle |
Huaian Seamen Medical Technology Co., LTD |
Xinjie Zhang |
| K221862 |
06/27/2022 |
YY-A02-B Overlapped Compression Therapy |
Huizhou XINYI Technology Co., LTD. |
Jason Ye |
| K221580 |
06/01/2022 |
Single-Use Flexible Cystoscope |
Hunan Vathin Medical Instrument Co., Ltd. |
Du Jing |
| K221581 |
06/01/2022 |
Single-Use Flexible Rhinolaryngoscope |
Hunan Vathin Medical Instrument Co., Ltd. |
Du Jing |
| K221648 |
06/07/2022 |
Iconic Latex Glove |
Iconic medicare sdn bhd |
Tan Cho Chia |
| K221817 |
06/22/2022 |
ALFIS Vitamin D, ALFIS-3 Analyzer |
Immunostics Inc. |
Young Mi Kim |
| DEN220040 |
06/29/2022 |
Fibresolve |
Imvaria, Inc |
Joshua Reicher |
| K221846 |
06/24/2022 |
Artix Ballon Guiding Sheath |
Inari Medical |
Elllen Nguyen |
| K221764 |
06/17/2022 |
InBody Blood pressure monitor, Model BPBIO480KV |
InBody Co, Ltd. |
Kichul Cha |
| K221854 |
06/27/2022 |
Reprocesses Umbilical Cable |
Innovative Health, LLC. |
Rick Ferreira |
| K221763 |
06/17/2022 |
CUSA Clarity Ultrasonic Surgical Aspirator System |
Integra LifeSciences Corporation |
Alexandra Wells |
| K221835 |
06/23/2022 |
CUSA Clarity Ultrasonic Surgical Aspirator System |
Integra Lifesciences Corporation |
Alexandra Wells |
| K221840 |
06/24/2022 |
Hakim Programmable Valves, Hakim Precision Fixed Pressure Valves |
Integra LifeSciences Production Corporation |
Amanda Erwin |
| K221811 |
06/22/2022 |
Vista BC Sealer |
Inter-Med, Inc. |
Alex Johnson |
| K221653 |
06/07/2022 |
InfaTherm Disposable Infant Warming Mattress |
International Biomedical |
Amy Pieper |
| K221669 |
06/09/2022 |
IOB Warming Blankets |
IOB Medical Inc |
Jiulin Xia |
| K221714 |
06/13/2022 |
Flat Panel Detector |
iRay Technology Taicang Ltd. |
Guo Wu |
| K221814 |
06/22/2022 |
OK Handpiece |
Jaintek Co.,Ltd |
Jung Gun Lee |
| K221743 |
06/15/2022 |
Radio Frequency Plasma Surgical Systems; Radio Frequency Plasma Surgical Electrodes |
Jiangsu Bonss Medical Technology Co., Ltd. |
Feir Zeng |
| K221694 |
06/10/2022 |
External Drainage System |
JMED(Shenzhen) Technology Limited |
Anna Xiao |
| K221626 |
06/06/2022 |
Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs and Fentanyl Citrate |
JR Engineering & Medical Technologies (M) SDN. BHD. |
Ganesan Subramaniam |
| K221682 |
06/10/2022 |
Ideal Med Pro 3-Ply Disposable Face Mask |
JSN Holdings, LLC |
Brian Tedesco |
| K221893 |
06/29/2022 |
KARL STORZ Bipolar Resectoscopes with HF Cable |
KARL STORZ Endoscopy America, Inc |
Leigh Spotten |
| K221853 |
06/27/2022 |
OTC DDR |
Konica Minolta Healthcare Americas, Inc |
Jan Maniscalco |
| K221575 |
06/01/2022 |
Pre-Formed Blue |
Lake Region Medical |
Deko Hussein |
| K221806 |
06/22/2022 |
TruLift Lateral Expandable Spacer System & Lateral Plate System |
Life Spine Inc. |
Angela Batker |
| K221775 |
06/21/2022 |
LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003) |
Light Tree Ventures Europe B.V. |
Kim Laurens |
| K221758 |
06/16/2022 |
SMR Stemless Anatomic |
LimaCorporate S.p.A |
Roberto Gabetta |
| K221902 |
06/30/2022 |
LimFlow Vector |
LimFlow, Inc. |
Zachary Woodson |
| K221766 |
06/17/2022 |
Solon |
LMG Lasers Comercio, Importacao e Exportacao Ltda |
Leticia de Paula Souza Moraes |
| K221659 |
06/08/2022 |
Luminopia One |
Luminopia, Inc. |
Scott Xiao |
| K221634 |
06/06/2022 |
Oxymag - Transport and Emergency Ventilator |
Magnamed Tecnologia Medica S/A |
Toru Kinjo |
| K221706 |
06/13/2022 |
AccuContour |
Manteia Technologies Co., Ltd. |
Dandan Chen |
| K221802 |
06/21/2022 |
iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL) |
Mawi DNA Technologies |
Bassam EL-Fahmawi |
| K221734 |
06/15/2022 |
Maxtec MaxO2 ME+p |
Maxtec, LLC |
Sidra Hankins |
| K221598 |
06/02/2022 |
Wearable breast pump |
Mayborn (UK) Limited |
Sean Neasham |
| K221725 |
06/14/2022 |
Advanced MyHip Planner |
Medacta International S.A. |
Stefano Baj |
| K221850 |
06/27/2022 |
GMK 3D Metal Tibial Tray |
Medacta International S.A. |
Stefano Baj |
| K221870 |
06/28/2022 |
CarnaLife Holo |
MedApp S.A. |
Andrzej Skalski |
| K221654 |
06/07/2022 |
medi pneumatic compression system (pcs)-genius (Model 652) |
medi USA, L.P. |
Moses Lipshaw |
| K221632 |
06/06/2022 |
Spine CAMPÖ |
Medical Metrics, Inc. |
Kirk Johnson |
| K221646 |
06/06/2022 |
CD HORIZONÖ ASTUTEÖ SPINAL SYSTEM; CD HORIZONÖ Growth Rod Conversion Set; CD HORIZONÖ SPINAL SYSTEM; CD HorizonÖ Fenestrated Screw Set; COLORADO 2Ö SPINAL System; GDLHÖ POSTERIOR SPINAL SYSTEM; SHILLAÖ Growth Guidance System; TENORÖ SPINAL SYSTEM |
Medtronic Sofamor Danek USA, Inc. |
Shana Foster |
| K221896 |
06/30/2022 |
BreathID Hp System |
Meridian Bioscience Israel Ltd. |
Raffi Werner |
| K221782 |
06/21/2022 |
Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes |
Merit Medical Pte. Ltd. |
Pauline Liow |
| K221784 |
06/21/2022 |
Single-use Video Pancreaticobiliary Scope, PB Digital Controller |
Micro-Tech (Nanjing) Co., Ltd |
Sally He |
| K221702 |
06/13/2022 |
CompuFlo Epidural Computer Controlled Anesthesia System |
Milestone Scientific, Inc. |
Arjan Haverhals |
| K221818 |
06/23/2022 |
Rebellion; Phantom Multi-Bite Kerrison Rongeur |
Morpheus AG |
Timo Rack |
| DEN220033 |
06/06/2022 |
MISHA Knee System |
Moximed, Inc. |
Nancy E. Issac |
| K221762 |
06/17/2022 |
BoneMRI v1.4 |
MRlguidance B.V. |
Marijn van Stralen |
| K221795 |
06/21/2022 |
STERN FIX Sternal Stabilization System |
Neos Surgery SL |
Eduard Garcia Puig |
| K221738 |
06/15/2022 |
NS-HGlio |
Neosoma Inc. |
Aly H Abayazeed |
| K221667 |
06/08/2022 |
Non Sterile Powder Free Latex Examination Glove |
New Era Medicare Sdn. Bhd. |
Fatin Nor Irdina binti Ahmad Fauzi |
| K221772 |
06/21/2022 |
NeuroRPM |
New Touch Digital Inc. |
Chan Lee |
| K221615 |
06/03/2022 |
Newclip Patient-matched instrumentation non sterile PSI |
Newclip Technics |
Gaelle Gourbiere |
| K221847 |
06/24/2022 |
Ni2 Implant System |
Newton Implant Systems, Inc |
Pedro Yang |
| K221866 |
06/27/2022 |
S-Plant Dental Implant System |
Newton Implant Systems, Inc. |
Pedro Yang |
| K221610 |
06/03/2022 |
Nextra CH Cannulated Hammertoe System |
Nextremity Solutions, Inc. |
Elise Fox |
| K221905 |
06/30/2022 |
INERTIA CONNEXX Modular Pedicle Screw System |
Nexxt Spine LLC |
Andy Elsbury |
| K221666 |
06/08/2022 |
Normatec Go |
NormaTec Industries, LP |
Steve Henderson |
| K221813 |
06/22/2022 |
Nova Allegro UACR Assay, Nova Allegro Analyzer |
Nova Biomedical Corporation |
Cesidio Tempesta |
| K221900 |
06/30/2022 |
Stat Profile Prime Plus Analyzer System |
Nova Biomedical Corporation |
Sharvari Nayak |
| K221872 |
06/28/2022 |
ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System |
Nova Eye Inc. (Business name Nova Eye Medical) |
Don Watton |
| K221783 |
06/21/2022 |
SafetiCET Safety Lancet |
NSP Tech Pte Ltd |
HC Tan |
| K221604 |
06/02/2022 |
SafetiHeel, MediHeel, Novaplus |
NSP Tech Pte Ltd |
HC Tan |
| K221751 |
06/16/2022 |
NuVasive Cohere ALIF System Intervertebral Body Fusion Device |
NuVasive, Incorporated |
Jessica LeBlanc |
| K221690 |
06/10/2022 |
OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5), OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5R), LIGHT GUIDE ADAPTER (MAJ-1413) |
Olympus Medical Systems Corp. |
Shinichiro Kawachi |
| K221638 |
06/06/2022 |
Rhino-Laryngo Videoscope Olympus ENF-VH, Rhino-Laryngo Videoscope Olympus ENF-V3 |
Olympus Medical Systems Corp. |
Shinichiro Kawachi |
| K221660 |
06/08/2022 |
RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE-XP |
Olympus Medical Systems Corp. |
Shinichiro Kawachi |
| K221631 |
06/06/2022 |
Tracheal Intubation Fiberscope OLYMPUS LF-P, VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V |
Olympus Medical Systems Corp. |
Shinichiro Kawachi |
| K221683 |
06/10/2022 |
CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2R), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-VH) and CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-VHR) |
Olympus Medical Systems Corporation |
Shinichiro Kawachi |
| K221773 |
06/21/2022 |
Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For Use With the Opioid Fentanyl Citrate, Simulated Gastric Acid, and Fentanyl In Gastric Acid |
ONETEXX SDN BHD |
Freddy Low |
| K221684 |
06/10/2022 |
Osstem Abutment System |
Osstem Implant Co., Ltd. |
Seungju Kang |
| K221613 |
06/03/2022 |
Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets |
Owen Mumford Ltd |
Darren Mansell |
| K221892 |
06/29/2022 |
VISIONAIR |
PacificMD Biotech Llc |
Jetmir Palushi |
| K221768 |
06/17/2022 |
Oxfore«100 (hexafocon A) Rigid Gas Permeable Contact Lenses |
Paragon Vision Sciences, Inc. |
Vimala Punsammy |
| K221628 |
06/06/2022 |
exGraft, exGraft Carbon |
PECA Labs |
Doug Bernstein |
| K221822 |
06/23/2022 |
BENCHMARK BMX81 Access System |
Penumbra, Inc |
Sindokht (Sisi) Soltanzadeh |
| K221779 |
06/21/2022 |
ASEPT Peritoneal Drainage System |
PFM Medical, Inc. |
Jessica Jho |
| K221686 |
06/10/2022 |
NovoSorb Matrix |
PolyNovo Biomaterials Pty Ltd |
Tarun Nekkenti |
| K221860 |
06/27/2022 |
PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe |
Poonglim Pharmatech Inc. |
Hee Min Cho |
| K221642 |
06/06/2022 |
SIRIUS Endoscope System |
Precision Robotics (Hong Kong) Limited |
Ping Lai Benny Lo |
| K221707 |
06/13/2022 |
SafeSept« Transseptal Guidewire (SS-140) |
Pressure Products Medical Device Manufacturing LLC. |
Andrew Armour |
| K221889 |
06/29/2022 |
ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device with Patient Monitoring |
ProSomnus Sleep Technologies |
Divya Mavalli |
| K221671 |
06/09/2022 |
CellFX« System |
Pulse Biosciences, Inc. |
Punam Gollamudi |
| K221688 |
06/10/2022 |
ASTar BC G- Kit and ASTar Instrument |
Q-linea AB |
Jonas Melin |
| K221875 |
06/28/2022 |
Sterilization Pouch and Roll |
Qianjiang Kingphar Medical Packaging & Printing Co., Ltd. |
Zhao Fusong |
| K221910 |
06/30/2022 |
QRS Dental Implants System |
QRS Medical Ltd. |
Iman Khorshid |
| K221868 |
06/27/2022 |
QOCA image Smart CXR Image Processing System |
Quanta Computer Inc. |
Joe Wang |
| DEN220039 |
06/16/2022 |
Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set |
Quidel Corporation |
Xiaoxi Wang |
| K221652 |
06/07/2022 |
NIKKICART |
Renal Care Dialysis Solutions, S.A. DE C.V. |
Jose Enrique Aguirre Valades |
| K221898 |
06/30/2022 |
Gastrointestinal Boundary Identifier (GIBI HD) |
ReShape Lifesciences |
Michelle Ravert |
| K221696 |
06/10/2022 |
ReWalk P6.0 |
ReWalk Robotics Ltd. |
Miri Pariente |
| K221612 |
06/03/2022 |
ClearRead CT |
Riverain Technologies, Inc. |
Jonathan Jackson |
| K221693 |
06/10/2022 |
Elecsys Anti-HCV II (08837031190) |
Roche Diagnostics |
Bin Sun |
| K221842 |
06/24/2022 |
Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSF |
Roche Diagnostics |
Greg Mondics |
| K221890 |
06/29/2022 |
Elecsys Tg II |
Roche Diagnostics |
Edie Eads |
| K221765 |
06/17/2022 |
ONLINE DAT Benzodiazepines II |
Roche Diagnostics |
Khoa Tran |
| K221741 |
06/15/2022 |
TRAUS Air Dental Handpiece |
Saeshin Precision Co., Ltd. |
Gung San Nam |
| K221599 |
06/02/2022 |
HS40 Diagnostic Ultrasound System |
Samsung Medison Co., Ltd. |
Jee Young Ju |
| K221827 |
06/23/2022 |
Mais Central Venous Catheter |
Saudi Mais Co. for Medical Products |
Salman Rashid |
| K221591 |
06/02/2022 |
Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source |
Schoelly Fiberoptic GmbH |
Sandra Baumann |
| K221803 |
06/22/2022 |
PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress. |
SEDECAL SA |
Ma Luisa Gomez de Aguero |
| K221917 |
06/30/2022 |
Stent Positioning Assistance System (SPAS) |
Seven Sons Ltd. |
Nancy Zhang |
| K221770 |
06/21/2022 |
Fiber Laser Treatment System |
Shanghai Apolo Medical Technology Co., Ltd. |
Felix Li |
| K221838 |
06/23/2022 |
Surgical Face Mask (HNFM0103) |
Shanghai Hua En Industrial CO LTD |
Lisa Zhao |
| K221745 |
06/16/2022 |
Sterile Posterior Spinal Fixation System |
Shanghai REACH Medical Instrument Co., Ltd |
Mingsha Ye |
| K221798 |
06/21/2022 |
Finger Pulse Oximeter, Model: X1906P |
Shenzhen Changkun Technology Co., Ltd. |
Wang Qingpeng |
| K221643 |
06/06/2022 |
Hair Removal Device (Model: IPL-D26, IPL-D19) |
Shenzhen Desida Technology Co., Ltd. |
Gong Yong |
| K221635 |
06/06/2022 |
IPL sapphire ice cooling hair remove device |
Shenzhen Desida Technology Co., Ltd. |
Shuangcheng Yuan |
| K221679 |
06/09/2022 |
IPL Hair Remover, Model: G993, G996, G998 and G885 |
Shenzhen Mywin Technology Co., Ltd. |
Meiyun Liu |
| K221589 |
06/01/2022 |
Starly pad |
Shenzhen Xingyuanli Technology Co., Ltd. |
Tse Adrian |
| K221752 |
06/16/2022 |
Stella |
Shinhung MST CO., LTD. |
Sun Ho Lee |
| K221852 |
06/27/2022 |
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter |
Shockwave Medical, Inc. |
Danica Van |
| K221801 |
06/21/2022 |
ADVIA Centaur« Anti-Mⁿllerian Hormone (AMH) |
Siemens Healthcare Diagnostics Inc. |
Mey Vasquez |
| K221605 |
06/02/2022 |
Emit« II Plus Buprenorphine Assay |
Siemens Healthcare Diagnostics, Inc. |
Julie Warren |
| K221733 |
06/15/2022 |
MAGNETOM Sola, MAGNETOM Altea, MAGNETOM Sola Fit |
Siemens Medical Solutions USA, Inc. |
Alina Goodman |
| K221727 |
06/14/2022 |
syngo.CT Extended Functionality |
Siemens Medical Solutions USA, Inc. |
Monsuru Bello |
| K221808 |
06/22/2022 |
InterOss Collagen |
SigmaGraft Inc. |
Elcin Chang |
| K221625 |
06/06/2022 |
2-Way 100% Silicone ClearTract Catheter |
Silq Technologies Corporation |
Sigi Caron |
| K221799 |
06/21/2022 |
Electric Wheelchair, Model: 9000N |
Silver Fox Corporation Limited |
Chen Yan |
| K221697 |
06/10/2022 |
INJECTION PIN (KIP(02031-02061) (03031-03061)) |
SLK Ortho Llc |
Lawrence Kluge |
| K221597 |
06/02/2022 |
CO2 Laser System |
Smedtrum Medical Technology Co., Ltd. |
Crimson Wu |
| K221792 |
06/21/2022 |
Acute QC Strut and Components |
Smith & Nephew, Inc. |
Amanda Lammey |
| K221740 |
06/15/2022 |
SMITH & NEPHEW INTELLIO 4K CAMERA CONTROL UNIT, NETWORK ENABLED (72205447), SMITH & NEPHEW INTELLIO 4K CAMERA CONTROL UNIT, NON-NETWORK ENABLED (72205448) |
Smith and Nephew, Inc. |
Renesha Srivastava |
| K221578 |
06/01/2022 |
Hexanium ACIF |
SpineVision, S.A.S. |
Quang Tran |
| K221678 |
06/09/2022 |
SprintRay High Impact Denture Base |
SprintRay Inc. |
Sara Moghtadernejad |
| K221611 |
06/03/2022 |
780 nm L11 LED Light Source with AIM |
Stryker |
Michelle Hughes |
| K221728 |
06/14/2022 |
Aviator« Anterior Cervical Plating (ACP) System, LITe« Plate System, DynaTranÖ Anterior Cervical Plating (ACP) System, ReflexÖ Hybrid ACP System, UniViseÖ Spinous Process Fixation Plate |
Stryker Corporation |
Katie McNeil |
| K221855 |
06/27/2022 |
Universal CMF System |
Stryker Leibinger GmbH & Co. KG |
Amelia Kesti |
| K221886 |
06/29/2022 |
Sublime Microcatheter |
Surmodics Inc. |
Holly Ramirez |
| K221778 |
06/21/2022 |
Disposable Safety Lancets |
Suzhou Kyuan Medical Apparatus Co., Ltd. |
Shi Ye |
| K221869 |
06/28/2022 |
BCR-ABL1 (p210) % IS Kit (Digital PCR Method) |
Suzhou Sniper Medical Technologies Co., Ltd |
Peng Zhang |
| K221843 |
06/24/2022 |
GEM Biover Microvascular Clamps |
Synovis Micro Companies Alliance, Inc. |
Julie Carlston |
| K221731 |
06/15/2022 |
FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire |
T.A.G. Medical Products Corporation, Ltd |
Shlomi Dines |
| K221844 |
06/24/2022 |
TDM Lumbar Interbody Fusion Cage System |
TDM Co., Ltd |
Jung Wook Choi |
| K221641 |
06/06/2022 |
Terragene« Bionova« Hyper Biological Indicator (BT98), Terragene« Bionova« Hyper Auto-reader Incubator (BHY), Terragene« Bionova« NanoBio Auto-reader Incubator (BNB) |
Terragene SA |
Hernando Carrizo |
| K221895 |
06/30/2022 |
Terumo Advanced Perfusion System 1 |
Terumo Cardiovascular Systems Corporation |
Eileen Dorsey |
| K221899 |
06/30/2022 |
The Sensititre YeastOne Susceptibility System with Caspofungin in the dilution range of 0.015-16ug/ml |
Thermo Fisher Scientific |
Cynthia Knapp |
| K221724 |
06/14/2022 |
Conductive Gel |
Tone-A-Matic International Inc. |
Manuel Chuck |
| K221785 |
06/21/2022 |
TCL3 Motion Tracking System |
TracInnovations A/S |
Stefan Glimberg |
| K221829 |
06/23/2022 |
Wet Flavored Personal Lubricants |
Trigg Laboratories, Inc. |
Marla Bolden |
| DEN220041 |
06/29/2022 |
Tristel Duo ULT |
Tristel Solutions Limited |
Julija Shabanova |
| K221614 |
06/03/2022 |
TytoCare Lung Sounds Analyzer |
Tyto Care Ltd. |
Stella Raizelman Perry |
| K221909 |
06/30/2022 |
J-Temp |
Ultradent Products, Inc. |
Matthew Buck |
| K221717 |
06/13/2022 |
Disposable Surgical Gown UM-148 |
Unimax Medical Products Co., Ltd. |
Haibo Ning |
| K221705 |
06/13/2022 |
U2 Total Knee System-PF+ |
United Orthopedic Corporation |
Lois Ho |
| K221675 |
06/09/2022 |
United U2 femoral head, 22mm delta ceramic head |
United Orthopedic Corporation |
Lois Ho |
| K221797 |
06/21/2022 |
BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes and Length Assessment Device |
Varian Medical Systems Inc. |
Peter J. Coronado |
| K221791 |
06/21/2022 |
ProBeam 360░ Proton Therapy System |
Varian Medical Systems, Inc. |
Peter J. Coronado |
| K221644 |
06/06/2022 |
Synthetic Bone Putty |
Ventris Medical |
John Brunelle |
| K221911 |
06/30/2022 |
VINNO 6PRO, VINNO 6EXP, VINNO 5PRO, VINNO 5EXP, VINNO 3, VINNO 3PRO, VINNO 3EXP |
VINNO Technology (Suzhou) Co.,Ltd. |
Cordelia Liu |
| K221655 |
06/07/2022 |
Multiflex Steerable Sheath |
VizaraMed, Inc. |
Jack P Douglas |
| K221572 |
06/01/2022 |
VyPlate Anterior Cervical Plate System |
Vy Spine, LLC |
Jordan Hendrickson |
| K221794 |
06/21/2022 |
Vario-Cup System |
Waldemar Link GmbH & Co. KG |
Pia Mueller |
| K221859 |
06/27/2022 |
Atalante |
Wandercraft SAS |
Matthieu Masselin |
| K221777 |
06/21/2022 |
Disposable Sterile Syringe |
Weihai Shengjie Medical Technology Co., Ltd |
Huihui Wang |
| K221816 |
06/22/2022 |
Wesper Lab |
Wesper Inc. |
Amir Reuveny |
| K221819 |
06/23/2022 |
35g Standard SMMS Surgical Gown; 35g Reinforced SMMS Surgical Gown;43g Standard SMMS Surgical Gown;43g Reinforced SMMS Surgical Gown ;50g Standard SMMS Surgical Gown; 50g Reinforced SMMS Surgical Gown;BVB Surgical Gown |
Winner Medical Co., Ltd. |
Mingni Liu |
| K221754 |
06/16/2022 |
Ag Foam Dressing Non-Adhesive (OTC); Ag Foam Dressing Adhesive (OTC); Silicone Ag Foam Dressing (OTC); Silicone Ag Foam Dressing with Border (OTC) |
Winner Medical Co., Ltd. |
Zhiqin Liang |
| K221755 |
06/16/2022 |
Antimicrobial gauze sponge dressing; Antimicrobial super sponge dressing; Antimicrobial non-woven sponge dressing |
Winner Medical Co., Ltd. |
Zhiqin Liang |
| K221720 |
06/13/2022 |
Extra Silver Gelling Fiber Dressing |
Winner Medical Co., Ltd. |
Mingni Liu |
| K221645 |
06/06/2022 |
PROstep(TM) MIS 5mm Chamfer Screw System |
Wright Medical Technology |
Anna Bushart |
| K221621 |
06/03/2022 |
Pro-X1Ö Trochanteric Nailing System |
X-Bolt Orthopedics |
Brian Thornes |
| K221753 |
06/16/2022 |
Kangbeier Child Surgical Mask |
Xinxiang Kangbeier Medical Technology Co., Ltd. |
Shaoju Tian |
| K221627 |
06/06/2022 |
PerfusionGo Plus |
Yukun (Beijing) Technology Co., Ltd. |
Qi Wang |
| K221726 |
06/14/2022 |
Uni-FuZe-C Bone Strip |
Zavation Medical Products, LLC |
Elke Carter |
| K221673 |
06/09/2022 |
Bonafix TiBase |
Zentek Medical LLC |
Michael Vinnik |
| K221800 |
06/21/2022 |
Infrared Thermometer (Model: Y20001, Y20002) |
Zhangzhou Easepal Medical Science And Technology Co.,Ltd. |
Flower Flower |
| K221857 |
06/27/2022 |
Aneroid sphygmomanometer with stethoscope, QL-50, Aneroid sphygmomanometer, QL-20, Aneroid sphygmomanometer, QL-201 |
Zhejiang LuDe Technology Development Co., Ltd. |
Iris Du |
| K221700 |
06/13/2022 |
AutoPulse NXT Resuscitation System |
ZOLL Circulation, Inc. |
Brian Robey |
| K221858 |
06/27/2022 |
ZSFab Lumbar Interbody System |
ZS Fab Inc. |
Xuewei Ma |
