| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K221432 |
08/03/2022 |
Customize |
3D-Side SA |
Laurent Paul |
| K221213 |
08/18/2022 |
EnSite X EP System |
Abbott |
Alexandra Agre |
| K212525 |
08/19/2022 |
Advcare Vial Direct to Bag (VDB) Needle-free Admixture Devices |
Advcare Medical |
Meng T. Tan |
| K222277 |
08/26/2022 |
BriefCase |
Aidoc Medical, Ltd. |
Amalia Schreier |
| K221027 |
08/12/2022 |
Isolation Gown (S, M, L, XL, XXL (Yellow, Blue)) |
Allmed Medical (Hubei) Protective Products Co., Ltd |
Vince Tian |
| K220900 |
08/10/2022 |
Safety Blood Collection Needles with/without Needle Holder |
Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. |
Bingyi Xiang |
| K212140 |
08/25/2022 |
GlucoSure Link Blood Glucose Monitoring System |
Apex Biotechnology Corp. |
Lisa Liu |
| K221365 |
08/25/2022 |
LapBox Tissue Containment Removal System |
ARK Surgical, Ltd. |
Stav Tori |
| K220835 |
08/12/2022 |
Arkligners |
Arklign Laboratories |
Rex Ho |
| K220280 |
08/30/2022 |
Arrow Stiffening Stylet |
Arrow International, LLC (a subsidiary of Teleflex, Inc.) |
Fallon Young |
| K220363 |
08/22/2022 |
VPS Rhythm DLX Device with TipTracker Technology |
Arrow International, LLC (a subsidiary of Teleflex, Inc.) |
Elizabeth Duncan |
| K221485 |
08/22/2022 |
Arthrex FiberTape and TigerTape Cerclage Sutures |
Arthrex Inc. |
Kelsey N. Roberts |
| K222161 |
08/11/2022 |
Arthrex Knotless FiberTak Biceps Suture Anchor |
Arthrex Inc. |
Kelsey N Roberts |
| K222263 |
08/26/2022 |
Arthrex Self Punching SwiveLock Suture Anchors |
Arthrex Inc. |
Tiffany Mentzel |
| K221546 |
08/23/2022 |
OneTouch Delica Plus Lancing System |
Asahi Polyslider Co., Ltd. |
Yoshitaka Akagi |
| K220903 |
08/17/2022 |
WebCeph |
AssembleCircle Corp. |
Jang Hoon Kim |
| K213109 |
08/22/2022 |
Auxilock Draw Tight Suture-Based Anchor |
Auxein Medical Private Limited |
Rahul Luthra |
| K210797 |
08/18/2022 |
Bio-MEM Ti Reinforced Membrane |
B&Medi Co., Ltd. |
Taesu Kwon |
| K222232 |
08/24/2022 |
Sherlock 3CG« Tip Positioning System (TPS) Stylet/T-Lock Assembly |
Bard Access Systems, Inc. |
Teresa Do-McCage |
| K211124 |
08/30/2022 |
Dose IQ Safety Software |
Baxter Healthcare Corporation |
Michelle Rixie |
| K211125 |
08/30/2022 |
Novum IQ Syringe Pump |
Baxter Healthcare Corporation |
Dhiraj Bizzul |
| K220193 |
08/19/2022 |
BD MAX Enteric Parasite Panel |
Becton, Dickinson and Company |
Joseph Basore |
| K220268 |
08/23/2022 |
Picosecond Laser System (Model PS10-A and PS10-B) |
Beijing ADSS Development Co., Ltd. |
Song Ying |
| K220385 |
08/12/2022 |
Intense Pulsed Light Equipment |
Beijing Globalipl Development Co., Ltd. |
Jun Liu |
| K220061 |
08/23/2022 |
Safety Insulin Syringes |
Berpu Medical Technology Co., Ltd. |
David Yu |
| K222449 |
08/27/2022 |
Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue) |
Better Care Plastic Technology Co., Ltd. |
Zhu Chunyan |
| K212364 |
08/10/2022 |
BLT Dental Implant System |
Bio Concept Co., Ltd |
Tianshui Li |
| K221789 |
08/09/2022 |
IRIS Pi Q switched Nd YAG laser |
Bio-Med USA Inc |
Young Chi |
| K202739 |
08/12/2022 |
Bioland G-425-2V Blood Glucose Monitoring System, Bioland G-425-2 Blood Glucose Monitoring System |
Bioland Technology Ltd. |
Yiqing Feng |
| K212243 |
08/08/2022 |
VITEK 2 AST- Gram Positive Telavancin (<=0.015 - >=1 ╡g/mL) |
bioMerieux, Inc |
Cherece L. Jones |
| K213072 |
08/23/2022 |
2.1 x 255mm Drill, 22mm Stop |
Biomet Micofixation |
Mark Wladkowski |
| K210949 |
08/11/2022 |
Foundation Dermal Regeneration Scaffold (DRS) Solo |
Bionova Medical Inc. |
Alex Greene |
| K221112 |
08/17/2022 |
CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM) |
Biosense Webster, Inc. |
Phuong Park |
| K212790 |
08/15/2022 |
XLase Plus |
Biotec Italia, SRL |
Edoardo Milanello |
| K221224 |
08/19/2022 |
REAL INTELLIGENCE CORI |
Blue Belt Technologies, Inc. |
Corrine Herlinger |
| K220163 |
08/15/2022 |
Her-2, ER, PR IHControls |
Boston Cell Standards, Inc. |
Steven Bogen |
| K221124 |
08/04/2022 |
MANTIS Clip |
Boston Scientific Corporation |
Jia Huang |
| K221618 |
08/30/2022 |
Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma, Alignment System Spine, Alignment Software Spine, Cirq Arm System |
Brainlab AG |
Chiara Cunico |
| K220819 |
08/26/2022 |
BrainsWay Deep TMS System |
BrainsWay Ltd. |
Ahava Stein |
| K221879 |
08/10/2022 |
Patient Monitor, models LM-8, LM-10, LM-12 and LM-15 |
CAF Medical Solutions Inc. |
Oscar Arriaga Yamin |
| K221616 |
08/01/2022 |
Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17 |
CAF Medical Solutions Inc. |
Oscar Arriaga Yamin |
| K222387 |
08/31/2022 |
Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR |
Canon Medical Systems Corporation |
Janine F Reyes |
| K213993 |
08/05/2022 |
Powder Free Chloroprene Examination Glove Coloured (Blue, Green) |
Careglove Global SDN BHD |
Lim Kwee Shyan |
| K213933 |
08/19/2022 |
Percent Oxygen Sensors |
CareOx, LLC |
Young Kim |
| K221549 |
08/01/2022 |
X-ray Flat Panel Detectors (CareView 1800 RF) |
CareRay Digital Medical Technology Co., Ltd. |
Xu Wei |
| K213527 |
08/15/2022 |
FORUM |
Carl Zeiss Meditec AG |
Stefan Wimmer |
| K222236 |
08/24/2022 |
miCOR System Lens Fragmentation System |
Carl Zeiss Meditec Cataract Technology Inc. |
Gary Mocnik |
| K222082 |
08/12/2022 |
aprevo« anterior and lateral lumbar interbody fusion devices, aprevo« transforaminal lumbar interbody fusion devices |
Carlsmed, Inc. |
Karen Liu |
| K211614 |
08/04/2022 |
CenterMed Patient Matched Assisted Surgical Planning (ASP) System |
CenterMed, Inc. |
Jash Bhayani |
| K222558 |
08/30/2022 |
Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set |
Centers for Disease Control and Prevention |
Julie Villanueva, PhD |
| K221848 |
08/19/2022 |
prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments |
Centinel Spine LLC |
Jessica Staub |
| K221668 |
08/08/2022 |
Dental Impression Material |
Chemoment Materials Co.,ltd |
Mabel Lu |
| K221824 |
08/19/2022 |
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 |
| K213645 |
08/08/2022 |
ClearPoint Maestro Brain Model |
ClearPoint Neuro, Inc. |
Pete Piferi |
| K221104 |
08/04/2022 |
ActeraÖ hip system |
Conformis Inc. |
Mary Kruitwagen |
| K214058 |
08/26/2022 |
Beamer AVEO Electrosurgical Generator, Beamer AVEO Argon Module, Beamer AVEO Cart, Beamer AVEO Wired Foot Pedal, Beamer AVEO Argon Pressure Reducer |
ConMed Corporation |
Kavita Amin |
| K220736 |
08/01/2022 |
Consolidated HC Steam Sterilizer |
Consolidated Machine Corp. |
Arthur Trapotsis |
| K221832 |
08/22/2022 |
SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation Catheter |
Cordis US Corp. |
Luis Davila |
| K221776 |
08/09/2022 |
NextGen Pedicle Screw System |
CoreLink, LLC |
Steven Mounts |
| K222278 |
08/26/2022 |
LOSPA TKR System Instrumentation, EXULT TKR System Instrumentation |
Corentec Co., Ltd. |
Yoorim Bae |
| K212273 |
08/17/2022 |
Cross Protection ResQ300 Plus Surgical Face Mask |
Cross Protection (M) Sdn Bhd |
Grace Tan |
| K213524 |
08/10/2022 |
CytonPro-5000 |
Cytonsys Inc |
Li-Da Huang |
| K222357 |
08/09/2022 |
DenMat Glutaraldehyde Desensitizer |
DenMat Holding, LLC |
Murisa Woodlin |
| K221467 |
08/31/2022 |
INHANCETM Reverse Glenoid Peripheral Posts |
Depuy Ireland UC |
Yayoi Fujimaki |
| K220055 |
08/25/2022 |
Disposable, vinyl examination gloves, Yellow |
Dezhou Hengchang Medical Technology Co., Ltd |
Jing Li |
| K202508 |
08/12/2022 |
Hemo-Lyte C Cartridge |
Di-Chem, Inc. |
Keith Buchholz |
| K220001 |
08/04/2022 |
Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay |
Diazyme Laboratories Inc. |
Abhijit Datta |
| K220045 |
08/05/2022 |
TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) |
DK Medivision Co., Ltd. |
Henry Hong |
| K220067 |
08/30/2022 |
Medical Surgery Mask, Model:2626-7 |
Dongguan Missadola Technology Co., Ltd |
Adeline Hong |
| K220308 |
08/11/2022 |
Patient Monitor: RespArray |
Edan Instruments, Inc. |
Joan. Wei |
| K213791 |
08/05/2022 |
Unispace SA Cervical Cage |
Edisoninno Co., Ltd. |
So-yeon Jang |
| K221528 |
08/22/2022 |
Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Catheter |
Edwards Lifesciences, LLC |
Mahvish Iqbal |
| K221177 |
08/11/2022 |
Erbe's Tubing/Cap Sets |
Erbe USA, Inc. |
Jeff Dill |
| K222145 |
08/12/2022 |
EzDent-i / E2 / Prora View/ Smart M Viewer |
Ewoosoft Co., Ltd |
Young Seok Kim |
| K201730 |
08/22/2022 |
Powered Inflatable Tube Massager - SLIM UP DRAIN |
Foggiare Technologies LLC |
Thierry Germanovitch |
| K222274 |
08/23/2022 |
FONA XDC |
FONA S.r.l |
Luigi Germano |
| K220237 |
08/01/2022 |
Disposable Medical Nitrile Examination Gloves |
Fujian Jixiang Medical Technology Co.,Ltd |
Jiatian Yang |
| K221952 |
08/04/2022 |
Endoscope Model EG-580UT and Endoscope Model EG-580UR |
FUJIFILM Corporation |
Randy Vader |
| K221238 |
08/19/2022 |
FUJIFILM Ultrasonic Endoscope EG-740UT |
FUJIFILM Corporation |
Randy Vader |
| K213802 |
08/26/2022 |
StimOnTM Pain Relief System (GM2439) |
Gimer Medical Co., Ltd. |
Rex Chang |
| K220032 |
08/02/2022 |
iStent infinite Trabecular Micro-Bypass System, Model iS3 |
Glaukos Corporation |
David S. Fernquist |
| K221737 |
08/11/2022 |
InstaFill Graft Delivery System, SIGNIFY Bioactive |
Globus Medical Inc. |
Jennifer Antonacci |
| K220329 |
08/16/2022 |
G-CAM |
Graphenano Dental S.L. |
Maria Simon Garcia |
| K222414 |
08/11/2022 |
TERA HARZ DENTURE |
Graphy Inc. |
Tae-woo Kim |
| K220676 |
08/29/2022 |
Blood Pressure Monitor |
Guangdong Transtek Medical Electronics Co., Ltd. |
Ada Liang |
| K221487 |
08/26/2022 |
NEOVEIL Staple Line Reinforcement |
Gunze Limited |
Hidenori Nishioka |
| K220910 |
08/11/2022 |
Medical image processing software |
Hangzhou Deepwise & league of PHD Technology Co.,Ltd. |
Hailong Xu |
| K220603 |
08/23/2022 |
Disposable Medical Safety Hypodermic Needle |
Hantech Medical Device Co., Ltd. |
Arnold YANG |
| K221871 |
08/30/2022 |
Healstone Accurate (TM) Drug of Abuse Urine Test Cup, Healstone Accurate (TM) Drug of Abuse Urine Test Cup Rx |
Healstone Biotech Inc |
Bryan Fang |
| K221143 |
08/25/2022 |
Nitrile Exam Gloves (Blue, Black) |
Hebei Astro Medical Supply Co., Ltd. |
Ning Zheng |
| K212248 |
08/29/2022 |
GlucoLeader Enhance 2 Blood Glucose Monitoring System |
HMD BioMedical Inc. |
Chin-Hsiung Hsu |
| K221164 |
08/30/2022 |
Powder Free Nitrile Examination Glove - Blue, Non-Sterile, Tested for use with Chemotherapy Drugs and Fentanyl |
Hong Seng Gloves SDN BHD |
Zahari Bin Darus |
| K221999 |
08/30/2022 |
Ultrasound Transmission Gels |
Hony Medical Co., Ltd. |
Zhu Huina |
| K212856 |
08/18/2022 |
iClean Viral Transport System (VTM-RT kit) |
Huachenyang (Shenzhen) Technology Co. Ltd. |
Robin Chu |
| K203078 |
08/19/2022 |
CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AW |
HuiZhou TianChang Industrial Co., Ltd |
Johnny Chan |
| K210935 |
08/31/2022 |
I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) |
I.T.S. GmbH |
Florian Grill |
| K221648 |
08/25/2022 |
Iconic Latex Glove |
Iconic medicare sdn bhd |
Tan Cho Chia |
| K220056 |
08/10/2022 |
iSyncWave |
iMediSync Inc. |
Seung Wan Kang |
| K213609 |
08/09/2022 |
NOVA RESIN dual cure, self adhesive resin cement |
Imicryl Dis Malzemeleri Sanayi Ve Ticaret A.S. |
Hⁿsamettin Sonmez |
| K220077 |
08/09/2022 |
IMICRYL Composite, Composite Flow Materials |
IMICRYL DIS MALZEMELERI SANAYI VE TICARET AS |
Husamettin Sonmez |
| K210678 |
08/17/2022 |
implaFit« hip stems |
implantcast, GmbH |
Juliane Hoppner |
| K220887 |
08/04/2022 |
Mini-ClotTriever Thrombectomy System |
Inari Medical |
Ellen Nguyen |
| K220875 |
08/26/2022 |
HAcancellous PEEK-C Porous HA PEEK Cervical IBF System |
Innovasis, Inc. |
Marshall McCarty |
| K221854 |
08/06/2022 |
Reprocesses Umbilical Cable |
Innovative Health, LLC. |
Rick Ferreira |
| K213426 |
08/16/2022 |
HemosIL ReadiPlasTin |
Instrumentation Laboratory Co. |
Carol Marble |
| K220394 |
08/19/2022 |
SmartAdjust(TM) technology |
Insulet Corporation |
Alexander Hamad |
| K222239 |
08/19/2022 |
SmartBolus Calculator |
Insulet Corporation |
Alexander Hamad |
| K221835 |
08/22/2022 |
CUSA Clarity Ultrasonic Surgical Aspirator System |
Integra Lifesciences Corporation |
Alexandra Wells |
| K214095 |
08/15/2022 |
da Vinci X/Xi (IS4200/IS4000) 8mm Reusable Instruments |
Intuitive Surgical, Inc. |
Kunal Gunjal |
| K222257 |
08/23/2022 |
1.5 T/R Quad Extremity Coil, 1.5T 8CH T/R Knee Coil |
Invivo Corporation (Business Trade Name: Philips) |
Connie Pascual |
| K222325 |
08/31/2022 |
8ch Wrist Coil |
Invivo Corporation (Business Trade Name: Philips) |
Connie Pascual |
| K213735 |
08/08/2022 |
dS Sentinelle Breast 16ch 1.5T Coil |
Invivo Corporation (Business Trade Name: Philips) |
Ann Lebar |
| K213727 |
08/08/2022 |
dS Sentinelle Breast 16ch 3.0T Coil |
Invivo Corporation (Business Trade Name: Philips) |
Ann Lebar |
| K213686 |
08/12/2022 |
SKOUT Software |
Iterative Scopes Inc. |
Daniel Wang |
| K222212 |
08/24/2022 |
ivWatch Model 400 |
ivWatch, LLC |
Holly Novak |
| K213477 |
08/03/2022 |
Root ZX3 |
J. Morita USA, Inc. |
Fujio Zushi |
| K212518 |
08/18/2022 |
Jeesung Safety Syringe and Single Use Needles |
JeeSung Medical Co., Ltd. |
Choi Yong Hyun |
| K221920 |
08/24/2022 |
ARIX Small Fragment System |
Jeil Medical Corporation |
Bora Kim |
| K212846 |
08/30/2022 |
Sterile Hypodermic Syringe for Single Use, with/without Needle, Sterile Hypodermic Needle for Single Use |
Jiangsu Jichun Medical Devices Co., Ltd. |
Zhu Pingnan |
| K212385 |
08/16/2022 |
YUWELL Finger Pulse Oximeter |
Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. |
Yuzhuo Wang |
| K221040 |
08/31/2022 |
Electronic Sphygmomanometers, Model: X1, X2, X5, X6, X7,X8, X11) |
Jiangxi AICARE Medical Technology Co., Ltd |
Lizhu Xiao |
| K221157 |
08/30/2022 |
JR Medic |
JR Engineering & Medical Technologies (M) SDN.BHD. |
Ganesan Subramaniam |
| K221255 |
08/31/2022 |
SimpliShade Bulk Fill, SimpliShade Bulk Fill Flow |
Kerr Corporation |
Haiyan Wei |
| K221475 |
08/31/2022 |
MyClearALIGN Dental Aligner System |
Key Dental Technologies, LLC |
Larry Moray |
| K221381 |
08/10/2022 |
KDG Abutments |
Keystone Dental Inc. |
Nancy DeAngelo |
| K220050 |
08/11/2022 |
KLS Martin IPS Distraction |
KLS Martin L.P. |
Jennifer Damato |
| K222083 |
08/09/2022 |
LimFlow V-Ceiver |
LimFlow Inc. |
Zachary Woodson |
| K221541 |
08/31/2022 |
LimFlow ARC |
LimFlow, Inc. |
Zachary Woodson |
| K221189 |
08/29/2022 |
OLIZ LTB-1000A |
LTBIO Co., Ltd. |
Min-Ho Kim |
| K221953 |
08/04/2022 |
Masimo CARESCAPE SpO2 û Masimo with SpHb |
Masimo Corporation |
Unji Lee |
| K220452 |
08/17/2022 |
Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase Shoulder Planner |
Materialise NV |
Jenny Jones |
| K213614 |
08/03/2022 |
Cannulated Screws |
Maxxion Medical, LLC |
Guilherme Esteves Pontes |
| K220303 |
08/04/2022 |
MDHearingAid app, MDHearingAid Smart hearing aids |
MDHearingAid |
Doug Breaker |
| K221850 |
08/23/2022 |
GMK 3D Metal Tibial Tray |
Medacta International S.A. |
Stefano Baj |
| K222169 |
08/16/2022 |
FairFix Adjustable Button System |
Medacta International SA |
Stefano Baj |
| K220357 |
08/26/2022 |
MedCAD AccuShape Titanium Patient-Specific Cranial Implant |
MedCAD |
Brian Buss |
| K211298 |
08/25/2022 |
WiEMSpro |
Medical Cables S.L. |
JosΘ Fuertes Pe±a |
| K213934 |
08/06/2022 |
Pro Guard Nitrile Powder Free Examination Glove |
Medical Glove Co., Ltd |
Teoh Choh Shee |
| K221325 |
08/25/2022 |
CONDUIT Lateral Switch Plate |
Medos International, SARL |
LiJuan He |
| K220812 |
08/19/2022 |
DynaClip« Bone Staple |
MedShape, Inc. |
Courtney Kline |
| K221962 |
08/25/2022 |
LINQ II Insertable Cardiac Monitor |
Medtronic, Inc. |
Dianna L. Johannson |
| K213845 |
08/15/2022 |
HeRO Graft |
Merit Medical Systems, Inc. |
Susan Christensen |
| K222256 |
08/26/2022 |
BonOs« Inject Bone Cement; NEO Pedicle Screw SystemÖ |
Neo Medical SA |
Jonas Larsson |
| K222230 |
08/24/2022 |
NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar Advanced Therapy System for Mental Health |
Neuronetics, Inc. |
Amanda Pentecost |
| K221405 |
08/05/2022 |
Neurophet SCALE PET |
NEUROPHET, Inc. |
Boreum Yoo |
| K220472 |
08/11/2022 |
NEUWAVE Microwave Ablation System and Accessories |
NeuWave Medical Inc. |
Mohamed Shariff |
| K211675 |
08/08/2022 |
Dasky Disposable Sampling Tube (Model name: VSM02) |
Ningbo Dasky Life Science Co., Ltd. |
Wilson Wong |
| K221604 |
08/22/2022 |
SafetiHeel, MediHeel, Novaplus |
NSP Tech Pte Ltd |
HC Tan |
| K213937 |
08/16/2022 |
Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution |
O & M Halyard, Inc. |
Steven Dowdley |
| K213929 |
08/01/2022 |
Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid |
O & M Halyard, Inc. |
Steven Dowdley |
| K213905 |
08/25/2022 |
ONX Large External Fixation System |
OrthoNovis, Inc. |
Ken West |
| K221385 |
08/11/2022 |
LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02) |
Ovesco Endoscopy AG |
Marc O. Schurr |
| K221126 |
08/12/2022 |
Unistik« 3, sterile single-use safety lancets; Unistik« 3 Value, sterile single-use safety lancets; Abbott SF sterile single-use safety lancets |
Owen Mumford Ltd |
Darren Mansell |
| K220897 |
08/17/2022 |
Disposable Brain Biopsy Needle 2.0 |
PAJUNK GmbH Medizintechnologie |
Christian G. H. Quass |
| K222194 |
08/19/2022 |
Baby Gorilla«/Gorilla« Plating System |
Paragon 28, Inc. |
Haylie Hertz |
| K220139 |
08/03/2022 |
QScreen |
PATH MEDICAL GmbH |
Johann Oswald |
| K212361 |
08/11/2022 |
Novo |
PathAI, INC. |
Kathy Wack |
| K222072 |
08/08/2022 |
Dolphin Imaging 12.0 |
Patterson Dental Supply, Inc |
Erin Daly |
| K221628 |
08/04/2022 |
exGraft, exGraft Carbon |
PECA Labs |
Doug Bernstein |
| K213390 |
08/18/2022 |
Benchmark BMX96 Access System |
Penumbra, Inc. |
Buu Buu Ly |
| K212181 |
08/03/2022 |
ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP Allergen f416, Allergen component rTri a 19 Omega-5 Gliadin, Wheat, ImmunoCAP Allergen f449, Allergen component rSes i 1 Sesame seed |
Phadia AB |
Anna Torell Holm |
| K220241 |
08/09/2022 |
ôPOINTö Kinguide Robotic-Assisted Surgical System |
Point Robotics MedTech Inc. |
Wayne Kao |
| K220816 |
08/02/2022 |
BruxZir NOW |
Prismatik Dentalcraft, Inc. |
So Hyun Park |
| K213803 |
08/23/2022 |
FIBERGRAFT Aeridyan Matrix Bone Graft Substitute |
Prosidyan, Inc |
Charanpreet S. Bagga |
| K221671 |
08/01/2022 |
CellFX« System |
Pulse Biosciences, Inc. |
Punam Gollamudi |
| K220933 |
08/31/2022 |
QT Scanner 2000 Model A |
QT Imaging, Inc. |
John Klock |
| K210179 |
08/02/2022 |
QOCA Portable ECG Monitoring Device |
Quanta Computer Inc. |
Vivian Yang |
| K221353 |
08/18/2022 |
Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F, Quantum Perfusion Dual Lumen Cannula 29F, Quantum Perfusion Dual Lumen Cannula 24F-V1, Quantum Perfusion Dual Lumen Cannula 27F-V |
Qura S.r.l. |
Raffaella Tommasini |
| K220598 |
08/24/2022 |
AutoContour Model RADAC V2 |
Radformation, Inc. |
Kurt Sysock |
| K220582 |
08/22/2022 |
ClearCalc Model RADCA V2 |
Radformation, Inc. |
Kurt Sysock |
| K220583 |
08/23/2022 |
ClearCheck Model RADCC V2 |
Radformation, Inc. |
Kurt Sysock |
| K213520 |
08/19/2022 |
AXIR-CX |
Radisen Co., Ltd |
John Lim |
| K221955 |
08/31/2022 |
Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20 |
RealCloud Imaging Inc. dba RealCloud Imaging |
Douglas A Golay |
| K221520 |
08/18/2022 |
Miro3D Wound Matrix |
Reprise Biomedical, Inc. |
Herzog Kathy |
| K221336 |
08/05/2022 |
AvΘli |
Revelle Aesthetics, Inc. |
Melissa Viotti |
| K221350 |
08/05/2022 |
Non-Sterile Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) |
Rubberex Alliance Products Sdn Bhd |
Sabri Bin Abdul Hamid |
| K212905 |
08/18/2022 |
Sotair Device |
Safe BVM Corporation |
Haris Shekhani |
| K220618 |
08/30/2022 |
SaliPen |
Saliwell Ltd. |
Ben Beiski |
| K221599 |
08/22/2022 |
HS40 Diagnostic Ultrasound System |
Samsung Medison Co., Ltd. |
Jee Young Ju |
| K212810 |
08/05/2022 |
MONOFIX PGCL, knotless wound closure device |
Samyang Holdings Corp., Ltd. |
Ahram Kim |
| K220799 |
08/29/2022 |
K-SHIELD Zen |
SB-Kawasumi Laboratories, Inc. |
Shiro Agehama |
| K221347 |
08/03/2022 |
Transpara 1.7.2 |
ScreenPoint Medical B.V. |
Robin Barwegen |
| K214118 |
08/30/2022 |
Riva Cem Automix |
SDI Limited |
Antonella Kotefski |
| K220530 |
08/17/2022 |
Tetragraph Neuromuscular Transmission Monitor |
Senzime AB |
Johanna Faris |
| K221206 |
08/25/2022 |
Compass Steerable Needle |
Serpex Medical, Inc. |
Sasha Schrode |
| K221302 |
08/15/2022 |
Recon Steerable Sheath |
Serpex Medical, Inc. |
Sasha Schrode |
| K221917 |
08/19/2022 |
Stent Positioning Assistance System (SPAS) |
Seven Sons Ltd. |
Nancy Zhang |
| K220680 |
08/12/2022 |
Denture Base Polymers |
Shandong Huge Dental Material Corporation |
Maggie Zheng |
| K212033 |
08/17/2022 |
Disposable Sterile Syringe, with/without needle;luer/luer-lock, Disposable insulin syringe, Disposable Hypodermic needle |
Shandong Zhushi Pharmaceutical Group Co., Ltd |
Junhui Zhu |
| K220159 |
08/26/2022 |
Flexible Ureterorenoscope (Model: US31D-12-EU), Flexible Ureterorenoscope (Model: US31D-12-US) |
Shanghai AnQing Medical Instrument Co., Ltd. |
Shuwen Fan |
| K221838 |
08/17/2022 |
Surgical Face Mask (HNFM0103) |
Shanghai Hua En Industrial CO LTD |
Lisa Zhao |
| K212972 |
08/18/2022 |
KDL Safety Needles |
Shanghai Kindly Enterprise Development Group Co., Ltd |
Liu Huarong |
| K221416 |
08/31/2022 |
Sterile Safety Syringes for Single Use |
Shanghai Kindly Enterprise Development Group Co., Ltd |
Liu Hualong |
| K220576 |
08/05/2022 |
FAMA Male Latex Condoms |
Shanghai Personage Hygiene Products Co.,Ltd. |
Haijiang Song |
| K221745 |
08/31/2022 |
Sterile Posterior Spinal Fixation System |
Shanghai REACH Medical Instrument Co., Ltd |
Mingsha Ye |
| K221466 |
08/12/2022 |
IPL Hair Removal Device, model: AI01, AI06, AI08, AI16, AI17 |
Shenzhen Century Dongyuan Technology Co Ltd. |
He Wang |
| K221635 |
08/31/2022 |
IPL sapphire ice cooling hair remove device |
Shenzhen Desida Technology Co., Ltd. |
Shuangcheng Yuan |
| K220998 |
08/24/2022 |
Transcutaneous Electrical Nerve Stimulator, Model: KTR-405 |
Shenzhen Kentro Medical Electronics Co., Ltd. |
Zewu Zhang |
| K221451 |
08/01/2022 |
IPL hair removal |
Shenzhen Lizbella Technology Co.,Ltd |
Shiwei Zhang |
| K213026 |
08/16/2022 |
Clear Aligner |
Shenzhen Meiming Dentistry Technology Co., Ltd |
Fei Hu |
| K221212 |
08/26/2022 |
Upper Arm Blood Pressure Monitor |
Shenzhen Yolanda Technology Co., Ltd |
Xuejun Wang |
| K221852 |
08/16/2022 |
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter |
Shockwave Medical, Inc. |
Danica Van |
| K220262 |
08/26/2022 |
Dimension EXL LOCI BRAHMS Procalcitonin (PCT) |
Siemens Healthcare Diagnostics, Inc. |
Amy Tyler |
| K213713 |
08/11/2022 |
AI-Rad Companion (Pulmonary) |
Siemens Healthcare GmBh |
Lauren Bentley |
| K220433 |
08/16/2022 |
syngo Application Software (VE21) |
Siemens Medical Solution USA, Inc. |
Patricia D. Jones |
| K221190 |
08/16/2022 |
ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select Diagnostic Ultrasound System |
Siemens Medical Solutions USA, Inc. |
Sulgue Choi |
| K222172 |
08/19/2022 |
MI View&GO |
Siemens Medical Solutions USA, Inc. |
Clayton Ginn |
| K202461 |
08/12/2022 |
ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System |
Smisson-Cartledge Biomedical LLC |
Calder Clay III |
| K221792 |
08/25/2022 |
Acute QC Strut and Components |
Smith & Nephew, Inc. |
Amanda Lammey |
| K220959 |
08/18/2022 |
OR3O Dual Mobility System |
Smith & Nephew, Inc. |
Rose Beifuss |
| K213718 |
08/30/2022 |
SOL-GUARD Safety Pull Button Collection Set |
Sol-Millennium Medical, Inc. |
PJ Pasia |
| K191131 |
08/03/2022 |
Solidence Multipockets |
Solidence Surgical Corporation |
Morris Azad |
| K212784 |
08/24/2022 |
TightRail Guardian Motorized Dilator Sheath |
Spectranetics, Inc. |
Jordan Baum |
| K211841 |
08/25/2022 |
MRI Planner |
Spectronic Medical AB |
Per Bruhn |
| K221023 |
08/19/2022 |
Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman G3/HA Minuteman G3, HA Minuteman G3-R, Minuteman G5 |
Spinal Simplicity LLC |
Adam Rogers |
| K222362 |
08/29/2022 |
Salvo« Spine System |
Spine Wave, Inc. |
Ronald K Smith |
| K213876 |
08/05/2022 |
Spineology Navigation Instruments |
Spineology Inc. |
Andrew Adams |
| K212482 |
08/09/2022 |
Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural White |
Sri Trang Gloves (Thailand) Public Company Limited |
Jarinya Jirokjul |
| K212554 |
08/19/2022 |
Bonvadis Topical Cream |
StemCyte Inc. |
Angel Hsieh |
| K221507 |
08/31/2022 |
Disposable Blood Lancet |
SteriLance Medical (Suzhou) Inc. |
Susan Sun |
| K221970 |
08/30/2022 |
Lancing device |
SteriLance Medical(Suzhou) Inc. |
Susan Sun |
| K222543 |
08/25/2022 |
AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector |
Steris |
Anthony Piotrkowski |
| K222272 |
08/18/2022 |
truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5 Pack, PN 2000181; 20Fr CDT 5 Pack, PN ACCCC3CDT05; Active Venting Spray Kit, 20 Fr CDT, PN 2000177; Active Venting Spray Kit 16 Fr CDT, PN 20000516; Rapid AV Catheter |
STERIS Corporation |
Carroll Martin |
| K222130 |
08/19/2022 |
1688 4K Camera System with Advanced Imaging Modality |
Stryker |
Marlene Fraga |
| K220731 |
08/11/2022 |
Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem |
Stryker |
Gregg Ritter |
| K221403 |
08/19/2022 |
Cortera Spinal Fixation System |
Surgalign Spine Technologies |
Jessica Jho |
| K220387 |
08/17/2022 |
Disposable Blood Lancets |
Suzhou Kyuan Medical Apparatus Co., Ltd. |
Shi Ye |
| K221131 |
08/12/2022 |
Tasso+ |
Tasso, Inc. |
Trish Kan Brown |
| K221844 |
08/17/2022 |
TDM Lumbar Interbody Fusion Cage System |
TDM Co., Ltd |
Jung Wook Choi |
| K222279 |
08/29/2022 |
Rusch Intermittent Urethral Catheters |
Teleflex Medical |
Kelly Breheim |
| K220349 |
08/12/2022 |
TeraRecon Neuro |
TeraRecon, Inc |
Michael Sosebee |
| K212095 |
08/22/2022 |
SurGuard3 Safety Hypodermic Needle |
Terumo Europe N.V. |
L. Decoster |
| K221328 |
08/04/2022 |
Bloomi Smooth Water Based Lubricant |
The Bloomi Inc.. |
Rebecca Story |
| K211771 |
08/24/2022 |
The GOOD High Fluid-Resistant Surgical Mask, The GOOD High Fluid-Resistant Surgical Procedure KF Mask, The GOOD Super Guard Design High Fluid-Resistant Surgical Mask, The KOEASY High Fluid-Resistant Surgical Mask, The KOEASY High Fluid-Resistant Surgical |
The GOOD Corporation |
Hak Rae Lee |
| K220434 |
08/12/2022 |
Blue Eye (TS-905) |
The Standard Co., Ltd. |
Sung Nam Kim |
| K221111 |
08/29/2022 |
Non-Mydriatic Retinal Camera NW500 |
Topcon Corporation |
Ryota Kitawaki |
| K221785 |
08/29/2022 |
TCL3 Motion Tracking System |
TracInnovations A/S |
Stefan Glimberg |
| K220696 |
08/19/2022 |
uCerv Flux-C 3D Porous Titanium Cervical Interbody |
Ulrich Medical USA |
Hans Stover |
| K220647 |
08/18/2022 |
GuideLiner Coast, 5.5F (5270); GuideLiner Coast, 6F (5271); GuideLiner Coast, 7F (5272); GuideLiner Coast, 8F (5273) |
Vascular Solutions LLC |
Steph Pahl |
| K220648 |
08/11/2022 |
OMF ASP System |
VHA DEAN |
Beth Ripley |
| DEN210052 |
08/26/2022 |
Vibrant System |
Vibrant Ltd. |
Lior Ben Tsur |
| K220016 |
08/19/2022 |
Viramed Borrela All-In-One ViraChip Test Kit |
Viramed Biotech AG |
Martin Kintrup |
| K220090 |
08/12/2022 |
Visibly Digital Acuity Product |
Visibly, Inc. |
Paul Foley |
| K212763 |
08/10/2022 |
UniVit HE, UniVit UHS |
VisionCare Devices, LLC. |
Rick Morgan |
| K221100 |
08/29/2022 |
Viz RV/LV |
Viz.ai, Inc. |
Vi Ma |
| K220640 |
08/23/2022 |
Bifix Hybrid Abutment Cement |
VOCO GmbH |
M. Th. Plaumann |
| K212370 |
08/29/2022 |
Leaderflex Mini and Leaderflex Nano |
Vygon USA |
Lauren Doyle |
| K213758 |
08/19/2022 |
Lexa PLUS RIS-311 |
W&H Sterilization s.r.l. |
Paola Zampino |
| K212253 |
08/25/2022 |
Apollo Duet (Model : APD-4000) |
Weero Co. |
Jimin Han |
| K220524 |
08/04/2022 |
Well-Life Mini TENS Stimulator(WL-23XXC/WL-23XXE Series) |
Well-Life Healthcare Limited |
Jenny Hsieh |
| K213513 |
08/31/2022 |
Vented Vial Adapter 20mm |
West Pharma Services IL, Ltd. |
llanit Goldgraber |
| K221427 |
08/24/2022 |
V-Laser |
WON TECH Co., Ltd. |
Hyun Sik Yoon |
| K211601 |
08/22/2022 |
Powder Free Latex Examination Glove, Non-Sterile |
WRP Asia Pacific SDN. BHD. |
Siti Syamimie Atirah Binti Mat |
| K220403 |
08/12/2022 |
Vibe SF Self-Fitting Hearing Aid |
WSAUD A/S |
Kristine Klitgaard Pedersen |
| K220091 |
08/26/2022 |
Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device |
Xiros Ltd |
Steve Curran |
| K221486 |
08/30/2022 |
INDEX BPM |
Ya Horng Electronic Co., Ltd. |
Jerry Hsu |
| K220292 |
08/19/2022 |
Disposable Endoscope Injection Needle |
Yangzhou Fartley Medical Instrument Technology Co., Ltd. |
Tina Han |
| K221049 |
08/12/2022 |
Zavation VariSync Plate System and VariSync Spacer System |
Zavation Medical Products, LLC |
Katie Motley |
