| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K230777 |
10/06/2023 |
Patient Examination Gloves |
3A Glove Sdn. Bhd. |
Kumar Durarajen |
| K232173 |
10/06/2023 |
Ascend VBR System, Ascend NanoTec VBR System |
Alphatec Spine, Inc. |
Sandy Gill |
| K232044 |
10/06/2023 |
Invictus Robotic Navigation Instruments |
Alphatec Spine, Inc. |
Unnati Bhuptani |
| K231960 |
10/03/2023 |
NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Capsule and NaviCam Tether |
AnX Robotica Corporation |
Tim Thomas |
| K232755 |
10/06/2023 |
Arthrex FiberTape and TigerTape Cerclage Sutures |
Arthrex Inc. |
Ruth Segall |
| K223905 |
10/06/2023 |
Vivio« LVEDP System |
Avicena, LLC |
Sean Brady |
| K231567 |
10/04/2023 |
Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and select other drugs (Blue) |
Better Care Plastic Technology Co., Ltd. |
Zhu Chunyan |
| K232395 |
10/05/2023 |
ETEST« Sulbactam/Durlobactam (SUD) (0.004/4-64/4 ╡g/mL), ETEST« SUD |
bioMΘrieux |
Sophie Quiblier |
| K232844 |
10/04/2023 |
The IQoolTM System |
BrainCool AB |
Martin Waleij |
| K231300 |
10/06/2023 |
Nutricair Enteral Syringe with ENFit |
Cair LG |
Irving L. Wiesen, Esq. |
| K232480 |
10/06/2023 |
ProtekDuo Veno-Venous Cannula Sets |
CardiacAssist, Inc. |
Mariah McMinn |
| K230681 |
10/02/2023 |
Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl |
Central Medicare Sdn. Bhd. |
Chua Kah Ying |
| K232704 |
10/05/2023 |
Clarius Ultrasound Scanner |
Clarius Mobile Health Corp. |
Agatha Szeliga |
| K230135 |
10/04/2023 |
Copioumed Chemotherapy Isolation Gown |
Copioumed International Inc. |
James Liu |
| K232367 |
10/05/2023 |
cmAngio« V1.0 |
CureMetrix, Inc. |
Kevin Harris |
| K231001 |
10/05/2023 |
DeepTek CXR Analyzer v1.0 |
DeepTek Medical Imaging Pvt Ltd |
Carrillo Rory |
| K230144 |
10/06/2023 |
Denti.AI Detect |
Denti.AI Technology, Inc. |
Lyudmila Tuzova |
| K232056 |
10/06/2023 |
IPL Hair Removal Device, Model(s): PB1, PB2, PB3, PB4, TM002 |
Dongguan Lide Electric Appliance Co., Ltd |
Xiang Guojun |
| K232722 |
10/03/2023 |
endo.digital Platform |
DreaMed Diabetes Ltd |
Eran Atlas |
| K231025 |
10/04/2023 |
EFAI NeuroSuite CT ICH Assessment System |
Ever Fortune.AI Co., Ltd. |
Joseph Chang |
| DEN220087 |
10/06/2023 |
Edison System |
HistoSonics, Inc. |
Daniel Kosednar |
| K232675 |
10/05/2023 |
Heating Tens, FT-615 |
Hivox Biotek Inc. |
Leslie Peng |
| K232760 |
10/06/2023 |
Swoop« Portable MR Imaging System« |
Hyperfine, Inc. |
Christine Kupchick |
| K230085 |
10/03/2023 |
Lung-CAD |
Imagen Technologies, Inc |
Rebecca Jones |
| K230265 |
10/06/2023 |
MoMe« ARC Wireless Ambulatory ECG Monitoring and Detection System |
InfoBionic, Inc. |
Dave MacCutcheon |
| K232787 |
10/06/2023 |
ScanNav Anatomy Peripheral Nerve Block |
Intelligent Ultrasound Limited |
Bhaskar Chikkanna |
| K232762 |
10/03/2023 |
dS Breast Coil 7ch 1.5T |
Invivo Corporation (Business Trade Name: Philips) |
Liselotte Kornmann |
| K232064 |
10/02/2023 |
Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with Chemotherapy Drugs and Fentanyl Citrate) |
Isikel Manufacturing LLC |
Chris Betts |
| K223740 |
10/05/2023 |
Oxygen Concentrator (Model: KSW-5, KSN-5, KSOC-5) |
Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd. |
Heidi Zhang |
| K232406 |
10/03/2023 |
KARL STORZ OR1Ö SCB CONTROL (WU300) |
Karl Storz SE & Co. KG |
Thomas Ostrowski |
| K232359 |
10/02/2023 |
Surgical face mask |
Kingstar Medical (Xianning) Co., Ltd. |
Fan Rong |
| K232094 |
10/03/2023 |
Orchid Safety Release ValveTM |
Linear Health Sciences LLC |
Daniel Clark |
| DEN230002 |
10/04/2023 |
DuraGraft |
Marizyme, Inc. |
Navdeep Kaur Cheema |
| K232767 |
10/04/2023 |
Nautilus VF ECMO Oxygenator |
MC3 Inc. |
Martha Rumford |
| K223926 |
10/06/2023 |
VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box |
Medimaging Integrated Solution Inc. (MiiS) |
Jung-Yi Yen |
| K232492 |
10/06/2023 |
2.7 mm GRYPHONÖ Flex Knotless PEEK Anchor; 2.7 mm GRYPHONÖ Flex Knotless Biocomposite Anchor |
Medos International SARL |
Elizabeth P. Messana |
| K223802 |
10/06/2023 |
accufit |
Mettler Electronics Corporation |
An Le |
| K232023 |
10/04/2023 |
Momentum Spine |
Momentum Health Inc. |
Evan Dimentberg |
| K230853 |
10/06/2023 |
EARP Nerve Cuff Electrode |
Nvision Biomedical Technologies, Inc. |
Diana Langham |
| K230242 |
10/05/2023 |
OsteoCentric Dental Implant System |
OsteoCentric Technologies |
Todd Evans |
| K232276 |
10/06/2023 |
Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 ╡g) SUD20 |
Oxoid Limited (Part of Thermo Fisher Scientific) |
Amie Lovatt |
| K230070 |
10/05/2023 |
MESORAM« Hypodermic Needle (710301); MESORAM« Hypodermic Needle (710302); MESORAM« Hypodermic Needle (712305); MESORAM« Hypodermic Needle (712315); MESORAM« Hypodermic Needle (710303); MESORAM« Hypodermic Needle (710307); MESORAM« Hypodermic Needle (71030 |
PromaMedical Inc. |
Christian Wehrenpfenning |
| K230091 |
10/06/2023 |
THE Cover |
Purgo Biologics Inc. |
Byungsun Kim |
| K221550 |
10/05/2023 |
Evidence MultiSTAT DOA Urine MultiPlex |
Randox Laboratories Limited |
Karena Shaw |
| K220451 |
10/05/2023 |
Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT |
Randox Laboratories Limited |
Karena Shaw |
| K232763 |
10/04/2023 |
Electrode Handpieces (VCT, RFTV, BMDT series) |
RF Medical Co., Ltd |
Kwang S Choi |
| K231078 |
10/05/2023 |
All-Suture Anchor |
Riverpoint Medical, LLC |
Edwin Anderson |
| K232411 |
10/06/2023 |
JuggerKnot Soft Anchor OC |
Riverpoint Medical, LLC |
Becca DeFrancia |
| K232407 |
10/06/2023 |
Cautery Protective Actuation System (CPAS) |
Safer Surgeries Medical Devices, LLC |
Rowland Grattan |
| K231772 |
10/03/2023 |
V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic Ultrasound System |
Samsung Medison Co., Ltd. |
Jee Young Ju |
| K232055 |
10/06/2023 |
Vial Adapter |
Shanghai Ling Fu Technology Co., Ltd. |
Esther Zhang |
| K232712 |
10/03/2023 |
uMI Panorama |
Shanghai United Imaging Healthcare Co., Ltd. |
Xin Gao |
| K231603 |
10/06/2023 |
Standard Staple-Line Reinforcement (SSLR23) |
Standard Bariatrics, Inc. |
Trevor Barton |
| K232918 |
10/03/2023 |
enspire 300 Series Automated Endoscope Reprocessor |
Steris Corporation |
Nalepka Jennifer |
| K232914 |
10/03/2023 |
SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6800); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6900) |
STERIS Corporation |
Jennifer Nalepka |
| K232279 |
10/05/2023 |
LifeStyles NRL Textured Condom |
Suretex Limited |
Alison Arnot |
| K231716 |
10/02/2023 |
OsteoFlo« HydroPuttyÖ |
SurGenTec, LLC |
Travis Greenhalgh |
| K233044 |
10/05/2023 |
Tandem Mobi insulin pump with interoperable technology |
Tandem Diabetes Care Inc. |
Louise Focht |
| K231520 |
10/02/2023 |
tmCMF Solution |
TechMah CMF |
Mohamed Mahfouz |
| K231863 |
10/06/2023 |
ProBeam 360░ Proton Therapy System v2.0 (Multiroom) |
Varian Medical Systems, Inc. |
Peter Coronado |
| K231398 |
10/04/2023 |
VUNO Med-DeepBrain |
VUNO Inc. |
Jiwon Song |
| K221972 |
10/02/2023 |
Warantec Custom Abutment |
Warantec Co., Ltd, |
Younggwang Choi |
| K221777 |
10/06/2023 |
Disposable Sterile Syringe |
Weihai Shengjie Medical Technology Co., Ltd |
Huihui Wang |
| K232046 |
10/06/2023 |
Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection |
Xeridiem Medical Devices, A Spectrum Plastics Group Company |
Steve Murray |
| K232230 |
10/03/2023 |
YJ-K1/K2 Wheelchair (YJ-K1F 16 NDE; YJ-K1F 16 NDS; YJ-K1F 18 NDE; YJ-K1F 18 NDS; YJ-K1F 20 NDE; YJ-K1F 20 NDS; YJ-K1F 18 NDEE; YJ-K1F 16 VDE; YJ-K1F 16 VDS; YJ-K1F 18 VDE; YJ-K1F 18 VDS; YJ-K1F 20 VDE; YJ-K1F 20 VDS; YJ-K2 16 VDFE; YJ-K2 16 VDFS; YJ-K2 18 |
Zhenjiang Assure Medical Equipment Co., Ltd. |
Ying Mei |
| K230780 |
10/05/2023 |
MFG-05 |
Zimmer MedizinSysteme GmbH |
Ute Killet |
