Oct 2, 2026
K260490
Ninenovo Blood Oxygen Ring (BORMB-01-6,BORMB-01-7,BORMB-01-8,BORMB-01-9,BORMB-01-10,BORMB-01-11,BORMB-01-12,BORMB-01-13,BORMB-01-14)
Shenzhen Ninenovo Technology Limited
- DQA
- Class II
510(k) clearances
Decision dates from openFDA device 510(k) records. Newest first.
746 records
Oct 2, 2026
K260487
stentFIX System Set (100.50n)
Ovesco Endoscopy AG
- PKL
- Class II
Oct 2, 2026
K260468
H100Plus Hemoglobin Testing System
Shenzhen Lifotronic Technology Co., Ltd.
- PDJ
- Class II
Oct 2, 2026
K260233
Elecsys EBV IgM
Roche Diagnostics
- LJN
- Class I
Oct 2, 2026
K260232
Elecsys EBV VCA IgG
Roche Diagnostics
- LSE
- Class I
Oct 2, 2026
K260221
Elecsys EBV EBNA IgG
Roche Diagnostics
- LSE
- Class I
Oct 2, 2026
K260064
Neurora
Argus Cognitive, Inc.
- QPF
- Class II
Oct 2, 2026
K260044
Ventricular Catheters, Thomale Catheter
Aesculap, Inc.
- JXG
- Class II
Oct 2, 2026
K254030
cCeLL405
VPIX Medical, Inc.
- QFX
- Class II
Oct 2, 2026
K253422
OAB Delivery Catheter
Cognition Medical Corp.
- QJP
- Class II
Oct 1, 2026
K263092
Dual Stage Venous Cannulae
Sorin Group Italia S.R.L.
- DWF
- Class II
Oct 1, 2026
K263062
NOVIX Pedicle Screw System
Tdm Co., Ltd.
- NKB
- Class II
Oct 1, 2026
K263016
Intra-Operative Positioning System (IOPS) and IOPS Visionary System
Centerline Biomedical
- DQK
- Class II
Oct 1, 2026
K262473
NEXUS® Hip Stem
Microport Orthopedics, Inc.
- LZO
- Class II
Oct 1, 2026
K262208
Non-sterile, Powder Free Nitrile Examination Aloe Vera Green Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid;Non-sterile, Powder Free Nitrile Examination Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid – Blue;Non-sterile, Powder Free Nitrile Examination Gloves - Pink
Yty Industry (Manjung) Sdn Bhd
- LZA
- Class I
Oct 1, 2026
K261612
SwiftSight-BodyComposition
Airs Medical, Inc.
- LNH
- Class II
Oct 1, 2026
K260470
Electronic Blood Pressure Monitor (BP-204C, BP-204A, BP-215, BP-203C, BP-205A, BP-201C, BP-217, BP-202C, BP-202 BP-205, BP-205B,BP-206)
Shenzhen Brav Electronic Technologies Co., Ltd.
- DXN
- Class II
Oct 1, 2026
K260283
VITEK 2 AST-Streptococcus Meropenem (=0.06 - =4 µg/mL)
bioMerieux, Inc.
- LON
- Class II
Oct 1, 2026
K260029
Firstar Dental Handpieces
FDC Technology Industry Co.
- EFB
- Class I
Oct 1, 2026
K260027
Firstar Dental Electric Motor
FDC Technology Industry Co.
- EBW
- Class I
Sep 30, 2026
K263172
SAS MIS Pelvic Incidence Rods
Spinal Alignment Solutions, Inc.
- NKB
- Class II
Sep 30, 2026
K263035
CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel (includes Influenza A/B Typing Kit, Influenza A Subtyping Kit, Influenza A(H5) Subtyping Kit, and Influenza B Lineage Genotyping Kit)
Centers for Disease Control and Prevention
- OZE
- Class II
Sep 30, 2026
K263033
Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000, Matrix 7800)
Fussen Technology Co., Ltd.
- OAS
- Class II
Sep 30, 2026
K262893
Eonis™ SMA kit
Revvity, Inc.
- QUE
- Class II
Sep 30, 2026
K262712
Duet™ Spinal Fixation System
Duet Spine Holdings, LLC
- NKB
- Class II