Sep 10, 2026
K261409
BioTeke® Multi-Drug Urine Test Cup
Bioteke Corporation (Wuxi) Co., Ltd.
- NFT
- Class II
510(k) clearances
Decision dates from openFDA device 510(k) records. Newest first.
746 records
Sep 10, 2026
K260879
4DM
INVIA, LLC
- QIH
- Class II
Sep 10, 2026
K260110
danumed Extension Set for Gastrostomy Button
Danumed Medizintechnik GmbH
- PIF
- Class II
Sep 10, 2026
K254246
LT Antibacterial Foam with Silver Dressing
Zhejiang Longterm Medical Technology Co., Ltd.
- NAD
- Class I
Sep 10, 2026
K254111
Irrigation/Urology Sets
B.Braun Medical, Inc.
- LJH
- Class II
Sep 10, 2026
K254074
TruPress
Procerus Enterprises
- DRS
- Class II
Sep 10, 2026
K254009
Portable Dental Unit (PC 2630, OMC 2375CV, MC 3600CV)
Lakong Medical Devices Co., Ltd.
- SJH
- Class I
Sep 10, 2026
K253856
Geniant Cranial (Navigated Neurosurgical Positioning Robot)
Koh Young Technology, Inc.
- HAW
- Class II
Sep 9, 2026
K262542
Biodegradable Nitrile Powder Free Examination Glove, Green; Biodegradable Nitrile Powder Free Examination Glove, Violet Blue Tested for Use With 32 Chemotherapy Drugs, Fentanyl & Gastric Acid Permeation Resistance Claim
Top Glove Sdn. Bhd.
- LZA
- Class I
Sep 9, 2026
K262488
Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9, RP-U-C06S3)
Guangzhou Red Pine Medical Instrument Co., Ltd.
- FGB
- Class II
Sep 9, 2026
K261793
Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color)
Maxter Healthcare, Inc.
- LZA
- Class I
Sep 9, 2026
K261470
QF10
E.A.M Benelux B.V
- NHV
- Class II
Sep 9, 2026
K260997
SIS BLU (SISBLU-30-01);SIS BLU (SISBLU-15-01)
Endoclot Plus Co., Ltd.
- PLL
- Class II
Sep 9, 2026
K260652
ColActive Plus
Covalon Technologies, Ltd.
- KGN
- Unclassified
Sep 9, 2026
K252486
ChestView US (1.1)
Gleamer
- MYN
- Class II
Sep 9, 2026
K251417
ReVISION 2
Argus Cognitive, Inc.
- QIH
- Class II
Sep 8, 2026
K262341
b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem Extensions
B-One Ortho, Corp.
- JWH
- Class II
Sep 8, 2026
K262173
N22 Offset Humeral Head
Shoulder Innovations, Inc.
- KWT
- Class II
Sep 8, 2026
K261987
Reusable SmartPeg
Osstell AB
- EKX
- Class I
Sep 8, 2026
K261956
Dental Barriers and Sleeves (AB0006)
ANI Co., Ltd.
- PEM
- Class II
Sep 8, 2026
K261823
da Vinci Surgical System, Model IS5000
Intuitive Surgical, Inc.
- NAY
- Class II
Sep 8, 2026
K261715
Emboliner Embolic Protection System (EPC-03)
Emboline, Inc.
- PUM
- Class II
Sep 8, 2026
K261462
LANDMARK Total Knee System
Smith & Nephew, Inc.
- MBH
- Class II
Sep 8, 2026
K260312
Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim; Nitrile Powder Free Examination Glove, Violet Blue Tested for Use with 32 Chemotherapy Drugs, Xylazine, Fentanyl & Gastric Acid
Gmp Medicare Sdn. Bhd.
- LZA
- Class I
Sep 8, 2026
K260229
Electric wheelchair (HC819N, HC830N, HC831N)
Yongkang Hengyi Vehicle Co., Ltd.
- ITI
- Class II