Oct 16, 2026
K260315
cCeLL - In vivo
VPIX Medical, Inc.
- GWG
- Class II
510(k) clearances
Decision dates from openFDA device 510(k) records. Newest first.
746 records
Oct 16, 2026
K260180
Carecube Negative Pressure Isolation Chamber (1BY)
Carecubes, Inc.
- LGM
- Class II
Oct 16, 2026
K260168
Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14)
Skycade Med Corporation
- DQX
- Class II
Oct 16, 2026
K254094
Endox High Level Disinfectant
Whiteley USA, Inc.
- MED
- Class II
Oct 16, 2026
K252344
BD Vacutainer® Serum Blood Collection Tubes; BD Vacutainer® Rapid Serum Tubes (RST)
Becton, Dickinson and Company
- JKA
- Class II
Oct 15, 2026
K263269
Park's Pectus System
Tdm Co., Ltd.
- HRS
- Class II
Oct 15, 2026
K262904
INDIGO® Aspiration System
Penumbra, Inc.
- QEW
- Class II
Oct 15, 2026
K262674
Giranel Guiding Sheath Set
Kossel Medtech (Suzhou) Co., Ltd.
- DYB
- Class II
Oct 15, 2026
K262576
twiist Loop Algorithm
Deka Research and Development Corp.
- QJI
- Class II
Oct 15, 2026
K262522
Odys-SI Screw
Medyssey Co, Ltd.
- OUR
- Class II
Oct 15, 2026
K262447
The Circadia CX00 System (CX00)
Circadia Health, Inc.
- DRT
- Class II
Oct 15, 2026
K262214
Disposable Reflective Marker Spheres (AM-BK115S, AM-BL130S)
Guangzhou Aimooe Technology Co., Ltd.
- HAW
- Class II
Oct 15, 2026
K262097
MICOR 700 System (N/A); MICOR 700 Extractor (FG-50621)
Carl Zeiss Meditec Cataract Technologies
- HQC
- Class II
Oct 15, 2026
K261616
Single-Use EBUS Balloon
Micro-Tech (Nanjing) Co., Ltd.
- PSV
- Class II
Oct 15, 2026
K261361
TORUS Ultrasonic Aspirator System; and accessories (TORUS Single-Use Tubing Sets, TORUS Single-Use Torque Wrenches, TORUS Handpieces, TORUS Tip Packs, TORUS Tip Clearing Stylet)
Carl Zeiss Meditec, AG
- LFL
- Unclassified
Oct 15, 2026
K260827
Oncomine ™ Dx Express Test
Life Technologies Corporation
- SBY
- Class II
Oct 15, 2026
K260530
epi-ConneKt™ Wound Matrix
MLM Biologics, Inc.
- KGN
- Unclassified
Oct 14, 2026
K263208
Vantage Lumbar Decompression Kit
SurGenTec, LLC
- HRX
- Class II
Oct 14, 2026
K262885
308nm Ultraviolet Light Therapy Device (XWYL-401A, XWYL-403A)
Guangxi Hope Medical Devices Technology Co., Ltd.
- FTC
- Class II
Oct 14, 2026
K262455
da Vinci 5 Handheld Camera Head (470080);da Vinci 5 Handheld Camera Laparoscope, 0 degree (470081);da Vinci 5 Handheld Camera Laparoscope, 30 degree (470082);da Vinci 5 Handheld Camera Tray (400526);da Vinci 5 Firefly Imaging System
Intuitive Surgical, Inc.
- GCJ
- Class II
Oct 14, 2026
K262432
CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test; CorDx Tyfast Flu A/B & COVID-19 Multiplex Rapid Test
CorDx, Inc.
- SCA
- Class II
Oct 14, 2026
K262044
Mediclose Cartridge System
Health Value Creation B.V. (trading as Corporis Medical)
- OCW
- Class II
Oct 14, 2026
K262042
Sterilization Cassette (CASS-1)
Alliedstar Medical Equipment Co., Ltd.
- KCT
- Class II
Oct 14, 2026
K261961
Ntegrate Threaded Nail System
Nvision Biomedical Technologies
- HWC
- Class II
Oct 14, 2026
K261169
Power Wheelchair (D39)
Anhui JBH Medical Apparatus Co., Ltd.
- ITI
- Class II