Sep 4, 2026
K253529
Peerbridge COR MDx (Cor MDx)
Peerbridge Health, Inc.
- MWJ
- Class II
510(k) clearances
Decision dates from openFDA device 510(k) records. Newest first.
746 records
Sep 3, 2026
K262769
Permatage XT Settable Nonabsorbable Hemostatic Bone Putty (OS-PER-1001XT)
Orthocon, Inc.
- MTJ
- Unclassified
Sep 3, 2026
K262460
Rezum System
Boston Scientific
- KNS
- Class II
Sep 3, 2026
K262315
NeuroBlate System
Monteris Medical
- ONO
- Class II
Sep 3, 2026
K262243
Profisil Free
Kettenbach GmbH & Co. KG
- LBH
- Class II
Sep 3, 2026
K261800
Helo Max Thrombectomy System (HEL2090)
Endovascular Engineering
- QEW
- Class II
Sep 3, 2026
K261647
Tempo Plating System; Ultra Compression Screw System
Pace Surgical
- HRS
- Class II
Sep 3, 2026
K261622
Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52, SCF593/62); Philips Avent Natural Care Warming Hands-free Wearable Electric Breast Pump (Model: SCF594/52, SCF594/62)
Philips Consumer Lifestyle B.V.
- HGX
- Class II
Sep 3, 2026
K261281
CROSSLEAD Standard 035 and CROSSLEAD Stiff 035
Filmecc Co., Ltd.
- DQX
- Class II
Sep 3, 2026
K260503
Triton 1 System
Neptune Medical, Inc.
- FDF
- Class II
Sep 3, 2026
K254035
Mayumi™ Thrombectomy System
MicroVention, Inc., d/b/a Terumo Neuro
- QEZ
- Class II
Sep 3, 2026
K254000
Happy Health Blood Pressure Monitor
Happy Health, Inc.
- DXN
- Class II
Sep 3, 2026
K253989
HARU Orgasm by jack herer water based lubricant (WL-OJ); HARU Orgasm water based lubricant (WL-OR); HARU STEAMY water based lubricant (WL-ST)
Maxigen Biotech, Inc.
- NUC
- Class II
Sep 3, 2026
K253673
M•care System (MW-20)
Marani Health, Inc.
- LQK
- Class II
Sep 3, 2026
K251794
Tenax® Laser Resistant Endotracheal Tube
Bryan Medical, Inc.
- BTR
- Class II
Sep 3, 2026
DEN250044
Queen of Hearts (ACS AI ECG Model)
Powerful Medical, Inc.
Sep 2, 2026
K262809
ArthroTAK Tendon Anchor Kit
ArthroTAK, LLC
- MBI
- Class II
Sep 2, 2026
K262420
Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000)
Serpex Medical
- GEH
- Class II
Sep 2, 2026
K262364
Ellian Enigma RF Device
Ellian Corp
- GEI
- Class II
Sep 2, 2026
K262153
Pivot Insulin Delivery System
Modular Medical, Inc.
- LZG
- Class II
Sep 2, 2026
K261749
Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Cardinalhealth
- LZA
- Class I
Sep 2, 2026
K261589
1927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02)
Zhengzhou PZ Laser Slim Technology Co., Ltd.
- GEX
- Class II
Sep 2, 2026
K261313
Vivid Explorer/Vivid Advanced/Vivid Focus
GE Medical Systems Ultrasound and Primary Care Diagnostics
- IYN
- Class II
Sep 2, 2026
K261311
HYALOMATRIX
Anika Therapeutics, Inc.
- QSZ
- Unclassified
Sep 2, 2026
K260432
Ruby Intravascular Catheter
Venocare, Inc.
- FOZ
- Class II