FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: 2026–2026 ×
2,517 results
313–336 of 2,517
Search insights Median review: 135d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Sep 04, 2026
NeoPEX™ Pre-Mixed Obturation Paste
K253909 · KIF
NuSmile, Ltd.
Dental · 270d
Cleared Sep 04, 2026
FCT iStream Phase 2
K253836 · JAK
Fujifilm Corporation
Radiology · 277d
Cleared Sep 04, 2026
Peerbridge COR MDx (Cor MDx)
K253529 · MWJ
Peerbridge Health, Inc.
Cardiovascular · 295d
Cleared Sep 03, 2026
Permatage XT Settable Nonabsorbable Hemostatic Bone Putty (OS-PER-1001XT)
K262769 · MTJ
Orthocon, Inc.
Orthopedic · 30d
Cleared Sep 03, 2026
Rezum System
K262460 · KNS
Boston Scientific
Gastroenterology & Urology · 48d
Cleared Sep 03, 2026
NeuroBlate System
K262315 · ONO
Monteris Medical,
Neurology · 57d
Cleared Sep 03, 2026
Profisil Free
K262243 · LBH
Kettenbach GmbH & Co. KG
Dental · 64d
Cleared Sep 03, 2026
Helo Max Thrombectomy System (HEL2090)
K261800 · QEW
Endovascular Engineering
Cardiovascular · 94d
Cleared Sep 03, 2026
Tempo Plating System
K261647 · HRS
Pace Surgical
Orthopedic · 107d
Cleared Sep 03, 2026
Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model:...
K261622 · HGX
Philips Consumer Lifestyle B.V.
Obstetrics & Gynecology · 111d
Cleared Sep 03, 2026
CROSSLEAD Standard 035 and CROSSLEAD Stiff 035
K261281 · DQX
Filmecc Co., Ltd.
Cardiovascular · 139d
Cleared Sep 03, 2026
Triton 1 System
K260503 · FDF
Neptune Medical, Inc.
Gastroenterology & Urology · 198d
Cleared Sep 03, 2026
Mayumi™ Thrombectomy System
K254035 · QEZ
MicroVention, Inc., d/b/a Terumo Neuro
Cardiovascular · 261d
Cleared Sep 03, 2026
Happy Health Blood Pressure Monitor
K254000 · DXN
Happy Health, Inc.
Cardiovascular · 262d
Cleared Sep 03, 2026
HARU Orgasm by jack herer water based lubricant (WL-OJ)
K253989 · NUC
Maxigen Biotech, Inc.
Obstetrics & Gynecology · 265d
Cleared Sep 03, 2026
M•care System (MW-20)
K253673 · LQK
Marani Health, Inc.
Obstetrics & Gynecology · 286d
Cleared Sep 03, 2026
Tenax® Laser Resistant Endotracheal Tube
K251794 · BTR
Bryan Medical, Inc.
Anesthesiology · 448d
Cleared Sep 02, 2026
ArthroTAK Tendon Anchor Kit
K262809 · MBI
ArthroTAK, LLC
Orthopedic · 26d
Cleared Sep 02, 2026
Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000)
K262420 · GEH
Serpex Medical
General & Plastic Surgery · 48d
Cleared Sep 02, 2026
Ellian Enigma RF Device
K262364 · GEI
Ellian Corp
General & Plastic Surgery · 54d
Cleared Sep 02, 2026
Pivot Insulin Delivery System
K262153 · LZG
Modular Medical, Inc.
Chemistry · 68d
Cleared Sep 02, 2026
Cardinal Health Nitrile Blue Examination Gloves Tested for Use with...
K261749 · LZA
Cardinalhealth
General Hospital · 97d
Cleared Sep 02, 2026
1927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02)
K261589 · GEX
Zhengzhou PZ Laser Slim Technology...
General & Plastic Surgery · 112d
Cleared Sep 02, 2026
Vivid Explorer/Vivid Advanced/Vivid Focus
K261313 · IYN
GE Medical Systems Ultrasound and...
Radiology · 134d