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

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175,820 results
289–312 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 08, 2026
EXSYS DEXi (EXSYS DEXi-S40S)
K260227 · KPR
DRTECH Corporation
Radiology · 225d
Cleared Sep 08, 2026
MODI System
K260062 · QRX
DreaMed Diabetes, Ltd.
Chemistry · 243d
Cleared Sep 08, 2026
Power Wheelchair (OS-R-M01I)
K260053 · ITI
Beijing OrionStar Technology Co., Ltd.
Physical Medicine · 243d
Cleared Sep 08, 2026
Single-use Digital Hysteroscope (GYUT-A 12.6- 0, GYUT-A12.6- 12, GYUT-A...
K254294 · HIH
Zhejiang Geyi Medical Instrument Co.,...
Obstetrics & Gynecology · 251d
Cleared Sep 08, 2026
LiteSet Trays
K253988 · KCT
Nobel Biocare AB
General Hospital · 270d
Cleared Sep 06, 2026
Electrical Muscle Stimulator (AST-105DJ, AST-105EJ, AST- 105BJ, AST-105GJ,...
K261131 · NUH
Shenzhen Osto Medical Technology Co.,Ltd
Neurology · 153d
Cleared Sep 06, 2026
KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100,...
K260396 · OBP
Fidelity BioPharma Co.
Neurology · 212d
Cleared Sep 05, 2026
FreezeSpray TA
K261684 · MLY
Cryosurgery, Inc.
Physical Medicine · 107d
Cleared Sep 05, 2026
LipoSurg ARTIST
K254135 · QPB
NOUVAG AG
General & Plastic Surgery · 257d
Cleared Sep 04, 2026
KHEIRON® Spinal Fixation System, including patient specific K-ROD
K262828 · NKB
S.M.A.I.O
Orthopedic · 25d
Cleared Sep 04, 2026
Gastric Alimetry
K262292 · MYE
Alimetry , Ltd.
Gastroenterology & Urology · 59d
Cleared Sep 04, 2026
70 NeuGlide Catheter
K262277 · QJP
Piraeus Medical, Inc.
Neurology · 60d
Cleared Sep 04, 2026
ApexCut ™ Blade with Automated EM Tracking (187BL4012EM)
K262235 · PGW
Medtronic Xomed, Inc.
Ear, Nose, Throat · 65d
Cleared Sep 04, 2026
ATTUNE Revision Knee System
K262130 · JWH
DePuy Orthopaedics, Inc.
Orthopedic · 72d
Cleared Sep 04, 2026
3D-RD-S
K262060 · LLZ
Radiopharmaceutical Imaging &...
Radiology · 78d
Cleared Sep 04, 2026
Surgical and Prosthetic Trays
K261935 · KCT
Dentsply Sirona, Inc.
General Hospital · 87d
Cleared Sep 04, 2026
ActivaScrew™ Cannulated COM
K261057 · HWC
Bioretec, Ltd.
Orthopedic · 157d
Cleared Sep 04, 2026
TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221)
K260756 · EZL
Sentinel Medical Technologies,
Gastroenterology & Urology · 179d
Cleared Sep 04, 2026
NextMR Spine
K260525 · QIH
MRI2CT, Inc.
Radiology · 199d
Cleared Sep 04, 2026
IMMULITE 2000 3gAllergy Specific IgE Vantage
K260331 · DHB
Siemens Healthcare Diagnostics...
Immunology · 214d
Cleared Sep 04, 2026
Digital Indeflator INFLANTE
K260035 · MAV
UAB Telemedicina
Cardiovascular · 241d
Cleared Sep 04, 2026
Sofia 2 SARS Antigen+ FIA
K254264 · QVF
Ortho-Clinical Diagnostics, Inc....
Microbiology · 248d
Cleared Sep 04, 2026
Sofia Influenza A+B FIA
K254262 · PSZ
Ortho-Clinical Diagnostics, Inc....
Microbiology · 248d
Cleared Sep 04, 2026
NeoPEX™ Pre-Mixed Obturation Paste
K253909 · KIF
NuSmile, Ltd.
Dental · 270d