FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

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174,955 results
1–24 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 27, 2026
MIST IC
K261122 · NHA
Imagine Milling Technologies, LLC
Dental · 85d
Cleared Jun 27, 2026
SOMNUM (SOMNUM)
K253390 · OLZ
Honeynaps Co., Ltd.
Neurology · 270d
Cleared Jun 27, 2026
BraiN20® (BraiN20)
K253301 · GWF
Time IS Brain, S.L.
Neurology · 271d
Cleared Jun 26, 2026
LightningWire Transseptal Puncture System (TPS)
K261745 · DXF
ElectroWire Medical
Cardiovascular · 30d
Cleared Jun 26, 2026
Arterial Pressure Monitoring Set/Tray
K261455 · DQO
Spectrum Vascular
Cardiovascular · 56d
Cleared Jun 26, 2026
Charlotte ACC25 Surface Electrode Array
K261442 · GXY
Cadwell Industries, Inc.
Neurology · 57d
Cleared Jun 26, 2026
SALGINA 2.5mm Distal Radius System
K261351 · HRS
Bonebridge AG
Orthopedic · 63d
Cleared Jun 26, 2026
Laser Hair Growth Devices (HR-H1, HR-H2, HR-H3, HR-H4, HR-H5, HR-H6, HR-H7,...
K261253 · OAP
Ziree Co., Ltd.
General & Plastic Surgery · 71d
Cleared Jun 26, 2026
i-STAT Crea cartridge with the i-STAT 1 System
K261039 · CGL
Abbott Point of Care, Inc.
Chemistry · 88d
Cleared Jun 26, 2026
MammoScreen® (5)
K260714 · QDQ
Therapixel
Radiology · 113d
Cleared Jun 26, 2026
TENS 7000 Rechargeable 4 Channel (TENS 7000H)
K260412 · NUH
Shenzhen Dongdixin Technology Co., Ltd.
Neurology · 137d
Cleared Jun 26, 2026
BioHorizons CEREC Compatible Ti-Bases (TP3CTB1~PBCTB3 and CNTE0~CRTE2)
K260061 · NHA
BioHorizons Implant Systems, Inc.
Dental · 169d
Cleared Jun 26, 2026
Arthrex FiberButton
K260018 · MBI
Arthrex, Inc.
Orthopedic · 172d
Cleared Jun 26, 2026
ECLIPTIS Left Atrial Appendage Exclusion System (ECS135)
K254232 · PZX
Edwards Lifesciences
Cardiovascular · 179d
Cleared Jun 26, 2026
VERTICALE® Navigation Instruments
K253921 · OLO
Silony Medical GmbH
Orthopedic · 200d
Cleared Jun 26, 2026
PhAST instrument and PhAST Blood Culture Gram-negative Panel
K253316 · SAN
Phast Corp.
Microbiology · 269d
Cleared Jun 26, 2026
BioTracker 2.0
K253306
Biotracker, LLC
Cardiovascular · 270d
Cleared Jun 26, 2026
Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3)
K250070 · HGX
Shenzhen Changkun Technology Co., Ltd.
Obstetrics & Gynecology · 532d
Cleared Jun 25, 2026
ATTUNE Total Knee System
K261458 · JWH
Depuy Ireland UC
Orthopedic · 55d
Cleared Jun 25, 2026
SimplGuide
K261242 · DYB
Pendracare
Cardiovascular · 71d
Cleared Jun 25, 2026
Wearable breast pump (QY-101, QY-102, QY-108)
K261025 · HGX
Shenzhen Qinyi Electronic Technology...
Obstetrics & Gynecology · 87d
Cleared Jun 25, 2026
iD3 Nav Decompression Probe (NTX-9005)
K260992 · PDQ
Neuralytix
Neurology · 91d
Cleared Jun 25, 2026
Arthrex Sterile VAL and VAL KreuLock™ Compression Screw System
K260809 · HWC
Arthrex, Inc.
Orthopedic · 105d
Cleared Jun 25, 2026
G-Series Grind Guard
K260790 · OBR
ASESSO HEALTH, Inc.
Dental · 106d