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

Filters: Cleared only ×
174,955 results
7561–7584 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 21, 2024
X-Guide Surgical Navigation System
K232148 · QRY
X-Nav Technologies, LLC
Dental · 217d
Cleared Feb 21, 2024
Oneday Implant Abutment
K231753 · NHA
Oneday Biotech Co., Ltd.
Dental · 251d
Cleared Feb 21, 2024
Pulmonary Function Tester, Model: A9
K231561 · BTY
Guangzhou Homesun Medical Technology...
Anesthesiology · 266d
Cleared Feb 20, 2024
Mjolnir Pro. (Multi–electrode plasma)
K233760 · QVJ
Shenzhen Leaflife Technology Co., Ltd.
General & Plastic Surgery · 88d
Cleared Feb 20, 2024
Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120)
K233471 · NLQ
Stryker Sustainability Solutions
General & Plastic Surgery · 118d
Cleared Feb 20, 2024
ONLINE TDM Methotrexate
K233454 · LAO
Roche Diagnostics Operations
Toxicology · 123d
Cleared Feb 20, 2024
TS Abutment System
K233194 · NHA
Osstem Implant Co., Ltd.
Dental · 145d
Cleared Feb 20, 2024
NET BRAND Osteosynthesis Nailing System
K233150 · JDS
Narang Medical , Ltd.
Orthopedic · 146d
Cleared Feb 20, 2024
Diode Laser Therapy System
K231896 · GEX
Beijing Adss Development Co., Ltd.
General & Plastic Surgery · 237d
Cleared Feb 18, 2024
BD Prevue™ II Peripheral Vascular Access System
K240146 · IYO
Bard Access Systems, Inc.
Radiology · 30d
Cleared Feb 16, 2024
SCIg60 Infusion System
K240148 · PKP
Emed Technologies Corporation
General Hospital · 28d
Cleared Feb 16, 2024
Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System
K240137 · GXR
Neos Surgery S.L
Neurology · 29d
Cleared Feb 16, 2024
VasQ
K240119 · QVQ
Laminate Medical Technologies , Ltd.
Cardiovascular · 31d
Cleared Feb 16, 2024
Access CK-MB
K234005 · JHX
Beckman Coulter, Inc.
Chemistry · 59d
Cleared Feb 16, 2024
S-Patch (S-Patch ExL)
K233906 · DSH
Wellysis Corp.
Cardiovascular · 66d
Cleared Feb 16, 2024
NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01)
K233708 · DYB
Synaptic Medical Corporation
Cardiovascular · 88d
Cleared Feb 16, 2024
Biowy Tym Tube (TT)
K233658 · ETD
Biowy Corporation
Ear, Nose, Throat · 93d
Cleared Feb 16, 2024
Contour Hand/Wrist (Q7000232)
K233652 · MOS
Quality Electrodynamics
Radiology · 94d
Cleared Feb 16, 2024
Montage Flowable Settable, Resorbable Bone Paste
K232771 · GXP
Orthocon, Inc.
Neurology · 158d
Cleared Feb 16, 2024
Airgle Room Air Purifier
K232645 · FRA
Airgle Corporation
General Hospital · 170d
Cleared Feb 16, 2024
Zenition 30
K232420 · OWB
Philips Medical Systems Nederland B.V.
Radiology · 189d
Cleared Feb 16, 2024
Dental LT Comfort Resin
K232087 · MQC
Formlabs Ohio, Inc.
Dental · 218d
Cleared Feb 16, 2024
Endoscopic Video Image Processor (RP-IPD-V2000A, RP-IPD-V2000B,...
K232043 · FDF
Guangzhou Red Pine Medical Instrument...
Gastroenterology & Urology · 221d
Cleared Feb 16, 2024
Disposable Grounding Pad
K231985 · GEI
Shenzhen Mecun Medical Supply Co., Ltd.
General & Plastic Surgery · 226d