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
601–624 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 31, 2026
ZSAlign Cervical Interbody System
K261451 · OVE
Zsfab, Inc.
Orthopedic · 91d
Cleared Jul 31, 2026
VitalFlow Set with Balance™ Biosurface
K261335 · QJZ
Medtronic, Inc.
Cardiovascular · 99d
Cleared Jul 31, 2026
I-Genius (100019400)
K261331 · LNH
Esaote, S.P.A.
Radiology · 100d
Cleared Jul 31, 2026
Hearing Aid Feature
K261187 · SCR
Samsung Electronics Co., Ltd.
Ear, Nose, Throat · 112d
Cleared Jul 31, 2026
EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)
K261183 · ODG
Olympus Medical Systems Corporation
Gastroenterology & Urology · 112d
Cleared Jul 31, 2026
RadioViewAI
K260936 · LLZ
Neurocareai, Inc. (Dba Savelife.Ai)
Radiology · 133d
Cleared Jul 31, 2026
MAGNETOM Flow.Elite
K260852 · LNH
Siemens Healthineers AG
Radiology · 137d
Cleared Jul 31, 2026
Shield System (Siemens 30x40)
K260607 · OWB
Radiaction , Ltd.
Radiology · 157d
Cleared Jul 31, 2026
WatchPAT SW
K254042 · MNR
Itamar Medical , Ltd.
Anesthesiology · 227d
Cleared Jul 31, 2026
Affinity
K253835 · QIH
Hermes Medical Solutions AB
Radiology · 242d
Cleared Jul 31, 2026
0909FCE, 0909FCE-HS
K253800 · MQB
Rayence Co., Ltd.
Radiology · 245d
Cleared Jul 31, 2026
Angled Screwdriver MED (M-SD090)
K253655 · DZI
W&H Dentalwerk B?rmoos GmbH
Dental · 253d
Cleared Jul 31, 2026
Flexitouch® Plus Advanced Pneumatic Compression System
K253555 · JOW
Tactile Medical
Cardiovascular · 259d
Cleared Jul 31, 2026
UniPearls® Embolic Microspheres
K252812 · KRD
Suzhou Haowei Medical Technology Co.,...
Gastroenterology & Urology · 330d
Cleared Jul 30, 2026
AIR+ All-Inside Meniscal Repair Device, Curved Up
K262369 · MBI
Stryker Endoscopy
Orthopedic · 20d
Cleared Jul 30, 2026
dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS...
K262330 · MOS
Philips Medical Systems Nederland B.V.
Radiology · 21d
Cleared Jul 30, 2026
Obsidian® Press Over Zirconia
K262239 · EIH
Prismatik Dentalcraft, Inc.
Dental · 29d
Cleared Jul 30, 2026
LOGIQ Focus
K261835 · IYN
GE Medical Systems Ultrasound and...
Radiology · 58d
Cleared Jul 30, 2026
neXus Ultrasonic Surgical Aspirator System
K261448 · LFL
Misonix, LLC
General & Plastic Surgery · 90d
Cleared Jul 30, 2026
Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral...
K261410 · OLO
Suite 201, National Innovation Centre
Orthopedic · 91d
Cleared Jul 30, 2026
PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)
K261389 · CCL
Salter Labs
Anesthesiology · 93d
Cleared Jul 30, 2026
Handheld Ultrasound Scanner
K261288 · IYN
IMGFAX CO., LTD.
Radiology · 101d
Cleared Jul 30, 2026
cmAngio® V2.0
K260980 · QIH
Curemetrix, Inc.
Radiology · 127d
Cleared Jul 30, 2026
Arthrex Radial Head Replacement System
K260624 · KWI
Arthrex, Inc.
Orthopedic · 154d