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
1345–1368 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 09, 2026
Ceribell Instant EEG Headset
K254033 · GXY
Ceribell, Inc.
Neurology · 55d
Cleared Feb 09, 2026
Holter ECG and ABP system (HolterABP)
K251591 · DQK
Edan Instruments, Inc.
Cardiovascular · 262d
Cleared Feb 06, 2026
LiveMedica Enterprise PACS
K253927 · LLZ
Live Medica, LLC
Radiology · 60d
Cleared Feb 06, 2026
MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile...
K253852 · GAM
Ethicon, Inc.
General & Plastic Surgery · 66d
Cleared Feb 06, 2026
SIGNA™ Bolt
K253780 · LNH
Ge Medical Systems, LLC
Radiology · 72d
Cleared Feb 06, 2026
Hood DH-084STR
K253568 · FDS
Fujifilm Corporation
Gastroenterology & Urology · 81d
Cleared Feb 06, 2026
Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro)
K253221 · IYO
Eieling Technology (Shenzhen) Limited
Radiology · 130d
Cleared Feb 06, 2026
Q Interbody Instruments
K252873 · OLO
K2m, Inc.
Orthopedic · 149d
Cleared Feb 06, 2026
Spine Guidance 5.3 Software
K252871 · OLO
Stryker Leibinger GmbH & Co KG
Orthopedic · 149d
Cleared Feb 06, 2026
IntelliVue Multi-Measurement Module X3 (867030)
K252726 · MHX
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 162d
Cleared Feb 06, 2026
Kneevoice Cartilage Evaluation System (750-3600-001)
K252076 · DQD
Kneevoice, Inc.
Cardiovascular · 219d
Cleared Feb 06, 2026
ROSA Knee System with UltraSound Imaging Platform (USIP)
K252058 · OLO
Balmoral Medical, LLC
Orthopedic · 220d
Cleared Feb 06, 2026
Dermatrix Duo
K251836 · GEI
Shenzhen Gsd Technology Co., Ltd.
General & Plastic Surgery · 235d
Cleared Feb 06, 2026
Stainless Steel Surgical Kits
K251614 · KCT
Dentsply Sirona, Inc.
General Hospital · 255d
Cleared Feb 06, 2026
LAIA XR
K251577 · LLZ
Augmented Reality Software S.L.
Radiology · 260d
Cleared Feb 06, 2026
Atellica® IM TSH3-Ultra II (TSH3ULII)
K251543 · JLW
Siemens Healthcare Diagnostics, Inc.
Chemistry · 262d
Cleared Feb 06, 2026
INTEGRE LIO
K251507 · HQF
Quantel Medical
Ophthalmic · 266d
Cleared Feb 06, 2026
Median LCS (internal name) / eyonis LCS (trade name) (1.0)
K251474 · QDQ
Median Technologies
Radiology · 269d
Cleared Feb 06, 2026
Spectra S1 Pro
K251423 · HGX
Uzinmedicare Co., Ltd.
Obstetrics & Gynecology · 274d
Cleared Feb 06, 2026
SafeBeat Rx App
K251218 · DQK
Safebeat Rx, Inc.
Cardiovascular · 291d
Cleared Feb 06, 2026
Aptiva APS IgA Reagent
K243979 · MSV
Inova Diagnostics, Inc.
Immunology · 410d
Cleared Feb 06, 2026
Athelas Home
K243348 · GKZ
Athelas, Inc.
Hematology · 466d
Cleared Feb 05, 2026
CLEANER™ Vac Thrombectomy System, CLEANER™ Vac Aspiration Catheter with...
K260028 · QEW
Argon Medical Devices, Inc.
Cardiovascular · 31d
Cleared Feb 05, 2026
Primevision 3D
K253959 · OAS
Dentsply Sirona
Radiology · 57d