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
1057–1080 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 13, 2026
InferCare RECIST
K252261 · QIH
Beijing Infervision Healthcare...
Radiology · 235d
Cleared Mar 13, 2026
Extremity CT Imaging System
K252249 · JAK
Mars Bioimaging , Ltd.
Radiology · 238d
Cleared Mar 13, 2026
BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin...
K252040 · JKA
Becton, Dickinson and Company
Chemistry · 256d
Cleared Mar 13, 2026
Promogran Prisma™ Collagen Matrix with ORC and Silver
K251999 · FRO
Solventum Germany GmbH
General & Plastic Surgery · 259d
Cleared Mar 13, 2026
GenBody COVID-19 Ag Home Test
K251916 · QYT
Genbody.Inc.
Microbiology · 263d
Cleared Mar 13, 2026
Pentacam® Cornea OCT
K251848 · MXK
Oculus Optikger?te GmbH
Ophthalmic · 270d
Cleared Mar 12, 2026
Liv Pre-lubricated Intermittent Catheter
K260502 · EZD
HR Healthcare
Gastroenterology & Urology · 27d
Cleared Mar 12, 2026
Remote Wave Electrode (AE03-50)
K260453 · GXY
Bionit Labs Srl
Physical Medicine · 29d
Cleared Mar 12, 2026
MEDPOR Customized Implant Kit
K254233 · FWP
Stryker Leibinger GmbH & Co KG
General & Plastic Surgery · 73d
Cleared Mar 12, 2026
LungFlow Basket Catheter
K254040 · KTI
Free Flow Medical, Inc.
Anesthesiology · 86d
Cleared Mar 12, 2026
Power Mobility Scooter (MJMA01, MJMA02)
K253936 · INI
Nanjing Mijo Technology Co., Ltd.
Physical Medicine · 93d
Cleared Mar 12, 2026
MiniMed Flex pump
K253743 · QFG
Medtronic Minimed, Inc.
Chemistry · 108d
Cleared Mar 12, 2026
Taurus Clip
K253734 · PKL
Taurus Endoscopy
Gastroenterology & Urology · 108d
Cleared Mar 12, 2026
Zionic Pro Max (EMS)
K253636 · NGX
Termosalud S.L.
Physical Medicine · 113d
Cleared Mar 12, 2026
Affixus Retrograde Femoral Nailing System
K253566 · HSB
Zimmer, Inc.
Orthopedic · 115d
Cleared Mar 12, 2026
Urocross Expander System (Model Numbers ES2018 and ES3025)
K253525 · QKA
Prodeon Medical, Inc.
Gastroenterology & Urology · 119d
Cleared Mar 12, 2026
Genadyne ASTRA NPWT
K253429 · OMP
Genadyne Biotechnologies, Inc.
General & Plastic Surgery · 162d
Cleared Mar 12, 2026
Tigertriever 25 Revascularization Device
K253062 · NRY
Rapid Medical , Ltd.
Neurology · 171d
Cleared Mar 12, 2026
Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head
K252824
Signature Orthopaedics Pty, Ltd.
Orthopedic · 188d
Cleared Mar 12, 2026
Mini Moon electric breast pump (PA221)
K252583 · HGX
A Cute Baby, Inc.
Obstetrics & Gynecology · 209d
Cleared Mar 12, 2026
VantageTM Lumbar Decompression Kit
K252546 · HRX
Allevion Medical, LLC
Orthopedic · 212d
Cleared Mar 12, 2026
Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W
K252541 · DTR
Spectrum Medical S.R.L.
Cardiovascular · 212d
Cleared Mar 12, 2026
implaFit® short stems
K252401 · LZO
Implantcast GmbH
Orthopedic · 224d
Cleared Mar 12, 2026
Dental X-RAY Unit (AJX200)
K252110 · EHD
Guangzhou Ajax Medical Equipment Co.,...
Radiology · 248d