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: 2026–2026 ×
1,642 results
1081–1104 of 1,642
Search insights Median review: 137d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
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
Cleared Mar 12, 2026
Tyto Stethoscope (G3)
K252089 · DQD
Tyto Care , Ltd.
Cardiovascular · 253d
Cleared Mar 12, 2026
Mimics Thoracic Planner
K251964 · LLZ
Materialise NV
Radiology · 259d
Cleared Mar 12, 2026
VPAP Pediatric Face Mask
K251888 · CBK
Hsiner Co., Ltd.
Anesthesiology · 265d
Cleared Mar 12, 2026
Trax EX Anchor
K251750 · MBI
Trax Surgical, Inc.
Orthopedic · 276d
Cleared Mar 12, 2026
Medical Mesh Nebulizer (AirICU Max+)
K251584 · SFP
AIRICU, Inc.
Anesthesiology · 293d
Cleared Mar 12, 2026
InVera Infusion Device
K250794 · KRA
Invera Medical
Cardiovascular · 363d
Cleared Mar 12, 2026
Deep Capsule® (Deep Capsule US)
K250655 · QZF
Digestaid - Artificial Intelligence...
Gastroenterology & Urology · 372d
Cleared Mar 12, 2026
Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3)
K240934 · DTZ
Spectrum Medical S.R.L.
Cardiovascular · 706d
Cleared Mar 11, 2026
Venus Diamond
K260783 · EBF
Kulzer, LLC
Dental · 1d
Cleared Mar 11, 2026
Picasso Pro Diode Laser (002-00460)
K254197 · GEX
CAO Group, Inc.
General & Plastic Surgery · 78d
Cleared Mar 11, 2026
Hair Removal Device (CT10, CT10 Pro, CT11, CT11 Pro, CT12, CT12 Pro, CTU05,...
K254047 · OHT
Shenzhen Chuangtong Yigou Technology...
General & Plastic Surgery · 84d
Cleared Mar 11, 2026
da Vinci Force Feedback Instruments
K253986 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 89d
Cleared Mar 11, 2026
Xpert Hand
K253906 · HRS
Newclip Technics
Orthopedic · 96d
Cleared Mar 11, 2026
Strut Suture
K253693 · MBI
Riverpoint Medical, LLC
Orthopedic · 110d
Cleared Mar 11, 2026
INHANCE™ Reverse Shoulder System
K253624 · PHX
Depuy Ireland UC
Orthopedic · 113d