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
2209–2232 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 24, 2025
Hushd Pro Z-Link
K251784 · LRK
Good Sleep CO Pte , Ltd.
Dental · 135d
Cleared Oct 24, 2025
Mobile X-ray unit (!M1)
K251710 · IZL
Solutions For Tomorrow AB
Radiology · 143d
Cleared Oct 24, 2025
VersaD Delivery Catheter
K251372 · QJP
Unity Medical, Inc.
Neurology · 175d
Cleared Oct 24, 2025
Vesalio Peripheral System
K251312 · QEZ
Vesalio, Inc.
Cardiovascular · 179d
Cleared Oct 24, 2025
Syngo Carbon Clinicals (VA41)
K251059 · QIH
Siemens Healthineers AG
Radiology · 203d
Cleared Oct 24, 2025
Atalante X
K250904 · PHL
Wandercraft SAS
Neurology · 212d
Cleared Oct 24, 2025
AccuCheck
K250696 · IYE
Manteia Technologies Co., Ltd.
Radiology · 231d
Cleared Oct 24, 2025
Cocoon Solo (DX-7020s)
K250687 · MUH
Dexcowin Global, Inc.
Radiology · 232d
Cleared Oct 24, 2025
Medline Bag Decanter
K250345 · LHI
Medline Industries, LP
General Hospital · 260d
Cleared Oct 23, 2025
UV5000W Handle
K253226 · FAJ
Uroviu Corporation
Gastroenterology & Urology · 24d
Cleared Oct 23, 2025
MultiPulse TFL
K253100 · GEX
Asclepion Laser Technologies GmbH
General & Plastic Surgery · 29d
Cleared Oct 23, 2025
Invisalign® Palatal Expander System
K252931 · NXC
Align Technology, Inc.
Dental · 38d
Cleared Oct 23, 2025
1927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02)
K252732 · GEX
Zhengzhou PZ Laser Slim Technology...
General & Plastic Surgery · 56d
Cleared Oct 23, 2025
Silatrix Oral Gel
K252425 · OLR
Sa3, LLC
Dental · 83d
Cleared Oct 23, 2025
DESS® Dental Smart Solutions
K252384 · NHA
Terrats Medical SL
Dental · 84d
Cleared Oct 23, 2025
Picosecond Laser Device (PF131-BI)
K252345 · GEX
Risu Medical Technology Co., Ltd.
General & Plastic Surgery · 87d
Cleared Oct 23, 2025
PerQseal Introducers
K252309 · DYB
Vivasure Medical Limited
Cardiovascular · 91d
Cleared Oct 23, 2025
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs,...
K250861 · LZA
Hartalega NGC Sdn. Bhd.
General Hospital · 216d
Cleared Oct 23, 2025
TeraRecon Cardiovascular.Calcification.CT
K250288 · QIH
Terarecon,Inc.
Radiology · 265d
Cleared Oct 22, 2025
FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone...
K253147 · MQV
Prosidyan, Inc.
Orthopedic · 27d
Cleared Oct 22, 2025
Pre-Sutured Tendon
K253145 · GAT
Rti Surgical, Inc.
Orthopedic · 27d
Cleared Oct 22, 2025
Freedom® Total Knee System – Titan PCK Components
K253144 · JWH
Maxx Orthopedics, Inc.
Orthopedic · 27d
Cleared Oct 22, 2025
Carrier XL Delivery Catheter
K252569 · QJP
Balt USA, LLC
Neurology · 69d
Cleared Oct 22, 2025
QIAstat-Dx Gastrointestinal Panel 2
K252329 · PCH
QIAGEN GmbH
Microbiology · 89d