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
4201–4224 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 19, 2025
AVIEW
K243689 · QIH
Coreline Soft Co., Ltd.
Radiology · 110d
Cleared Mar 19, 2025
1NEED Pro
K243472 · QAI
Campomats S.R.L.
General & Plastic Surgery · 131d
Cleared Mar 19, 2025
EXPD 4343N1
K243443 · MQB
DRTECH Corporation
Radiology · 133d
Cleared Mar 19, 2025
AcuPebble Ox (200)
K243092 · MNR
Acurable Limited
Anesthesiology · 170d
Cleared Mar 19, 2025
Tyber Medical Anatomical Plating System
K242486 · HRS
Tyber Medical, LLC
Orthopedic · 210d
Cleared Mar 19, 2025
Sunny
K242241 · GEI
ShenB Co., Ltd.
General & Plastic Surgery · 231d
Cleared Mar 19, 2025
Luer-Split MAJ-2092
K241842 · ODC
Olympus Medical Systems Corporation
Gastroenterology & Urology · 266d
Cleared Mar 19, 2025
Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS...
K241791 · GEX
Gigaalaser Company , Ltd.
General & Plastic Surgery · 271d
Cleared Mar 18, 2025
The OsteoCentric Bone Plate and Screw System
K250494 · HRS
OsteoCentric Technologies
Orthopedic · 26d
Cleared Mar 18, 2025
Aglaia LED Beauty Device (BP-D2309)
K250413 · OHS
Shenzhen Perfect Idea Technology Limited
General & Plastic Surgery · 33d
Cleared Mar 18, 2025
Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432P
K243807 · LQR
Olympus Medical Systems Corp.
Gastroenterology & Urology · 97d
Cleared Mar 18, 2025
Lux HD 35 Detector (Lux HD 35)
K243556 · MQB
Iray Imaging Technology (Haining)...
Radiology · 120d
Cleared Mar 18, 2025
QuikClot Control+ Hemostatic Device
K243553 · POD
Teleflex Medical
General & Plastic Surgery · 120d
Cleared Mar 18, 2025
QP-Prostate® CAD
K242683 · QDQ
Quibim S.L.
Radiology · 193d
Cleared Mar 18, 2025
Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile,...
K242533 · LZA
Better Care Plastic Technology Co., Ltd.
General Hospital · 204d
Cleared Mar 18, 2025
Radlink GPS Pro Imaging
K242161 · LLZ
Radlink, Inc.
Radiology · 237d
Cleared Mar 18, 2025
Klarity SGRT System (ARSG-E1A, ARSG-E3A)
K241937 · IYE
Klarity Medical & Equipment (GZ) Co.,...
Radiology · 259d
Cleared Mar 18, 2025
FortiVy™ OsteoVy™ Lumbar IBF
K241783 · MAX
Vy Spine, LLC
Orthopedic · 271d
Cleared Mar 18, 2025
Hard Splint & Thermo-Adaptive Splint
K241729 · MQC
Whip Mix Corporation
Dental · 277d
Cleared Mar 18, 2025
CarbonCool® System
K240933 · NZE
Global Healthcare SG Sdn. Bhd
Cardiovascular · 347d
Cleared Mar 18, 2025
LYHER® Oral fluid Multi-Drug Test Kit (Cube)
K240287 · DJC
Hangzhou Laihe Biotech Co., Ltd.
Toxicology · 411d
Cleared Mar 17, 2025
UPT Series Medical RO Water Treatment System
K250514 · FIP
Specialty Water Technologies, Inc.
Gastroenterology & Urology · 24d
Cleared Mar 17, 2025
BPS Wrist Fracture System
K250498 · HRS
Orthonovis, Inc.
Orthopedic · 25d
Cleared Mar 17, 2025
SIGNA Prime Elite
K250379 · LNH
Ge Medical Systems, LLC
Radiology · 34d