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
2305–2328 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 15, 2025
InbellaMulti System
K252367 · GEI
Inbella Medical, Inc.
General & Plastic Surgery · 77d
Cleared Oct 15, 2025
AGFA HealthCare Enterprise Imaging
K252199 · LLZ
Agfa Healthcare N.V.
Radiology · 93d
Cleared Oct 15, 2025
TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly
K252020 · HRX
Hand Biomechanics Lab, Inc.
Orthopedic · 107d
Cleared Oct 15, 2025
syngo.CT Dual Energy
K251805 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 125d
Cleared Oct 15, 2025
Bonafix Implant Abutments
K251294 · NHA
Zentek Medical, LLC
Dental · 173d
Cleared Oct 15, 2025
Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature...
K250979 · NZE
Zoll Circulation, Inc.
Cardiovascular · 198d
Cleared Oct 15, 2025
Sure-Fine Insulin Syringes
K250510 · FMF
Shina Med Corporation
General Hospital · 236d
Cleared Oct 15, 2025
V-soft Line™ Barbed Surgical Suture (Various)
K250107 · NEW
Feeltech Co., Ltd.
General & Plastic Surgery · 273d
Cleared Oct 14, 2025
Demi Pro
K253461 · EBZ
Meta Systems Co., Ltd.
Dental · 7d
Cleared Oct 14, 2025
PressON Spinal Fixation System
K253331 · NKB
Nexus Spine
Orthopedic · 14d
Cleared Oct 14, 2025
LIFEPAK 15 AC Power Adapter (41577-000333)
K253099 · MPD
Physio-Control, Inc.
Cardiovascular · 20d
Cleared Oct 14, 2025
Mini Superhawk Suture Anchor System
K253010 · MBI
Responsive Arthroscopy, LLC
Orthopedic · 25d
Cleared Oct 14, 2025
Community Containers (Flap and Daisy)
K252637 · MMK
Keter Canada, Inc.
General Hospital · 55d
Cleared Oct 14, 2025
IPL Home Use Hair Removal Device (Models: FDA11, FDA12, FDA13, FDA14, FDA15,...
K252234 · OHT
Shenzhen Qiaochengli Technology Co.,...
General & Plastic Surgery · 89d
Cleared Oct 14, 2025
PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013)
K251874 · MMK
Pureway Compliance, Inc.
General Hospital · 118d
Cleared Oct 14, 2025
FlowArt® Vial Access Device Vented
K251715 · LHI
Asset Medikal
General Hospital · 132d
Cleared Oct 14, 2025
Lithoblast Single Use Holmium Laser Fibers
K250776 · GEX
Dawell Medical, LLC
General & Plastic Surgery · 214d
Cleared Oct 14, 2025
Hemastyl(™) Wound Dressing
K250115 · FRO
Rapid Nexus Nanotech Wound Solutions,...
General & Plastic Surgery · 271d
Cleared Oct 13, 2025
Mg OSTEOINJECT™
K251522 · MQV
Bone Solutions, Inc.
Orthopedic · 150d
Cleared Oct 12, 2025
COVID-19 Detect Rapid Self -Test
K251595 · QYT
InBios International, Inc.
Microbiology · 138d
Cleared Oct 12, 2025
Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-70)
K251034 · NFO
Shenzhen Nuon Medical Equipment Co.,...
Neurology · 192d
Cleared Oct 12, 2025
GENEO X ELITE
K242227 · PAY
Pollogen, Ltd.
General & Plastic Surgery · 439d
Cleared Oct 10, 2025
Verruca-Freeze H Plus
K252903 · GEH
Cryosurgery, Inc.
General & Plastic Surgery · 29d
Cleared Oct 10, 2025
DeGen Medical Latitude-C AM Cervical Interbody Fusion System
K252737 · ODP
Degen Medical
Orthopedic · 43d