FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
913–936 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 24, 2026
Enhanced Boundary for PCCT
K253560 · JAK
Ge Medical Systems, LLC
Radiology · 219d
Cleared Jun 24, 2026
CLEAR™ Aspiration System
K253404
Insera Therapeutics, Inc.
Cardiovascular · 267d
Cleared Jun 24, 2026
Single-use Balloon Dilatation Catheter (AG-5251-083018 AG-5251-085518...
K253393 · FGE
Hangzhou AGS MedTech Co., Ltd.
Gastroenterology & Urology · 267d
Cleared Jun 24, 2026
ConvaVAC™ Negative Pressure Wound Therapy System
K253263 · OMP
Convatec Limited, Gdc Building
General & Plastic Surgery · 268d
Cleared Jun 24, 2026
Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Tested for...
K252117 · LZA
Sw Technologies, Inc.
General Hospital · 352d
Cleared Jun 24, 2026
SilverCeuticals® Antimicrobial Wound Gel
K251929 · FRO
Silverceuticals, Inc.
General & Plastic Surgery · 366d
Cleared Jun 23, 2026
Codman® Distal Peritoneal Catheter, Barium Open End (82-1682)
K261004 · JXG
Integra Lifesciences Production...
Neurology · 89d
Cleared Jun 23, 2026
AQUABEAM Robotic System
K253211 · PZP
Procept Biorobotics
Gastroenterology & Urology · 267d
Cleared Jun 23, 2026
CURASYS 2 (EMDN0003)
K253199 · OMP
CG Bio Co., Ltd.
General & Plastic Surgery · 270d
Cleared Jun 23, 2026
Microlife Digital Peak Flow Meter, Model PF200B (PF200B)
K253180 · BZH
Microlife Corporation
Anesthesiology · 270d
Cleared Jun 22, 2026
Health Line Tearaway Introducer
K261950 · DYB
Health Line International Corporation
Cardiovascular · 12d
Cleared Jun 22, 2026
Urocross Expander System (UES-2018-C1)
K261342 · QKA
Prodeon Medical, Inc.
Gastroenterology & Urology · 60d
Cleared Jun 22, 2026
DeltaNEC Interbody System
K261279 · OVE
Nexus Spine
Orthopedic · 66d
Cleared Jun 22, 2026
Caregiver-assisted wheelchair (MS02)
K261076 · IOR
GuangDong Yong Yi Rehabilitation...
Physical Medicine · 82d
Cleared Jun 22, 2026
Manual Wheelchair (MS01)
K261075 · IOR
GuangDong Yong Yi Rehabilitation...
Physical Medicine · 82d
Cleared Jun 22, 2026
CMN Capillary Function with Oncology Virtual Expert
K260316
Cercare Medical A/S
Radiology · 143d
Cleared Jun 22, 2026
Medline Reusable Blood Pressure Cuff
K254287 · DXQ
Medline Industries, LP
Cardiovascular · 173d
Cleared Jun 22, 2026
Flow Water-Based Personal Lubricant
K254011 · NUC
LBDO Group, Inc.
Obstetrics & Gynecology · 189d
Cleared Jun 22, 2026
Perfusion Measurement Platform v1
K253421 · LLZ
Quantified Imaging Limited
Radiology · 264d
Cleared Jun 22, 2026
TearView
K253176 · HKI
Beyond 700 Pty, Ltd.
Ophthalmic · 269d
Cleared Jun 22, 2026
RX-1 Sleep
K253148 · MNR
Vivaquant, Inc. Dba Rhythm Express
Anesthesiology · 270d
Cleared Jun 20, 2026
Dynamis Robotic Surgical System
K260369 · OLO
LEM Surgical AG
Orthopedic · 135d
Cleared Jun 18, 2026
Synapse PACS (7.6.0)
K261713 · QIH
Fujifilm Healthcare Americas Corporation
Radiology · 27d
Cleared Jun 18, 2026
MEMO 4D Curve™ Semirigid mitral annuloplasty ring
K261707 · KRH
Corcym S.r.l.
Cardiovascular · 27d