FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
313–336 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 25, 2026
UNIQA® Dental Implants System
K251188 · DZE
Uniqa Dental, Ltd.
Dental · 434d
Cleared Jun 24, 2026
Concerto Versa™ Detachable Coil
K261866 · KRD
Medtronic, Inc.
Cardiovascular · 20d
Cleared Jun 24, 2026
Target Xtra Detachable Coil
K261772 · HCG
Stryker Neurovscular
Neurology · 26d
Cleared Jun 24, 2026
HD Camera Head OLYMPUS CH-S200-08-LB
K261260 · FET
Olympus Medical Systems Corporation
General & Plastic Surgery · 69d
Cleared Jun 24, 2026
AMSCO 700 Steam Sterilizer
K261055 · FLE
STERIS Corporation
General Hospital · 85d
Cleared Jun 24, 2026
Microdacyn Wound Irrigation Solution
K261023 · FRO
Sonoma Pharmaceuticals, Inc.
General & Plastic Surgery · 86d
Cleared Jun 24, 2026
Ceribell Neurology Review Software
K260998 · OMB
Ceribell, Inc.
Neurology · 90d
Cleared Jun 24, 2026
Smart Electric Wheelchair (R1-Std-BK, R1-Pro-BK, R1-Ultra-GK, R1-Ultra-WK)
K260937 · ITI
Shanghai Waylong Intelligent...
Physical Medicine · 96d
Cleared Jun 24, 2026
Endoform Dermal Template
K260669 · KGN
Aroa Biosurgery , Ltd.
General & Plastic Surgery · 114d
Cleared Jun 24, 2026
Hydrophilic coated intermittent nalaton catheter for single use-ready to use...
K260394 · EZD
Hangzhou Jimushi Meditech Co., Ltd.
Gastroenterology & Urology · 138d
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