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: 2026–2026 ×
1,922 results
313–336 of 1,922
Search insights Median review: 132d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Jun 25, 2026
EliA CTD 13 Screen
K253367 · LLL
Phadia AB
Immunology · 268d
Cleared Jun 25, 2026
A5 Anesthesia System (A5)
K253330 · BSZ
Shenzhen Mindray Bio-Medical...
Anesthesiology · 268d
Cleared Jun 25, 2026
BedDot (G1)
K253274 · BZQ
Intelligent Dots, LLC
Anesthesiology · 269d
Cleared Jun 25, 2026
IntraOp Alignment System
K253216 · SIN
Alphatec Spine, Inc.
Radiology · 269d
Cleared Jun 25, 2026
Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B,...
K252584 · HIF
Weyo Surgical Technology , Ltd.
Obstetrics & Gynecology · 314d
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