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
73033–73056 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 12, 2002
OMRON AUTOMATIC BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODELS HEM-773,...
K021682 · DXN
Omron Healthcare, Inc.
Cardiovascular · 204d
Cleared Dec 12, 2002
GEBAUER'S INSTANT ICE
K021726 · MLY
Gebauer Co.
Physical Medicine · 202d
Cleared Dec 12, 2002
INTRAUTERINE DELIVERY SYSTEM - INJECTOR
K023051 · LKF
Prosurg, Inc.
Obstetrics & Gynecology · 90d
Cleared Dec 12, 2002
UNIDUS MALE LATEX CONDOM
K023059 · HIS
Unidus Corp.
Obstetrics & Gynecology · 90d
Cleared Dec 12, 2002
ANALOG MULTIPLEXED CABLE TELEMETRY (AMT) ELECTROMYOGRAPH, MODELS AMT-16,...
K023147 · IKN
Bortec Biomedical, Ltd.
Neurology · 83d
Cleared Dec 12, 2002
VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS
K023180 · NLH
Vanguard Medical Concepts, Inc.
Cardiovascular · 79d
Cleared Dec 12, 2002
METHADONE ENZYME IMMUNOASSAY
K023317 · DJR
Lin-Zhi International, Inc.
Toxicology · 70d
Cleared Dec 12, 2002
REINFORCED ABSORBABLE SYNTHETIC SURGICAL MESH
K023328 · FTL
Center For Biomaterials and Advanced...
General & Plastic Surgery · 69d
Cleared Dec 12, 2002
K2 HEMI TOE IMPLANT SYSTEM (FORMERLY ZOBEL GREAT TOE IMPLANT SYSTEM)
K023770 · KWD
Kinetikos Medical, Inc.
Orthopedic · 30d
Cleared Dec 12, 2002
ERBE VIO ESU WITH ACCESSORIES, MODEL VIO 300 D
K023886 · GEI
Erbe USA, Inc.
General & Plastic Surgery · 21d
Cleared Dec 12, 2002
SONOSITE HAND-CARRIED ULTRASOUND SYSTEM (C2 SERIES)
K023957 · IYN
Sonosite,Inc.
Radiology · 15d
Cleared Dec 12, 2002
MILLENNIUM SERIES MANUAL WHEELCHAIRS
K024030 · IOR
Evermed Corp.
Physical Medicine · 6d
Cleared Dec 11, 2002
NXSTAGE CARTRIDGE EXPRESS
K014152 · KDI
Nxstage Medical, Inc.
Gastroenterology & Urology · 358d
Cleared Dec 11, 2002
KSEA DEPLOYABLE CARDIOVASCULAR CLAMP
K014277 · DXC
KARL STORZ Endoscopy-America, Inc.
Cardiovascular · 349d
Cleared Dec 11, 2002
BOWTI ANTERIOR BUTTRESS STAPLE SYSTEM
K021039 · KWQ
Depuyacromed
Orthopedic · 254d
Cleared Dec 11, 2002
ACUBEAM, SUPER NOVA, DIO
K022888 · ILY
Light Force Therapy, Inc.
Physical Medicine · 103d
Cleared Dec 11, 2002
HUDSON 2020, 2040, 2060,ULTRASOUND SCANNERS
K022928 · IYO
Hudson Diagnostic Imaging, LLC
Radiology · 98d
Cleared Dec 11, 2002
W.O.M. LASER U100
K023041 · GEX
W.O.M. World of Medicine AG
General & Plastic Surgery · 90d
Cleared Dec 11, 2002
PRESS-FIT HEAD RESURFACING DEVICE
K023188 · KXA
Biomet Orthopedics, Inc.
Orthopedic · 78d
Cleared Dec 11, 2002
SPLATRFREE SWANGLE 360 DISPOSABLE PROPHYLAXIS ANGLE
K023232 · EFS
Smartpractice
Dental · 75d
Cleared Dec 11, 2002
T2 SUPRACONDYLAR NAIL SYSTEM
K023267 · HSB
Howmedica Osteonics Corp.
Orthopedic · 72d
Cleared Dec 11, 2002
ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM
K023299 · MNI
Alphatec Mfg., Inc.
Orthopedic · 69d
Cleared Dec 11, 2002
BILIRUBIN-SL (TOTAL) ASSAY, MODEL 284-10/30
K023330 · CIG
Diagnostic Chemicals , Ltd.
Chemistry · 68d
Cleared Dec 11, 2002
COOPERSURGICAL EMBRYO TRANSFER CATHETER, COOPERSURGICAL ASSISTED REPRODUCTION...
K023379 · MQF
Cooper Surgical
Obstetrics & Gynecology · 64d