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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
73537–73560 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 13, 2002
ENHANCE HTF MEDIUM WITH HEPES
K023655 · MQL
Conception Technologies
Obstetrics & Gynecology · 44d
Cleared Dec 13, 2002
SPERM WASH MEDIUM WITH GENTAMICIN
K023717 · MQL
Conception Technologies
Obstetrics & Gynecology · 38d
Cleared Dec 13, 2002
COLUMBUS (CR) TOTAL KNEE SYSTEM
K023788 · JWH
Aesculap, Inc.
Orthopedic · 30d
Cleared Dec 13, 2002
LAURAIN DEWALD ANTERIOR FIXATION SYSTEM
K023797 · KWP
Medtronic Sofamor Danek
Orthopedic · 29d
Cleared Dec 13, 2002
PARAGON INFUSION SYSTEM WITH BOLUS
K023827 · FRN
I-Flow Corp.
General Hospital · 25d
Cleared Dec 13, 2002
SURESTEP HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM
K023832 · NBW
Lifescan, Inc.
Chemistry · 25d
Cleared Dec 13, 2002
K-ASSAY LP(A) CONTROLS
K023853 · DFC
Kamiya Biomedical Co.
Immunology · 24d
Cleared Dec 13, 2002
MODIFICATION TO INSPECTRA TISSUE SPECTROMETER SYSTEM, MODEL 325
K023938 · MUD
Hutchinson Technology, Inc.
Cardiovascular · 17d
Cleared Dec 12, 2002
AURORA SYSTEM 1000 SERIES HOME SELF-CARE SINGLE PATIENT DELIVERY SYSTEM
K013562 · KDI
Baxter Healthcare Corp
Gastroenterology & Urology · 412d
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