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
79657–79680 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 12, 2001
ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-2200
K003514 · IYN
Shimadzu Medical Systems
Radiology · 90d
Cleared Feb 12, 2001
ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200
K003515 · IYN
Shimadzu Medical Systems
Radiology · 90d
Cleared Feb 12, 2001
SPECIALTY 55 UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY...
K003526 · LPL
Specialty Ultravision, Inc.
Ophthalmic · 88d
Cleared Feb 12, 2001
SONOLITH PRAKTIS, ENDOUROLOGY TABLE PRAKTIS
K003529 · LNS
Edap Technomed, Inc.
Gastroenterology & Urology · 88d
Cleared Feb 12, 2001
SERENOCEM, MODEL BC 010
K003567 · NEA
Corinthian Medical , Ltd.
Ear, Nose, Throat · 84d
Cleared Feb 12, 2001
SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE
K003571 · FMF
Terumo Medical Corp.
General Hospital · 84d
Cleared Feb 12, 2001
AUTODELFIA NEONATAL IRT KIT, MODEL B005-112
K003668 · CGZ
Wallac OY
Chemistry · 76d
Cleared Feb 12, 2001
ASSERACHROM HPIA TEST KIT
K003767 · LCO
Diagnostica Stago, Inc.
Hematology · 68d
Cleared Feb 12, 2001
TOTAL BILIRUBIN
K003829 · CIG
Jas Diagnostics, Inc.
Chemistry · 63d
Cleared Feb 12, 2001
MODIFICATION TO AT HOME DRUG TEST, MODELS 9150, 9068, AND 9175
K003858 · MVO
Phamatech
Toxicology · 61d
Cleared Feb 12, 2001
VORTEX ACCESS SYSTEM
K010189 · LJT
Horizon Medical Products, Inc.
General Hospital · 21d
Cleared Feb 12, 2001
MXR-2000 MOBILE X-RAY UNIT
K010304 · IZL
Irom Imaging, Inc.
Radiology · 11d
Cleared Feb 09, 2001
3I CALCIUM SODIUM PHOSPHATE BONE CEMENT
K003493 · LYC
Biomet, Inc.
Dental · 88d
Cleared Feb 09, 2001
REMVIEW SLEEP RECORDER, MODEL 320
K003499 · LEL
Respironics, Inc.
Neurology · 88d
Cleared Feb 09, 2001
(DISPOSABLE) VAGINAL SPECULUM
K003540 · HIB
Feminica, Inc.
Obstetrics & Gynecology · 85d
Cleared Feb 09, 2001
SYNTHES MODIFIED BIORESORBABLE SUTURE ANCHOR SYSTEM
K003743 · MAI
Synthes (Usa)
Orthopedic · 67d
Cleared Feb 09, 2001
AML HIP PROSTHESIS
K003800 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 63d
Cleared Feb 09, 2001
POWDERFREE NITRILE PATIENT EXMINATION GLOVE
K003985 · LZA
Guthrie Medicare Products (Melaka)...
General Hospital · 45d
Cleared Feb 09, 2001
COSMIC
K010044 · EJT
Jeneric/Pentron, Inc.
Dental · 35d
Cleared Feb 09, 2001
NONSTERILE POWDERED PURPLE LATEX EXAMINATION GLOVES, WITH & WITHOUT GRAPE...
K010095 · LYY
Sgmp Co., Ltd.
General Hospital · 29d
Cleared Feb 09, 2001
SONIC MODEL SO-300
K010102 · IMI
Metron Medical Australia, Pty, Ltd.
Physical Medicine · 28d
Cleared Feb 09, 2001
MODIFICATION TO EXACTECH ACUMATCH INTEGRATED HIP SYSTEM, M-SERIES HIGH...
K010120 · LPH
Exactech, Inc.
Orthopedic · 24d
Cleared Feb 09, 2001
STERILE BUTTON PLATE
K010121 · MBI
Synthes (Usa)
Orthopedic · 24d
Cleared Feb 09, 2001
64 CHANNEL EEG / MODEL NUMBER EX-NW-64
K010150 · GWQ
Excel Tech. , Ltd.
Neurology · 23d