Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
160417–160440 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 14, 1982
ARGYLE INTRAMEDICUT CATHETER KIT
K821324 · DYB
Sherwood Medical Co.
Cardiovascular · 71d
Cleared Jul 14, 1982
DESERET CAPACITY PLUS ELECTROSURG. PAD
K821356 · GEI
Warner-Lambert Co.
General & Plastic Surgery · 69d
Cleared Jul 14, 1982
DISPOSABLE SURGICAL SCRUB BRUSHES
K821497 · GEC
Medical Systems Research
General & Plastic Surgery · 56d
Cleared Jul 14, 1982
MODEL 16800 TREND RECORDER
K821612 · DSF
Healthdyne, Inc.
Cardiovascular · 42d
Cleared Jul 14, 1982
AS20 MONITORING SYSTEM
K821614 · DXN
Narco Scientific
Cardiovascular · 42d
Cleared Jul 14, 1982
THE SOFT PEDAL
K821696 · JOW
Habco Products, Inc.
Cardiovascular · 36d
Cleared Jul 14, 1982
A O MICROSCOPE VIDEO SYSTEM
K821865 · IBJ
Warner-Lambert Co.
Pathology · 20d
Cleared Jul 14, 1982
ULTRAZYME PLUS 2GT
K821871 · JPZ
Harleco Diagnostics
Chemistry · 19d
Cleared Jul 14, 1982
ULTRACHEM URIC ACID AIDH
K821872 · CDO
Harleco Diagnostics
Chemistry · 19d
Cleared Jul 14, 1982
ULTRACHEM T-BILI
K821873 · CIG
Harleco Diagnostics
Chemistry · 19d
Cleared Jul 14, 1982
ULTRAZYME PLUS HBD
K821877 · JMK
Harleco Diagnostics
Chemistry · 19d
Cleared Jul 14, 1982
ULTRAZYME PLUS LDH
K821878 · CFJ
Harleco Diagnostics
Chemistry · 19d
Cleared Jul 14, 1982
ULTRACHEM T.P.
K821879 · CEX
Harleco Diagnostics
Chemistry · 19d
Cleared Jul 14, 1982
ULTRA CHEM ALB
K821880 · CIX
Harleco Diagnostics
Chemistry · 19d
Cleared Jul 14, 1982
ULTRACHEM CREA
K821881 · CGX
Harleco Diagnostics
Chemistry · 19d
Cleared Jul 14, 1982
ULTRAZYME PLUS GPT
K821882 · CKA
Harleco Diagnostics
Chemistry · 19d
Cleared Jul 14, 1982
ULTRAZYME PLUS CK-I
K821883 · CGS
Harleco Diagnostics
Chemistry · 19d
Cleared Jul 14, 1982
HEARING AID, UNITRON MODELS UE3/3-N
K821899 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 16d
Cleared Jul 14, 1982
HEARING AID, UNITRON MODEL UE5
K821900 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 16d
Cleared Jul 14, 1982
LITTMAN TUNABLE STETHOSCOPE 2136
K821909 · LDE
3M Company
Cardiovascular · 16d
Cleared Jul 14, 1982
MCSCK838 CATHETER IN A TRAY (KIT)
K821954 · LFJ
Medcomp
Gastroenterology & Urology · 14d
Cleared Jul 14, 1982
MCSCK638 CATHETER IN A TRAY (KIT)
K821955 · LFJ
Medcomp
Gastroenterology & Urology · 14d
Cleared Jul 14, 1982
JAPANESE MADE MICROWAVE THERAPY EQUIPMENT
K827584
Heiwa Electronic Industrial Co., Ltd.
Radiology · 30d
Cleared Jul 13, 1982
DAKO PAP KIT K509
K820336 · LIJ
Dako Corp.
Pathology · 155d