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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
159577–159600 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jul 13, 1982
HUMAN C-PEPTIDE OF INSULIN BY RADIOIMM.
K820666 · JKD
Immuno Nuclear Corp.
Chemistry · 124d
Cleared Jul 13, 1982
BIOMEDICAL FLUOROPTIC
K821070 · FLL
Luxtron
General Hospital · 88d
Cleared Jul 13, 1982
ALBUMIN REAGENT SET
K821193 · CIX
Omega Medical Electronics
Chemistry · 77d
Cleared Jul 13, 1982
CHOLESTEROL REAGENT SET
K821195 · CHD
Omega Medical Electronics
Chemistry · 77d
Cleared Jul 13, 1982
SERUM CALCIUM REAGENT SET
K821196 · CIC
Omega Medical Electronics
Chemistry · 77d
Cleared Jul 13, 1982
TOTAL BILIRUBIN REAGENT SET
K821197 · CIG
Omega Medical Electronics
Chemistry · 77d