FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
124777–124800 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 27, 1990
JOINT MOTON IMAGER(TM)
K902583 · JAA
Concord Imaging, Ltd.
Radiology · 107d
Cleared Sep 27, 1990
RADIOPAQUE RULER
K902606 · KPR
Professional Medical Services
Radiology · 107d
Cleared Sep 27, 1990
MODIFICATION TYPE 9266 SA02 SYSTEM ATHENA
K902779 · DQA
S & W Medico Teknik
Anesthesiology · 113d
Cleared Sep 27, 1990
BARD FILTERED CARDIOTOMY RESERVOIR
K902856 · DTP
C.R. Bard, Inc.
Cardiovascular · 90d
Cleared Sep 27, 1990
INTELECT 170
K902860 · IMG
Chattanooga Group, Inc.
Physical Medicine · 90d
Cleared Sep 27, 1990
NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE*
K902872 · GAW
United States Surgical, A Division of...
General & Plastic Surgery · 90d
Cleared Sep 27, 1990
NONABSORBABLE DACRON SURGICAL SUTURE*
K902873 · GAS
United States Surgical, A Division of...
General & Plastic Surgery · 90d
Cleared Sep 27, 1990
INTELECT 750 MP
K902875 · IMG
Chattanooga Group, Inc.
Physical Medicine · 87d
Cleared Sep 27, 1990
ROCHE COBAS READY HDL CHOLESTEROL REAGENT
K902935 · JHM
Roche Diagnostic Systems, Inc.
Chemistry · 86d
Cleared Sep 27, 1990
KODAK EKTACHEM SOLUTION 7%BSA BOVINE SERUM ALBUMIN
K903071 · JJE
Eastman Kodak Company
Chemistry · 77d
Cleared Sep 27, 1990
SITERITE NEEDLE GUIDE
K903158 · DQY
Dymax Corp
Cardiovascular · 71d
Cleared Sep 27, 1990
COULOCHEM II
K903231 · LEQ
Esa, Inc.
Toxicology · 66d
Cleared Sep 27, 1990
TECHNICON CHEM I SYSTEM CARBON DIOXIDE METHOD
K903305 · KHS
Technicon Instruments Corp.
Chemistry · 65d
Cleared Sep 27, 1990
SYVA(R) ETS(R) PLUS SYSTEM
K903357 · JJF
Syva Co.
Chemistry · 63d
Cleared Sep 27, 1990
MAGNETIC RESONANCE DIAGNOSTIC DEVICE-OR 41 MAGNET
K903527 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 52d
Cleared Sep 27, 1990
LASER CANE
K903558 · HPG
Nurion Industries
Ophthalmic · 50d
Cleared Sep 27, 1990
GUIDEWIRE TORQUE DEVICE AND GUIDEWIRE INTRODUCER
K903606 · LIT
North American Instrument Corp.
Cardiovascular · 59d
Cleared Sep 27, 1990
SYNERMED URIC ACID REAGENT KIT
K903727 · KNK
Synermed, Inc.
Chemistry · 42d
Cleared Sep 27, 1990
DRUG OF ABUSE ANALYSIS SYSTEM FREE RADICAL ASSAY
K903824 · DKZ
Technicon Instruments Corp.
Toxicology · 38d
Cleared Sep 27, 1990
DRUG OF ABUSE ANALYSIS SYSTEM
K903825 · DIS
Technicon Instruments Corp.
Toxicology · 38d
Cleared Sep 27, 1990
HI CHEM PROTEIN/LIPIDS LINEARITY
K903888 · JIX
Hichem Diagnostics
Chemistry · 36d
Cleared Sep 27, 1990
PARAMAX URINE/CSF CALIBRATOR LEVEL I AND II
K903913 · JIX
Baxter Healthcare Corp
Chemistry · 34d
Cleared Sep 27, 1990
GEN-PROBE LUMINOMETER-LEADER 50
K903934 · JJQ
Gen-Probe, Inc.
Chemistry · 31d
Cleared Sep 27, 1990
GARDOSI BIRTHING CUSHION
K903973 · KNC
Graphic Controls Corp.
Obstetrics & Gynecology · 30d