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
124825–124848 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 25, 1990
ROUTINE DRESSING TRAY
K902811 · MCY
Orion Life Systems, Inc.
General & Plastic Surgery · 90d
Cleared Sep 25, 1990
LONDON DIAGNOSTICS LUMATAG(TM) INTACT PTH ASSAY
K903130 · CEW
London Diagnostics, Inc.
Chemistry · 70d
Cleared Sep 25, 1990
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (ECO2)
K903144 · KHS
Eastman Kodak Company
Chemistry · 69d
Cleared Sep 25, 1990
AUTO SUTURE ENDOSCOPIC SUCTION/IRRIGATRION DEVICE
K903207 · HET
United States Surgical, A Division of...
Obstetrics & Gynecology · 67d
Cleared Sep 25, 1990
LABMASTER BETA-2-MICROGLOBULIN ELISA TEST KIT TM
K903215 · JZG
Bioproducts For Science, Inc.
Chemistry · 64d
Cleared Sep 25, 1990
ABBOTT TESTPACK PLUS TM HCG-COMBO
K903219 · JHI
Abbott Laboratories
Chemistry · 64d
Cleared Sep 25, 1990
FLOCARE F
K903404 · BZO
Flocare Medical
Anesthesiology · 56d
Cleared Sep 25, 1990
D.I.C. TRACHEOSTOMY TUBES & LARYNGECTOMY TUBES
K903730 · BTO
Concord/Portex
Anesthesiology · 40d
Cleared Sep 25, 1990
AST REAGENT
K903829 · CIT
Amresco, Inc.
Chemistry · 35d
Cleared Sep 25, 1990
DISPOSABLE FACE MASK
K904195 · BYG
Bp , Ltd.
Anesthesiology · 13d
Cleared Sep 24, 1990
CORE DISPOSABLE INSUFFLATION TUBING
K901413 · HES
Core Dynamics, Inc.
Obstetrics & Gynecology · 182d
Cleared Sep 24, 1990
EYE SPY SUNGLASSES
K902519 · HQY
E. M. Intl. Products , Ltd.
Ophthalmic · 110d
Cleared Sep 24, 1990
BARTELS EXTRACELLULAR MATRIX
K902726 · KIR
Baxter Healthcare Corp
Pathology · 95d
Cleared Sep 24, 1990
OPTILITE FIBEROPTIC DELIVERY SYSTEMS
K902871 · GEX
Xintec Corporation
General & Plastic Surgery · 87d
Cleared Sep 24, 1990
IRIS OCULIGHT SL DIODE LASER PHOTOCOAG/MODIFIED
K903288 · GEX
Iriderm Div.
General & Plastic Surgery · 88d
Cleared Sep 24, 1990
DADE IMMUNOASSAY CONTROLS, LEVELS I, II, III
K903566 · JJY
Baxter Healthcare Corp
Immunology · 48d
Cleared Sep 24, 1990
BIO* NEPHROSS ANDANTE, MODERATO, ALLEGIO H.F.
K903567 · FJI
Organon Teknika Corp.
Gastroenterology & Urology · 48d
Cleared Sep 24, 1990
BARRIER FREE CEILING LIFT, MDLS HRS-1/2F,1/4F,1/6F
K903723 · FNG
Barrier Free Lifts, Inc.
General Hospital · 39d
Cleared Sep 24, 1990
SARAH COVENTRY SUNGLASSES
K903826 · HQY
R. N. Koch, Inc.
Ophthalmic · 35d
Cleared Sep 24, 1990
N. M. BEALE COMPANY VU-THRU WATER BOTTLE
K903834 · OCX
N.M. Beale Co., Inc.
Gastroenterology & Urology · 34d
Cleared Sep 24, 1990
PUMUCKL AND/OR DIETERLE
K904037 · HQZ
Pumuckl
Ophthalmic · 20d
Cleared Sep 24, 1990
MYOGLOBIN RIA TEST KIT
K904038 · DDR
Immuno Diagnostic Center, Inc.
Immunology · 20d
Cleared Sep 24, 1990
UC IMU A
K904125 · DER
Eucardio Laboratory, Inc.
Immunology · 18d
Cleared Sep 21, 1990
PUNCTUR-GUARD(TM) BLOOD COLLECTION NEEDLE
K895024 · FMI
Bio-Plexus, Inc.
General Hospital · 409d