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
124225–124248 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 26, 1990
PROLAX DISPOSABLE LATEX GLOVES (PROCEDURE STERILE)
K903351 · LYY
Prolax Medical Products, Inc.
General Hospital · 62d
Cleared Sep 26, 1990
MEDRAD MARK V-PLUS INJECTOR
K903390 · DXT
Medrad, Inc.
Cardiovascular · 61d
Cleared Sep 26, 1990
INSULIN SYRINGE GUIDE
K903426 · FMF
Bay State Anesthesia, Inc.
General Hospital · 57d
Cleared Sep 26, 1990
DEFLECTING WIRE GRASPER
K903707 · HCZ
Cook, Inc.
Obstetrics & Gynecology · 42d
Cleared Sep 26, 1990
PERCUTANEOUS CATHETER INTRODUCER KIT
K903906 · DYB
Intec Medical, Inc.
Cardiovascular · 34d
Cleared Sep 25, 1990
OR-340 INTRAOPERATIVE ULTRASOUND SYSTEM
K900881 · IYO
Codman & Shurtleff, Inc.
Radiology · 211d
Cleared Sep 25, 1990
PERCOR STAT DL 8.5 FR 40CC IAB ONLY/LABELING CHANG
K902057 · DSP
Datascope Corp.
Cardiovascular · 141d
Cleared Sep 25, 1990
COACUTE ANTITHROMBIN CHROMOGENIC ASSAY
K902393 · JBQ
Kabi Diagnostica
Hematology · 118d
Cleared Sep 25, 1990
CENTAURI ERBIUM YITTRIUM ALUMINUM GARNET LASER
K902534 · GEX
Pfizer Laser Systems
General & Plastic Surgery · 109d
Cleared Sep 25, 1990
LIQUID STABLE CHOLESTEROL REAGENT KIT
K902678 · CHH
Trace Scientific , Ltd.
Chemistry · 98d
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