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
124801–124824 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 27, 1990
SYNERMED ALKALINE PHOSPHATASE REAGENT KIT
K904030 · CJE
Synermed, Inc.
Chemistry · 27d
Cleared Sep 27, 1990
CEDIA TOTAL T3 ASSAY
K904098 · CDP
Microgenics Corp.
Chemistry · 21d
Cleared Sep 27, 1990
REFLOTRON CREATINE KINASE TEST TABS
K904102 · CGS
Boehringer Mannheim Corp.
Chemistry · 21d
Cleared Sep 27, 1990
IRON 5 X CONC REAGENT
K904116 · JMO
Trace Scientific , Ltd.
Chemistry · 21d
Cleared Sep 27, 1990
CIBA CORNING MODEL 238 PH/ BLOOD GAS ANALYZER
K904188 · CHL
Ciba Corning Diagnostics Corp.
Chemistry · 15d
Cleared Sep 26, 1990
MODELS 5069/5071 MYOCARDIAL PACING LEADS
K902002 · DTB
Medtronic Vascular
Cardiovascular · 147d
Cleared Sep 26, 1990
SCHNEIDER MONORAIL(TM) SOFTRAC-PTA(TM) CATHETER
K902091 · LIT
Schneider Intl., Ltd.
Cardiovascular · 140d
Cleared Sep 26, 1990
PERCUTANEOUS INTRODUCER SET
K902275 · DYB
Thomas Medical Products, Inc.
Cardiovascular · 128d
Cleared Sep 26, 1990
GERBER PRECIOUS CARE ELECTRIC BREAST PUMP
K902552 · HGY
Gerber Products Co.
Obstetrics & Gynecology · 110d
Cleared Sep 26, 1990
STICK-GARD STERILE CAP
K902682 · LDQ
Integrated Medical Systems, Inc.
General & Plastic Surgery · 99d
Cleared Sep 26, 1990
LAB-SITE SAFETY NEEDLE
K902881 · CBT
Migada, Ltd.
Anesthesiology · 86d
Cleared Sep 26, 1990
FDI 2000 ULTRASONIC SKIN SCANNER
K902965 · IYO
Fulmer Dyson Intl.
Radiology · 82d
Cleared Sep 26, 1990
TWIN BALLOON INJECTOR
K902975 · LKF
Zinnanti Surgical Instruments, Inc.
Obstetrics & Gynecology · 82d
Cleared Sep 26, 1990
MICRO BRIGHT VENTILATION TUBES
K903285 · ETD
Invotec International, Inc.
Ear, Nose, Throat · 64d
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