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
133945–133968 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 04, 1988
TITANIUM GREENFIELD VENA CAVA FILTER CARRIER
K874096 · DTK
Medi-Tech, Inc.
Cardiovascular · 393d
Cleared Nov 04, 1988
OLV 1100
K881307 · DQA
Nihon Kohden America, Inc.
Anesthesiology · 221d
Cleared Nov 04, 1988
PORT-O-HEAT, MODEL 0100
K882151 · IRT
Arthotronics, Inc.
Physical Medicine · 165d
Cleared Nov 04, 1988
NIOBI-X RADIATION REDUCTION FILTER
K882939 · ITY
American Canadian Products, Inc.
Radiology · 114d
Cleared Nov 04, 1988
FORCE GUARD I
K882974 · IRN
Boulder Impact Monitors, Inc.
Physical Medicine · 112d
Cleared Nov 04, 1988
HP 77025A/77030A ULTRA. SYSTEM/HP 77020CV UPGRADE
K883481 · IYO
Hewlett-Packard Co.
Radiology · 80d
Cleared Nov 04, 1988
ICOR AGENT MONITOR
K883532 · CBQ
Icor AB
Anesthesiology · 78d
Cleared Nov 04, 1988
QM300 CONTROL E
K883537 · DHB
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 78d
Cleared Nov 04, 1988
METALASER VASCULASE
K883541 · GEX
Metatech Corp.
General & Plastic Surgery · 77d
Cleared Nov 04, 1988
CORONARY GUIDE WIRE
K883579 · DQX
Datascope Corp.
Cardiovascular · 74d
Cleared Nov 04, 1988
CIBA CORNING MAGIC LITE VITAMIN B12 IMMUNOASSAY
K883722 · CDD
Ciba Corning Diagnostics Corp.
Chemistry · 65d
Cleared Nov 04, 1988
MEDRAD OMNIPLANE 300 SYSTEM
K883834 · KPR
Medrad, Inc.
Radiology · 56d
Cleared Nov 04, 1988
CARDIOTOMY/VENOUS RESERVOIR NO.: CVR SERIES
K883923 · DTN
Gish Biomedical, Inc.
Cardiovascular · 49d
Cleared Nov 04, 1988
MEDITEC QL-15 ND:YAG LASER
K884060 · GEX
Storz Ophthalmics, Inc.
General & Plastic Surgery · 39d
Cleared Nov 04, 1988
TECHNICON DPA-1 ANALYTE ALPHA 1 ACID GLYCOPROTEIN
K884217 · LKL
Technicon Instruments Corp.
Immunology · 23d
Cleared Nov 04, 1988
ANTI-NATIVE DNA ANTIBODY TEST (CRITHIDIA LUCILIAE)
K884400 · DHN
Immco Diagnostics, Inc.
Immunology · 16d
Cleared Nov 03, 1988
SYMBION CENTRIFUGAL BLOOD PUMP MODEL I
K882129 · KFM
Symbion, Inc.
Cardiovascular · 167d
Cleared Nov 03, 1988
CTQ - CEDARS-SINAI QUANTITATIVE THALLIUM-201 ANALY
K882271 · LLZ
Nuccardiac Software, Inc.
Radiology · 156d
Cleared Nov 03, 1988
VARITEST
K882547 · JOM
Eureka AB
Cardiovascular · 135d
Cleared Nov 03, 1988
CAPD DISPOSABLE Y SYSTEM - DY SET
K883393 · KDJ
Medionics International , Ltd.
Gastroenterology & Urology · 86d
Cleared Nov 03, 1988
ACS SOFT-TIP CORONARY INFUSION CATH W/SIDE HOLES
K883564 · DQY
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 73d
Cleared Nov 03, 1988
SARNS TEMP. CONTROL AND MONITOR SYSTEM (TCM II)
K883603 · DWC
3M Health Care, Sarns
Cardiovascular · 72d
Cleared Nov 03, 1988
PREDICTOR II SIGNAL AVERAGING ECG
K883855 · DXG
Corazonix Corp.
Cardiovascular · 51d
Cleared Nov 03, 1988
GUIDING CATHETER (TIP SOFTNESS CHANGE)
K883981 · DWF
Devices For Vascular Intervention, Inc.
Cardiovascular · 43d