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
120625–120648 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 31, 1991
OMEGA ANGIOSCOPES (OMEGASCOPES)
K911090 · LYK
Omega Universal Technologies, Ltd.
Cardiovascular · 142d
Cleared Jul 31, 1991
ICON TELERADIOLOGY SYSTEM
K911752 · LLZ
Icon Medical Systems, Inc.
Radiology · 104d
Cleared Jul 31, 1991
DEVILBISS MODEL 5000
K911896 · CAF
Devilbiss Health Care, Inc.
Anesthesiology · 96d
Cleared Jul 31, 1991
ZOLL PD-1400 PACER/DEFIBRILLATOR
K911956 · DRO
Zmi Corp.
Cardiovascular · 90d
Cleared Jul 31, 1991
CODMAN SKULL CLAMP
K912011 · HBL
Codman & Shurtleff, Inc.
Neurology · 86d
Cleared Jul 31, 1991
MAGIC LITE SQ SPECIFIC IGE IMMUNOASSAY SYSTEM
K912582 · DHB
Ciba Corning Diagnostics Corp.
Immunology · 49d
Cleared Jul 31, 1991
HEARING AID, UNITRON MODEL UIK
K912870 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 33d
Cleared Jul 31, 1991
E.T. TAPE II
K912884 · CBH
B&B Medical Technologies, Inc.
Anesthesiology · 30d
Cleared Jul 31, 1991
MONOSCOPY(TM) BRAND, ELECTROSURGICAL RAKE
K913104 · GCJ
Dexide, Inc.
General & Plastic Surgery · 19d
Cleared Jul 31, 1991
CODMAN LHALO SPLIT RING RETRACTOR SYSTEM
K913233 · GZT
Codman & Shurtleff, Inc.
Neurology · 9d
Cleared Jul 30, 1991
QSI 9500
K904294 · OLU
Quantified Signal Imaging, Inc.
Neurology · 314d
Cleared Jul 30, 1991
ALTA CHANNEL PLATE CONNECTOR
K910482 · HRS
Howmedica Corp.
Orthopedic · 174d
Cleared Jul 30, 1991
PERMANENT IMPLANTABLE FH ENDOCARDIAL LEADS W/TIP
K910608 · DTB
Biotronik, GmbH & Co.
Cardiovascular · 168d
Cleared Jul 30, 1991
507 NON-INVASIVE VITAL SIGNS MONITOR
K910852 · DRT
Criticare Systems, Inc.
Cardiovascular · 153d
Cleared Jul 30, 1991
MODELS 5866-24M/5866-38M/5866-40M/6986M ADAPT KIT
K911302 · DTD
Medtronic Vascular
Cardiovascular · 127d
Cleared Jul 30, 1991
CYTOCLONE A & B EIA
K911958 · LLH
Cambridge Biotech Corp.
Microbiology · 88d
Cleared Jul 30, 1991
GOLD CUP EEG CUTANEOUS ELECTRODE W/LEAD AND EXT.
K911989 · GXY
Somnitec, Inc.
Neurology · 85d
Cleared Jul 30, 1991
MEDI-THERM (MTA-5900) & DETACHABLE HOSES
K912051 · DWJ
Gaymar Industries, Inc.
Cardiovascular · 82d
Cleared Jul 30, 1991
POLY BRAIDED PIGTAIL/PERC CARD CATH W/VAR TIP CONF
K912076 · DQO
The R Group
Cardiovascular · 81d
Cleared Jul 30, 1991
MEDTRONIC CARDIOCARE MEMORYTRACE ER MODEL 4221
K912084 · DXH
Medtronic Vascular
Cardiovascular · 78d
Cleared Jul 30, 1991
CHOLESTECH LIPID MONITORING SYS.
K912136 · CHH
Cholestech Corp.
Chemistry · 77d
Cleared Jul 30, 1991
SOFTOUCH(R) GUIDING CATHETER W/BUMPER TIP
K912191 · DQY
Mallinckrodt Medical
Cardiovascular · 74d
Cleared Jul 30, 1991
PA-393 GOLD BASED/PRECIOUS METAL ALLOYS CLIN USE
K912194 · EJS
Jelenko Co.
Dental · 74d
Cleared Jul 30, 1991
PA-396 GOLD BASED/PRECIOUS METAL ALLOYS CLIN USE
K912195 · EJS
Jelenko Co.
Dental · 74d