Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
149449–149472 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 10, 1985
FUKUDA DENSHI DS-1020A & DS-1040A DYNASCOPY SERIES
K850897 · DSI
Fukuda Denshi USA, Inc.
Cardiovascular · 37d
Cleared Apr 10, 1985
GLAS IONOMER CEMENT
K850913 · EMA
Shofu Dental Corp.
Dental · 36d
Cleared Apr 10, 1985
TILTING TABLE RADIOGRAPHIC A9006 TOMOJUPITER
K850948 · IXR
D&R X-Ray Products, Inc.
Radiology · 34d
Cleared Apr 10, 1985
BLOOD GAS SAMPLER KIT
K850958 · FMF
Churchill Corp.
General Hospital · 33d
Cleared Apr 10, 1985
HOFMANN G-S60 SINGLE PHASE X-RAY GENERATOR
K851011 · IZO
Hofmann X-Ray of America, Inc.
Radiology · 29d
Cleared Apr 10, 1985
BECKMAN TRIGLYCERIDES CONTROL LEVELS 1/2 &3
K851079 · JJX
Beckman Instruments, Inc.
Chemistry · 23d
Cleared Apr 10, 1985
PORTABLE DEFIBRILLATOR/MONITOR ED 425
K851092 · LDD
Honeywell, Inc.
Cardiovascular · 22d
Cleared Apr 10, 1985
AMERLEX-M LUTEINIZING HORMONE RADIOIMMUNO-KIT
K851104 · CEP
Amersham Corp.
Chemistry · 22d
Cleared Apr 10, 1985
IMPLANTABLE ELECTRODE LEAD 030-272 USING POLYURETH
K851294 · DTB
Telectronics, Inc.
Cardiovascular · 9d
Cleared Apr 10, 1985
IMPLANTABLE ELECTRODE LEAD 030-271 USING POLYURETH
K851295 · DTB
Telectronics, Inc.
Cardiovascular · 9d
Cleared Apr 10, 1985
IMPLANTABLE ELECTRODE LEAD, 030-270 USING POLYURET
K851297 · DTB
Telectronics, Inc.
Cardiovascular · 9d
Cleared Apr 09, 1985
CARDIO-NEC MODEL 365
K844101 · DPS
Birtcher Corp.
Cardiovascular · 168d
Cleared Apr 09, 1985
IVAC DRUG ADMINISTRATION DEVICE
K844843 · FPA
Y
General Hospital · 117d
Cleared Apr 09, 1985
IAI PROGRAM-COMPUTER PROGRAM
K844997 · DXG
Intl. Acoustics, Inc.
Cardiovascular · 104d
Cleared Apr 09, 1985
OMNI PHASE PENILE PROSTHESIS
K850019 · FAE
Dacomed Corp.
Gastroenterology & Urology · 96d
Cleared Apr 09, 1985
XMA 325 (X-RAY GENERATOR)
K850117 · IZO
Summit Industries, Inc.
Radiology · 85d
Cleared Apr 09, 1985
XMA INTEGRATED TABLE
K850118 · IXQ
Summit Industries, Inc.
Radiology · 85d
Cleared Apr 09, 1985
PRN ECG ELECTRODE
K850130 · DRX
Consolidated Medical Equipment, Inc.
Cardiovascular · 85d
Cleared Apr 09, 1985
DISPOSABLE CONDUCTIVE ADHESIVE DIAGNOSTIC ECG ELEC
K850132 · DRX
Consolidated Medical Equipment, Inc.
Cardiovascular · 85d
Cleared Apr 09, 1985
}IUSTIM - ELECTRONIC NEUROMUSCULAR STIMULATOR
K850167 · KPI
Urologics, Inc.
Gastroenterology & Urology · 83d
Cleared Apr 09, 1985
BOSCH IN THE EAR HEARING AID SUPERSTAR
K850188 · ESD
Robert Bosch Corp.
Ear, Nose, Throat · 81d
Cleared Apr 09, 1985
MASTER KIT A
K850246
Pro-Lab, Inc.
General & Plastic Surgery · 77d
Cleared Apr 09, 1985
VASCULON I.V. CANNULAE
K850278 · FOZ
Viggo Products
General Hospital · 76d
Cleared Apr 09, 1985
VIGGO ARTERIAL CANNULA
K850349 · FOZ
Viggo Products
General Hospital · 71d