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
134161–134184 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 17, 1988
DANTEC MAGNETIC STIMULATOR
K881915 · GWF
Dantec Electronics, Inc.
Neurology · 161d
Cleared Oct 17, 1988
CARDIOMEGA-T
K883410 · DSI
Grandcor Medical Systems
Cardiovascular · 67d
Cleared Oct 17, 1988
PPG BIOMEDICAL FLEXIBLE MICRO TRANSDUCER CATHETER
K883436 · DXO
Ppg Industries, Inc.
Cardiovascular · 63d
Cleared Oct 17, 1988
BULLARD INTUBATING LARYNGOSCOPE LAR-A & LAR-P
K883819 · CCW
Circon Acmi
Anesthesiology · 39d
Cleared Oct 17, 1988
SINGLE-FIL(TM) SYRINGE
K883955 · FMF
Bd Becton Dickinson Vacutainer...
General Hospital · 28d
Cleared Oct 17, 1988
MAESTRO(R) SERIES 100/200 SINGLE CHAMBER PACEMAKER
K884023 · DXY
Cardiac Control Systems, Inc.
Cardiovascular · 25d
Cleared Oct 17, 1988
STRAIGHT AND RIGHT ANGLE NON-CORING NEEDLES
K884211 · FMI
Marquette Medical, Inc.
General Hospital · 11d
Cleared Oct 17, 1988
WINGED NON-CORING NEEDLE SET
K884212 · FMI
Marquette Medical, Inc.
General Hospital · 11d
Cleared Oct 14, 1988
AIR PLETHYSMOGRAPH MODEL APG-1000
K881291 · DSB
Aci Medical, Inc.
Cardiovascular · 200d
Cleared Oct 14, 1988
PIPELLE DE CORNIER ENDOMETRIAL SUCTION CURETTE
K881456 · HHK
Laboratoire Ccd C/O Washington...
Obstetrics & Gynecology · 191d
Cleared Oct 14, 1988
BLOOD PRESSURE CUFF
K881799 · DXQ
Biomedical Dynamics, Inc.
Cardiovascular · 170d
Cleared Oct 14, 1988
ULTRAFLOTATION BED
K882607 · IOQ
Medical Flotation Systems, Inc.
Physical Medicine · 112d
Cleared Oct 14, 1988
TOWNLEY COX COMB ACETABULAR COMPONENT
K882869 · JDI
Biopro, Inc.
Orthopedic · 95d
Cleared Oct 14, 1988
MULTI-DRUG INFUSION SYSTEM
K883003 · FRN
I-Flow Corp.
General Hospital · 88d
Cleared Oct 14, 1988
SHARPLAN 4300 & 4310 ULTRASONIC SURGICAL APIRATORS
K883091 · LFL
Sharplan Lasers, Inc.
General & Plastic Surgery · 84d
Cleared Oct 14, 1988
MULTI-MED INFUSION CATHETER AND KIT DOUBLE/TRIPLE
K883174 · DQY
Baxter Healthcare Corp
Cardiovascular · 79d
Cleared Oct 14, 1988
MODEL 329-701 BIPOLAR ACTIVE-FIXATION LEAD
K883265 · DTB
Telectronics and Cordis Pacing Systems
Cardiovascular · 74d
Cleared Oct 14, 1988
ACS INDEFLATOR P/T 20
K883452 · DXT
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 63d
Cleared Oct 14, 1988
PORTABLE II DENTAL DELIVERY SYSTEM
K883775 · EIA
Dntl Corp.
Dental · 38d
Cleared Oct 14, 1988
POLYSAFE(TM) IMPLANTABLE PACING LEAD
K884024 · DTB
Cardiac Control Systems, Inc.
Cardiovascular · 22d
Cleared Oct 13, 1988
INTER TRON 4000
K880924 · LIH
Diversified Chiropractic Systems
Neurology · 223d
Cleared Oct 13, 1988
MEDTRONIC MODEL 4951P
K881810 · DTB
Medtronic Vascular
Cardiovascular · 168d
Cleared Oct 13, 1988
THERMO-BODY-WRAP SYSTEM
K881862 · IRT
Thermo Body Wrap Systems, Inc.
Physical Medicine · 163d
Cleared Oct 13, 1988
CIBA CORNING MAGIC LITE INTACT PTH IMMUNOASSAY
K882560 · CEW
Ciba Corning Diagnostics Corp.
Chemistry · 114d