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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
79105–79128 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 03, 2001
SUPREMCAST
K011705 · EJH
American Dent-All, Inc.
Dental · 60d
Cleared Aug 03, 2001
TRAVEL EASE ELECTRIC SCOOTER MODEL # PIONEER 2
K011707 · INI
Merits Medical Industries Co., Ltd.
Physical Medicine · 60d
Cleared Aug 03, 2001
FIRST FILL R.C.S.
K011748 · KIF
Jeneric/Pentron, Inc.
Dental · 58d
Cleared Aug 03, 2001
TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 4
K011753 · INI
Merits Health Products., Inc.
Physical Medicine · 58d
Cleared Aug 03, 2001
THERMO-THERAPY, MODELS TT-101, TT-201, AND TT-202
K011768 · LSB
Thermo-Electric Co.
Physical Medicine · 57d
Cleared Aug 03, 2001
ADVANCED HIP ASSESSMENT SOFTWARE
K011917 · KGI
Ge Lunar Corp.
Radiology · 44d
Cleared Aug 03, 2001
NAVIGUS TRAJECTORY GUIDE BIOPSY KIT, MODELS BK-7000 AND 8000
K011971 · HAW
Image-Guided Neurologics, Inc.
Neurology · 39d
Cleared Aug 03, 2001
WALLACE OOCYTE RETRIEVAL SETS 16G, WALLACE OOCYTE RETRIEVAL SET 17G, MODELS...
K012068 · MQE
Sims Portex , Ltd.
Obstetrics & Gynecology · 32d
Cleared Aug 03, 2001
NIDOIL
K012123 · MQL
Nidacon International AB
Obstetrics & Gynecology · 28d
Cleared Aug 03, 2001
1.5T INFINITY TWINSPEED MR SYSTEM
K012200 · LNH
GE Medical Systems
Radiology · 21d
Cleared Aug 03, 2001
EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229
K012257 · DKZ
Syva Co.
Chemistry · 16d
Cleared Aug 03, 2001
SOLARA JR. MANUAL WHEELCHAIR
K012370 · IOR
Invacare Corp.
Physical Medicine · 8d
Cleared Aug 02, 2001
MINOLTA PULSOX-3SI, PULSOX-3IA, PULSOX-3LI
K010413 · DQA
Konica Minolta Sensing, Inc.
Anesthesiology · 171d
Cleared Aug 02, 2001
DRY AC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS
K011368 · KPO
Gambro Renal Products
Gastroenterology & Urology · 90d
Cleared Aug 02, 2001
XTRAC EXCIMER LASER SYSTEM, MODEL AL 7000
K011382 · GEX
Photo Medex, Inc.
General & Plastic Surgery · 87d
Cleared Aug 02, 2001
SYNTHES STRAIGHT WRIST FUSION PLATE, 170MM
K011458 · KTW
Synthes (Usa)
Orthopedic · 83d
Cleared Aug 02, 2001
CADENCE PRECISION INJECTOR, MODEL 103-0304
K011535 · MJN
Micro Therapeutics, Inc.
Cardiovascular · 76d
Cleared Aug 02, 2001
EZ SYRINGE
K011951 · FMF
Owen Mumford, Ltd.
General Hospital · 42d
Cleared Aug 02, 2001
SOMNO STAR & SERIES SLEEP SYSTEM
K012085 · OLV
Sensor Medics Corp.
Neurology · 30d
Cleared Aug 01, 2001
CENTRAL VENOUS CATHETER
K003839 · LJS
Boston Scientific Corp
General Hospital · 232d
Cleared Aug 01, 2001
MEDTRONIC MODEL 7495LZ LOW IMPEDANCE EXTENSION
K010300 · GZB
Medtronic Vascular
Neurology · 181d
Cleared Aug 01, 2001
WAKO IMMUNOASSAY CALIBRATOR SET
K010332 · JIT
Wako Chemicals USA, Inc.
Immunology · 180d
Cleared Aug 01, 2001
THE ALBERTA LENS SM2, SULFOCON B
K010454 · HQD
Progressive Optical Research , Ltd.
Ophthalmic · 167d
Cleared Aug 01, 2001
AUTOMATED WORKCELL CONTROL SOFTWARE
K010500 · JJE
Lab-Interlink, Inc.
Chemistry · 161d