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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,724 results
68281–68304 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 31, 2004
ONEUSE- PLUS MICROKERATOME
K040297 · HMY
Moria SA
Ophthalmic · 51d
Cleared Mar 31, 2004
MANUAL WHEELCHAIR SERIES
K040561 · IOR
Shanghai Wheelchair Factory
Physical Medicine · 28d
Cleared Mar 31, 2004
MODIFICATION TO: CD HORIZON SPINAL SYSTEM
K040583 · MNI
Medtronic Sofamor Danek
Orthopedic · 26d
Cleared Mar 31, 2004
HERCULON SOFT TISSUE REATTACHMENT SYSTEM
K040594 · HWC
United States Surgical, A Division of...
Orthopedic · 23d
Cleared Mar 31, 2004
ULTRASOUND IMAGING SYSTEM, MODEL 7300
K040596 · IYN
Esaote, S.P.A.
Radiology · 23d
Cleared Mar 30, 2004
LIQUID OXYGEN SYSTEM
K032143 · BYJ
Micro Technology Services, Inc.
Anesthesiology · 260d
Cleared Mar 30, 2004
GEMINI SURGICAL LASER SYSTEM & ACCESSORIES
K034011 · GEX
Laserscope
General & Plastic Surgery · 97d
Cleared Mar 30, 2004
BOSTON SCIENTIFIC EXPRESS BILIARY SD PREMOUNTED STENT SYSTEM
K040027 · FGE
Boston Scientific
Gastroenterology & Urology · 82d
Cleared Mar 30, 2004
CARRARA INTERACTION CERAMIC SYSTEM
K040635 · EIH
Dentsply Intl.
Dental · 20d
Cleared Mar 29, 2004
DUREX FLAVORED LATEX CONDOM
K032227 · HIS
Ssl Americas, Inc.
Obstetrics & Gynecology · 252d
Cleared Mar 29, 2004
THE ULTRA SYSTEM
K032445 · KCT
Promedica, Inc.
General Hospital · 234d
Cleared Mar 29, 2004
MLT-1000 IR LASER SYSTEM
K033986 · ILY
Medical Laser Therapeutics LP
Physical Medicine · 97d
Cleared Mar 29, 2004
PROFILE 2000/3000 LASER SYSTEM
K040005 · GEX
Sciton, Inc
General & Plastic Surgery · 87d
Cleared Mar 29, 2004
NIO 5MP MEDICAL GRAYSCALE DISPLAY SYSTEM
K040040 · LLZ
Barco NV Barcoview
Radiology · 80d
Cleared Mar 29, 2004
NIO 3MP MEDICAL GRAYSCALE DISPLAY SYSTEM
K040041 · LLZ
Barco NV Barcoview
Radiology · 80d
Cleared Mar 29, 2004
JSA'S REPROCESSED COMPRESSION SLEEVE DEVICES
K040065 · JOW
Jack Speer and Assoc., Inc.
Cardiovascular · 76d
Cleared Mar 29, 2004
QONTRAST
K040399 · LLZ
Amid
Radiology · 41d
Cleared Mar 29, 2004
LINICAL ENZYME CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON...
K040535 · JJY
Cliniqa Corporation
Chemistry · 27d
Cleared Mar 26, 2004
RETISCAN, RETIPORT
K023525 · GWE
Roland Consult
Neurology · 522d
Cleared Mar 26, 2004
ULTRASONIC SCALER, MODELS VARIOS 350 LUX, VARIOS 350 (NO LIGHT), VARIOS 550,...
K031421 · ELC
Nakanishi, Inc.
Dental · 326d
Cleared Mar 26, 2004
UNI-VENT MODEL 730AEV (AUTOMATIC EMERGENCY VENTILATOR)
K032386 · BTL
Impact Instrumentation, Inc.
Anesthesiology · 235d
Cleared Mar 26, 2004
FIXION HIP SYSTEM
K032730 · JDI
Disc-O-Tech Medical Technologies, Ltd.
Orthopedic · 205d
Cleared Mar 26, 2004
QUANTUM LIGHT THERAPY SYSTEM
K032816 · NHN
Stargate International, Inc.
Physical Medicine · 199d
Cleared Mar 26, 2004
EN CIRCLR AL ADJUSTABLE LOOP MAPPING CATHETER MODELS, 1045AL1, 1045AL2,...
K033050 · DRF
Medtronic Vascular
Cardiovascular · 179d