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
81865–81888 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 11, 2000
NARKOMAT, MODEL 2000
K000995 · BSZ
Heyer America, Inc.
Anesthesiology · 197d
Cleared Oct 11, 2000
IRV2000 INDIVIDUAL RECREATIONAL VEHICLE
K001835 · INI
Trac About, Inc.
Physical Medicine · 117d
Cleared Oct 11, 2000
PINS AND WIRES
K002125 · HTY
Implant Resource, Inc.
Orthopedic · 89d
Cleared Oct 11, 2000
MAGNETOM ALLEGRA SYSTEM
K002179 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 84d
Cleared Oct 11, 2000
UNITED #1018-FREEDOM SERIES, UNITED #2018-COMFORT SERIES, UNITED...
K002318 · INO
United Chair Mfg., LLC
Physical Medicine · 72d
Cleared Oct 11, 2000
SURGI-VISION URETHRAL COIL
K002345 · MOS
Surgi-Vision, Inc.
Radiology · 70d
Cleared Oct 11, 2000
EMIT 2000 VALPROIC ACID ASSAY, EMIT 2000 VALPROIC ACID CALIBRATORS, MODEL...
K002551 · LEG
Dade Behring, Inc.
Chemistry · 55d
Cleared Oct 11, 2000
EZ-LIGHT 4000 SERIES MANUAL WHEELCHAIR
K002669 · IOR
Jiangsu Intco Medical Equipment &...
Physical Medicine · 44d
Cleared Oct 11, 2000
EZ-TRAVELER 3000 SERIES MANUAL WHEELCHAIR
K002670 · IOR
Jiangsu Intco Medical Equipment &...
Physical Medicine · 44d
Cleared Oct 11, 2000
EZ-TRAVELER 2500 SERIES MANUAL WHEELCHAIR
K002671 · IOR
Jiangsu Intco Medical Equipment &...
Physical Medicine · 47d
Cleared Oct 11, 2000
EZ-COMFORT TRANSPORTER 2000 SERIES
K002673 · IOR
Jiangsu Intco Medical Equipment &...
Physical Medicine · 44d
Cleared Oct 11, 2000
COMPOSIX E/X MESH
K002684 · FTL
C.R. Bard, Inc.
General & Plastic Surgery · 44d
Cleared Oct 11, 2000
MODEL 2500, PALMSAT HAND HELD PULSE OXIMETER, MODEL 2500
K002690 · DQA
Nonin Medical, Inc.
Anesthesiology · 43d
Cleared Oct 11, 2000
VINYL EXAMINATION GLOVES, POWDER FREE, VANILLA COLOR
K002746 · LYZ
Arista Latindo Industrial Ltd. P.T
General Hospital · 36d
Cleared Oct 11, 2000
JOBSITE ENHANCED MOBILITY CHAIR, MODEL JEM
K002876 · IOR
Suiter Medical LLC
Physical Medicine · 27d
Cleared Oct 11, 2000
VENTILATOR, CONTINUOUS (RESPIRATOR), MODEL LTV 1000
K002881 · CBK
Pulmonetic Systems, Inc.
Anesthesiology · 26d
Cleared Oct 11, 2000
TITANIUM MIDDLE EAR PROSTHESES
K002897 · ETB
Xomed, Inc.
Ear, Nose, Throat · 23d
Cleared Oct 11, 2000
EMIT TOX ACETAMINOPHEN ASSAY, MODEL 7A319UL
K002974 · LDP
Dade Behring, Inc.
Chemistry · 55d
Cleared Oct 11, 2000
C.T.M. POWER CHAIR, MODEL HS-5600
K002983 · ITI
Warepalmy Enterprise, LLC (Usa)
Physical Medicine · 16d
Cleared Oct 10, 2000
ALLIGER ULTRASONIC SURGICAL SYSTEM MODEL AUSS-4
K000927 · LFL
Misonix, Inc.
General & Plastic Surgery · 202d
Cleared Oct 10, 2000
Q-LUX PLASMA 100 LIGHT CURE UNIT
K001719 · EBZ
Rolence Enterprise Co. , Ltd.
Dental · 127d
Cleared Oct 10, 2000
COMBINED PHYSIOLOGICAL MONITORING SYSTEM
K002104 · IKN
Maryrose Cusimano, Ph.D. & Scott Zeff
Neurology · 90d
Cleared Oct 10, 2000
MENICON PROGENT REMOVER
K002140 · MRC
Menicon Co, Ltd.
Ophthalmic · 85d
Cleared Oct 10, 2000
TRACK 1.0 & 1.5 MM SYSTEMS-TISSUE REGENERATION BY ALVEOLAR CALLUS DISTRACTION
K002152 · MQN
KLS-Martin L.P.
Dental · 85d