FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
81265–81288 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Oct 10, 2000
ATOM INFA WARMER V-505
K002355 · FMT
Atom Medical Corp
General Hospital · 69d
Cleared Oct 10, 2000
MODEL 4815 ADAPTER
K002496 · DTN
Pace Medical
Cardiovascular · 57d
Cleared Oct 10, 2000
MODEL 4810 ANALYZER OUTPUT ADAPTER
K002497 · DTC
Pace Medical
Cardiovascular · 57d
Cleared Oct 10, 2000
LIGTHSPEED 3.0 CT SCANNER SYSTEM
K002978 · JAK
GE Medical Systems
Radiology · 15d
Cleared Oct 06, 2000
ACTICOAT 7 DRESSING
K001519 · FRO
Westaim Biomedical, Inc.
General & Plastic Surgery · 143d
Cleared Oct 06, 2000
RESUSCI INFLATE-A-SHIELD CPR BARRIER
K001742 · CBP
Laerdal Medical Corp.
Anesthesiology · 120d
Cleared Oct 06, 2000
SPEEDLINK TRANSVERSE CONNECTOR
K002082 · KWP
Spinal Concepts, Inc.
Orthopedic · 88d
Cleared Oct 06, 2000
BARD MEMOTHERM COVERED ESOPHAGEAL STENT, MODEL MULTIPLE
K002094 · ESW
C.R. Bard, Inc.
Gastroenterology & Urology · 87d