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
75913–75936 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 24, 2002
H/S PROCEDURE TRAY (5F), H/S PROCEDURE TRAY (7F), H/S ELLIPTOSPHERE PROCEDURE...
K020954 · LKF
Ackrad Laboratories
Obstetrics & Gynecology · 30d
Cleared Apr 24, 2002
MODIFICATION TO ZEUS SCIENTIFIC'S ATHENA MULTI-LYTE ANA TEST SYSTEM
K021103 · LKJ
Zeus Scientific, Inc.
Immunology · 19d
Cleared Apr 23, 2002
STG MULTICHANNEL LUNG SOUND ANALYSIS SYSTEM
K012387 · BZM
Stethographics, Inc.
Anesthesiology · 270d
Cleared Apr 23, 2002
DIASOL-BICARB
K020230 · KPO
Diasol, Inc.
Gastroenterology & Urology · 90d
Cleared Apr 23, 2002
NORTHWESTERN GATED BLOOD POOL SPECT (NUMUGAS)
K020300 · KPS
Syntermed, Inc.
Radiology · 84d
Cleared Apr 23, 2002
INTERCEPT ESOPHAGEAL INTERNAL MR COIL, INTERCEPT URETHRAL INTERNAL MR COIL,...
K020495 · MOS
Surgi-Vision, Inc.
Radiology · 68d
Cleared Apr 23, 2002
SYNTHES TRANSLATING MAXILLARY DISTRACTOR
K020505 · JEY
Synthes (Usa)
Dental · 67d
Cleared Apr 23, 2002
WARMTOUCH PATIENT WARMING SYSTEM, MODEL 5300
K020604 · DWJ
Nellcor Puritan Bennett, Inc.
Cardiovascular · 57d
Cleared Apr 23, 2002
ULTRA TOUCH POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM...
K020838 · LYY
Ar Alliance Healthcare Sdn. Bhd.
General Hospital · 40d
Cleared Apr 23, 2002
ANNULOFLO SYSTEM, MITRAL MODEL AR700
K021051 · KRH
Sulzer Carbomedics, Inc.
Cardiovascular · 22d
Cleared Apr 22, 2002
TIP DEFLRCTING ENDOBRONCHIAL BLOCKER
K013865 · CBI
Cook, Inc.
Anesthesiology · 152d
Cleared Apr 22, 2002
MODIFICATION EZ-1 SYSTEM REPIRATORY SENSORS
K013905 · MNR
Pro-Tech Services, Inc.
Anesthesiology · 147d
Cleared Apr 22, 2002
HOMMED CENTRAL STATION
K020184 · DXN
Hommed, LLC
Cardiovascular · 94d
Cleared Apr 22, 2002
SNAP EEG MONITOR
K020218 · OLW
Nicolet Biomedical, Inc.
Neurology · 90d
Cleared Apr 22, 2002
SYNTHES THORACOLUMBAR SPINE LOCKING PLATE (TSLP)
K020244 · KWQ
Synthes Spine
Orthopedic · 88d
Cleared Apr 22, 2002
MOTION TRACKING
K020294 · IYE
Accuray, Inc.
Radiology · 84d
Cleared Apr 22, 2002
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH PIPERACILLIN...
K020397 · LON
Dade Behring, Inc.
Microbiology · 75d
Cleared Apr 22, 2002
BOND-3 ADHESIVE
K020499 · KLE
Jeneric/Pentron, Inc.
Dental · 67d
Cleared Apr 22, 2002
SONATA MICRO HYBRID COMPOSITE
K020555 · EBF
Pentron Laboratory Technologies
Dental · 61d
Cleared Apr 22, 2002
3M COMPLY 1228 GAS PLASMA INDICATOR TAPE
K020589 · JOJ
3M Company
General Hospital · 59d
Cleared Apr 22, 2002
LYPHOCHEK WHOLE BLOOD METALS CONTROL MODEL # 527, 528, 529
K020610 · DIE
Bio-Rad
Chemistry · 56d
Cleared Apr 22, 2002
BIRD TBIRD VELA VENTILATOR
K020746 · CBK
Bird Products Corp.
Anesthesiology · 46d
Cleared Apr 22, 2002
DISTAL RADIUS PLATING SYSTEM
K020819 · HRS
Biomet, Inc.
Orthopedic · 40d
Cleared Apr 22, 2002
CASHMERE NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES (WHITE)
K020868 · LZA
Seal Polymer Industries Bhd.
General Hospital · 35d