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
78097–78120 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 14, 2001
MODIFICATION TO M2376A DEVICELINK SYSTEM
K013470 · MWI
Philips Medical Systems, Inc.
Cardiovascular · 27d
Cleared Nov 14, 2001
TROCHANTERIC DYAX NAIL SYSTEM
K013524 · HSB
Howmedica Osteonics Corp.
Orthopedic · 22d
Cleared Nov 13, 2001
BSM BONE SUBSTITUTE MATERIAL
K011048 · MQV
DePuy Orthopaedics, Inc.
Orthopedic · 221d
Cleared Nov 13, 2001
MODIFICATION TO COROMETRICS MODEL 120IS MATERNAL/FETAL MONITORING SYSTEM.
K012718 · HGM
Ge Medical Systems Information...
Obstetrics & Gynecology · 90d
Cleared Nov 13, 2001
SORING GMBH SONOCA 180/190
K012753 · LFL
Soring GmbH Medizintechnik
General & Plastic Surgery · 89d
Cleared Nov 13, 2001
SAFESKIN HEALTHTOUCH POWDER-FREE EXAM GLOVE WITH VITAMIN E AND ALOE
K012815 · LYY
Kimberly-Clark Corp.
General Hospital · 83d
Cleared Nov 13, 2001
SINGLE DOSE DISPENSING PIN, MODEL 2201
K013087 · LHI
Alaris Medical Systems, Inc.
General Hospital · 57d
Cleared Nov 13, 2001
WIENER LAB.FER-COLOR AA, MODEL 5X 20 ML CAT.N 1492003
K013097 · JIY
Wiener Laboratories Saic
Chemistry · 57d
Cleared Nov 13, 2001
WIENER LAB. FER-COLOR TRANSFERRINA, MODEL AUX. REAGENTS FOR 25 SAMPLES CAT....
K013102 · JMO
Wiener Laboratories Saic
Chemistry · 57d
Cleared Nov 13, 2001
NORDIX INC RECHARGEABLE BATTERY PART NUMBER 2116
K013133 · MOQ
Nordix, Inc.
General & Plastic Surgery · 55d
Cleared Nov 13, 2001
SCANTAC MEMBRANE OR SCANTAC STRIP
K013170 · ITX
Sonotech, Inc.
Radiology · 50d
Cleared Nov 13, 2001
TINA-QUANT APOLIPOPROTEIN B VER.2
K013207 · DFC
Roche Diagnostics Corp.
Chemistry · 49d
Cleared Nov 13, 2001
AUTOJECT 2
K013362 · KZH
Owen Mumford USA, Inc.
General Hospital · 34d
Cleared Nov 13, 2001
MODEL MES-9000/EMG SYSTEM
K013399 · HCC
Myotronics-Noromed, Inc.
Neurology · 29d
Cleared Nov 13, 2001
MODIFICATION TO:MICRO TOUCH (R) POWDER FREE LATEX SURGICAL GLOVES , MODEL...
K013603 · KGO
Ansell Healthcare Products, Inc.
General Hospital · 13d
Cleared Nov 13, 2001
MODIFICATION TO: ULTRALON (R) POWDER FREE LATEX SURGICAL GLOVES
K013604 · KGO
Ansell Healthcare Products, Inc.
General Hospital · 13d
Cleared Nov 13, 2001
SSA-770A, APLIO ULTRASOUND SYSTEM
K013633 · IYO
Toshiba America Medical Systems, In.C
Radiology · 8d
Cleared Nov 09, 2001
VT-1
K012619 · LKY
Vts, Inc.
Gastroenterology & Urology · 88d
Cleared Nov 09, 2001
SE-200
K012620 · LKY
Vts, Inc.
Gastroenterology & Urology · 88d
Cleared Nov 09, 2001
REPROCESSED LINVATEC ARTHROSCOPIC BURS
K012630 · HRX
Alliance Medical, Inc.
Orthopedic · 88d
Cleared Nov 09, 2001
SE-300 VACUUM THERAPY SYSTEM
K012639 · LKY
Vts, Inc.
Gastroenterology & Urology · 88d
Cleared Nov 09, 2001
TONOPORT V
K012647 · DXN
Par Medizintechnik GmbH
Cardiovascular · 88d
Cleared Nov 09, 2001
SE-100 VACUUM ERECTION DEVICE
K012662 · LKY
Vts, Inc.
Gastroenterology & Urology · 88d
Cleared Nov 09, 2001
ULTRA THICK MALE LATEX CONDOM WITH SILICONE LUBRICANT
K012664 · HIS
Innolatex Sdn. Bhd
Obstetrics & Gynecology · 88d