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
65041–65064 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 24, 2005
UNIGLIDE UNICONDYLAR KNEE PROSTHESIS
K050764 · HRY
Corin USA
Orthopedic · 153d
Cleared Aug 24, 2005
H12+ HOLTER RECORDER
K050896 · DSH
Mortara Instrument, Inc.
Cardiovascular · 138d
Cleared Aug 24, 2005
ACCESS BREAST COIL
K052045 · MOS
Confirma, Inc.
Radiology · 27d
Cleared Aug 24, 2005
HOSPIRA PLUM A+ INFUSION PUMP SYSTEM V11.5, HOSPIRA PLUM A+ 3 INFUSION PUMP...
K052052 · FRN
Hospira, Inc.
General Hospital · 26d
Cleared Aug 24, 2005
MODIFICATION TO: LIFESTENT VALEO BILIARY STENT SYSTEM
K052132 · FGE
Edwards Lifesciences, LLC
Gastroenterology & Urology · 19d
Cleared Aug 24, 2005
SPYGLASS DIRECT VISUALIZATION PROBE AND OCULAR
K052194 · ODF
Boston Scientific Corp
Gastroenterology & Urology · 13d
Cleared Aug 23, 2005
VITALCARE I.V. ADMINISTRATION SET
K050906 · FPA
Vitalcare Group, Inc.
General Hospital · 134d
Cleared Aug 23, 2005
ACCUCHEK INSTANT PLUS DUAL TESTING SYSTEM, ACCUCHEK INSTANT PLUS CHOLESTEROL,...
K051376 · CHH
Roche Diagnostics
Chemistry · 89d
Cleared Aug 23, 2005
APTUS TITANIUM OSTEOSYNTHESIS SYSTEM
K051567 · HRS
Medartis, Inc.
Orthopedic · 70d
Cleared Aug 23, 2005
GAV - GENERAL ANAESTHETIC VAPORIZER
K051666 · CAD
General Anaesthetic Services Limited
Anesthesiology · 62d
Cleared Aug 23, 2005
FORMULA 418 BILIARY STENT
K051785 · FGE
Cook, Inc.
Gastroenterology & Urology · 53d
Cleared Aug 23, 2005
PC COMPATIBLE BLOOD PRESSURE MONITOR, MODEL AK-4000TU, BP-410U, BP-410R
K051862 · DXN
Ya Horng Electronic Co., Ltd.
Cardiovascular · 46d
Cleared Aug 23, 2005
DATEX-OHMEDA S/5 BIS MODULE, E-BIS AND ACCESSORIES
K052145 · OLW
Ge Healthcare
Neurology · 15d
Cleared Aug 23, 2005
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
K052180 · KWP
Medtronic Sofamor Danek
Orthopedic · 13d
Cleared Aug 23, 2005
CUTANEOUS ELECTRODE
K052188 · GXY
Rhythmlink International, LLC
Neurology · 12d
Cleared Aug 23, 2005
BARD ATLAS PTA BALLOON DILATATION CATHETER
K052236 · DQY
Bard Peripheral Vascular, Inc.
Cardiovascular · 6d
Cleared Aug 22, 2005
OX-GEN FLEXIBLE O2 GENERATION SYSTEM, MODEL 6-OX-03
K033863 · CAW
Ox-Gen, Inc.
Anesthesiology · 619d
Cleared Aug 22, 2005
NORMOCARD 25 (STERILE BICARBONATE RENAL DIALYSIS CONCENTRATE)
K050827 · KPO
Dialysis Solutions, Inc.
Gastroenterology & Urology · 143d
Cleared Aug 22, 2005
RESORB-X SF
K051236 · JEY
KLS-Martin L.P.
Dental · 101d
Cleared Aug 22, 2005
GC FUJI FIL LC
K051427 · EMA
GC America, Inc.
Dental · 82d
Cleared Aug 22, 2005
MILLIKEN SILVER WOUND DRESSINGS
K051445 · FRO
Milliken Chemical
General & Plastic Surgery · 81d
Cleared Aug 22, 2005
OLYMPUS CRP LATEX REAGENT, OSR6199
K051564 · NQD
Olympus America, Inc.
Chemistry · 69d
Cleared Aug 22, 2005
FR.O.H. CALCANEUS REPAIR SYSTEM
K051642 · NDF
I.T.S. Implantat-Technologie-Systeme...
Orthopedic · 63d
Cleared Aug 22, 2005
WH ACCU TEST ONE-STEP URINE/SERUM COMBO PREGNANCY TEST
K051841 · JHI
W.H.P.M., Inc.
Chemistry · 46d