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
166249–166272 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 23, 1980
OMNI SCANNER CT 6000
K802206 · JAK
Omnimedical
Radiology · 42d
Cleared Oct 23, 1980
SURETY COLUMN
K802209 · JKA
Scientific Specialties, Inc.
Chemistry · 41d
Cleared Oct 23, 1980
SERUM SEPARATOR
K802211 · JKA
Scientific Specialties, Inc.
Chemistry · 41d
Cleared Oct 23, 1980
COS-UPHOFF INT'L DS-5 DRAINAGE SYSTEM
K802214 · GCY
Cox-Uphuff Intl.
General & Plastic Surgery · 41d
Cleared Oct 23, 1980
VIEW-LITE, MODEL-S
K802215 · IXC
Med-Western Electronics, Inc.
Radiology · 41d
Cleared Oct 23, 1980
VIEW-LITE, MODEL-DL
K802216 · IXC
Med-Western Electronics, Inc.
Radiology · 41d
Cleared Oct 23, 1980
VIEW-LITE, MODEL-SL
K802217 · IXC
Med-Western Electronics, Inc.
Radiology · 41d
Cleared Oct 23, 1980
SD-900 OSCILLOMETRIC BP MONITOR
K802218 · DXN
Industrial & Biomedical Sensors Corp.
Cardiovascular · 41d
Cleared Oct 23, 1980
ANALYTE T3 UPTAKE
K802246 · KHQ
Technicon Instruments Corp.
Chemistry · 37d
Cleared Oct 23, 1980
SP 120 SOPHISTICATE
K802251 · JQP
Vickers America Medical Corp.
Chemistry · 37d
Cleared Oct 23, 1980
TRIGLYCERIDES DETERMINATION
K802256 · CDT
Coleman Laboratories Corp.
Chemistry · 37d
Cleared Oct 23, 1980
TRANSVENOUS PACEMAKER ELECTRODE KIT
K802259 · LDF
Stanco Medical, Inc.
Cardiovascular · 37d
Cleared Oct 23, 1980
HGB3 (1:251)
K802266 · GKR
R&D Systems, Inc.
Hematology · 37d
Cleared Oct 23, 1980
THE IMMOBILIZER FOR OPEN & ARTHROSCOPIC
K802271 · BWN
The Anspach Effort, Inc.
General & Plastic Surgery · 36d
Cleared Oct 23, 1980
FTA-ABS BIOPAK
K802276 · JWL
Bioware Products
Microbiology · 35d
Cleared Oct 23, 1980
ANTISERA TO HUMAN FREE KAPPA CHAINS
K802283 · DFH
Kallestad Laboratories, Inc.
Immunology · 34d
Cleared Oct 23, 1980
ANTISERA TO HUMAN FREE LAMBDA LIGHT CH.
K802284 · CZQ
Kallestad Laboratories, Inc.
Immunology · 34d
Cleared Oct 23, 1980
ARGLE LATEX PENROSE TUBING
K802286 · KGZ
Sherwood Medical Co.
General & Plastic Surgery · 34d
Cleared Oct 23, 1980
VIVONEX JEJUNOSTOMY KIT
K802300 · KNT
Norwich Eaton Pharmaceuticals, Inc.
Gastroenterology & Urology · 31d
Cleared Oct 23, 1980
CORDIS DOW INFUSION PUMP
K802301 · FRN
Cordis Corp.
General Hospital · 31d
Cleared Oct 23, 1980
IL TOTAL PROTEIN REAGENT
K802310 · CEK
Instrumentation Laboratory CO
Chemistry · 30d
Cleared Oct 23, 1980
MO8 OXYGEN FLOWMETER
K802311 · CAX
Timeter Instrument Corp.
Anesthesiology · 30d
Cleared Oct 23, 1980
ARGYLE SILICONE THORACIC CATHETER
K802318 · GBS
Sherwood Medical Co.
General & Plastic Surgery · 30d
Cleared Oct 23, 1980
CRITERION II PACING SYSTEM MONITORS
K802325 · DRT
Dart Medical Equipment
Cardiovascular · 30d