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
166225–166248 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 23, 1980
FTA-ABS TEST
K801959 · JWL
Immuno-Diagnostic Products, Inc.
Microbiology · 65d
Cleared Oct 23, 1980
CMV TEST KIT
K801963 · GQH
Immuno-Diagnostic Products, Inc.
Microbiology · 65d
Cleared Oct 23, 1980
IN-LINE SCAN HEAD MODIFICATION MARK III
K801971 · ITX
Advanced Technology Laboratories, Inc.
Radiology · 65d
Cleared Oct 23, 1980
TRUE SPECTRUM ANALYSIS/MARK IV DUPLEX
K801972 · IYN
Advanced Technology Laboratories, Inc.
Radiology · 65d
Cleared Oct 23, 1980
IN-LINE SCAN HEAD MARK IV DUPLEX ULTRA
K801973 · ITX
Advanced Technology Laboratories, Inc.
Radiology · 65d
Cleared Oct 23, 1980
SCOTT NEEDLE & SCOTT MICK IMPLANTER
K801983 · IWJ
Mick Radio-Nuclear Instruments, Inc.
Radiology · 65d
Cleared Oct 23, 1980
MINI MICK APPLICATOR
K802032 · JWJ
Mick Radio-Nuclear Instruments, Inc.
Orthopedic · 62d
Cleared Oct 23, 1980
CORTISOL125 RADIOIMMUNOASSAY
K802036 · CGR
Corning Medical & Scientific
Chemistry · 62d
Cleared Oct 23, 1980
PHENYTOIN REAGENT TEST KIT
K802038 · DID
Beckman Instruments, Inc.
Toxicology · 59d
Cleared Oct 23, 1980
PHENOBARBITAL REAGENT TEST KIT
K802039 · DLZ
Beckman Instruments, Inc.
Toxicology · 59d
Cleared Oct 23, 1980
AMPCO SHAVE PREP TRAYS, CAT.#SP4020
K802041 · LDQ
Associated Medical Products Co.
General & Plastic Surgery · 65d
Cleared Oct 23, 1980
G.E. SCAN CAPABILITY CAT.#B7815F
K802045 · JAK
General Electric Co.
Radiology · 59d
Cleared Oct 23, 1980
AMX-III
K802047 · IZL
General Electric Co.
Radiology · 59d
Cleared Oct 23, 1980
ENDAB THEOPHYLLINE ENZYME IMMUNOASSAY
K802066 · KLS
Immunotech Corp.
Immunology · 57d
Cleared Oct 23, 1980
UNIPOLAR TO BIPOLAR PULSE GEN. ADAPTER
K802077 · DTD
Cardiac Pacemakers, Inc.
Cardiovascular · 56d
Cleared Oct 23, 1980
105MM SPOT FILM CAMERA
K802132 · IZJ
Instrumentation Camera, Inc.
Radiology · 50d
Cleared Oct 23, 1980
JK INT'L, INC. SOLTRON UVA TANNING BED
K802134 · LEJ
Mottek Intl. Corp.
Radiology · 49d
Cleared Oct 23, 1980
DIGITAL RADIOGRAPHY SYSTEM
K802150 · JAA
Adac Laboratories
Radiology · 45d
Cleared Oct 23, 1980
MODEL 633A THREE CHANNEL STRESS TEST
K802190 · DPS
Quinton, Inc.
Cardiovascular · 43d
Cleared Oct 23, 1980
MINOCYCLINE 30MCG. SENSI DISC
K802194 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 43d
Cleared Oct 23, 1980
DEHYDROEPIANDROSTERONE SULFATE KIT RIA
K802195 · JKC
Radioassay Systems Laboratories, Inc.
Chemistry · 43d
Cleared Oct 23, 1980
VERTIX 3D-U
K802200 · KPR
Siemens Corp.
Radiology · 42d
Cleared Oct 23, 1980
SD-700 BLOOD PRESSURE MONITOR
K802201 · DXN
Industrial & Biomedical Sensors Corp.
Cardiovascular · 42d
Cleared Oct 23, 1980
SD-800 BLOOD PRESSURE MONITOR
K802202 · DXN
Industrial & Biomedical Sensors Corp.
Cardiovascular · 42d