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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
147649–147672 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 19, 1985
DESERET THERMODILUTION CARDIAC OUTPUT
K841967 · DXG
Parke-Davis Co.
Cardiovascular · 461d
Cleared Aug 19, 1985
ESPE KETAC-BOND
K844845 · EBD
Espe GmbH (Us)
Dental · 249d
Cleared Aug 19, 1985
MEDIPART FACE MASK MP-XM-I
K850836 · IYT
Medipart Jerry Alexander
Radiology · 171d
Cleared Aug 19, 1985
MEDIPART FACE MASK & FILTER MP-30XM-I
K850837 · IYT
Medipart Jerry Alexander
Radiology · 171d
Cleared Aug 19, 1985
VDRL CARBON ANTIGEN TEST S900500, S900250 & S90010
K851504 · GMP
Ncs Diagnostics, Inc.
Microbiology · 126d
Cleared Aug 19, 1985
SARTORIUS MINISART FH 16534
K851816 · FPB
Sartorius Filters, Inc.
General Hospital · 115d
Cleared Aug 19, 1985
SARTORIUS MINI-SART FH 16555
K851817 · FPB
Sartorius Filters, Inc.
General Hospital · 115d
Cleared Aug 19, 1985
SARTORIUS MINI SART FH 16592
K851818 · FPB
Sartorius Filters, Inc.
General Hospital · 115d
Cleared Aug 19, 1985
VSM MODELS A & B
K851916 · DRT
Physio-Control Corp.
Cardiovascular · 109d
Cleared Aug 19, 1985
DOME, DISPOSABLE, STERILE
K851989 · DRS
Transamerica Delaval, Inc.
Cardiovascular · 104d
Cleared Aug 19, 1985
MODEL 21225A CW COPPLER/IMAGING TRANSDUCER
K852132 · ITX
Hewlett-Packard Co.
Radiology · 95d
Cleared Aug 19, 1985
RESPIRATORY SYNCYTIAL VIRUS DIRECT FLUORESCENT ANT
K852185 · LKT
Bartels Immunodiagnostic Supplies, Inc.
Microbiology · 91d
Cleared Aug 19, 1985
COPAL UA-512 DIGITAL BLOOD PRESSURE MONITOR
K852564 · DXN
Takeda Medical, Inc.
Cardiovascular · 91d
Cleared Aug 19, 1985
GENERAL DIAGNOSTICS CEFTAZIDIME 30 MCG SUSC DISK
K852689 · JTN
Warner-Lambert Co.
Microbiology · 55d
Cleared Aug 19, 1985
CEFTAZIDIME 30MCG. SENI-DISC
K852873 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 42d
Cleared Aug 19, 1985
GENERAL DIAGNOSTICS' CEFTRIAXONE 30MCG SUSDEP DISK
K852967 · JTN
Warner-Lambert Co.
Microbiology · 35d
Cleared Aug 19, 1985
GLYCO-SEP/ALC TEST KIT FOR SEPARAT OF HEMOGLOBIN
K852986 · LCP
Clinical Technology Corp.
Hematology · 35d
Cleared Aug 19, 1985
CARIESCREEN - SM
K852987 · JSJ
Pharma-Medica of Scandinavia, Ltd.
Microbiology · 35d
Cleared Aug 19, 1985
RAPI - STAPH
K852997 · JWX
Advanced Medical Technology, Inc.
Microbiology · 35d
Cleared Aug 19, 1985
SECONDARY ADMINISTRATION SET
K853086 · FPA
Lyphomed, Inc.
General Hospital · 27d
Cleared Aug 19, 1985
125I ESTRADIOL DIRECT RADIOIMMUNOASSAY
K853208 · CHP
Travenol Laboratories, S.A.
Chemistry · 19d
Cleared Aug 19, 1985
APL LEVINE EMB AGAR
K853225 · JSI
Apl Medical Supplies
Microbiology · 18d
Cleared Aug 19, 1985
APL BIGGY AGAR(NICKERSON)
K853226 · JSI
Apl Medical Supplies
Microbiology · 18d
Cleared Aug 19, 1985
APL PHENYLETHYL ALCOHOL AGAR(WITH 5% SHEEP BLOOD)
K853227 · JSJ
Apl Medical Supplies
Microbiology · 18d