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
160225–160248 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 06, 1982
CAPIOX CR-CARDIOTOMY RESERVOIR
K821538 · DTP
Terumo Medical Corp.
Cardiovascular · 74d
Cleared Aug 06, 1982
HEART*AID, ALS, MODEL 95
K821673 · DRO
Cardiac Resucitator Corp.
Cardiovascular · 60d
Cleared Aug 06, 1982
POROUS SURFACED PLATINUM IRIDIUM
K821889 · DTB
Cordis Corp.
Cardiovascular · 42d
Cleared Aug 06, 1982
FASTPASS IMPLANTABLE ENDOCARD. PACING
K821947 · DTB
Pacesetter Systems
Cardiovascular · 37d
Cleared Aug 06, 1982
NAGASHIMA SU-A CEILING MOUNT UNIT FOR
K822014 · EPT
Kelleher Corp.
General & Plastic Surgery · 29d
Cleared Aug 06, 1982
CKG 8000
K822020 · DSB
Cardio Kinetics, Inc.
Cardiovascular · 28d
Cleared Aug 06, 1982
MEDTRONIC ENERTRAX MODEL 7100
K822147 · DXY
Medtronic Vascular
Cardiovascular · 15d
Cleared Aug 06, 1982
NONINVASIVE TEMPORARY PACEMAKER
K822246 · DRO
Ross Research, Inc.
Cardiovascular · 8d
Cleared Aug 06, 1982
MODEL 8000 SECTOR IMAGER SYSTEM
K827286
Ote Biomedica
Radiology · 52d
Cleared Aug 06, 1982
MODEL 8100 SECTOR IMAGER
K827287
Ote Biomedica
Radiology · 52d
Cleared Aug 05, 1982
MONAGHAN'S PRESSURE ALARM
K821649 · CAP
Monaghan Medical Corp.
Anesthesiology · 62d
Cleared Aug 05, 1982
RESPIRACULT-STREP DEEP BED CULTURE PAD
K821659 · JSH
Orion Diagnostica, Inc.
Microbiology · 62d
Cleared Aug 05, 1982
SOLUTION ADMINISTRATION SET (W/O NEEDLE)
K821995 · FPA
Bertex Laboratories, Inc.
General Hospital · 29d
Cleared Aug 05, 1982
ACRO PACK
K822121 · JRL
Gelman Sciences, Inc.
Chemistry · 17d
Cleared Aug 05, 1982
ISOPROPANOL HEMOGLOBIN STABILITY TEST
K822123 · GKA
Helena Laboratories
Hematology · 17d
Cleared Aug 05, 1982
VOLU-SOL CARNOY FLUID
K822126 · IGM
Volu Sol Medical Industries
Pathology · 17d
Cleared Aug 05, 1982
VOLU-SOL ZENKERS FIXATIVE
K822127 · IFH
Volu Sol Medical Industries
Pathology · 17d
Cleared Aug 05, 1982
VOLU-SOL SINGLE DIFFERENTIAL STAIN
K822128 · ICN
Volu Sol Medical Industries
Pathology · 17d
Cleared Aug 05, 1982
VOLU-SOL BOVINS FIXATIVE
K822129 · IGN
Volu Sol Medical Industries
Pathology · 17d
Cleared Aug 05, 1982
DADE CHILL TRAY
K822132 · JRR
American Dade
Chemistry · 16d
Cleared Aug 05, 1982
IMMUCHEM COVALENT-COAT
K822140 · JKC
Immuchem Corp.
Chemistry · 16d
Cleared Aug 05, 1982
CORNING 101 PRINTER
K822146 · JQP
Corning Medical & Scientific
Chemistry · 15d
Cleared Aug 05, 1982
UREA NITROGEN (ENZYMATIC) DETERMINATION
K822154 · CDN
The Dow Chemical Co.
Chemistry · 13d
Cleared Aug 05, 1982
2XC MICROSCOPE
K822207 · IBJ
Amarel Precision Instruments, Inc.
Pathology · 13d