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
157201–157224 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 30, 1983
AMWA TDA THEOPHYLLINE TEST
K831514 · LER
Miles Laboratories, Inc.
Toxicology · 49d
Cleared Jun 30, 1983
DINAMAP VITAL SIGNS MONITOR #1846
K831515 · DXN
Critikon Company, LLC
Cardiovascular · 49d
Cleared Jun 30, 1983
MODEL TP THERMISTOR PROBE
K831528 · DRF
Scimed Life Systems, Inc.
Cardiovascular · 49d
Cleared Jun 30, 1983
CCS MODEL SJ-103 IMPLANTABLE ATRIAL
K831529 · DTB
Cardiac Control Systems, Inc.
Cardiovascular · 49d
Cleared Jun 30, 1983
MAGIC T4 125I RADIOIMMUNOASSAY
K831533 · CDX
Corning Medical & Scientific
Chemistry · 48d
Cleared Jun 30, 1983
E.P.T. PLUS TM
K831535 · JHJ
Warner-Lambert Co.
Chemistry · 48d
Cleared Jun 30, 1983
ARM SLINGS
K831549 · ILI
Fred Sammons, Inc.
Physical Medicine · 49d
Cleared Jun 30, 1983
CERTAIN *DENTAL RESTORATIVE
K831559 · EBF
Johnson & Johnson Professionals, Inc.
Dental · 45d
Cleared Jun 30, 1983
SONTEK INFUSION CATHETER
K831562 · DQO
Sontek Corp.
Cardiovascular · 45d
Cleared Jun 30, 1983
CORONARY GUIDING CATHETER-MODIFIED
K831563 · DQY
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 45d
Cleared Jun 30, 1983
RELIANCE TEMPO OPHTH. INSTR STAND
K831568 · HHF
F. & F. Koenigkramer
Obstetrics & Gynecology · 45d
Cleared Jun 30, 1983
REAGENT CUPS
K831569 · JJG
American Scientific Products
Chemistry · 45d
Cleared Jun 30, 1983
ROTOR
K831571 · JJG
American Scientific Products
Chemistry · 45d
Cleared Jun 30, 1983
NU-CAP CALCIUM HYDROX. PULP CAPPING
K831575 · EJK
Coe Laboratories, Inc.
Dental · 45d
Cleared Jun 30, 1983
AORTIC ROOT CANNULA W/INTEGRAL PRESS
K831591 · DWF
Dlp, Inc.
Cardiovascular · 44d
Cleared Jun 30, 1983
SERO/TEX RED CELL RF TEST
K831597 · DHR
Texas Immunology, Inc.
Immunology · 44d
Cleared Jun 30, 1983
HEMATOLOGY PAK
K831605 · IAF
Mercedes Scientific Co., Inc.
Hematology · 43d
Cleared Jun 30, 1983
ACCU-FLUSH
K831637 · KRA
Accu-Line
Cardiovascular · 38d
Cleared Jun 30, 1983
DENTURE RELINING, REPAIR/REBASING RESIN
K831647 · EBI
Dentsply Intl.
Dental · 38d
Cleared Jun 30, 1983
ARTHROSCOPY KNIVES/PROBES/BENDING TOOL
K831656 · HRX
Richards Manufacturer Co.
Orthopedic · 38d
Cleared Jun 30, 1983
OXY-SWAB
K831673 · JTO
Austin Biological Laboratories
Microbiology · 38d
Cleared Jun 30, 1983
RIM-CAMP TEST
K831674 · JTO
Austin Biological Laboratories
Microbiology · 38d
Cleared Jun 30, 1983
TWIST LOCK DRILL 1120
K831675 · GET
Micro-Aire Surgical Instruments, Inc.
General & Plastic Surgery · 38d
Cleared Jun 30, 1983
PRIVATE LABEL DEODORANT MAXISHIELD
K831691 · HHL
Int'L Consumer Disposables
Obstetrics & Gynecology · 37d