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
141049–141072 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 12, 1987
MODIFIED IMAGEN(TM) CHLAMYDIA TEST
K864539 · LJP
Boots-Celltech Diagnostics, Inc.
Microbiology · 113d
Cleared Mar 12, 1987
IQ FREE T4 IMMUNOASSAY
K864658 · CEC
Bd Becton Dickinson Vacutainer...
Chemistry · 104d
Cleared Mar 12, 1987
ANA TEST KIT
K864668 · LKJ
Val Tech Diagnostics, Inc.
Immunology · 100d
Cleared Mar 12, 1987
INFRALUX HEAT LAMP
K864714 · ILY
Infralux International, Inc.
Physical Medicine · 99d
Cleared Mar 12, 1987
NIBP NON-INVAS. BLOOD PRESS. CART. MODEL 88 35 340
K864737 · DXN
Siemens Medical Solutions USA, Inc.
Cardiovascular · 98d
Cleared Mar 12, 1987
SOUNDTEK MODEL UT-4700
K864766 · IMJ
Soundtek, Inc.
Physical Medicine · 97d
Cleared Mar 12, 1987
AFFINITY(TM) HTSH IMMUNIT(TM)
K865081 · JLW
Bd Becton Dickinson Vacutainer...
Chemistry · 72d
Cleared Mar 12, 1987
AFFINITY(TM) SYSTEM
K865105 · JJE
Bd Becton Dickinson Vacutainer...
Chemistry · 72d
Cleared Mar 12, 1987
TOTAL/IGE THEOPHYLLINE CONTROL SERA
K870151 · JJX
3M Company
Immunology · 58d
Cleared Mar 12, 1987
FERRITIN MAB SOLID PHASE COMPONENT SYSTEM
K870570 · DBF
Bd Becton Dickinson Vacutainer...
Immunology · 30d
Cleared Mar 12, 1987
OXY-THERM
K870832 · IMD
M.D. Intl., Inc.
Physical Medicine · 9d
Cleared Mar 11, 1987
ERA-20
K853194 · DTE
Biotronik Sales, Inc.
Cardiovascular · 589d
Cleared Mar 11, 1987
AUSTENAL ACUPAC 20 DENTURE BASE MATERIAL
K863630 · EBI
Austenal Dental, Inc.
Dental · 175d
Cleared Mar 11, 1987
TRACETS 2000/ELECTRODES
K863674 · DRX
Lectec Corp.
Cardiovascular · 173d
Cleared Mar 11, 1987
SPACELABS MODEL 90419 PULSE OXIMETER MODULE
K864279 · DQA
Spacelabs, Inc.
Anesthesiology · 132d
Cleared Mar 11, 1987
PONTALLOR 4 DENTAL ALLOY
K870024 · EJT
Degussa Dental, Inc.
Dental · 65d
Cleared Mar 11, 1987
TORQUEDRIVER WRENCH
K870053 · HXC
Jerome Medical
Orthopedic · 63d
Cleared Mar 11, 1987
MODEL MS-II MINISTIM
K870338 · BXN
Life-Tech Intl., Inc.
Anesthesiology · 42d
Cleared Mar 11, 1987
ESCORT EC CUSTOM IN-THE-EAR HEARING AID
K870350 · ESD
Hearing Tech, Inc.
Ear, Nose, Throat · 41d
Cleared Mar 11, 1987
MODEL 78534C MONITOR/TERMINAL W/OPTIONS A03
K870380 · DPS
Hewlett-Packard Co.
Cardiovascular · 41d
Cleared Mar 11, 1987
MODEL 350 WIRELESS BICROS/MULTICROS HEARING AIDS
K870434 · ESD
Telex Communications, Inc.
Ear, Nose, Throat · 36d
Cleared Mar 11, 1987
MODEL 350 WIRELESS CROS/CROS LOW OUTPUT HEAR. AID
K870435 · ESD
Telex Communications, Inc.
Ear, Nose, Throat · 36d
Cleared Mar 11, 1987
HEARING AID, UNITRON MODEL UM60
K870503 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 35d
Cleared Mar 11, 1987
WARSAW ORTHOPEDIC POINTED REAMER
K870845 · HTO
Warsaw Orthopedic, Inc.
Orthopedic · 8d