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
143713–143736 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 16, 1986
ANGIOMEDICS CATH SHEATH INTRODUC W/HEMOSTASIS VALV
K861238 · DYB
Angiomedics, Inc.
Cardiovascular · 105d
Cleared Jul 16, 1986
MONABRITE RESPIR SYNCYTIAL VIRUS(RSV) TEST KIT
K861379 · LKT
Serono Diagnostics, Inc.
Microbiology · 93d
Cleared Jul 16, 1986
STOCKERT-SHILEY MULTIFLOW ROLLER PUMP MODULE
K861714 · DWB
Shiley, Inc.
Cardiovascular · 72d
Cleared Jul 16, 1986
SIEMENS RADIOTHERM 706, MICROWAVE THERAPY UNIT
K862029 · IOA
Elmed, Inc.
Physical Medicine · 49d
Cleared Jul 16, 1986
IN SITU EAR GAIN AUDIO TEST STAT TYPE 2118/WH 1823
K862086 · ETW
A/S Bruel & Kjaer
Ear, Nose, Throat · 44d
Cleared Jul 16, 1986
STOCKERT-SHILEY DOUBLE HEAD PUMP MODULE
K862116 · DWB
Shiley, Inc.
Cardiovascular · 43d
Cleared Jul 16, 1986
IMTECH FIXATION SYSTEMS
K862139 · JEY
Imtech, Inc.
Dental · 42d
Cleared Jul 16, 1986
MICRODILUTION PANELS
K862140 · JWY
American Micro Scan
Microbiology · 42d
Cleared Jul 16, 1986
INEARSET IES HEARING AID
K862222 · ESD
Inearset, Inc.
Ear, Nose, Throat · 35d
Cleared Jul 16, 1986
POROUS COATED HIP FEMORAL PROSTHESIS
K862326 · LPH
Johnson & Johnson Professionals, Inc.
Orthopedic · 27d
Cleared Jul 16, 1986
SURGICAL DRAPES AND DRAPE ACCESSORIES
K862438 · KKX
Avery Intl.
General Hospital · 20d
Cleared Jul 16, 1986
LYNX EL MICROSCOPY TISSUE PROCESSOR
K862457 · IDZ
Australian Biomedical Corporation , Ltd.
Pathology · 16d
Cleared Jul 16, 1986
MS-179 ELECTRONIC MUSCLE STIMULATOR
K862485 · IPF
Electro Med Supply, Inc.
Physical Medicine · 16d
Cleared Jul 16, 1986
MS-159 ELECTRONIC MUSCLE STIMULATOR
K862486 · IPF
Electro Med Supply, Inc.
Physical Medicine · 16d
Cleared Jul 16, 1986
MS-139 ELECTRONIC MUSCLE STIMULATOR
K862487 · IPF
Electro Med Supply, Inc.
Physical Medicine · 16d
Cleared Jul 16, 1986
FAST CHOLESTEROL (TOTAL CHOLESTEROL TEST)
K862507 · CHH
Sclavo, Inc.
Chemistry · 15d
Cleared Jul 16, 1986
IMMPULSE PHENOBARBITAL ASSAY REAGENTS
K862528 · LGQ
Sclavo, Inc.
Toxicology · 14d
Cleared Jul 16, 1986
HEARING AID (ALL-IN-EAR)
K862545 · ESD
Vibrasonic, Inc.
Ear, Nose, Throat · 13d
Cleared Jul 16, 1986
IMMPULSE PHENYTOIN ASSAY REAGENT
K862554 · LGR
Sclavo, Inc.
Toxicology · 13d
Cleared Jul 16, 1986
ULTRAMARK 1 ULTRASOUND SYSTEM
K862681 · IYO
Advanced Technology Laboratories, Inc.
Radiology · 1d
Cleared Jul 15, 1986
PINNACLE MULTI-PROGRAMMABLE PACING SYS
K853771 · DXY
Cardio-Pace Medical, Inc.
Cardiovascular · 309d
Cleared Jul 15, 1986
SIEMENS SIRECUST MODELS 403P,403-2P & 403N
K855096 · DPS
Analogic Corp.
Cardiovascular · 204d
Cleared Jul 15, 1986
THE KEYMED FIBERSCOPE STERILIZATION CASE
K860528 · KCT
Keymed, Inc.
General Hospital · 154d
Cleared Jul 15, 1986
UNICARE BREAST SHELLS
K861608 · HFS
Unicare Medical Products, Inc.
General Hospital · 77d