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
157705–157728 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 09, 1983
ANGIOGRAPHIC NEEDLE
K831189 · DQO
Medrad, Inc.
Cardiovascular · 27d
Cleared May 09, 1983
VESSEL DILATOR
K831190 · DRE
Medrad, Inc.
Cardiovascular · 27d
Cleared May 09, 1983
VASCULAR CATHETER
K831191 · DOY
Medrad, Inc.
Toxicology · 27d
Cleared May 09, 1983
WESTERGREN DISPETTE FOR ESR
K831195 · JPH
Ulster Scientific, Inc.
Hematology · 27d
Cleared May 09, 1983
MODEL 343D HEARING AID
K831197 · ESD
Telex Communications, Inc.
Ear, Nose, Throat · 27d
Cleared May 09, 1983
IMMUNOHEMATOLOGICAL SALINE #97139
K831200 · JCE
Emd Chemicals, Inc.
Chemistry · 28d
Cleared May 09, 1983
IGE-QUANT DIAGNOSTIC TEST KIT
K831208 · DGC
Leeco Diagnostics, Inc.
Chemistry · 25d
Cleared May 09, 1983
DELTA TEETH
K831214 · ELM
Dentsply Intl.
Dental · 25d
Cleared May 09, 1983
MODEL BERNAFON T-86
K831217 · ESD
Bernafon, Inc.
Ear, Nose, Throat · 24d
Cleared May 09, 1983
CLOSTRIDIUM DIFFICILE MEDIA
K831220 · JSJ
Gibco Laboratories Life Technologies,...
Microbiology · 24d
Cleared May 09, 1983
CARBAMEZEPINE REAGENT TEST KIT
K831222 · KLT
Beckman Instruments, Inc.
Chemistry · 24d
Cleared May 09, 1983
SUPER SNAPS
K831229 · FHJ
Shofu Dental Corp.
Obstetrics & Gynecology · 24d
Cleared May 09, 1983
SPIROMED RESPIROMETER
K831237 · BZK
Draeger Medical, Inc.
Anesthesiology · 24d
Cleared May 09, 1983
OXYMED
K831238 · CCL
Draeger Medical, Inc.
Anesthesiology · 24d
Cleared May 09, 1983
LANCER HEMOGLOBIN ANALYZER REAGENTS
K831253 · KMG
Sherwood Medical Co.
Hematology · 21d
Cleared May 09, 1983
DENTAL FLOSS HOLDER
K831254 · JES
Sewon Industry
Dental · 21d
Cleared May 09, 1983
RESERVOIR 1.5CC #9210 W/25 GAUGE/NEEDLE
K831259 · FRN
Cardiac Pacemakers, Inc.
General Hospital · 21d
Cleared May 09, 1983
DENTOLOCK DENTURE ADHESIVE CREAM
K831265 · KOQ
Solar Dental Co., Inc.
Dental · 21d
Cleared May 09, 1983
DOPPLER FOR DETECTING OCCLUSIONS AND TAKING SYSTOLIC BLOOD PRESSURE
K837085
E.M. Adams
Radiology · 27d
Cleared May 09, 1983
MODELS 246 AND 210F LINEAR ARRAY ULTRASOUND SCANNER
K837304
Aloka Co., Ltd.
Radiology · 52d
Cleared May 09, 1983
CORNEOMAP 4500 ULTRASOUND MEASUREMENT
K837331
Radionics Medical, Inc.
Radiology · 60d
Cleared May 09, 1983
BEAM BLOCK SHAPER
K837344
Mick Radio-Nuclear Instruments, Inc.
Radiology · 49d
Cleared May 06, 1983
MEDIGROUP 2.2MM NEEDLESCOPE CANNULA&
K823295 · HET
Medigroup
Obstetrics & Gynecology · 182d
Cleared May 06, 1983
ST-610 NEEDLESCOPE STERILIZATION TRAY
K823297 · HET
Medigroup
Obstetrics & Gynecology · 182d