FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
156865–156888 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared May 06, 1983
OPTISON ULTRASONIC SCALER
K837382
Pelton & Crane Co.
Radiology · 63d
Cleared May 05, 1983
PREALBUMIN ENZYME IMMUNOASSAY
K821135 · JZJ
Abbott Laboratories
Hematology · 380d
Cleared May 05, 1983
MEDIGROUP LG-102 LIGHT GUIDE
K823293 · HET
Medigroup
Obstetrics & Gynecology · 181d
Cleared May 05, 1983
VARICELISA TEST KIT
K823805 · LFY
M.A. Bioproducts
Microbiology · 139d
Cleared May 05, 1983
DIAGNON FERRITIN 125 I RIA KIT
K830580 · DBF
Iagnon Corp.
Microbiology · 71d
Cleared May 05, 1983
DUO DERM FLEX HYDROACTIVE DRESSINGS &
K830708 · FRO
Convatec, A Division of E.R. Squibb &...
General & Plastic Surgery · 59d