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
165121–165144 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 24, 1980
HELIOMAT
K802684 · EAY
Vivadent (Usa), Inc.
Dental · 27d
Cleared Nov 24, 1980
PLASTIC ADHESIVE BANDAGE
K802764 · KGX
Dyn-A-Med Products
General & Plastic Surgery · 20d
Cleared Nov 24, 1980
CELLAMIN
K802796 · ITG
Secol Co.
Physical Medicine · 20d
Cleared Nov 24, 1980
NARCO AIR-SHEILDS SYS. 100 MONITOR SYS
K802800 · DXG
Narco Air-Shields
Cardiovascular · 18d
Cleared Nov 24, 1980
MONOJECT ROOT CANAL FILLING MAT. NEEDLE
K802811 · DZM
Sherwood Medical Co.
Dental · 17d
Cleared Nov 24, 1980
KETAC-CEM IN REF. TO K802048
K802819 · EMA
Espe Dental Products
Dental · 17d
Cleared Nov 21, 1980
VITAMIN B12 FOLATE RADIOASSAY
K802037 · CCN
Corning Medical & Scientific
Chemistry · 91d
Cleared Nov 20, 1980
RIGHT ATRIAL LINE KIT
K802287 · DQY
Stanco Medical, Inc.
Cardiovascular · 62d
Cleared Nov 20, 1980
SWAN GANZ CATHETER PLACEMENT KIT
K802288 · DYG
Stanco Medical, Inc.
Cardiovascular · 62d
Cleared Nov 19, 1980
LITHICRON 0520 P-SYNCHRONEOUS PULSE GEN.
K792609 · DXY
Medcor, Inc.
Cardiovascular · 337d
Cleared Nov 19, 1980
SAVE MOR
K801945 · DRM
Cardia Concepts Corp.
Cardiovascular · 97d
Cleared Nov 19, 1980
CPR HELPER
K801946 · DRM
Cardia Concepts Corp.
Cardiovascular · 97d
Cleared Nov 19, 1980
CPR TRAVELER
K801947 · DRM
Cardia Concepts Corp.
Cardiovascular · 97d
Cleared Nov 19, 1980
MAPPING PROBE MODEL #6540
K802058 · DRF
Cardiac Pacemakers, Inc.
Cardiovascular · 86d
Cleared Nov 19, 1980
PMT DEPTHALON DEPTH CORTICOGRAPHY ELEC
K802151 · GZL
Progress Mankind Technology
Neurology · 72d
Cleared Nov 19, 1980
PMT DEPTHALON DEPTH #2102
K802152 · GZL
Progress Mankind Technology
Neurology · 72d
Cleared Nov 19, 1980
CHRONOCOR IV MODEL 250
K802221 · DTE
Cordis Corp.
Cardiovascular · 68d
Cleared Nov 19, 1980
MICROLET FAMILY OF NEEDLE/DEPTH ELECT-
K802249 · GZL
Progress Mankind Technology
Neurology · 64d
Cleared Nov 19, 1980
HELFET ELBOW PROSTHESIS
K802460 · JDB
Depuy, Inc.
Orthopedic · 42d
Cleared Nov 19, 1980
CARDIACINDEX COMPUTER MODEL SP 1435
K802476 · DXG
Gould, Inc.
Cardiovascular · 41d
Cleared Nov 19, 1980
REIGNING DENTURE
K802490 · EBI
Oki Shiks USA , Ltd.
Dental · 40d
Cleared Nov 19, 1980
MODEL 3003 UNIPOLAR DEMAND CARDIAC GEN.
K802588 · DXY
Arco Medical Products Co.
Cardiovascular · 30d
Cleared Nov 19, 1980
CARBIDE CUTTING INSTRUMENT/INTRAARTICU
K802598 · HTT
The Anspach Effort, Inc.
Orthopedic · 29d
Cleared Nov 19, 1980
TERPERATUR SENSING DEVICE
K802607 · FLL
Burditt & Calkins-Siemens-Elema
General Hospital · 29d