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
165961–165984 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 24, 1980
ANSWER AT-HOME PREGNANCY TEST KIT
K802660 · JHJ
Armkel, LLC
Chemistry · 31d
Cleared Nov 24, 1980
CYBREX TOBRAMYCIN
K802668 · LCR
Abbott Laboratories
Toxicology · 28d
Cleared Nov 24, 1980
CARDIOACTIVE DRUGS CONTROL
K802672 · DIF
Fisher Scientific Co., LLC
Toxicology · 28d
Cleared Nov 24, 1980
HELIOBOND
K802681 · KLE
Vivadent (Usa), Inc.
Dental · 27d
Cleared Nov 24, 1980
CONTACT SEAL
K802682 · EBC
Vivadent (Usa), Inc.
Dental · 27d
Cleared Nov 24, 1980
HELIOSIT
K802683 · EBF
Vivadent (Usa), Inc.
Dental · 27d
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