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
159409–159432 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 03, 1982
DISPOSABLE LINEAR STAPLER-(LSR)
K821994 · GDW
Ethicon, Inc.
General & Plastic Surgery · 27d
Cleared Aug 03, 1982
JACKSON BITE BLOCKS
K822018 · JXL
Kelleher Corp.
Neurology · 26d
Cleared Aug 03, 1982
IMMUNO DIAGNOSTICS ASSAY
K822026 · CZP
Helena Laboratories
Chemistry · 22d
Cleared Aug 03, 1982
VOLU-SOL GILLS EA
K822035 · HZJ
Volu Sol Medical Industries
Pathology · 22d
Cleared Aug 03, 1982
VOLU-SOL DECALCIFER
K822036 · KDX
Volu Sol Medical Industries
Pathology · 22d
Cleared Aug 03, 1982
VOLU-SOL TAP WATER SUBSTITUTE
K822037 · PPM
Volu Sol Medical Industries
Pathology · 22d
Cleared Aug 03, 1982
VOLU-SOL ORANGE G-6(GILLS-MOD
K822038 · HZH
Volu Sol Medical Industries
Pathology · 22d
Cleared Aug 03, 1982
ACCESSORY MEDIA FOR FLOW TITERTEK MIC
K822119 · JTZ
Flow Laboratories, Inc.
Microbiology · 15d
Cleared Aug 03, 1982
DERMATOPHYTE TEST MEDIUM
K822131 · JSD
Granite Diagnostics, Inc.
Microbiology · 15d
Cleared Aug 03, 1982
IGE/THE OPHYLLINE CONTROL SERUM I,II,III
K822133 · JJY
Kallestad Laboratories, Inc.
Chemistry · 14d
Cleared Aug 03, 1982
SHIELY DUEL LUMEN SUBCLAVIAN CANNULA
K822134 · LFJ
Shiley, Inc.
Gastroenterology & Urology · 14d
Cleared Aug 03, 1982
PHADEBAS RAST TEST
K822141 · DHB
Pharmacia, Inc.
Immunology · 14d
Cleared Aug 02, 1982
NEUMOVENT 980
K821792 · CBK
Ultramar Marketing Corp.
Anesthesiology · 46d
Cleared Jul 30, 1982
HASSON BUEC-3
K820672 · HDP
Bivona Medical Technologies
Obstetrics & Gynecology · 141d
Cleared Jul 30, 1982
IVEX-HP PEDIATRIC EXTENSION SET-SL
K821013 · FPB
Abbott Laboratories
General Hospital · 109d
Cleared Jul 30, 1982
ENI ANTIBODY TO MEASLES(RUBEOLA) VIRUS
K821249 · GRE
Electro-Nucleonics Laboratories, Inc.
Microbiology · 91d
Cleared Jul 30, 1982
EKG (ECG) ELECTRODES
K821434 · DRX
Dupaco, Inc.
Cardiovascular · 79d
Cleared Jul 30, 1982
ARGYLE FERGUSON LEFT ATRIAL VENT CATH
K821445 · DWF
Sherwood Medical Co.
Cardiovascular · 77d
Cleared Jul 30, 1982
MEASELISA TEST KIT
K821762 · LJB
M.A. Bioproducts
Immunology · 45d
Cleared Jul 30, 1982
CENTURION ELECTRODE BELT
K821802 · DRX
Clinical Data, Inc.
Cardiovascular · 45d
Cleared Jul 30, 1982
UROGARD
K821829 · KNX
Buckman Consultants
Gastroenterology & Urology · 38d
Cleared Jul 30, 1982
PREGNANCY (W) EDGE
K821836 · QSB
Body Therapeutics, Inc.
Obstetrics & Gynecology · 38d
Cleared Jul 30, 1982
LDS MONITORING ELECTRODE
K821846 · DRX
Life Design Systems, Inc.
Cardiovascular · 38d
Cleared Jul 30, 1982
AUTOMATIC SINGLE CHANNEL ECG #399
K821888 · DPS
Birtcher Corp.
Cardiovascular · 35d