FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

1,136 results for "smith"
1081–1104 of 1,136
Search insights Median review: 86d Cleared: 100% Top manufacturer: Smith & Nephew, Inc. Lead specialty: Orthopedic
Cleared Mar 10, 1982
DEEP CONVEX FACE PLATE
K820493 · EXB
Smith'S Ostomy Products, Inc.
Gastroenterology & Urology · 15d
Cleared Nov 16, 1981
SKI 5000
K812646 · DXK
Smithkline Diagnostics, Inc.
Cardiovascular · 60d
Cleared Sep 14, 1981
SPIN-CHEM LD-L REAGENT
K812472 · CFJ
Smithkline Diagnostics, Inc.
Chemistry · 14d
Cleared Sep 14, 1981
SPIN-CHEM TRIGLYCERIDES REAGENT
K812471 · CDT
Smithkline Diagnostics, Inc.
Chemistry · 14d
Cleared Aug 31, 1981
SMITH'S SYSTEMIC FUNGAL MEDIUM
K812187 · JSI
American Scientific Products
Microbiology · 28d
Cleared Aug 18, 1981
HEMASPINNER
K811534 · GKJ
Geometric Data, Div. Smithkline Corp.
Hematology · 78d
Cleared Jul 23, 1981
ESKAFLOW TEST FOR TRIGLYCERIDES
K811850 · CDT
Smithkline Diagnostics, Inc.
Chemistry · 22d
Cleared Jul 20, 1981
CRYSTONA
K811754 · ITG
Smith & Nephew, Inc.
Physical Medicine · 28d
Cleared Jul 15, 1981
ESKAFLOW TEST FOR GLUCOSE
K811849 · CFR
Smithkline Diagnostics, Inc.
Chemistry · 14d
Cleared May 08, 1981
5CM SMALL PARTS SCANNER
K810914 · IYO
Smithkline Diagnostics, Inc.
Radiology · 32d
Cleared Feb 26, 1981
ESKACHEM PAP REAGENT
K803234 · JFH
Smithkline Diagnostics, Inc.
Chemistry · 66d
Cleared Oct 31, 1980
OSTOMATE THIRD HAND
K802424 · EXB
Smith'S Ostomy Products, Inc.
Gastroenterology & Urology · 25d
Cleared Aug 13, 1980
ELASTIC ADHESIVE BANDAGES(STERILE)
K801794 · KGX
Smith & Nephew, Inc.
General & Plastic Surgery · 15d
Cleared Jun 04, 1980
HIGH RESOLUTION 10CM DIAG. ULTRA. SCANNE
K801060 · IYO
Smithkline Diagnostics, Inc.
Radiology · 29d
Cleared May 14, 1980
MODEL SKI-200 ABDOMINAL SCANNER
K800824 · IYO
Smithkline Diagnostics, Inc.
Radiology · 30d
Cleared Apr 10, 1980
S.K. DIAG. ULTRASOUND BODY SCANNER
K800532 · IYO
Smithkline Diagnostics, Inc.
Radiology · 34d
Cleared Apr 10, 1980
S.K. DIAG. ULTRASND. SMALL PARTS SCAN
K800531 · IYO
Smithkline Diagnostics, Inc.
Radiology · 34d
Cleared Mar 19, 1980
SMITH'S SYSTEMIC FUNGAL MEDIUM
K792715 · JSJ
Meridian Diagnostics, Inc.
Microbiology · 83d
Cleared Feb 22, 1980
SMITH SUBTALAR PEG
K792670 · LXH
Dow Corning Wright
Orthopedic · 57d
Cleared Oct 30, 1979
ESKACHEM, CK-MB REAGENT
K792023 · JHS
Smithkline Diagnostics, Inc.
Chemistry · 21d
Cleared Sep 04, 1979
HEMATRAK ABNORMAL RECOGNITION
K791041 · GKZ
Geometric Data, Div. Smithkline Corp.
Hematology · 91d
Cleared Jul 24, 1979
PLUS CHEM S.C.E. REAGENT
K791080 · CIT
Smithkline Diagnostics, Inc.
Chemistry · 42d
Cleared Jul 17, 1979
CONTEXT FILTER
K791108 · GKZ
Geometric Data, Div. Smithkline Corp.
Hematology · 33d
Cleared Jul 17, 1979
PLUS CHEM, DETERMINATION OF LD (LDH-P)
K791085 · CFJ
Smithkline Diagnostics, Inc.
Chemistry · 35d