FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

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

1,107 results for "smith"
1009–1032 of 1,107
Search insights Median review: 85d Cleared: 100% Top manufacturer: Smith & Nephew, Inc. Lead specialty: Orthopedic
Cleared Mar 05, 1986
SKD ELECTROCHEMICAL SYSTEM (ECS)
K854723 · CEM
Smithkline Diagnostics, Inc.
Chemistry · 103d
Cleared Jul 24, 1985
RAPID DIRECT STREP A LATEX AGGLUTINATION TEST
K852841 · GTZ
Smithkline Diagnostics, Inc.
Microbiology · 19d
Cleared Jul 23, 1985
OPSITE WOUND DRESSING
K852211 · NAD
Smith & Nephew, Inc.
General & Plastic Surgery · 63d
Cleared May 07, 1985
HYPAFIX POST OPERATIVE DRESSING
K850282 · NAD
Smith & Nephew, Inc.
General & Plastic Surgery · 104d
Cleared Apr 25, 1985
PRATT-SMITH T FORCEPS 1830-40 PCS. SS 420 OR 420F
K851106 · GEN
The Huxley Instrument Corp.
General & Plastic Surgery · 37d
Cleared Mar 13, 1985
MOBILCHAIR 360 ELECTRIC-POWERED CHAIR
K844847 · ITI
Davis-Smith Corp.
Physical Medicine · 90d
Cleared Sep 27, 1984
MPL HYPO BRAND BREECH LOAD ASPIR SYRINGE
K843314 · EJI
Smith & Nephew, Mpl Division
Dental · 34d
Cleared Sep 05, 1984
AUTOLYZER 800
K841852 · GKZ
Geometric Data, Div. Smithkline Corp.
Hematology · 125d
Cleared May 21, 1984
SOLOPAK BRAND FILTER NEEDLE W/5 MICRO
K841280 · FPB
Smith & Nephew, Mpl Division
General Hospital · 54d
Cleared Apr 17, 1984
SELECTIVE AND DIFFERENTIAL
K841209 · JSI
Smith River Biologicals
Microbiology · 36d
Cleared Apr 17, 1984
NON-SELECTIVE & NON-DIFFERENTIAL
K841207 · JSI
Smith River Biologicals
Microbiology · 36d
Cleared Apr 17, 1984
NON-SELECTIVE & DIFFERENTIAL
K841206 · JSH
Smith River Biologicals
Microbiology · 36d
Cleared Apr 17, 1984
MULTIPLE BIOCHEMICAL TEST
K841204 · JSE
Smith River Biologicals
Microbiology · 36d
Cleared Apr 05, 1984
SELECTIVE BROTH
K841211 · JSD
Smith River Biologicals
Microbiology · 24d
Cleared Apr 05, 1984
PROPAGATING TRANSPORT
K841208 · JSN
Smith River Biologicals
Microbiology · 24d
Cleared Apr 05, 1984
MAX-I-PROBE PERIODONTAL ENDODONTIC PROB
K840237 · EIC
Smith & Nephew, Mpl Division
Dental · 76d
Cleared Apr 04, 1984
ANTIMICROBIAL SUSCEPT-CULTURE MEDIA
K841213 · JTZ
Smith River Biologicals
Microbiology · 23d
Cleared Apr 04, 1984
SINGLE BIOCHEMICAL TEST
K841212 · JSF
Smith River Biologicals
Microbiology · 23d
Cleared Apr 04, 1984
SELECTIVE & NON-DIFFERENTIAL
K841210 · JSJ
Smith River Biologicals
Microbiology · 23d
Cleared Apr 04, 1984
NON PROPAGATING TRANSPORT
K841205 · JSM
Smith River Biologicals
Microbiology · 23d
Cleared Apr 04, 1984
GENERAL NUTRIENT BROTH
K841203 · JSG
Smith River Biologicals
Microbiology · 23d
Cleared Mar 30, 1984
HYPO BRAND DISPOS. DENTAL NEEDLES-PLAST
K833304 · DZM
Smith & Nephew, Mpl Division
Dental · 189d
Cleared Mar 19, 1984
MELOLITE
K833954 · KGX
Smith & Nephew, Inc.
General & Plastic Surgery · 124d
Cleared Mar 12, 1984
HYPAFIX DRESSING RETENTION SHEET
K833916 · KGX
Smith & Nephew, Inc.
General & Plastic Surgery · 119d