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"
601–624 of 1,136
Search insights Median review: 86d Cleared: 100% Top manufacturer: Smith & Nephew, Inc. Lead specialty: Orthopedic
Cleared Jun 14, 2004
CONTOUR HA COATED RECONSTRUCTION RING
K040680 · MEH
Smith & Nephew, Inc.
Orthopedic · 90d
Cleared Jun 10, 2004
JAX-TCP
K033552 · MQV
Smith & Nephew, Inc.
Orthopedic · 211d
Cleared Jun 07, 2004
SMITH & NEPHEW ULTRABRAID SUTURE
K041216 · GAT
Smith & Nephew, Inc.
General & Plastic Surgery · 28d
Cleared Jun 04, 2004
DURABRAID SUTURE
K040789 · GAT
Smith & Nephew, Inc.
General & Plastic Surgery · 67d
Cleared May 27, 2004
SMITHS MEDICAL INSULIN INFUSION PUMP WITH COZMONITOR GLUCOSE METER
K031738 · LZG
Smiths Medical MD, Inc.
General Hospital · 358d
Cleared May 25, 2004
TRIGEN ADOLESCENT TAN
K040929 · HSB
Smith & Nephew, Inc.
Orthopedic · 46d
Cleared May 25, 2004
MODIFICATION TO SMITH & NEPHEW INTRAMEDULLARY HIP SCREW
K040656 · HWC
Smith & Nephew, Inc.
Orthopedic · 74d
Cleared May 19, 2004
CADD ADMINISTRATION SET WITH FLOW STOP, MEDICATION CASSETTE RESERVOIR WITH...
K040636 · FPA
Smiths Medical MD, Inc.
General Hospital · 70d
Cleared Apr 29, 2004
VERSABOND AB BONE CEMENT
K022688 · LOD
Smith & Nephew, Inc.
Orthopedic · 625d
Cleared Apr 27, 2004
SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM, MODEL SW4000
K040632 · DWJ
Smiths Medical Asd, Inc.
Cardiovascular · 48d
Cleared Apr 14, 2004
SMITH AND NEPHEW TITANIUM INTERFERENCE SCREWS
K040331 · HWC
Smith & Nephew, Inc.
Orthopedic · 63d
Cleared Mar 23, 2004
TRIGEN TROCHANTERIC ANTEGRADE NAIL
K040462 · HSB
Smith & Nephew, Inc.
Orthopedic · 29d
Cleared Mar 16, 2004
SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE
K034012 · GXI
Smith & Nephew, Inc.
Neurology · 83d
Cleared Feb 25, 2004
SMITH & NEPHEW ELECTROTHERMAL 20S SPINE GENERATOR, MODEL 7209975
K033981 · GEI
Smith & Nephew, Inc.
General & Plastic Surgery · 64d
Cleared Feb 20, 2004
TRIGEN INTERTAN
K040212 · JDS
Smith & Nephew, Inc.
Orthopedic · 21d
Cleared Jan 23, 2004
PORT-A-CATH II REGIONAL ARTERIAL PORTAL SYSTEM
K033686 · LJT
Smiths Medical MD, Inc.
General Hospital · 60d
Cleared Jan 13, 2004
MODIFICATION TO JET-X HA COATED HALF PINS
K033289 · JDW
Smith & Nephew, Inc.
Orthopedic · 91d
Cleared Dec 10, 2003
SMITH & NEPHEW LOCKING BONE PLATE SYSTEM (LOCKING BONE PLATES AND SCREWS)
K033669 · HRS
Smith & Nephew, Inc.
Orthopedic · 19d
Cleared Dec 02, 2003
SMITH & NEPHEW IUR MORCELLATION SYSTEM
K031787 · HIH
Smith & Nephew, Inc.
Obstetrics & Gynecology · 175d
Cleared Nov 28, 2003
MODIFICATION TO VERSABOND BONE CEMENT
K033509 · LOD
Smith & Nephew, Inc.
Orthopedic · 22d
Cleared Nov 26, 2003
REFLECTION CONSTRAINED LINER
K033442 · KWZ
Smith & Nephew, Inc.
Orthopedic · 28d
Cleared Oct 29, 2003
TRIVEX SYSTEM
K032387 · DWQ
Smith & Nephew, Inc.
Cardiovascular · 86d
Cleared Oct 15, 2003
GENESIS II POROUS PLUS HA KNEE SYSTEM
K032683 · MBH
Smith & Nephew, Inc.
Orthopedic · 47d
Cleared Oct 01, 2003
TRIGEN STRAIGHT HUMERAL NAIL SYSTEM
K032722 · HSB
Smith & Nephew, Inc.
Orthopedic · 28d