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"
697–720 of 1,136
Search insights Median review: 86d Cleared: 100% Top manufacturer: Smith & Nephew, Inc. Lead specialty: Orthopedic
Cleared Aug 29, 2000
SMITH & NEPHEW OFF-CENTERED PORP
K002464 · ETB
Gyrus Ent LLC
Ear, Nose, Throat · 19d
Cleared Aug 23, 2000
OFFICE BASED ANESTHESIA MACHINE, MODEL OBA-1
K000859 · BSZ
Charles A. Smith
Anesthesiology · 159d
Cleared Jul 26, 2000
VOCOM SILICONE SYSTEM
K001466 · MIX
Smith & Nephew, Inc.
Ear, Nose, Throat · 77d
Cleared Jun 26, 2000
SMITH + NEPHEW RF ARTHROSCOPIC WAND SYSTEM
K001226 · HRX
Smith & Nephew, Inc.
Orthopedic · 70d
Cleared Jun 14, 2000
MICROPERFORATION INSTRUMENT
K001507 · LXH
Smith & Nephew, Inc.
Orthopedic · 30d
Cleared May 23, 2000
NEER III TOTAL SHOULDER SYSTEM
K994350 · KWS
Smith & Nephew, Inc.
Orthopedic · 152d
Cleared Mar 30, 2000
SMITH & NEPHEW SUTURELOK, MODEL 7207321
K000717 · OCW
Smith & Nephew, Inc.
Gastroenterology & Urology · 27d
Cleared Mar 13, 2000
DYONICS ELECTROBLADE
K994365 · GEI
Smith & Nephew, Inc.
General & Plastic Surgery · 77d
Cleared Mar 01, 2000
VOCOM IMPLANT- 8MM
K000533 · MIX
Smith & Nephew, Inc.
Ear, Nose, Throat · 13d
Cleared Feb 25, 2000
ACUFEX SPIKED WASHER SYSTEM, ACUFEX SUTURE WASHER SYSTEM, ACUFEX CANCELLOUS...
K994202 · HWC
Smith & Nephew, Inc.
Orthopedic · 74d
Cleared Feb 25, 2000
RADIAL HEAD PROSTHESIS
K992220 · KWI
Smith & Nephew, Inc.
Orthopedic · 239d
Cleared Feb 18, 2000
SMITH & NEPHEW EXTERNAL FIXATION SYSTEM [UNILATERAL (LINEAR) & MULTILATERAL...
K994143 · JDW
Smith & Nephew, Inc.
Orthopedic · 72d
Cleared Jan 28, 2000
BIOLOX ALUMINA CERAMIC FEMORAL HEAD
K991162 · LZO
Smith & Nephew, Inc.
Orthopedic · 296d
Cleared Jan 20, 2000
SMITH & NEPHEW XENON LIGHT SOURCES AND ACCESSORIES
K994084 · FFS
Smith & Nephew, Inc.
Gastroenterology & Urology · 48d
Cleared Jan 12, 2000
BIORCI SCREW
K992396 · HWC
Smith & Nephew Endoscopy, Inc.
Orthopedic · 177d
Cleared Dec 20, 1999
SMITH & NEPHEW COMPRESSION HIP SCREW SYSTEM, INTRAMEDULLARY HIP SCREW SYSTEM
K993289 · KTT
Smith & Nephew, Inc.
Orthopedic · 80d
Cleared Dec 09, 1999
SMITH & NEPHEW BONE PLATE SYSTEM (BONE PLATES, BONE SCREWS AND ACCESSORIES)
K993106 · HRS
Smith & Nephew, Inc.
Orthopedic · 83d
Cleared Nov 18, 1999
RCI FIXATION SCREWS (WITH ASSORTED SIZES)
K992945 · HWC
Smith & Nephew, Inc.
Orthopedic · 78d
Cleared Oct 22, 1999
REFLECTION CROSSLINKED UHMWPE ACETABULAR COMPONENTS
K991026 · LPH
Smith & Nephew, Inc.
Orthopedic · 207d
Cleared Oct 05, 1999
DYONICS VARICOSE VEIN ABLATION BLADE
K990723 · GEI
Smith & Nephew, Inc.
General & Plastic Surgery · 214d
Cleared Aug 06, 1999
HYDROXYAPATITE (HA) REFLECTION ACETABULAR SHELL, HYDROXYAPATITE (HA)...
K990666 · MEH
Smith & Nephew, Inc.
Orthopedic · 157d
Cleared Jul 30, 1999
CICACARE ROLL-ON GEL-SCAR MANAGEMENT LIQUID GEL.
K991968 · MDA
Smith & Nephew, Inc.
General & Plastic Surgery · 49d
Cleared Jul 20, 1999
CICACARE MANAGEMENT FOR SCARS
K991957 · MDA
Smith & Nephew, Inc.
General & Plastic Surgery · 40d
Cleared Jul 14, 1999
SMITH & NEPHEW SUTURE LOK
K991500 · OCW
Smith & Nephew Endoscopy, Inc.
Gastroenterology & Urology · 76d