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"
361–384 of 1,136
Search insights Median review: 86d Cleared: 100% Top manufacturer: Smith & Nephew, Inc. Lead specialty: Orthopedic
Cleared Jan 05, 2011
ENDOBUTTON DIRECT
K102982 · MAI
Smith & Nephew Inc., Endoscopy Division
Orthopedic · 90d
Cleared Jan 05, 2011
SMITH & NEPHEW HIP ARTHROSCOPY REPAIR INSTRUMENT TRAY
K102544 · KCT
Smith & Nephew Inc., Endoscopy Div.
General Hospital · 124d
Cleared Dec 13, 2010
BIORAPTOR CURVED 2.3 PK SUTURE ANCHORS
K102660 · MBI
Smith & Nephew Endoscopy, Inc.
Orthopedic · 89d
Cleared Nov 22, 2010
SMITH & NEPHEW MILTI-PURPOSE STERILIZATION TRAY MODEL 72202428
K102122 · KCT
Smith & Nephew, Inc.
General Hospital · 116d
Cleared Nov 04, 2010
SMITH & NEPHEW, INC. SURESHOT DISTAL TARGETING SYSTEM V2.0.2
K102967 · OLO
Smith & Newphew, Inc.
Orthopedic · 30d
Cleared Oct 20, 2010
THERA- HEAT HEATED HUMIDIFIER, MODEL RC70000, RC70072, RC70075, RC70077, RC70012
K092256 · BTT
Smiths Medical Asd, Inc.
Anesthesiology · 449d
Cleared Oct 05, 2010
JOURNEY UNICONDYLAR TIBIAL BASEPLATES
K102069 · HSX
Smith & Nephew, Inc.
Orthopedic · 74d
Cleared Sep 30, 2010
SPINESMITH CYNCH SPINAL SYSTEM - VISUALIF INTERBODY FUSION IMPLANT SYSTEM
K102090 · OVD
Spine Smith Partners L.P.
Orthopedic · 66d
Cleared Sep 28, 2010
BIOTENE DRY MOUTH MOUTHWASH, BIOTENE PBF DRY MOUTH MOUTHWASH
K101477 · LFD
Glaxosmithkline Consumer Healthcare...
Dental · 123d
Cleared Sep 27, 2010
SMITH & NEPHEW CIRCULAR FIXATION SYSTEM
K093047 · KTT
Smith & Nephew, Inc.
Orthopedic · 362d
Cleared Sep 17, 2010
RENASYS F/-AB ABDOMINAL WOUND DRESSING KIT
K100787 · FTL
Smith & Nephew, Inc.
General & Plastic Surgery · 182d
Cleared Sep 14, 2010
SMITH & NEPHEW INSTRUMENT TRAYS
K092551 · KCT
Smith & Nephew Inc., Endoscopy Div.
General Hospital · 390d
Cleared Sep 02, 2010
JET-X BAR SYSTEM CLAMPS AND POSTS REPROCESSING
K100795 · KTT
Smith & Nephew, Inc.
Orthopedic · 164d
Cleared Aug 26, 2010
JOURNEY CR KNEE SYSTEM
K101499 · JWH
Smith & Nephew, Inc.
Orthopedic · 86d
Cleared Aug 06, 2010
MODIFICATION TO RENASYS EZ PLUS NEGATIVE PRESSURE WOUND THERAPY
K102001 · OMP
Smith & Nephew, Inc.
General & Plastic Surgery · 22d
Cleared Aug 03, 2010
GRIPPER MICRO BLUNT CANNULA, NON-CORING SAFETY NEEDLE (GRIPPER MICRO NEEDLE)...
K101180 · FPA
Smiths Medical MD, Inc.
General Hospital · 98d
Cleared Jul 15, 2010
SMITH & NEPHEW MDF MODULAR SLEEVE
K100481 · MEH
Smith & Nephew, Inc.
Orthopedic · 147d
Cleared Jul 02, 2010
ACTIPROTECT UC N95 RESPIRATOR
K093189 · ORW
Glaxosmithkline Consumer Healthcare
General Hospital · 266d
Cleared Jul 01, 2010
SPINESMITH CYNCH SPINAL SYSTEM
K101085 · MAX
Spine Smith Partners L.P.
Orthopedic · 73d
Cleared May 13, 2010
LEGION POROUS + HA TIBIAL BASEPLATES
K100897 · MBH
Smith & Nephew, Inc.
Orthopedic · 43d
Cleared May 10, 2010
ACTIPROTECT UF N95 RESPIRATOR
K093161 · ONT
Glaxosmithkline Consumer Healthcare
General Hospital · 216d
Cleared May 05, 2010
BIOLOX DELTA CERAMIC FEMORAL HEADS
K100412 · LZO
Smith & Nephew, Inc.
Orthopedic · 78d
Cleared May 04, 2010
PERI-LOC LOCKING HOLE INSERTS AND CABLE ACCESSORIES
K100325 · HWC
Smith & Nephew, Inc.
Orthopedic · 89d
Cleared Apr 26, 2010
SURESHOT TAN NAILS AND ACCESSORIES
K092748 · HSB
Smith & Nephew, Inc.
Orthopedic · 230d