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"
913–936 of 1,136
Search insights Median review: 86d Cleared: 100% Top manufacturer: Smith & Nephew, Inc. Lead specialty: Orthopedic
Cleared Feb 03, 1994
CICA-CARE SILICONE GEL SHEET
K935803 · MDA
Smith & Nephew United, Inc.
General & Plastic Surgery · 63d
Cleared Jan 28, 1994
BERMAN AIRWAY
K936134 · CAE
Smiths Industries Medical Systems, Inc.
Anesthesiology · 36d
Cleared Jan 27, 1994
PNEUMATIC WIRE TENSIONER
K934431 · HSZ
Smith & Nephew Richards, Inc.
Orthopedic · 136d
Cleared Jan 14, 1994
DIC TRACHEOSTOMY TUBE AND PORTEX BLUE LINE
K934465 · BTR
Smiths Industries Medical Systems, Inc.
Anesthesiology · 123d
Cleared Dec 22, 1993
ENCORE POWDER-FREE SURGICAL GLOVES MICROPTIC
K932665 · KGO
Smith & Nephew Perry
General Hospital · 203d
Cleared Dec 22, 1993
ENCORE POWDER-FREE SURGICAL GLOVES ORTHOPAEDIA
K932664 · KGO
Smith & Nephew Perry
General Hospital · 203d
Cleared Nov 30, 1993
ORTHOPAEDIC POLYETHYLENE CABLE
K924141 · JDQ
Smith & Nephew Richards, Inc.
Orthopedic · 469d
Cleared Nov 18, 1993
PERRY ENHANCED PROTECTION LATEX SURGICAL GLOVE
K931399 · LYY
Smith & Nephew Perry
General Hospital · 244d
Cleared Oct 06, 1993
NEUTRALIZER
K932320 · GZJ
Smith and Nephew Donjoy, Inc.
Neurology · 148d
Cleared Oct 01, 1993
PRINCE
K933309 · EJJ
Goldsmith & Revere, Inc.
Dental · 86d
Cleared Oct 01, 1993
SOLOSITE DERMAL WOUND GEL
K932263 · MGQ
Smith & Nephew United, Inc.
General & Plastic Surgery · 164d
Cleared Sep 21, 1993
RMHS POROUS DISTAL SLEEVE
K930108 · JDI
Smith & Nephew Richards, Inc.
Orthopedic · 253d
Cleared Aug 10, 1993
NASAL DORSUM
K925743 · FZE
Smith & Nephew Richards, Inc.
General & Plastic Surgery · 270d
Cleared Jul 26, 1993
ACCESSORIES FOR ENDOSCOPES FOR SINUS SURGERY
K932988 · EOB
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 38d
Cleared Jul 26, 1993
SILICONE TYMPANOSTOMY TUBES
K932166 · ETD
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 83d
Cleared Jul 13, 1993
INTRASITE GEL
K926508 · NAE
Smith & Nephew United, Inc.
General & Plastic Surgery · 195d
Cleared Jun 21, 1993
SMITH RIVER MICROBIOLOGICAL CULTURE MEDIA
K923892 · JSO
Smith River Biologicals
Microbiology · 321d
Cleared May 18, 1993
BLUE LINE(R) PDT(TM) PORTEX DIRECTIONAL TUBE
K931735 · BTR
Smiths Industries Medical Systems, Inc.
Anesthesiology · 41d
Cleared May 05, 1993
NASAL CAVITY WOUND DRESSING
K923957 · KMF
Smith & Nephew Richards, Inc.
General & Plastic Surgery · 272d
Cleared Apr 08, 1993
RMHS MONOLITHIC FEMORAL COMPONENT
K923275 · JDI
Smith & Nephew Richards, Inc.
Orthopedic · 276d
Cleared Apr 02, 1993
HIP JOINT PROTHESIS
K921400 · LPH
Smith & Nephew Richards, Inc.
Orthopedic · 374d
Cleared Mar 23, 1993
DYONICS ARTHROSCOPIC KIT
K920267 · LRO
Smith & Nephew Dyonics, Inc.
General & Plastic Surgery · 427d
Cleared Mar 18, 1993
ATTIC DEFECT PLATE
K921433 · ETC
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 358d
Cleared Mar 08, 1993
INCUDOSTAPEDIAL JOINT
K925443 · ETB
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 131d