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"
841–864 of 1,136
Search insights Median review: 86d Cleared: 100% Top manufacturer: Smith & Nephew, Inc. Lead specialty: Orthopedic
Cleared Jul 03, 1995
RICHARDS TORP
K952549 · ETA
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 31d
Cleared Jun 27, 1995
VENTILATION MECHANICS MONITOR MODEL VMM-100
K936156 · MOD
Smith Industries Medical Systems (Sims)
Anesthesiology · 547d
Cleared Jun 23, 1995
MUSCLESENSE ELECTROMYOGRAPHY DEVICE
K951350 · HCC
Smith and Nephew Donjoy, Inc.
Neurology · 91d
Cleared Jun 22, 1995
ROUNDED CANNULATED INSIDE-OUT (RCI) ACL SCREW
K945687 · HWC
Smith and Nephew Donjoy, Inc.
Orthopedic · 213d
Cleared Jun 20, 1995
SIMMONS PLATING SYSTEM BOLT AND SCREW
K930353 · MNH
Smith & Nephew, Inc.
Orthopedic · 880d
Cleared Jun 16, 1995
RICHARDS PORP
K952481 · ETB
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 17d
Cleared Jun 14, 1995
IMPROVED PASSIVATION METHOD FOR METALLIC ORTHOPAEDIC IMPLANTS
K934590 · HWC
Smith & Nephew Richards, Inc.
Orthopedic · 628d
Cleared Jun 14, 1995
ROGOZINSKI SPINAL ROD SYSTEM SCREW
K930298 · MNH
Smith & Nephew Richards, Inc.
Orthopedic · 874d
Cleared Jun 07, 1995
NASAL SEPTAL SPLINT
K952207 · LYA
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 28d
Cleared May 25, 1995
ULTRA SPHERICAL AMALGAM ALLOY
K951865 · EJJ
Goldsmith & Revere, Inc.
Dental · 34d
Cleared May 19, 1995
TIBIA-TALUS-CALCANEUS NAIL
K950394 · HSB
Smith & Nephew Richards, Inc.
Orthopedic · 107d
Cleared May 11, 1995
ROSSITER SINUS STENT
K951803 · KAM
Smith & Nephew Richards, Inc.
General & Plastic Surgery · 22d
Cleared May 01, 1995
HYPO(R) SAFETY CARTRIDGE SYRINGE
K936040 · MEG
Smith & Nephew, Inc.
General Hospital · 497d
Cleared Apr 04, 1995
RAINS FRONTAL SINUS STENT
K951066 · KAM
Smith & Nephew Richards, Inc.
General & Plastic Surgery · 27d
Cleared Mar 23, 1995
ENDOSCOPY SYSTEM FOR FACIAL PLASTIC SURGERY
K935235 · GCM
Smith & Nephew Richards, Inc.
Gastroenterology & Urology · 507d
Cleared Mar 21, 1995
HAPEX MALLEABLE TORP
K950927 · ETA
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 20d
Cleared Mar 17, 1995
TIBIAL ROUTERS, FEMORAL ROUTERS AND TUBE GRAFT SIZER
K946313 · HRX
Smith and Nephew Donjoy, Inc.
Orthopedic · 79d
Cleared Mar 15, 1995
HAPES MALLEABLE INCUS STAPES
K950984 · ETB
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 12d
Cleared Mar 15, 1995
HAPEX INCUS
K950887 · ETB
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 15d
Cleared Mar 15, 1995
HAPEX PORP
K950886 · ETB
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 15d
Cleared Mar 15, 1995
HAPEX MALLEABLE PORP
K950885 · ETB
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 15d
Cleared Mar 03, 1995
LUNG DIFFUSION
K942864 · BZC
Nordan Smith Welding Supplies
Anesthesiology · 259d
Cleared Feb 09, 1995
ALLEVYN ADHESIVE
K945330 · KMF
Smith & Nephew United, Inc.
General & Plastic Surgery · 100d
Cleared Feb 03, 1995
AIMS CANNULATED ACL SCREW (7MM DIAMETER)
K945236 · HWC
Smith and Nephew Donjoy, Inc.
Orthopedic · 99d