FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

1,107 results for "smith"
913–936 of 1,107
Search insights Median review: 85d Cleared: 100% Top manufacturer: Smith & Nephew, Inc. Lead specialty: Orthopedic
Cleared Sep 14, 1992
BRINDLEY & SMITH ET-1000
K915100 · LIH
Zmi Corp.
Neurology · 307d
Cleared Jul 30, 1992
ZIRCONIUM ALLOY FRMORAL HEAD
K914878 · JDI
Smith & Nephew Richards, Inc.
Orthopedic · 274d
Cleared Jul 23, 1992
TURBINATE NASAL SPLINT
K921202 · LYA
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 133d
Cleared Jul 23, 1992
NASAL SEPTAL SPLINT
K921195 · LYA
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 133d
Cleared Jul 21, 1992
MODULAR ACETABULAR CUP SYSTEM
K920430 · JDI
Smith & Nephew Richards, Inc.
Orthopedic · 169d
Cleared Jul 17, 1992
INTRAMEDULLARY HIP SCREW
K921786 · KTT
Smith & Nephew Richards, Inc.
Orthopedic · 94d
Cleared Jul 08, 1992
EPISTAXIS NASAL BALLOON CATHETER
K921199 · EMX
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 118d
Cleared Jun 04, 1992
SMITH & NEPHEW DYONICS TMJ ARTHROSCOPY INFLOW SET
K914963 · HRX
Smith & Nephew Dyonics, Inc.
Orthopedic · 212d
Cleared Apr 22, 1992
PERRY(R) NATURAL POWDER-FREE GLOVES, STYLE 45
K914445 · KGO
Smith & Nephew Perry
General Hospital · 201d
Cleared Mar 06, 1992
SUCTION CONTROL FOOTSWITCH WITH SPEED CONTROL
K913401 · HRX
Smith & Nephew Dyonics, Inc.
Orthopedic · 220d
Cleared Feb 18, 1992
SMALL JOINT SYSTEM
K914559 · HRX
Smith & Nephew Dyonics, Inc.
Orthopedic · 126d
Cleared Feb 03, 1992
ALLEVLYN WOUND DRESSING, MODIFICATION
K914147 · KMF
Smith & Nephew United, Inc.
General & Plastic Surgery · 140d
Cleared Jan 31, 1992
PERRY(R) CUT-RESISTANT GLOVES
K914942 · LYY
Smith & Nephew Perry
General Hospital · 88d
Cleared Jan 21, 1992
RIHARDS TITANIUM HALF PIN
K920024 · KTT
Smith & Nephew Richards, Inc.
Orthopedic · 19d
Cleared Jan 13, 1992
TI-FIT FEMORAL COMPONENT
K914343 · LWJ
Smith & Nephew Richards, Inc.
Orthopedic · 108d
Cleared Jan 09, 1992
REMOVE ADHESIVE REMOVER
K915150 · KOX
Smith & Nephew United, Inc.
General & Plastic Surgery · 56d
Cleared Jan 09, 1992
SMITH & NEPHEW DYONICS LAPAROSCOPY SYSTEM
K914919 · GCJ
Smith & Nephew Dyonics, Inc.
General & Plastic Surgery · 66d
Cleared Dec 27, 1991
GENESIS UNICOMPARTMENTAL KNEE SYSTEM
K912735 · HSX
Smith & Nephew Richards, Inc.
Orthopedic · 190d
Cleared Dec 09, 1991
HYDROXYLAPATITE COATED TI-FIT FEMORAL COMPONENT
K913916 · MEH
Smith & Nephew Richards, Inc.
Orthopedic · 97d
Cleared Dec 04, 1991
WEHRS INCUS AND INCUS-STAPES PROSTHESES
K910685 · ETB
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 288d
Cleared Nov 22, 1991
SMITH AND DAVIS PRESSURE THERAPY SYSTEM
K913654 · INX
Smith & Davis Mfg. Co.
Physical Medicine · 98d
Cleared Oct 04, 1991
SIMMONS PLATING SYSTEM
K910681 · KWQ
Smith & Nephew Richards, Inc.
Orthopedic · 231d
Cleared Oct 02, 1991
PERRY(R) DERMAGUARD(R) PLUS GLOVES
K913402 · KGO
Smith & Nephew Perry
General Hospital · 64d
Cleared Oct 02, 1991
MODULAR HIP SYSTEM
K912593 · JDI
Smith & Nephew Richards, Inc.
Orthopedic · 114d