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"
817–840 of 1,136
Search insights Median review: 86d Cleared: 100% Top manufacturer: Smith & Nephew, Inc. Lead specialty: Orthopedic
Cleared Feb 05, 1996
GENESIS POROUS TIBIAL TRAYS & REVISION KNEE SYSTEM
K953274 · JWH
Smith & Nephew Richards, Inc.
Orthopedic · 206d
Cleared Jan 31, 1996
PROFIX POSTERIOR-STABILIZED KNEE SYSTEM
K954909 · JWH
Smith & Nephew Richards, Inc.
Orthopedic · 98d
Cleared Jan 05, 1996
EXPRESSAIRE TORUNIQUET SYSTEM
K955552 · KCY
Smith & Nephew Richards, Inc.
General & Plastic Surgery · 31d
Cleared Dec 18, 1995
ECTRA II LIGAMENT RELEASE SYSTEM
K954627 · HRX
Smith & Nephew Dyonics, Inc.
Orthopedic · 73d
Cleared Nov 27, 1995
DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADES
K954989 · ERL
Smith & Nephew Dyonics, Inc.
Ear, Nose, Throat · 27d
Cleared Nov 15, 1995
HYDROCELL NASAL AND SINUS PACKS
K954491 · EMX
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 49d
Cleared Oct 31, 1995
INTRAMEDULLARY HIP SCREW (MODIFICATION)
K954712 · KTT
Smith & Nephew Richards, Inc.
Orthopedic · 76d
Cleared Oct 31, 1995
HEX-FIX FIELD FIXATOR
K953397 · LXT
Smith & Nephew Richards, Inc.
Orthopedic · 103d
Cleared Oct 26, 1995
SIMS CPAP SYSTEM
K953485 · BYE
Smiths Industries Medical Systems, Inc.
Anesthesiology · 94d
Cleared Oct 24, 1995
SIMS BLUE LINE ENDOBRONCHIAL TUBE
K953483 · CBI
Smiths Industries Medical Systems, Inc.
Anesthesiology · 91d
Cleared Sep 15, 1995
DYONICS DISPOSABLE ARTHROSCOPIC BLADES
K953695 · HRX
Smith & Nephew Dyonics, Inc.
Orthopedic · 38d
Cleared Sep 12, 1995
TITANIUM CLASSIC COMPRESSION HIP SCREW SYSTEM
K952697 · HWC
Smith & Nephew Richards, Inc.
Orthopedic · 91d
Cleared Sep 08, 1995
GENESIS CONSTRAINED SYSTEM (GCS)
K952271 · JWH
Smith & Nephew Richards, Inc.
Orthopedic · 116d
Cleared Sep 01, 1995
ROGOZINSKI SPINAL ROD SYSTEM ROD-TO-BOLT (UNIVERSAL) CONNECTOR FOR USE WITH...
K950865 · MNH
Smith & Nephew Richards, Inc.
Orthopedic · 186d
Cleared Sep 01, 1995
WALLACE Y-CAN
K932947 · FOZ
Smiths Industries Medical Systems, Inc.
General Hospital · 806d
Cleared Sep 01, 1995
WALLACE IV CANNULA
K932946 · FOZ
Smiths Industries Medical Systems, Inc.
General Hospital · 806d
Cleared Aug 22, 1995
GENESIS II TOTAL KNEE SYSTEM
K951987 · JWH
Smith & Nephew Richards, Inc.
Orthopedic · 117d
Cleared Aug 15, 1995
AMD SYSTEM WORKING CHANNEL SCOPE AND ACCESSORIES
K950093 · HRX
Smith & Nephew Richards, Inc.
Orthopedic · 217d
Cleared Aug 09, 1995
ECTRA LIGAMENT RELEASE SYSTEM
K953387 · HRX
Smith & Nephew Dyonics, Inc.
Orthopedic · 21d
Cleared Aug 08, 1995
GENESIS POSTERIOR STABILIZED (P/S) KNEE SYSTEM
K946088 · JWH
Smith & Nephew Richards, Inc.
Orthopedic · 238d
Cleared Jul 28, 1995
ESSENTIAL SHAVER SYSTEM
K953096 · EQJ
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 25d
Cleared Jul 24, 1995
REUNION BONE SCREW SYSTEM
K951389 · HWC
Smith & Nephew Richards, Inc.
Orthopedic · 119d
Cleared Jul 14, 1995
PRO-VENT, LINE DRAW, PULSATOR
K952516 · JKA
Smiths Industries Medical Systems, Inc.
Chemistry · 44d
Cleared Jul 06, 1995
PROFIX CONFORMING PLUS TIBIAL INSERT
K946236 · KWH
Smith & Nephew Richards, Inc.
Orthopedic · 196d