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"
793–816 of 1,107
Search insights Median review: 85d Cleared: 100% Top manufacturer: Smith & Nephew, Inc. Lead specialty: Orthopedic
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
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