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"
841–864 of 1,107
Search insights Median review: 85d Cleared: 100% Top manufacturer: Smith & Nephew, Inc. Lead specialty: Orthopedic
Cleared Nov 28, 1994
ZIRCONIA CERAMIC FEMORAL HEAD
K935921 · LZO
Smith & Nephew Richards, Inc.
Orthopedic · 376d
Cleared Nov 18, 1994
OTOVIEW TELESCOPIC OTOSCOPES
K943721 · ERA
Smith & Nephew, Inc.
Ear, Nose, Throat · 109d
Cleared Nov 07, 1994
STERILE PLASTIC DRESSING
K944588 · KGX
Smith & Nephew, Inc.
General & Plastic Surgery · 49d
Cleared Nov 03, 1994
ORAFIX SPECIAL DENTURE ADHESIVE
K943486 · KOO
Smithkline Beecham Corp.
Dental · 107d
Cleared Oct 19, 1994
AIMS CANNULATED ACL SCREW
K943539 · HWC
Smith & Nephew, Inc.
Orthopedic · 89d
Cleared Sep 28, 1994
CURVED ROTATABLE DISPOSABLE ARTHROSCOPIC SURGERY BLADES
K941036 · HRX
Smith & Nephew, Inc.
Orthopedic · 205d
Cleared Sep 09, 1994
CONCORD/PORTEX EPIDURAL CATHETERS
K935927 · BSO
Smiths Industries Medical Systems, Inc.
Anesthesiology · 270d
Cleared Sep 06, 1994
PNEUMATIC WIRE TENSIONER
K942760 · HSZ
Smith & Nephew Richards, Inc.
Orthopedic · 85d
Cleared Sep 01, 1994
CLINICAL BLOOD GAS MIXTURE
K942866 · BXK
Nordan Smith Welding Supplies
Anesthesiology · 76d
Cleared Aug 25, 1994
SHARPSAFE CAT NO. 4105, 4115 AND 4120
K942937 · FMI
Smiths Industries Medical Systems, Inc.
General Hospital · 64d
Cleared Aug 23, 1994
LASER GAS MIXTURE
K942865 · GEX
Nordan Smith Welding Supplies
General & Plastic Surgery · 67d
Cleared Aug 19, 1994
CAVI-CARE CONFORMING FOAM DRESSING
K943619 · KMF
Smith & Nephew United, Inc.
General & Plastic Surgery · 23d
Cleared Aug 19, 1994
SMITH & NEPHEW DYONICS INC. ELECTRONIC ENDOSCOPE
K936071 · HET
Smith & Nephew Dyonics, Inc.
Obstetrics & Gynecology · 242d
Cleared Aug 19, 1994
THE RICHARDS WRIST
K931131 · JWJ
Smith & Nephew Richards, Inc.
Orthopedic · 532d
Cleared Aug 01, 1994
PELVIC RADIUS PLATE
K936233 · HRS
Smith & Nephew Richards, Inc.
Orthopedic · 215d
Cleared Jul 20, 1994
STIMULATING SURGICAL INSTRUMENTS
K934733 · ETN
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 292d
Cleared Jul 18, 1994
RICHARD ROD LENS LARYNGOSCOPE
K941264 · EOQ
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 124d
Cleared Jul 12, 1994
PAUL SMITH SPECTACLES LTD. BY OLIVER PEOPLES, INC.
K942348 · HQZ
Oliver Peoples, Inc.
Ophthalmic · 56d
Cleared Jun 29, 1994
INTRASITE
K942748 · NAE
Smith & Nephew United, Inc.
General & Plastic Surgery · 19d
Cleared Jun 29, 1994
SMITH AND NEPHEW SPINE DEFLECTING FORCEPS
K940222 · HRX
Smith & Nephew, Inc.
Orthopedic · 162d
Cleared Jun 15, 1994
VARIABLE ANGULAR HOLD BONE PLATE SYSTEM
K930480 · HRS
Smith & Nephew Richards, Inc.
Orthopedic · 502d
Cleared Jun 08, 1994
BLACK OVAL-TOP TORP/PORP
K934107 · ETA
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 289d
Cleared May 19, 1994
MUSCLEMAX ELECTRICAL MUSCLE STIMULATOR
K941049 · IPF
Smith & Nephew, Inc.
Physical Medicine · 73d
Cleared May 18, 1994
FLEXSURE HP
K934863 · LYR
Smithkline Diagnostics, Inc.
Microbiology · 218d