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"
865–888 of 1,136
Search insights Median review: 86d Cleared: 100% Top manufacturer: Smith & Nephew, Inc. Lead specialty: Orthopedic
Cleared Jan 24, 1995
DYONICS FIXATION SCREWS
K945182 · HWC
Smith & Nephew Dyonics, Inc.
Orthopedic · 92d
Cleared Jan 09, 1995
RICHARDS TOTAL KNEE SYSTEM
K933958 · JWH
Smith & Nephew Richards, Inc.
Orthopedic · 514d
Cleared Dec 22, 1994
PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES
K945777 · JKA
Smiths Industries Medical Systems, Inc.
Chemistry · 27d
Cleared Dec 19, 1994
ANTERIOR CERVIAL PLATING SYSTEM
K943523 · KWQ
Smith & Nephew Richards, Inc.
Orthopedic · 151d
Cleared Dec 15, 1994
AQUAFRESH PLAQUE FIGHTING GUM
K944575 · EJR
Smithkline Beecham Consumer...
Dental · 87d
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