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"
961–984 of 1,107
Search insights Median review: 85d Cleared: 100% Top manufacturer: Smith & Nephew, Inc. Lead specialty: Orthopedic
Cleared Jun 20, 1990
CANNULATED INTERFERENCE SCREW SYSTEM
K901616 · HWC
Smith & Nephew Dyonics, Inc.
Orthopedic · 75d
Cleared Jun 14, 1990
JAHN VENTILATION TUBE
K900267 · ETD
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 147d
Cleared Jun 12, 1990
TENSOPLUS LITE
K901378 · NAD
Smith & Nephew United, Inc.
General & Plastic Surgery · 82d
Cleared May 29, 1990
ENDOSCOPIC CARPAL TUNNEL RELEASE SYSTEM (ECTR)
K901617 · HRX
Smith & Nephew, Inc.
Orthopedic · 53d
Cleared May 02, 1990
RESPONSE EXTERNAL PENILE RIGIDITY DEVICE
K900559 · LKY
Smith-Collins Pharmaceutical, Inc.
Gastroenterology & Urology · 84d
Cleared Apr 18, 1990
ARTHROSCOPIC ELECTROSURGICAL PROBE
K901505 · HRX
Smith & Nephew Dyonics, Inc.
Orthopedic · 19d
Cleared Jan 09, 1990
VOYAGER PX
K895082 · BYJ
Smith-Perry Corp.
Anesthesiology · 148d
Cleared Dec 22, 1989
THE SMITHCOT
K896261 · FPP
Ram Marketing, Inc.
General Hospital · 53d
Cleared Dec 14, 1989
OPSITE*WOUND (FLEXIGRID APPLICATION SYSTEM)
K895408 · KGX
Smith & Nephew United, Inc.
General & Plastic Surgery · 99d
Cleared Nov 21, 1989
TENS PREP
K893604 · GYB
Smith & Nephew United, Inc.
Neurology · 189d
Cleared Nov 07, 1989
INTRASITE CAVITY WOUND DRESSING
K895354 · KOZ
Smith & Nephew United, Inc.
General & Plastic Surgery · 67d
Cleared Sep 28, 1989
OPSITE I.V. 3000
K895353 · KGX
Smith & Nephew United, Inc.
General & Plastic Surgery · 27d
Cleared Sep 19, 1989
PERRY* STERILE X-AM* GLOVES
K891444 · LYY
Smith & Nephew Medical
General Hospital · 188d
Cleared Aug 31, 1989
HYPAFIX DRESSING RETENTION SHEET
K894254 · NAD
Smith & Nephew United, Inc.
General & Plastic Surgery · 72d
Cleared Aug 09, 1989
INTRASITE* GEL (3) YEAR SHELF LIFE
K891870 · FRO
Smith & Nephew United, Inc.
General & Plastic Surgery · 152d
Cleared Aug 08, 1989
GLASS MERCURY FILLED THERMOMETERS
K893602 · FLK
Smith & Nephew United, Inc.
General Hospital · 85d
Cleared Aug 03, 1989
PRIMAPORE I.V.
K893900 · KGX
Smith & Nephew United, Inc.
General & Plastic Surgery · 48d
Cleared Jul 14, 1989
REMOVE ADHESIVE REMOVER
K893603 · KOX
Smith & Nephew United, Inc.
General & Plastic Surgery · 59d
Cleared May 25, 1989
PERRY* NON-STERILE X-AM* GLOVES
K892353 · LYY
Smith & Nephew Medical
General Hospital · 71d
Cleared May 15, 1989
SAFE-T-FACE DISPOSABLE FACE SHIELD
K892451 · FXX
Barry S. Smith Co.
General Hospital · 35d
Cleared Apr 27, 1989
PERRY* LATEX FLOOR GLOVES
K891712 · LYY
Smith & Nephew Medical
General Hospital · 38d
Cleared Apr 17, 1989
NON-ABSORB GAUZE SURG SPONGE & WOUND DRESS/EXT USE
K891460 · EFQ
Smith & Nephew United, Inc.
General & Plastic Surgery · 33d
Cleared Apr 17, 1989
NON-ABSORBABLE GAUZE, SURGICAL SPONGE & DRESSING
K891101 · NAB
Smith & Nephew United, Inc.
General & Plastic Surgery · 46d
Cleared Apr 07, 1989
ABSORBENT GAUZE ROLL
K890672 · NAB
Smith & Nephew United, Inc.
General & Plastic Surgery · 57d