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"
985–1008 of 1,136
Search insights Median review: 86d Cleared: 100% Top manufacturer: Smith & Nephew, Inc. Lead specialty: Orthopedic
Cleared Jun 28, 1990
INTRASITE CAVITY WOUND DRESSING (LABEL REVISION)
K901876 · KOZ
Smith & Nephew United, Inc.
General & Plastic Surgery · 63d
Cleared Jun 25, 1990
POSTEROMEDIAL GUIDE
K901765 · HRX
Smith & Nephew Dyonics, Inc.
Orthopedic · 68d
Cleared Jun 22, 1990
INTRASITE HYDROCOLLOID DRESSING (REVISED LABELING)
K901879 · KGX
Smith & Nephew United, Inc.
General & Plastic Surgery · 57d
Cleared Jun 22, 1990
INTRASITE GEL (LABELING REVISION)
K901878 · KMF
Smith & Nephew United, Inc.
General & Plastic Surgery · 57d
Cleared Jun 22, 1990
ALLEVYN DRESSING (LABELING REVISED)
K901877 · KMF
Smith & Nephew United, Inc.
General & Plastic Surgery · 57d
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