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"
1009–1032 of 1,136
Search insights Median review: 86d Cleared: 100% Top manufacturer: Smith & Nephew, Inc. Lead specialty: Orthopedic
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
Cleared Mar 08, 1989
ALLEVYN TRACHEOSTOMY DRESSING
K890748 · NAD
Smith & Nephew United, Inc.
General & Plastic Surgery · 23d
Cleared Feb 10, 1989
ABSORBENT GAUZE ROLL
K885143 · EFQ
Smith & Nephew, Inc.
General & Plastic Surgery · 57d
Cleared Jan 24, 1989
GAUZE SWABS, NON-STERILE
K885142 · EFQ
Smith & Nephew, Inc.
General & Plastic Surgery · 40d
Cleared Jan 04, 1989
VOYAGER/X
K884754 · NFB
Smith-Perry Corp.
Anesthesiology · 51d
Cleared May 23, 1988
HEMOCCULT SENSITIVE TEST
K880499 · KHE
Smithkline Diagnostics, Inc.
Hematology · 108d
Cleared May 16, 1988
CONDOM-MATE VAGINAL LUBRICANT
K881338 · KMJ
Upsher-Smith Laboratories, Inc.
General Hospital · 48d
Cleared Mar 21, 1988
AIRSTRIP* WATERPROOF FIRST AID DRESS/POST-OPERA.
K881048 · FRO
Smith & Nephew, Inc.
General & Plastic Surgery · 10d
Cleared Mar 01, 1988
(SKD) CHOLESTEROL TEST KIT
K875131 · CHH
Smithkline Diagnostics, Inc.
Chemistry · 77d
Cleared Nov 04, 1987
HENKE-JECT PRESSURE SYRINGE (MODIFICATION)
K864294 · EGM
Smith & Nephew, Inc.
Dental · 369d
Cleared Oct 23, 1987
SMITH & NEPHEW DAYLIGHTER(TM)
K873786 · FSY
Smith & Nephew, Inc.
General & Plastic Surgery · 36d
Cleared Sep 16, 1987
TRANSIGEN EXUDATE CONTROLLED WOUND DRESSING
K872988 · NAD
Smith & Nephew, Inc.
General & Plastic Surgery · 47d
Cleared Sep 04, 1987
AQUATULLE FINE MESH NON-ADHERING DRESSING
K872759 · EFQ
Smith & Nephew, Inc.
General & Plastic Surgery · 53d
Cleared Jul 31, 1987
THEATRE GOWNS
K872758 · FYA
Smith & Nephew, Inc.
General Hospital · 18d
Cleared Jul 29, 1987
INTRASITE INTERACTIVE HYDROCOLLOID WOUND DRESSING
K872624 · FRO
Smith & Nephew, Inc.
General & Plastic Surgery · 23d
Cleared Jul 28, 1987
OPSITE SPECIALITY DRAPES
K872757 · KKX
Smith & Nephew, Inc.
General Hospital · 15d
Cleared Jun 16, 1987
ALLEVYN HYDROPHILIC POLYURETHANE DRESSING
K871166 · NAD
Smith & Nephew, Inc.
General & Plastic Surgery · 84d
Cleared Jan 28, 1987
ECONOL (PORTABLE) ECONO 30 & 40 LITER BASE UNIT
K864280 · BYJ
Smith-Taylor Mfg. Co., Div. Allied...
Anesthesiology · 90d
Cleared Dec 29, 1986
TRICOTEX WOUND CONTACT LAYER DRESSING
K864264 · NAB
Smith & Nephew, Inc.
General & Plastic Surgery · 61d
Cleared Dec 09, 1986
HEMOCCULT WIPE TEST
K862849 · KHE
Smithkline Diagnostics, Inc.
Hematology · 133d