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"
937–960 of 1,107
Search insights Median review: 85d Cleared: 100% Top manufacturer: Smith & Nephew, Inc. Lead specialty: Orthopedic
Cleared Sep 30, 1991
MAX-I-PROBE IRRIGATION SYSTEM
K913030 · EFS
Smith & Nephew, Inc.
Dental · 83d
Cleared Sep 18, 1991
PALMER ARCH SUPPRESSOR
K913347 · HRX
Smith & Nephew Dyonics, Inc.
Orthopedic · 54d
Cleared Aug 26, 1991
INTELIJET TM FLUID MANAGEMENT SYSTEM
K912453 · HRX
Smith & Nephew Dyonics, Inc.
Orthopedic · 84d
Cleared Aug 14, 1991
INTRAMEDULLARY HIP SCREW, MODIFICATION
K912162 · KTT
Smith & Nephew Richards, Inc.
Orthopedic · 90d
Cleared Jul 19, 1991
PERRY NATURAL POWDER FREE GLOVES
K912797 · KGO
Smith & Nephew, Inc.
General Hospital · 24d
Cleared Jul 17, 1991
AIRSTRIP FIRST AID & POST-OP DRESSING
K911682 · KGX
Smith & Nephew United, Inc.
General & Plastic Surgery · 93d
Cleared Jun 17, 1991
INTRASITE HYDROCOLLOID WOUND DRESSING
K911660 · MGP
Smith & Nephew United, Inc.
General & Plastic Surgery · 66d
Cleared May 09, 1991
PERRY(R) ENCORE CHEMOTHERAPY GLOVE
K911633 · LYY
Smith & Nephew Perry
General Hospital · 28d
Cleared Apr 02, 1991
SHAMPAINE MODEL 3800 OR MURANAKA MODEL OR-604M
K910783 · BWN
Smith & Nephew Equipment Group
General & Plastic Surgery · 36d
Cleared Feb 15, 1991
GERI TOTAL HIP SYSTEM
K905186 · LWJ
Smith & Nephew Richards, Inc.
Orthopedic · 88d
Cleared Jan 16, 1991
SHAMPAINE 1000 SERIES ANGENIEUX AX-14 DUO,AX-4
K904965 · FSY
Smith & Nephew Equipment Group
General & Plastic Surgery · 72d
Cleared Jan 16, 1991
SPEEDWRAP, DYNAWRAP, DYNAPLAST TAPE
K903823 · KGX
Smith and Nephew Donjoy, Inc.
General & Plastic Surgery · 149d
Cleared Jan 11, 1991
PERRY XTENDA CUFF SURGICAL GLOVES
K905537 · KGO
Smith & Nephew Perry
General Hospital · 31d
Cleared Dec 05, 1990
ARTHROSCOPIC SURGICAL BLADE
K904284 · HRX
Smith & Nephew Dyonics, Inc.
Orthopedic · 79d
Cleared Nov 26, 1990
INTRASITE GEL (LABELING REVISION)
K904411 · KMF
Smith & Nephew United, Inc.
General & Plastic Surgery · 61d
Cleared Oct 23, 1990
ALLEVYN DRESSING CLAIMS CHANGE
K904412 · KOZ
Smith & Nephew United, Inc.
General & Plastic Surgery · 27d
Cleared Oct 19, 1990
CLUB FOOT CPM MACHINE
K903851 · BXB
Smith & Nephew Richards, Inc.
Physical Medicine · 59d
Cleared Oct 12, 1990
MODIFIED ENDOSCOPIC CARPAL TUNNEL RELEASE SYSTEM
K903620 · HRX
Smith & Nephew Dyonics, Inc.
Orthopedic · 66d
Cleared Aug 30, 1990
SMITH & NEPHEW DYONICS LEVELERT SYSTEM
K903193 · FLN
Smith & Nephew Dyonics, Inc.
General Hospital · 42d
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