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"
625–648 of 1,107
Search insights Median review: 85d Cleared: 100% Top manufacturer: Smith & Nephew, Inc. Lead specialty: Orthopedic
Cleared Oct 09, 2002
SMITH & NEPHEW SURETAC - EXPANDED INDICATIONS II
K020948 · JDR
Smith & Nephew, Inc.
Orthopedic · 198d
Cleared Oct 04, 2002
MODIFICATION TO SMITH & NEPHEW TWINFIX TI QUICK T
K023021 · HWC
Smith & Nephew, Inc.
Orthopedic · 23d
Cleared Oct 03, 2002
DYONICS VISION 635 IMAGE MANAGEMENT SYSTEM
K023053 · GCJ
Smith & Nephew, Inc.
General & Plastic Surgery · 20d
Cleared Oct 02, 2002
TOTAL HIP FEMORAL HEADS AND LINERS
K022958 · JDI
Smith & Nephew, Inc.
Orthopedic · 26d
Cleared Oct 02, 2002
SMITH & NEPHEW HIP SYSTEM
K022902 · LPH
Smith & Nephew, Inc.
Orthopedic · 29d
Cleared Sep 23, 2002
ORTHOGUARD AB ANTIMICROBIAL SLEEVE
K022676 · JEC
Smith & Nephew, Inc.
Orthopedic · 42d
Cleared Aug 28, 2002
REFLECTION MODIFIED ACETABULAR SHELLS
K022556 · LPH
Smith & Nephew, Inc.
Orthopedic · 26d
Cleared Aug 19, 2002
SMITH & NEPHEW IMAGE GUIDED SURGICAL SYSTEM FOR KNEE APPLICATIONS
K022460 · HAW
Smith & Nephew, Inc.
Neurology · 24d
Cleared Aug 19, 2002
TOTAL KNEE FEMORAL COMPONENT
K022010 · JWH
Smith & Nephew, Inc.
Orthopedic · 61d
Cleared Jul 11, 2002
AMC ANTIMICROBIAL PIN/WIRE SLEEVE
K012193 · JEC
Smith & Nephew, Inc.
Orthopedic · 364d
Cleared Jun 11, 2002
TOTAL HIP FEMORAL HEAD - 12/14 TAPER
K021673 · LZO
Smith & Nephew, Inc.
Orthopedic · 21d
Cleared Apr 17, 2002
MODIFICATION TO DYONICS INTELIJET REUSABLE CANNULAS
K020947 · FRN
Smith & Nephew, Inc.
General Hospital · 23d
Cleared Mar 26, 2002
SMITH & NEPHEW TWINFIX TI QUICK T
K020159 · HWC
Smith & Nephew, Inc.
Orthopedic · 68d
Cleared Mar 15, 2002
VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UNMWPE COMPONENTS IN THE...
K012788 · KWS
Smith & Nephew, Inc.
Orthopedic · 207d
Cleared Mar 15, 2002
VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UHMWPE COMPONENTS IN THE...
K012787 · LPH
Smith & Nephew, Inc.
Orthopedic · 207d
Cleared Mar 15, 2002
VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UHMWPE COMPONENTS IN THE...
K012778 · JWH
Smith & Nephew, Inc.
Orthopedic · 207d
Cleared Mar 12, 2002
RBM
K020480 · KGS
Smith & Nephew, Inc.
General & Plastic Surgery · 27d
Cleared Feb 08, 2002
SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR KNEE APPLICATIONS
K012938 · HAW
Smith & Nephew, Inc.
Neurology · 161d
Cleared Feb 01, 2002
DYONICS ELECTROBLADE RESECTOR
K012314 · GEI
Smith & Nephew, Inc.
General & Plastic Surgery · 193d
Cleared Jan 17, 2002
SMITH & NEPHEW OPERATIVE HYSTEROSCOPE, MODEL 7209208
K013870 · HIH
Smith & Nephew, Inc.
Obstetrics & Gynecology · 57d
Cleared Dec 19, 2001
ZIRCONIA CERAMIC FEMORAL HEAD - 12/14 TAPER
K013989 · LZO
Smith & Nephew, Inc.
Orthopedic · 15d
Cleared Dec 13, 2001
3D HUMERAL HEADS
K012378 · KWS
Smith & Nephew, Inc.
Orthopedic · 140d
Cleared Dec 05, 2001
MODIFICATION TO REFLECTION CROSS-LINKED UHMWPE ACETABULAR COMPONENTS
K013658 · LPH
Smith & Nephew, Inc.
Orthopedic · 29d
Cleared Nov 08, 2001
SMITH & NEPHEW VASCULAR VIDEOENDOSCOPE SYSTEM, MODEL 7209273
K012724 · LYK
Smith & Nephew, Inc.
Cardiovascular · 86d