Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

549 results for "Smith & Nephew, Inc."
145–168 of 549
Search insights Median review: 79d Cleared: 100% Top manufacturer: Smith & Nephew, Inc. Lead specialty: Orthopedic
Cleared Oct 30, 2013
SMITH & NEPHEW ULTRATAPE
K132357 · GAT
Smith & Nephew, Inc.
General & Plastic Surgery · 93d
Cleared Oct 23, 2013
RENASYS EZ MAX NEGATIVE PRESSURE WOUND THERAPY DEVICE
K132446 · OMP
Smith & Nephew, Inc.
General & Plastic Surgery · 78d
Cleared Oct 22, 2013
SMITH & NEPHEW GLOBAL FEMORAL HEAD TRIALS
K132435 · LZO
Smith & Nephew, Inc.
Orthopedic · 78d
Cleared Oct 17, 2013
DYONICS PLAN HIP IMPINGEMENT PLANNING SYSTEM
K132636 · LLZ
Smith & Nephew, Inc.
Radiology · 56d
Cleared Oct 10, 2013
POLARSTEM STANDARD AND LATERAL FEMORAL STEMS WITH TI/HA
K130728 · LZO
Smith & Nephew, Inc.
Orthopedic · 206d
Cleared Aug 04, 2013
SMITH & NEPHEW SURESHOT DISTAL TARGETING SYSTEM V3.0
K130748 · OLO
Smith & Nephew, Inc.
Orthopedic · 138d
Cleared Jun 28, 2013
SMITH & NEPHEW, INC. HIP SYSTEM INSTRUMENTATION
K123598 · JDI
Smith & Nephew, Inc.
Orthopedic · 219d
Cleared May 14, 2013
ILIZAROV DRILL TIP WIRES
K130479 · KTT
Smith & Nephew, Inc.
Orthopedic · 78d
Cleared May 03, 2013
SMITH & NEWPHEW, INC. DISPOSABLE KNEE INSTRUMENTS
K123159 · JWH
Smith & Nephew, Inc.
Orthopedic · 206d
Cleared Apr 11, 2013
HEALICOIL SUTURE ANCHOR WITH REGENESORB
K123393 · MAI
Smith & Nephew, Inc.
Orthopedic · 160d
Cleared Mar 18, 2013
ALL-SUTURE ANCHOR TWIST DRILL FOR ALL-SUTURE ANCHORS INLINE DRILL GUIDE FOR...
K122059 · MBI
Smith & Nephew, Inc.
Orthopedic · 248d
Cleared Mar 14, 2013
CHINA NAILS AND ACCESSORIES
K123948 · JDS
Smith & Nephew, Inc.
Orthopedic · 83d
Cleared Feb 20, 2013
TWINFIX TI 3.5MM SUTURE ANCHOR WITH TWO ULTRABRAID SUTURE #2 WITH NEEDLES, SL
K123425 · MBI
Smith & Nephew, Inc.
Orthopedic · 105d
Cleared Jan 25, 2013
SMITH & NEPHEW, INC SCREW AND PLATE SYSTEM INSTRUMENTATION
K123055 · HRS
Smith & Nephew, Inc.
Orthopedic · 116d
Cleared Jan 23, 2013
FOOTPRINT ULTRA PK4.5MM AND 5.5MM SUTURE ANCHOR, SL
K123579 · MBI
Smith & Nephew, Inc.
Orthopedic · 65d
Cleared Nov 20, 2012
ARTHROSCOPIC SURGICAL INSTRUMENTS - INTERFERENCE SCREW SYSTEMS
K122596 · HWC
Smith & Nephew, Inc.
Orthopedic · 88d
Cleared Oct 24, 2012
SMITH & NEPHEW SMF HIP STEM
K123012 · LPH
Smith & Nephew, Inc.
Orthopedic · 26d
Cleared Oct 19, 2012
SMITH & NEPHEW, INC. INTRAMEDULLARY NAIL SYSTEM INSTRUMENTATION
K122170 · HSB
Smith & Nephew, Inc.
Orthopedic · 88d
Cleared Oct 18, 2012
SMITH & NEPHEW ULTRA FAST-FIX MENISCAL REPAIR SYSTEM, SMITH & NEPHEW ULTRA...
K121861 · GAT
Smith & Nephew, Inc.
General & Plastic Surgery · 114d
Cleared Oct 16, 2012
SMITH & NEPHEW R3 CONSTRAINED LINERS
K122139 · KWZ
Smith & Nephew, Inc.
Orthopedic · 89d
Cleared Oct 15, 2012
SMITH & NEPHEW REDAPT REVISION FEMORAL SYSTEM
K121627 · MEH
Smith & Nephew, Inc.
Orthopedic · 133d
Cleared Oct 05, 2012
SMITH & NEPHEW RADIOPAQUE TRIAL NECKS
K113039 · MEH
Smith & Nephew, Inc.
Orthopedic · 359d
Cleared Sep 07, 2012
SMITH & NEPHEW, INC. SHOULDER SYSTEM INSTRUMENTS
K121714 · HSD
Smith & Nephew, Inc.
Orthopedic · 88d
Cleared Aug 28, 2012
SL-PLUS MIA FEMORAL STEMS WITH TI/HA COATING
K122296 · LZO
Smith & Nephew, Inc.
Orthopedic · 28d