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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

546 results for "Smith & Nephew, Inc."
241–264 of 546
Search insights Median review: 79d Cleared: 100% Top manufacturer: Smith & Nephew, Inc. Lead specialty: Orthopedic
Cleared Jul 02, 2009
SMITH & NEPHEW INSTRUMENT TRAYS
K091627 · KCT
Smith & Nephew, Inc.
General Hospital · 29d
Cleared Jun 08, 2009
SMITH & NEPHEW RAIL SYSTEM
K090926 · KTT
Smith & Nephew, Inc.
Orthopedic · 67d
Cleared Jun 04, 2009
SMITH & NEPHEW, INC. VLP FOOT PLATING, SCREW SYSTEM AND ACCESSORIES
K090675 · HRS
Smith & Nephew, Inc.
Orthopedic · 83d
Cleared Jun 03, 2009
INTERTAN CHS LIMITED COLLAPSE SET SCREW
K090656 · HWC
Smith & Nephew, Inc.
Orthopedic · 83d
Cleared May 27, 2009
SMITH & NEPHEW PIGALILEO SCREW TARGETING SYSTEM V 1.0
K090420 · OLO
Smith & Nephew, Inc.
Orthopedic · 98d
Cleared Mar 18, 2009
SMITH & NEPHEW INSTRUMENT TRAYS
K090562 · KCT
Smith & Nephew, Inc.
General Hospital · 16d
Cleared Mar 11, 2009
PIGALILEO TKR BASE V2.3 AND CAS V4.1
K090313 · OLO
Smith & Nephew, Inc.
Orthopedic · 30d
Cleared Mar 11, 2009
BIOLOX DELTA CERAMIC FEMORAL HEADS
K083762 · LZO
Smith & Nephew, Inc.
Orthopedic · 83d
Cleared Mar 03, 2009
R3 CONSTRAINED LINER, CONSTRAINED LINER
K083566 · KWZ
Smith & Nephew, Inc.
Orthopedic · 90d
Cleared Feb 25, 2009
RENASYS GO NEGATIVE PRESSURE WOUND THERAPY
K083375 · OMP
Smith & Nephew, Inc.
General & Plastic Surgery · 103d
Cleared Feb 20, 2009
PIGALILEO TOTAL HIP REPLACEMENT (THR) SOFTWARE APPLICATION V3.0
K083565 · HAW
Smith & Nephew, Inc.
Neurology · 79d
Cleared Feb 09, 2009
SMITH & NEPHEW SL-PLUS MIA STANDARD AND LATERAL FEMORAL HIP STEM
K082371 · LZO
Smith & Nephew, Inc.
Orthopedic · 175d
Cleared Jan 28, 2009
SMITH & NEPHEW BIPOLAR ADAPTER CABLE, MODEL 72200022
K083528 · GEI
Smith & Nephew, Inc.
General & Plastic Surgery · 61d
Cleared Jan 07, 2009
PERI-LOC BONE PLATING AND SCREW SYSTEM
K083032 · HRS
Smith & Nephew, Inc.
Orthopedic · 89d
Cleared Nov 25, 2008
SMITH & NEPHEW, INC. PATIENT MATCHED TECHNOLOGY
K082358 · JWH
Smith & Nephew, Inc.
Orthopedic · 99d
Cleared Nov 14, 2008
RENASYS-F NEGATIVE PRESSURE WOUND THERAPY FOAM DRESSING KITS
K082211 · OMP
Smith & Nephew, Inc.
General & Plastic Surgery · 100d
Cleared Oct 29, 2008
PIGALILEO CAS, VERSION 4.0 AND TKR BASE, VERSION 2.1
K082267 · HAW
Smith & Nephew, Inc.
Neurology · 79d
Cleared Sep 17, 2008
PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM HEXALOBULAR BONE SCREWS
K082516 · HWC
Smith & Nephew, Inc.
Orthopedic · 15d
Cleared Sep 05, 2008
RENASYS EZ
K082426 · OMP
Smith & Nephew, Inc.
General & Plastic Surgery · 14d
Cleared Sep 05, 2008
SMITH & NEPHEW, INC., PROMOS REVERSE SHOULDER SYSTEM
K081016 · PHX
Smith & Nephew, Inc.
Orthopedic · 149d
Cleared Aug 26, 2008
2.0 PK SUTURE ANCHOR T, 2.0 PK SUTURE ANCHOR S
K081511 · MBI
Smith & Nephew, Inc.
Orthopedic · 89d
Cleared Aug 21, 2008
SMITH & NEPHEW OXINIUM DH FEMORAL HEADS
K081566 · LPH
Smith & Nephew, Inc.
Orthopedic · 78d
Cleared Jul 31, 2008
MDF REVISION HIP SYSTEM
K081124 · MEH
Smith & Nephew, Inc.
Orthopedic · 101d
Cleared Jul 24, 2008
MODIFICATION TO JOURNEY UNICONDYLAR FEMORAL IMPLANT
K081351 · HSX
Smith & Nephew, Inc.
Orthopedic · 71d