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."
121–144 of 549
Search insights Median review: 79d Cleared: 100% Top manufacturer: Smith & Nephew, Inc. Lead specialty: Orthopedic
Cleared Jul 28, 2015
Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith and...
K151105 · MAI
Smith & Nephew, Inc.
Orthopedic · 95d
Cleared Jul 23, 2015
RENASYS¿ EZ MAX Negative Pressure Wound Therapy Device, RENASYS¿ AB Abdominal...
K143133 · OMP
Smith & Nephew, Inc.
General & Plastic Surgery · 265d
Cleared Jul 16, 2015
RENASYS¿ EZ PLUS Negative Pressure Wound Therapy Device
K151326 · OMP
Smith & Nephew, Inc.
General & Plastic Surgery · 59d
Cleared Jul 15, 2015
The VersaJet II Hydrosurgery System
K143115 · FQH
Smith & Nephew, Inc.
General Hospital · 258d
Cleared Apr 29, 2015
RENASYS
K142979 · OMP
Smith & Nephew, Inc.
General & Plastic Surgery · 196d
Cleared Apr 20, 2015
POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem with Ti/HA
K143739 · LZO
Smith & Nephew, Inc.
Orthopedic · 111d
Cleared Mar 24, 2015
SL-PLUS MIA and SL-PLUS Femoral Stems with Ti/HA
K143096 · LZO
Smith & Nephew, Inc.
Orthopedic · 147d
Cleared Feb 12, 2015
Visionaire Disposable Instruments
K143226 · JWH
Smith & Nephew, Inc.
Orthopedic · 94d
Cleared Feb 04, 2015
ACL SMART System
K143172 · MAI
Smith & Nephew, Inc.
Orthopedic · 92d
Cleared Jan 13, 2015
BIOSURE REGENESORB interference Screw
K142948 · MAI
Smith & Nephew, Inc.
Orthopedic · 95d
Cleared Dec 22, 2014
ANTHEM PS Total Knee System
K142807 · JWH
Smith & Nephew, Inc.
Orthopedic · 84d
Cleared Dec 18, 2014
VLP Mini-Mod Small Bone Plating System 1.5mm Plates and Screws
K143050 · HRS
Smith & Nephew, Inc.
Orthopedic · 56d
Cleared Nov 20, 2014
Smith & Nephew, Inc. Spatialframe.com V5.0 Web-based software
K142520 · KTT
Smith & Nephew, Inc.
Orthopedic · 73d
Cleared Nov 14, 2014
JOURNEY II XR KNEE SYSTEM
K141471 · JWH
Smith & Nephew, Inc.
Orthopedic · 164d
Cleared Aug 21, 2014
SMITH & NEPHEW DISPOSABLE FIN PUNCH
K141585 · JWH
Smith & Nephew, Inc.
Orthopedic · 69d
Cleared Jul 21, 2014
BIOSURE HEALICOIL PK INTERFERENCE SCREW
K140879 · MBI
Smith & Nephew, Inc.
Orthopedic · 105d
Cleared May 29, 2014
JOURNEY II BCS CONSTRAINED INSERTS
K140555 · JWH
Smith & Nephew, Inc.
Orthopedic · 86d
Cleared May 15, 2014
SMITH & NEPHEW CANNULATED CAPTURED SCREW
K133662 · HWC
Smith & Nephew, Inc.
Orthopedic · 167d
Cleared May 07, 2014
EVOS MINI-FRAGMENT PLATING SYSTEM
K140814 · HRS
Smith & Nephew, Inc.
Orthopedic · 36d
Cleared Feb 04, 2014
SMITH & NEPHEW VARIABLE-ANGLE LOCKING MINI-FRAGMENT PLATING SYSTEM
K132886 · HRS
Smith & Nephew, Inc.
Orthopedic · 141d
Cleared Jan 07, 2014
D-RAD SMART PACK
K132296 · HRS
Smith & Nephew, Inc.
Orthopedic · 168d
Cleared Dec 13, 2013
TRUCLEAR MORCELLATION SYSTEM AND TRUCLEAR MORCELLATORS
K132015 · HIH
Smith & Nephew, Inc.
Obstetrics & Gynecology · 165d
Cleared Dec 11, 2013
SMITH & NEPHEW PATIENT MATCHED CUTTING BLOCKS
K130708 · JWH
Smith & Nephew, Inc.
Orthopedic · 271d
Cleared Dec 05, 2013
TFCC FAST-FIX KIT
K132079 · GAT
Smith & Nephew, Inc.
General & Plastic Surgery · 153d