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"
241–264 of 1,107
Search insights Median review: 85d Cleared: 100% Top manufacturer: Smith & Nephew, Inc. Lead specialty: Orthopedic
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 21, 2014
SOLUM IV BONE VOID FILLER
K132470 · MQV
Spinesmith Partners, Llp
Orthopedic · 287d
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 09, 2013
CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0
K130394 · MEA
Smiths Medical Asd, Inc.
General Hospital · 297d
Cleared Dec 05, 2013
TFCC FAST-FIX KIT
K132079 · GAT
Smith & Nephew, Inc.
General & Plastic Surgery · 153d
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 Sep 16, 2013
PNEUPAC PARAPAC PLUS
K123957 · BTL
Smiths Medical International , Ltd.
Anesthesiology · 269d
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