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"
553–576 of 1,107
Search insights Median review: 85d Cleared: 100% Top manufacturer: Smith & Nephew, Inc. Lead specialty: Orthopedic
Cleared Jan 14, 2005
CABLING SYSTEM TROCHANTER HOOK
K043252 · JDQ
Smith & Nephew, Inc.
Orthopedic · 52d
Cleared Jan 12, 2005
SMITH & NEPHEW VIDEOARTHROSCOPE
K043395 · HRX
Smith & Nephew, Inc.
Orthopedic · 33d
Cleared Jan 12, 2005
SMITH & NEPHEW HYBRID KNEE FEMORAL
K042896 · NPJ
Smith & Nephew, Inc.
Orthopedic · 84d
Cleared Nov 24, 2004
TRIGEN HINDFOOT FUSION NAIL
K043052 · HSB
Smith & Nephew, Inc.
Orthopedic · 19d
Cleared Nov 19, 2004
SMITH & NEPHEW MODULAR HIP
K042127 · MEH
Smith & Nephew, Inc.
Orthopedic · 105d
Cleared Oct 07, 2004
IIIZAROV PULLEY SYSTEM
K042436 · KTT
Smith & Nephew, Inc.
Orthopedic · 29d
Cleared Oct 07, 2004
CLEO 90 INFUSION SET
K042172 · FPA
Smiths Medical MD, Inc.
General Hospital · 57d
Cleared Oct 07, 2004
IUR RECIPROCATING MORCELLATOR MODEL # 7210517
K041774 · HIH
Smith & Nephew, Inc.
Obstetrics & Gynecology · 98d
Cleared Sep 24, 2004
JET-X BAR CLAMPS AND PIN CLAMPS-NON-MAGNETIC/MR SAFE
K042312 · KTT
Smith & Nephew, Inc.
Orthopedic · 29d
Cleared Sep 10, 2004
SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR HIP APPLICATIONS
K033341 · HAW
Smith & Nephew, Inc.
Neurology · 329d
Cleared Aug 27, 2004
OASIS DRY MOUTH RELIEF DISCS OR OASIS MOUTH MOISTURIZING DISCS
K041563 · LFD
Glaxosmithkline Consumer Healthcare,...
Dental · 78d
Cleared Aug 23, 2004
SMITH & NEPHEW GRAFT DELIVERY SYSTEM
K041976 · FMF
Smith & Nephew, Inc.
General Hospital · 32d
Cleared Aug 19, 2004
SMITH & NEPHEW GTS SLEEVE AND GTS TAPERED SCREW
K040542 · HWC
Smith & Nephew, Inc.
Orthopedic · 170d
Cleared Jul 30, 2004
HUMERAL STAPLE
K041355 · HTY
Smith & Nephew, Inc.
Orthopedic · 71d
Cleared Jul 28, 2004
HYPODERMIC NEEDLE-PRO EDGE NEEDLE PROTECTION DEVICE
K041399 · FMI
Smiths Medical Asd, Inc.
General Hospital · 63d
Cleared Jul 27, 2004
SMITH & NEPHEW ELECTROBLADE RESECTOR/ADAPTOR
K041328 · GEI
Smith & Nephew, Inc.
General & Plastic Surgery · 69d
Cleared Jul 22, 2004
SMITH & NEPHEW TUMESCENT CATHETER INVERSION SYSTEM, MODEL 7210023
K041453 · DWQ
Smith & Nephew, Inc.
Cardiovascular · 51d
Cleared Jul 13, 2004
PORTEX ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT_WITH SERIAL DILATORS...
K041348 · JOH
Smiths Medical
Anesthesiology · 54d
Cleared Jul 01, 2004
REVISION KNEE SYSTEM
K041106 · JWH
Smith & Nephew, Inc.
Orthopedic · 64d
Cleared Jun 14, 2004
CONTOUR HA COATED RECONSTRUCTION RING
K040680 · MEH
Smith & Nephew, Inc.
Orthopedic · 90d
Cleared Jun 10, 2004
JAX-TCP
K033552 · MQV
Smith & Nephew, Inc.
Orthopedic · 211d
Cleared Jun 07, 2004
SMITH & NEPHEW ULTRABRAID SUTURE
K041216 · GAT
Smith & Nephew, Inc.
General & Plastic Surgery · 28d
Cleared Jun 04, 2004
DURABRAID SUTURE
K040789 · GAT
Smith & Nephew, Inc.
General & Plastic Surgery · 67d
Cleared May 27, 2004
SMITHS MEDICAL INSULIN INFUSION PUMP WITH COZMONITOR GLUCOSE METER
K031738 · LZG
Smiths Medical MD, Inc.
General Hospital · 358d