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"
457–480 of 1,107
Search insights Median review: 85d Cleared: 100% Top manufacturer: Smith & Nephew, Inc. Lead specialty: Orthopedic
Cleared Dec 13, 2007
GYRUS ACMI IPN-2505, INVISIO SMITH PERCUTANEOUS NEPHROSCOPE SYSTEM
K072594 · FGA
Gyrus Acmi, Inc.
Gastroenterology & Urology · 90d
Cleared Dec 10, 2007
TWINFIX FT PK
K072785 · HWC
Smith & Nephew Inc., Endoscopy Division
Orthopedic · 70d
Cleared Dec 06, 2007
LEGION STEM WITH HOLES
K072531 · JWH
Smith & Nephew, Inc.
Orthopedic · 90d
Cleared Nov 30, 2007
SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH SAF-HOLDER DEVICE, MODEL 99200,...
K072783 · JKA
Smiths Medical Asd, Inc.
Chemistry · 60d
Cleared Nov 29, 2007
HYPODERMIC NEEDLE-PRO SAFETY ALLERGY TRAY
K072482 · MEG
Smiths Medical Asd, Inc.
General Hospital · 86d
Cleared Nov 21, 2007
THERA-HEAT HEATED HUMIDIFIER AND ADULT DUAL AND SINGLE LIMB HEATED WIRE...
K071958 · BTT
Smiths Medical Asd, Inc.
Anesthesiology · 128d
Cleared Nov 20, 2007
TC-PLUS PRIMARY KNEE SYSTEM
K072858 · JWH
Smith & Nephew, Inc.
Orthopedic · 46d
Cleared Nov 19, 2007
PERI-LOC PERIARTRICULAR LCK PIT SYS-PROX FEM PLATES/SCREWS.CALBE ACCESS
K072818 · HRS
Smith & Nephew, Inc.
Orthopedic · 48d
Cleared Nov 09, 2007
ADVANTIV SAFETY I.V. CATHETER
K072419 · FOZ
Smiths Medical Asd, Inc.
General Hospital · 73d
Cleared Nov 09, 2007
POLYGRAFT BGS
K062607 · MQV
Smith & Nephew, Inc.
Orthopedic · 430d
Cleared Nov 01, 2007
GRIPPER MICRO NEEDLE
K072059 · FMI
Smiths Medical MD, Inc.
General Hospital · 98d
Cleared Oct 15, 2007
SMITH & NEPHEW ARTHROSCOPE
K072675 · HRX
Smith & Nephew, Inc.
Orthopedic · 24d
Cleared Oct 05, 2007
REFLECTION, TANDEM UNIPOLAR
K071160 · LPH
Smith & Nephew, Inc.
General & Plastic Surgery · 162d
Cleared Oct 04, 2007
PNEUPAC VR1 AIR MIX
K071527 · BTL
Smiths Medical International , Ltd.
Anesthesiology · 122d
Cleared Sep 19, 2007
CROSSLINKED POLYETHYLENE ARTICULAR INSERTS
K071071 · JWH
Smith & Nephew, Inc.
Orthopedic · 156d
Cleared Sep 18, 2007
ULTRA FAST-FIX AND ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEMS
K072322 · GAT
Smith & Nephew, Inc.
General & Plastic Surgery · 29d
Cleared Aug 17, 2007
GENESIS II TOTAL KNEE SYSTEM, LEGION REVISION KNEE SYSTEM, JOURNEY BCS KNEE...
K071790 · MBH
Smith & Nephew, Inc.
Orthopedic · 46d
Cleared Aug 17, 2007
BIORAPTOR 2.3 PK SUTURE ANCHOR
K071586 · MBI
Smith & Nephew Inc., Endoscopy Division
Orthopedic · 67d
Cleared Aug 08, 2007
PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM
K071563 · HRS
Smith & Nephew, Inc.
Orthopedic · 62d
Cleared Aug 03, 2007
ALLEVYN AG DRESSING
K063835 · FRO
Smith & Nephew, Inc.
General & Plastic Surgery · 220d
Cleared Aug 02, 2007
HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE, HYPODERMIC NEEDLE-PRO EDGE SAFETY...
K071785 · FMI
Smiths Medical Asd, Inc.
General Hospital · 31d
Cleared Aug 01, 2007
HEMODRAW ARTERIAL BLOOD SAMPLING SYSTEM
K071269 · CBT
Smiths Medical Asd, Inc.
Anesthesiology · 86d
Cleared Jul 20, 2007
MODIFICATION TO SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE
K071300 · GXI
Smith & Nephew, Inc.
Neurology · 72d
Cleared Jul 09, 2007
BCI AUTOCON 3304 DIGITAL PULSE OXIMETER
K070732 · DQA
Smiths Medical Pm, Inc.
Anesthesiology · 116d