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"
97–120 of 1,107
Search insights Median review: 85d Cleared: 100% Top manufacturer: Smith & Nephew, Inc. Lead specialty: Orthopedic
Cleared Oct 06, 2020
R3 HA Coated Acetabular Shells
K201701 · MBL
Smith & Nephew, Inc.
Orthopedic · 106d
Cleared Sep 18, 2020
Intellifuse Administration and Intellifuse Blood Administration Sets
K192375 · FPA
Smiths Medical Asd, Inc.
General Hospital · 385d
Cleared Jul 22, 2020
EVOS Straight Proximal Humerus 7-15 hole Plates (137-225mm)
K201527 · HRS
Smith & Nephew, Inc.
Orthopedic · 44d
Cleared Jul 20, 2020
Smith+Nephew Arthroscopes
K201349 · HRX
Smith & Nephew
Orthopedic · 60d
Cleared Jul 17, 2020
S+N Laparoscopes, 4KO, Autoclavable, S+N Bariactric Laparoscopes, 4KO,...
K201198 · GCJ
Smith & Nephew
General & Plastic Surgery · 74d
Cleared Jun 22, 2020
O-Mec 690 Series Laparoscopes
K201151 · GCJ
Omec Medical, Inc.
General & Plastic Surgery · 54d
Cleared Jun 04, 2020
Journey II XR Knee Instrument
K200227 · JWH
Smith & Nephew, Inc.
Orthopedic · 126d
Cleared Jun 04, 2020
Oxylight
K200104 · GEX
Raja Trading Company, Inc.
General & Plastic Surgery · 139d
Cleared Apr 24, 2020
Smith&Nephew VISIONAIRE Patient Matched Cutting Blocks
K200826 · JWH
Smith & Nephew, Inc.
Orthopedic · 25d
Cleared Apr 20, 2020
CapKlenZ
K192382 · QBP
Star Mountain Medical, Inc.
General Hospital · 234d
Cleared Mar 18, 2020
HEALICOIL Knotless Suture Anchors
K193558 · MAI
Smith & Nephew, Inc.
Orthopedic · 86d
Cleared Mar 13, 2020
LEGION Inserts with JRNY Lock
K200407 · JWH
Smith & Nephew, Inc.
Orthopedic · 23d
Cleared Feb 28, 2020
CONQUEST FN
K193029 · JDO
Smith & Nephew, Inc.
Orthopedic · 121d
Cleared Feb 27, 2020
INTELLIO Tablet Application
K192876 · ODA
Smith & Nephew
General & Plastic Surgery · 142d
Cleared Jan 10, 2020
CorticaLINK Spinal Fusion Platform
K193465 · NKB
Spine Smith Holdings, LLC
Orthopedic · 25d
Cleared Jan 03, 2020
PiccGuard
K191195 · PZW
Piccguard, LLC
General Hospital · 245d
Cleared Jan 02, 2020
Air Next
K183089 · BZG
Nuvoair AB
Anesthesiology · 422d
Cleared Dec 20, 2019
Surgical Direct Hand-held Laparoscopic Instruments
K193018 · GEI
Surgical Direct, Inc.
General & Plastic Surgery · 52d
Cleared Dec 20, 2019
IODOFLEX
K190756 · FRO
Smith & Nephew Medical, Ltd.
General & Plastic Surgery · 270d
Cleared Dec 20, 2019
IODOSORB
K190730 · FRO
Smith & Nephew Medical, Ltd.
General & Plastic Surgery · 274d
Cleared Dec 05, 2019
PICO 14 Single Use Negative Pressure Wound Therapy System
K191760 · OMP
Smith & Nephew Medical Limited
General & Plastic Surgery · 157d
Cleared Oct 31, 2019
OR3O Dual Mobility System
K191002 · LPH
Smith & Nephew, Inc.
Orthopedic · 198d
Cleared Oct 25, 2019
REDAPT Blade Augments
K190847 · LPH
Smith & Nephew, Inc.
Orthopedic · 207d
Cleared Oct 24, 2019
Acapella Choice Blue Vibratory PEP Device
K181660 · BWF
Smiths Medical
Anesthesiology · 486d