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"
25–48 of 1,107
Search insights Median review: 85d Cleared: 100% Top manufacturer: Smith & Nephew, Inc. Lead specialty: Orthopedic
Cleared Aug 22, 2024
TRIGEN INTERTAN 10S Nail System
K241804 · JDS
Smith & Nephew, Inc.
Orthopedic · 62d
Cleared Jun 27, 2024
CATALYSTEM Femoral Stems
K240381 · LZO
Smith & Nephew, Inc.
Orthopedic · 140d
Cleared Jun 20, 2024
Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, blue
K241435 · MBI
Smith & Nephew, Inc.
Orthopedic · 30d
Cleared May 31, 2024
Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space Syringe
K232943 · QNQ
Smiths Medical Asd, Inc.
General Hospital · 254d
Cleared May 24, 2024
Renasys Edge
K231939 · OMP
Smith & Nephew Medical, Ltd.
General & Plastic Surgery · 329d
Cleared Mar 18, 2024
CORIOGRAPH Knee Pre-Op Plan
K240113 · PBF
Smith & Nephew, Inc.
Orthopedic · 62d
Cleared Mar 13, 2024
ACCORD Cable System
K233949 · JDQ
Smith & Nephew, Inc.
Orthopedic · 90d
Cleared Jan 17, 2024
Footprint Mini PK, 3.5mm Suture Anchor
K233730 · MBI
Smith & Nephew
Orthopedic · 57d
Cleared Dec 21, 2023
Cannulated Screw System
K233396 · HWC
Smith & Nephew, Inc.
Orthopedic · 79d
Cleared Nov 13, 2023
ELLAVI UBT
K230849 · OQY
Sinapi Biomedical (Pty) , Ltd.
Obstetrics & Gynecology · 230d
Cleared Oct 27, 2023
OR3O Dual Mobility Liners
K232667 · LPH
Smith & Nephew, Inc.
Orthopedic · 56d
Cleared Oct 02, 2023
Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with...
K232064 · LZA
Isikel Manufacturing, LLC
General Hospital · 83d
Cleared Sep 08, 2023
Q-FIX ULTRA All-Suture Anchor
K232457 · MBI
Smith & Nephew
Orthopedic · 25d
Cleared Aug 18, 2023
ALLEVYN Ag+ Border Antimicrobial Silicone Gel Adhesive Composite...
K223526 · FRO
Smith & Nephew Medical Limited
General & Plastic Surgery · 268d
Cleared Aug 09, 2023
Q-FIX With Needles (Q-FIX With Needles, #0 Suture & Q-FIX With Needles,...
K231376 · MBI
Smith & Nephew, Inc.
Orthopedic · 89d
Cleared Aug 04, 2023
HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue)
K232005 · MBI
Smith & Nephew, Inc.
Orthopedic · 29d
Cleared Jul 19, 2023
TANDEM Hip System
K231448 · LZY
Smith & Nephew, Inc.
Orthopedic · 62d
Cleared Jun 20, 2023
F3
K222998 · OWB
Acrew Imaging, Inc.
Radiology · 265d
Cleared Jun 14, 2023
TRIGEN META-NAIL Nail System
K230761 · JDS
Smith & Nephew, Inc.
Orthopedic · 86d
Cleared Jun 07, 2023
AETOS Shoulder System
K230572 · KWS
Smith & Nephew, Inc.
Orthopedic · 98d
Cleared May 30, 2023
Smith & Nephew ACCORD™ Cable System
K223762 · HRS
Smith & Nephew
Orthopedic · 166d
Cleared May 16, 2023
VERSAJET Hydrosurgery System (III)
K220964 · FQH
Smith & Nephew Medical Limited
General & Plastic Surgery · 410d
Cleared May 11, 2023
Regeneten Bioinductive Implant
K222501 · OWY
Smith and Nephew, Inc.
Orthopedic · 266d
Cleared May 04, 2023
Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System,...
K230653 · JWH
Smith & Nephew, Inc.
Orthopedic · 56d