Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

470 results for "Synthes (Usa)"
1–24 of 470
Search insights Median review: 81d Cleared: 100% Top manufacturer: Synthes (Usa) Lead specialty: Orthopedic
Cleared Jun 11, 2026
MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction System
K254087 · KTT
Synthes USA Products, LLC
Orthopedic · 175d
Cleared Jan 28, 2022
SyntheCel Dura Repair
K212943 · GXQ
Synthes USA Products, LLC
Neurology · 135d
Cleared May 25, 2021
MAXFRAME Multi-Axial Correction System (aka MAXFRAME)
K211313 · KTT
Synthes USA Products, LLC
Orthopedic · 25d
Cleared Apr 08, 2021
DePuy Synthes Variable Angle Locking Patella Plating System
K210408 · HRS
Synthes USA Products, LLC
Orthopedic · 56d
Cleared Mar 26, 2021
DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur...
K210205 · HRS
Synthes USA Products, LLC
Orthopedic · 59d
Cleared Sep 23, 2020
DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking...
K201346 · HSB
Synthes USA Products, LLC
Orthopedic · 125d
Cleared Sep 18, 2020
DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional
K192702 · GXN
Synthes USA Products, LLC
Neurology · 357d
Cleared Sep 10, 2020
DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm)
K201944 · JEY
Synthes USA Products, LLC
Dental · 59d
Cleared Sep 09, 2020
DePuy Synthes Variable Angle Locking Patella Plating System
K201578 · HRS
Synthes USA Products, LLC
Orthopedic · 90d
Cleared Sep 03, 2020
DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary...
K201336 · JDS
Synthes USA Products, LLC
Orthopedic · 106d
Cleared Feb 26, 2020
DePuy Synthes Hammertoe Continuous Compression Implant
K191463 · JDR
Synthes USA Products, LLC
Orthopedic · 268d
Cleared Dec 30, 2019
Depuy Synthes Maxillofacial Portfolio - MR Conditional
K192655 · JEY
Synthes USA Products, LLC
Dental · 96d
Cleared Nov 26, 2019
DePuy Synthes Trauma Screws
K192745 · HWC
Synthes (Usa) Products, LLC / Depuy...
Orthopedic · 57d
Cleared Nov 07, 2019
DePuy Synthes 2.4mm LCP Straight Wrist Plate, Sterile
K192327 · HRS
Synthes USA Products, LLC
Orthopedic · 72d
Cleared Jul 23, 2019
DePuy Synthes Craniomaxillofacial Sternal Devices - MR Conditional
K190963 · HRS
Synthes USA Products, LLC
Orthopedic · 102d
Cleared May 09, 2019
DePuy Synthes Sterilization Container System
K181933 · KCT
Synthes (Usa) Products, LLC / Depuy...
General Hospital · 294d
Cleared Mar 13, 2019
DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio – MR...
K183472 · FTM
Synthes USA Products, LLC
General & Plastic Surgery · 89d
Cleared Mar 13, 2019
DePuy Synthes Maxillofacial Portfolio - MR Conditional
K183113 · MQN
Synthes USA Products, LLC
Dental · 124d
Cleared Dec 21, 2018
TruMatch Graft Cage - Long Bone
K180821 · HRS
Synthes (Usa), LLC
Orthopedic · 266d
Cleared Nov 01, 2018
DePuy Synthes Trauma Orthopedic Plates and Screws
K180310 · HRS
Synthes (Usa) Products, LLC / Depuy...
Orthopedic · 269d
Cleared Oct 19, 2018
Titanium TomoFix Medial High Tibia Plate Anatomical
K180213 · HRS
Synthes USA Products, LLC
Orthopedic · 267d
Cleared Oct 16, 2018
Depuy Synthes Femoral Neck System
K182154 · KTT
Synthes USA Products, LLC
Orthopedic · 68d
Cleared Jul 24, 2018
DePuy Synthes Static Staples
K180544 · JDR
Synthes USA Products, LLC
Orthopedic · 145d
Cleared Jun 21, 2018
DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins – MR Conditional,...
K172975 · JDQ
Synthes (Usa) Products, LLC / Depuy...
Orthopedic · 267d