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)"
25–48 of 470
Search insights Median review: 81d Cleared: 100% Top manufacturer: Synthes (Usa) Lead specialty: Orthopedic
Cleared Nov 14, 2017
DePuy Synthes Femoral Recon Nail System
K172157 · HSB
Synthes USA Products, LLC
Orthopedic · 119d
Cleared CT Sep 28, 2017
TRAUMACEM™ V+ Injectable Bone Cement
K170802 · LOD
Synthes USA Products, LLC
Orthopedic · 195d
Cleared Jun 30, 2017
DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy...
K160553 · HRS
Synthes (Usa) Products, LLC / Depuy...
Orthopedic · 487d
Cleared Jan 18, 2017
Taps for Resorbable Screws
K153587 · HBG
Synthes USA Products, LLC
Neurology · 399d
Cleared Nov 10, 2016
DePuy Synthes MAXFRAME Multi-Axial Correction System
K161417 · KTT
Synthes (Usa), LLC
Orthopedic · 171d
Cleared Nov 03, 2016
MatrixRIB Fixation System
K161590 · HRS
Synthes USA Products, LLC
Orthopedic · 147d
Cleared Sep 26, 2016
DePuy Synthes TFNA Augmentation System
K160167 · HSB
Synthes USA Products, LLC
Orthopedic · 243d
Cleared Dec 02, 2015
Zero-P Natural Plate System
K152239 · KWQ
Synthes (Usa), LLC
Orthopedic · 114d
Cleared Aug 21, 2015
SYNFIX Evolution Secured Spacer System
K150673 · OVD
Synthes USA Products, LLC
Orthopedic · 158d
Cleared Jun 23, 2015
Dental Bone Cutting Instruments
K150796 · DZJ
Synthes USA Products, LLC
Dental · 89d
Cleared Mar 30, 2015
DEPUY SYNTHES VARIABLE ANGLE LOCKING HAND SYSTEM
K141527 · HRS
Synthes (Usa)
Orthopedic · 294d
Cleared Mar 23, 2015
Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates...
K150099 · HRS
Synthes USA Products, LLC
Orthopedic · 62d
Cleared Oct 17, 2014
MATRIXWAVE MMF SYSTEM
K141165 · JEY
Synthes USA Products, LLC
Dental · 164d
Cleared Aug 29, 2014
DEPUY SYNTHES TOMOFIX OSTEOTOMY SYSTEM
K141796 · HRS
Synthes USA Products, LLC
Orthopedic · 57d
Cleared Aug 14, 2014
SYNTHES REUSABLE STERILIZATION CONTAINER SYSTEM
K130720 · KCT
Synthes USA Products, LLC
General Hospital · 514d
Cleared Aug 07, 2014
MATRIXRIB ENDO THORACOSCOPIC RIB PLATING SYSTEM
K141241 · HRS
Synthes USA Products, LLC
Orthopedic · 86d
Cleared Jun 13, 2014
MATRIXNEURO PREFORMED MESH (PART OF THE MATRIXNEURO CRANIAL PLATING SYSTEM)
K140462 · GWO
Synthes USA Products, LLC
Neurology · 109d
Cleared May 02, 2014
MATRIXRIB FIXATION SYSTEM
K133616 · HRS
Synthes USA Products, LLC
Orthopedic · 158d
Cleared Mar 31, 2014
SYNTHES SYNSONIC ULNA NAIL
K131984 · HSB
Synthes (Usa)
Orthopedic · 276d
Cleared Feb 28, 2014
SYNTHES TROCHANTERIC FIXATION NAIL - ADVANCED SYSTEM
K131548 · HSB
Synthes USA Products, LLC
Orthopedic · 274d
Cleared Jan 06, 2014
LATERAL SYNFIX
K131276 · OVD
Synthes USA Products, LLC
Orthopedic · 245d
Cleared Oct 08, 2013
SYNTHES 2.7MM AND 3.5MM VARIABLE ANGLE LCP MIDFOOT/HINDFOOT SYSTEM
K131186 · HRS
Synthes USA Products, LLC
Orthopedic · 166d
Cleared May 24, 2013
SYNTHES SYNCAGE EVOLUTION SPACER
K122639 · MAX
Synthes USA Products, LLC
Orthopedic · 268d
Cleared May 20, 2013
SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEM
K130146 · NDN
Synthes (Usa), LLC
Orthopedic · 118d