FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

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 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