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)"
49–72 of 470
Search insights Median review: 81d Cleared: 100% Top manufacturer: Synthes (Usa) Lead specialty: Orthopedic
Cleared Jan 08, 2013
FALCON SPACER
K123180 · MAX
Synthes USA Products, LLC
Orthopedic · 90d
Cleared Jul 06, 2012
SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL...
K121601 · HRS
Synthes (Usa)
Orthopedic · 35d
Cleared Jun 19, 2012
SYNTHES RADIAL HEAD PROSTHESIS SYSTEM
K112030 · KWI
Synthes (Usa), LLC
Orthopedic · 340d
Cleared Jun 18, 2012
SYNTHES VA LCP ANKLE TRAUMA SYSTEM
K120854 · HRS
Synthes (Usa)
Orthopedic · 89d
Cleared Jun 04, 2012
SYNTHES 3.5 MM VA-LCP PROXIMAL TIBIA PLATE SYSTEM
K120689 · HRS
Synthes USA Products, LLC
Orthopedic · 90d
Cleared May 25, 2012
SYNTHES ACIS/VERTEBRAL SPACER CR
K120275 · ODP
Synthes (Usa), LLC
Orthopedic · 116d
Cleared May 08, 2012
SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (MEDICAL AND POSTEROLATERAL DISTAL...
K120717 · HRS
Synthes (Usa)
Orthopedic · 61d
Cleared Mar 21, 2012
SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM
K120070 · HRS
Synthes (Usa)
Orthopedic · 72d
Cleared Feb 29, 2012
2.7MM LCP ULNA OSTEOTOMY SYSTEM
K113364 · HRS
Synthes USA Products, LLC
Orthopedic · 106d
Cleared Feb 08, 2012
SET SCREW FOR TI TROCHANTERIC FIXATION NAIL(TFN)
K120083 · HSB
Synthes (Usa)
Orthopedic · 28d
Cleared Dec 13, 2011
SYNTHES HEMOSTATIC BONE PUTTY
K113079 · MTJ
Synthes (Usa) Products, LLC/Norian...
General & Plastic Surgery · 57d
Cleared Dec 05, 2011
SYNTHES CORTICAL SCREWS
K112583 · HWC
Synthes USA Products, LLC
Orthopedic · 90d
Cleared Dec 05, 2011
SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS
K111667 · JDS
Synthes (Usa)
Orthopedic · 174d
Cleared Nov 28, 2011
SYNTHES BRAINLAB TRAUMA COMPATIBLE INSTRUMENTS
K111891 · HSB
Synthes USA Products, LLC
Orthopedic · 146d
Cleared Nov 17, 2011
SYNTHES LCP PEDIATRIC PLATE SYSTEMS
K112085 · HRS
Synthes USA Products, LLC
Orthopedic · 119d
Cleared Aug 10, 2011
SYNTHES RIA SYSTEM (EXPANDED INDICATIONS)
K111437 · HTO
Synthes USA Products, LLC
Orthopedic · 78d
Cleared Aug 08, 2011
SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM
K111540 · HRS
Synthes (Usa)
Orthopedic · 67d
Cleared Jul 28, 2011
SYNTHES STERNAL ZIPFIX SYSTEM
K110789 · JDQ
Synthes (Usa)
Orthopedic · 128d
Cleared Jul 25, 2011
3.7MM/5.0MM DYNAMIC LOCKING SCREW
K110592 · HWC
Synthes (Usa)
Orthopedic · 145d
Cleared May 24, 2011
SYNTHES 3.5MM LOW PROFILE CORTICAL SCREW
K111230 · HWC
Synthes USA Products, LLC
Orthopedic · 22d
Cleared Apr 21, 2011
2.4 MM VA-LCP VOLAR RIM DISTAL RADIUS SYSTEM
K110125 · HRS
Synthes (Usa)
Orthopedic · 93d
Cleared Mar 04, 2011
4.5MM VA-LCP CURVED CONDYLAR PLATE SYSTEM
K110354 · JDP
Synthes (Usa)
Orthopedic · 25d
Cleared Mar 02, 2011
SYNTHES MULTILOC PROXIMAL HUMERAL NAILING SYSTEM
K103002 · HSB
Synthes (Usa)
Orthopedic · 145d
Cleared Jan 21, 2011
2.4MM VA-LCP INTERCARPAL FUSION SYSTEM
K103243 · HRS
Synthes (Usa)
Orthopedic · 81d