FDA 510(k) Applications Submitted by KATHY ANDERSON

FDA 510(k) Number Submission Date Device Name Applicant
K050110 01/18/2005 SYNTHES (USA) LCP MODULAR FOOT PLATES SYNTHES (USA)
K050606 03/10/2005 SYNTHES 1.0MM TI. CORTEX, SELF-DRILLING SCREWS (CARNIOFACIAL) SYNTHES (USA)
K050607 03/10/2005 SYNTHES 1.0MM TI. CORTEX, SELF-DRILLING SCREWS (HAND & NEURO) SYNTHES (USA)
K050646 03/14/2005 SYNTHES (USA) 3.5/4.5MM LCP MEDIAL PROXIMAL TIBIA PLATES SYNTHES (USA)
K050683 03/17/2005 SYNTHES (USA) 3.5MM CONICAL SCREWS SYNTHES (USA)
K051049 04/25/2005 SYNTHES (USA) LOW-PROFILE WRIST FIXATOR SYNTHES (USA)
K121701 06/08/2012 SYSTEMS INTEGRATION OLYMPUS MEDICAL SYSTEMS CORP.
K051600 06/16/2005 SYNTHES (USA) DISTRACTION OSTEOGENESIS SYSTEM SYNTHES (USA)
K051720 06/27/2005 SYNTHES (USA) BONE MARROW ASPIRATION SYRINGE SYNTHES (USA)
K051879 07/11/2005 SYNTHES (USA) POROUS POLYETHYLENE IMPLANTS SYNTHES (USA)
K072002 07/23/2007 FILTER CARESTAR 30; FILTER SAFESTAR 55; FILTER/HME TWINSTAR 55 DRAEGER MEDICAL AG & CO. KG
K072412 08/27/2007 OPTION SMARTCARE FOR EVITAXL,SMARTCARE KIT CAPNO PACKAGE, CO2 SENSOR CAPNOSMART, MODELS 8415941, 8415942, 6871500 DRAGER MEDICAL AG & CO. KGAA
K042606 09/24/2004 MODIFICATION TO:SYNTHES (USA) TITANIUM WIRE SYNTHES (USA)
K072884 10/09/2007 FABIUS MRI DRAEGER MEDICAL AG & CO. KG
K072885 10/09/2007 CARINA SYSTEM, MODEL 8419350; CARINA BASIC DEVICE, MODEL 5704110 DRAEGER MEDICAL AG & CO. KG
K043039 11/04/2004 SYNTHES (USA) EXTERNAL FIXATION COMPONENT LINE EXTENSION - MR SAFE SYNTHES (USA)
K043045 11/04/2004 SYNTHES (USA) CHRONOS SYNTHES (USA)
K043555 12/27/2004 SYNTHES 9USA) ALVEOLAR RIDGE DISTRACTOR SYNTHES (USA)


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact