FDA 510(k) Applications Submitted by SHEILA HEMEON-HEYER, JD, RAC

FDA 510(k) Number Submission Date Device Name Applicant
K020285 01/28/2002 CMA CEREBRAL TISSUE MONITORING SYSTEM CMA MICRODIALYSIS AB
K990528 02/19/1999 ORTHOPHOS 3/3 CEPH/3 DS SIRONA DENTAL SYSTEMS GMBH
K000672 02/28/2000 HELIODENT VARIO SIRONA DENTAL SYSTEMS GMBH
K010935 03/28/2001 BRITESMILE BARRIER MATERIAL BRITESMILE, INC.
K040797 03/29/2004 BRITESMILE MASKING CREAM BRITESMILE, INC.
K001026 03/30/2000 3D-MSPECT THE REAGENTS OF THE UNIVERSITY OF MICHIGAN
K021100 04/04/2002 300 PV COMPLETE ELECTROTHERAPY SYSTEM EMPI
K031196 04/16/2003 SURGETICS ORTHO KNEELOGICS NAVIGATION SYSTEM PRAXIM
K991549 05/03/1999 EMBOSPHERE MICROSPHERES BIOSPHERE MEDICAL
K991874 06/02/1999 EMS SURFACE MOUNT SCALER (EMS SA) ELECTRO MEDICAL SYSTEMS
K021809 06/03/2002 V-2100G ADVANCED INFANT INCUBATOR ATOM MEDICAL CORP.
K972249 06/16/1997 ORTHOPHOS PLUS AND ORTHOPHOS PLUS/CD PELTON & CRANE CO.
K001903 06/22/2000 NEOCONTROL PELVIC FLOOR THERAPY SYSTEM NEOTONUS, INC.
K992251 07/06/1999 SWISS LITHOCLAST MULTIPURPOSE PROBE ELECTRO MEDICAL SYSTEMS SA
K012127 07/09/2001 PULSEMASTER ERBIUM DENTAL LASER SYSTEM AMERICAN DENTAL TECHNOLOGIES, INC.
K022239 07/11/2002 SURGETICS ENTACT ENDONASAL NAVIGATION SYSTEM PRAXIM
K972630 07/14/1997 COOPERSURGICAL DIGITAL COLPOSCOPY SYSTEM COOPERSURGICAL, INC.
K992505 07/27/1999 TERATECH, MODEL 2000 IMAGING IMAGING TERATECH CORP.
K012445 08/01/2001 EMS SWISS LITHOCLAST MASTER (A.K.A. SWISS LITHOCLAST ULTRA) ELECTRO MEDICAL SYSTEMS SA
K002355 08/02/2000 ATOM INFA WARMER V-505 ATOM MEDICAL CORP.
K992644 08/06/1999 SIDEXIS DIGITAL RADIOGRAPHY IMAGING SYSTEM SIRONA DENTAL SYSTEMS GMBH
K012517 08/06/2001 CEREC3 VITABLOCKS SIRONA DENTAL SYSTEMS GMBH
K002484 08/14/2000 EMS SWISS ORTHOCLAST CHISELS FOR NON-CEMENTED PROSTHESIS REMOVAL ELECTRO MEDICAL SYSTEMS SA
K132616 08/21/2013 EPAD SAFEOP SURGICAL, INC.
K002889 09/15/2000 PNS MAGNETIC STIMULATOR SYSTEM NEOTONUS, INC.
K013659 11/06/2001 MODIFICATION TO SIDEXIS DIGITAL RADIOGRAPHY IMAGING SYSTEM SIRONA DENTAL SYSTEMS GMBH
K133638 11/27/2013 GEKO FIRSTKIND LIMITED
K994172 12/10/1999 CEREC 3 SIRONA DENTAL SYSTEMS GMBH
K965101 12/20/1996 CARDIOBEEPER CB-12L MERIDIAN MEDICAL TECHNOLOGIES, INC.
K134001 12/27/2013 FIREFLY FIRSTKIND LIMITED
K023481 10/17/2002 MICROVISION SCLERAL BUCKLING COMPONENTS MICROVISION, INC.
K983057 09/01/1998 ORTHOPHOS 5/PLUS/CD SIRONA DENTAL SYSTEMS GMBH
K013650 11/06/2001 ORTHOPHOS DS/DC CEPH, ORTHOPHOS 5/PLUS/CD SIRONA DENTAL SYSTEMS GMBH
K003568 11/20/2000 XISCAN 6000 IMAGING SYSTEM XITEC, INC.
K984406 12/09/1998 XISCAN OFFICE EXPERT IMAGING SYSTEM, XISCAN SURGICAL EXPERT IMAGING SYSTEM XITEC, INC.


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