|
Device |
sterilization wrap containers, trays, cassettes & other accessories |
Product Code | KCT |
Regulation Number |
880.6850
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
ADVANCED STERILIZATION PRODUCTS |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
AESCULAP INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AESCULAP, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AESCULAP, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
8
|
AESCULAP, LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AMMED SURGICAL EQUIPMENT, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ANTHOGYR |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
ARGON MED. PRODUCTIONS VERTRIEBS GESELLSCHAFT MBH CO KG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AVALIGN TECHNOLOGIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AVINENT IMPLANT SYSTEM S.L.U. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AVINENT IMPLANT SYSTEM, S.L.U. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AYGUN SURGICAL INSTRUMENTS CO., INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BAHADIR USA CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
BAHADIR USA LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BEGO IMPLANT SYSTEMS GMBH & CO. KG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOTECH DENTAL, SAS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CALDERA MEDICAL, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CAREFUSION 2200 INC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CAREFUSION 2200, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CASE MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CASE MEDICAL, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CASE MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
COCHLEAR |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
COCHLEAR AMERICAS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CODMAN & SHURTLEFF, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CONFORMIS, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CONMED CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
CONMED LINVATEC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
COVIDIEN |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
COVIDIEN, FORMERLY VALLEYLAB, A DIVISION OF TYCO H |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CROSSROADS EXTREMITY SYSTEMS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CROSSROADS EXTREMITY SYSTEMS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DENTSPLY SIRONA |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
DENTSPLY SIRONA INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ELLIPSE TECHNOLOGIES, INCORPORATED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ENTELLUS MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ERMIS MEDIZINTECHNIK |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FXDEVICES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GYRUS ACMI, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
HOLOGIC, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HOLOGIC, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
IMPLANT DIRECT SYBRON MANUFACTURING , LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
IMPLANT DIRECT SYBRON MANUFACTURING, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
INSTITUT STRAUMANN AG |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
INTUITIVE SURGICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INTUITIVE SURGICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
JEWEL PRECISION SHEET METAL & MACHINE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S.A. |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
JJGC INDÚSTRIA E COMÉRCIO DE MATERIAIS DENTÁRIOS S.A. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
K1 MEDICAL LLC |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
KARL STORZ ENDOSCOPY AMERICA INC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
KARL STORZ ENDOSCOPY-AMERICA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KARL STORZ ENDOSCOPYAMERICA INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MACPHERSON MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDTRONIC SOFAMOR DANEK USA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MEDTRONIC SOFAMOR DANEK, USA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MICROLINE SURGICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MILTEX, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEOTRACT, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
NOBEL BIOCARE AB |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
NOBEL BIOCARE SERVICES AG |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NUVASIVE, INCORPORATED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
O&M HALYARD, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OLYMPUS KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT) LT |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OLYMPUS WINTER & IBE GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
OSTEOMED LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
OSUNG MND CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OTICON MEDICAL AB |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PARAGON MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
PARAGON MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PMBS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
RESTORE MEDICAL SOLUTIONS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ROBINSON MEDSURG LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RP MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
S.I.N. - SISTEMA DE IMPLANTE NACIONAL S.A. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
S.I.N. – SISTEMA DE IMPLANTE NACIONAL S.A. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SCICAN LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SKELETAL DYNAMICS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SKLAR CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SMITH & NEPHEW INC., ENDOSCOPY DIV. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SMITH & NEPHEW INC., ENDOSCOPY DIVISION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SMITH & NEPHEW, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
SOADCO, S.L. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SOUTHERN IMPLANTS (PTY) LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STERICUBE, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STERILUCENT, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STERIS CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
9
|
STERIZIGN PRECISION TECHNOLOGIES, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STRAUMANN USA, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SUMMIT MEDICAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
SUMMIT MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
SUMMITT MEDICAL LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SWEDEN & MARTINA S.P.A. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SYBRON DENTAL SPECIALTIES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SYMMETRY SURGICAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SYNTHES (USA) PRODUCTS LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SYNTHES (USA) PRODUCTS LLC / DEPUY ORTHOPAEDICS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
T.A.G. MEDICAL PRODUCTS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
THINK SURGICAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
THINK SURGICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
THOMPSON SURGICAL INSTRUMENTS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
Z-SYSTEMS AG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|