Gammatom S R L

FDA Filings

This page includes the latest FDA filings for Gammatom S R L. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number9681465
FEI Number3002807113
NameGammatom S.r.l.
Owner & OperatorGAMMATOM Srl
Contact AddressVIA XXIV MAGGIO, 14 --
GUANZATE IT-CO Como 22070 IT
Official Correspondent
  • Gerardo - Soldini
  • 039-031-976035-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressVIA XXIV MAGGIO, 14
GUANZATE (CO) Como, 22070 IT
Establishment TypeSterilize Medical Device for Another Party (Contract Sterilizer)



FDA Filings

Device
Company
DeviceDate
Gammatom S.r.l. [GAMMATOM Srl]
Copan Easy-Swab Collection and Transport System2019-12-12
Gammatom S.r.l. [GAMMATOM Srl]
BD BBL CultureSwab EZ2019-12-12
Gammatom S.r.l. [GAMMATOM Srl]
EcoFLX Empty Mixing Container2019-12-12
Gammatom S.r.l. [GAMMATOM Srl]
MinMax - Cementless anatomical stems size 92019-12-12
Gammatom S.r.l. [GAMMATOM Srl]
MasterLoc Stem - Sizes 13 and 142019-12-12
Gammatom S.r.l. [GAMMATOM Srl]
MectaScrew PEEK Interference Screw2019-12-12
Gammatom S.r.l. [GAMMATOM Srl]
M.U.S.T. MINI Posterior Cervical Screw System - Straight rods2019-12-12
Gammatom S.r.l. [GAMMATOM Srl]
MectaLIF Anterior Stand Alone Extension2019-12-12
Gammatom S.r.l. [GAMMATOM Srl]
MOTO Lateral Partial Knee System2019-12-12
Gammatom S.r.l. [GAMMATOM Srl]
M.U.S.T. MINI Posterior Cervical Screw System - OC2019-12-12
Gammatom S.r.l. [GAMMATOM Srl]
MectaLIF Posterior Extension2019-12-12
Gammatom S.r.l. [GAMMATOM Srl]
Glenoid Polyaxial Non-locking Screw2019-12-12
Gammatom S.r.l. [GAMMATOM Srl]
SMS2019-12-12
Gammatom S.r.l. [GAMMATOM Srl]
Quadra-P2019-12-12
Gammatom S.r.l. [GAMMATOM Srl]
Copan Viral Transystem2019-12-12
Gammatom S.r.l. [GAMMATOM Srl]
Disposable Transfer Pipettes2019-12-12
Gammatom S.r.l. [GAMMATOM Srl]
BD Inoculation Loops2019-12-12
Gammatom S.r.l. [GAMMATOM Srl]
HealthLink Transporter2018-10-29
Gammatom S.r.l. [GAMMATOM Srl]
Copan Venturi Transystem Amies Medium with Charcoal2018-10-29
Gammatom S.r.l. [GAMMATOM Srl]
Copan M40 Transystem2018-10-29
Gammatom S.r.l. [GAMMATOM Srl]
BD BBL CultureSwab2018-10-29
Gammatom S.r.l. [GAMMATOM Srl]
BD BBL CultureSwab Plus2018-10-29
Gammatom S.r.l. [GAMMATOM Srl]
BD BBL CultureSwab MaxV Plus2018-10-29
Gammatom S.r.l. [GAMMATOM Srl]
HealthLink Transporter2018-10-29
Gammatom S.r.l. [GAMMATOM Srl]
Copan Venturi Transystem Liquid Amies Medium2018-10-29
Gammatom S.r.l. [GAMMATOM Srl]
BD BBL CultureSwab2018-10-29
Gammatom S.r.l. [GAMMATOM Srl]
BD BBL CultureSwab MaxV2018-10-29
Gammatom S.r.l. [GAMMATOM Srl]
HealthLink Transporter2018-10-29
Gammatom S.r.l. [GAMMATOM Srl]
Copan Venturi Transystem Amies Medium without Charcoal2018-10-29
Gammatom S.r.l. [GAMMATOM Srl]
Copan M40 Transystem2018-10-29
Gammatom S.r.l. [GAMMATOM Srl]
BD BBL CultureSwab2018-10-29
Gammatom S.r.l. [GAMMATOM Srl]
BD BBL CultureSwab Plus2018-10-29
Gammatom S.r.l. [GAMMATOM Srl]
BD BBL CultureSwab MaxV Plus2018-10-29
Gammatom S.r.l. [GAMMATOM Srl]
Copan Venturi Transystem Cary-Blair Medium2018-10-29
Gammatom S.r.l. [GAMMATOM Srl]
BD BBL CultureSwab2018-10-29
Gammatom S.r.l. [GAMMATOM Srl]
HealthLink Transporter2018-10-29
Gammatom S.r.l. [GAMMATOM Srl]
Copan Venturi Transystem Stuarts Medium2018-10-29
Gammatom S.r.l. [GAMMATOM Srl]
BD BBL CultureSwab2018-10-29
Gammatom S.r.l. [GAMMATOM Srl]
BD BBL CultureSwab MaxV2018-10-29
Gammatom S.r.l. [GAMMATOM Srl]
HealthLink Transporter2018-10-29
Gammatom S.r.l. [GAMMATOM Srl]
Copan Venturi Transystem Amies Medium With Charcoal2018-10-29
Gammatom S.r.l. [GAMMATOM Srl]
Copan M40 Transystem2018-10-29
Gammatom S.r.l. [GAMMATOM Srl]
BD BBL CultureSwab2018-10-29
Gammatom S.r.l. [GAMMATOM Srl]
BD BBL CultureSwab Plus2018-10-29
Gammatom S.r.l. [GAMMATOM Srl]
BD BBL CultureSwab MaxV Plus2018-10-29
Gammatom S.r.l. [GAMMATOM Srl]
HealthLink Transporter2018-10-29
Gammatom S.r.l. [GAMMATOM Srl]
CultureSwab ALLIGENCE2018-10-29
Gammatom S.r.l. [GAMMATOM Srl]
Copan Venturi Transystem Stuarts Medium2018-10-29
Gammatom S.r.l. [GAMMATOM Srl]
Copan Venturi Transystem Liquid Stuarts Medium2018-10-29
Gammatom S.r.l. [GAMMATOM Srl]
Cepheid Liquid Stuart Venturi Transystem2018-10-29
Gammatom S.r.l. [GAMMATOM Srl]
BD BBL CultureSwab2018-10-29
Gammatom S.r.l. [GAMMATOM Srl]
BD BBL CultureSwab MaxV2018-10-29
Gammatom S.r.l. [GAMMATOM Srl]
Copan FecalSwab2018-10-29
Gammatom S.r.l. [GAMMATOM Srl]
Copan FecalSwab2018-10-29
Gammatom S.r.l. [GAMMATOM Srl]
Copan Liquid Amies ESwab2018-10-29
Gammatom S.r.l. [GAMMATOM Srl]
BD ESwab2018-10-29
Gammatom S.r.l. [GAMMATOM Srl]
Copan Liquid Amies ESwab2018-10-29
Gammatom S.r.l. [GAMMATOM Srl]
BD ESwab2018-10-29
Gammatom S.r.l. [GAMMATOM Srl]
Dry Swab Tube2018-10-29
Gammatom S.r.l. [GAMMATOM Srl]
BC+2018-10-29
Gammatom S.r.l. [GAMMATOM Srl]
HealthLink Transporter2018-10-26
Gammatom S.r.l. [GAMMATOM Srl]
Copan Venturi Transystem Amies Medium Without Charcoal2018-10-26
Gammatom S.r.l. [GAMMATOM Srl]
Copan M40 Transystem2018-10-26
Gammatom S.r.l. [GAMMATOM Srl]
BD BBL CultureSwab2018-10-26
Gammatom S.r.l. [GAMMATOM Srl]
BD BBL CultureSwab Plus2018-10-26
Gammatom S.r.l. [GAMMATOM Srl]
BD BBL CultureSwab MaxV Plus2018-10-26
Gammatom S.r.l. [GAMMATOM Srl]
AMIStem-H Proximal Coating AMIStem-P and AMIStem-P Collared2018-10-26
Gammatom S.r.l. [GAMMATOM Srl]
MySpine Pedicle Screw Placement Guides ? MC and Drill Pilot Instruments2018-10-26
Gammatom S.r.l. [GAMMATOM Srl]
MasterLoc Stem: Lateralized Plus2018-10-26
Gammatom S.r.l. [GAMMATOM Srl]
Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markers2018-10-26
Gammatom S.r.l. [GAMMATOM Srl]
GMK Hinge GMK Revision2018-10-26
Gammatom S.r.l. [GAMMATOM Srl]
Mpact? 3D Metal? Implants and Augments 3D Metal?2018-10-26
Gammatom S.r.l. [GAMMATOM Srl]
M.U.S.T. Combined Set Screws2018-10-26
Gammatom S.r.l. [GAMMATOM Srl]
M-ARS ACL: Anatomic Ribbon Surgery System2018-10-26
Gammatom S.r.l. [GAMMATOM Srl]
M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System2018-10-26
Gammatom S.r.l. [GAMMATOM Srl]
M.U.S.T. MINI Posterior Cervical Screws System2018-10-26
Gammatom S.r.l. [GAMMATOM Srl]
M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional Screws2018-10-26
Gammatom S.r.l. [GAMMATOM Srl]
Medacta Shoulder System: Threaded Glenoid Baseplate2018-10-26
Gammatom S.r.l. [GAMMATOM Srl]
Medacta Anatomic Shoulder Prosthesis2018-10-26
Gammatom S.r.l. [GAMMATOM Srl]
MiniMAX2018-10-26
Gammatom S.r.l. [GAMMATOM Srl]
M-Vizion Femoral Revision System2018-10-26
Gammatom S.r.l. [GAMMATOM Srl]
MectaLIF Anterior Stand Alone2018-10-26
Gammatom S.r.l. [GAMMATOM Srl]
Medacta Shoulder System2018-10-26
Gammatom S.r.l. [GAMMATOM Srl]
3DMetal Tibial Cones2018-10-26
Gammatom S.r.l. [GAMMATOM Srl]
MyKnee PPS-Pin Positioners2018-10-26
Gammatom S.r.l. [GAMMATOM Srl]
GMK Revision Femoral Distal Augmentation2018-10-26
Gammatom S.r.l. [GAMMATOM Srl]
MOTO Partial Knee System2018-10-26
Gammatom S.r.l. [GAMMATOM Srl]
M.U.S.T. Pedicle Screw System2018-10-26
Gammatom S.r.l. [GAMMATOM Srl]
GMK UNI2018-10-26
Gammatom S.r.l. [GAMMATOM Srl]
AMIStem-H Proximal Coating2018-10-26
Gammatom S.r.l. [GAMMATOM Srl]
MectaLIF Anterior Stand-Alone2018-10-26
Gammatom S.r.l. [GAMMATOM Srl]
MasterLoc Stem2018-10-26
Gammatom S.r.l. [GAMMATOM Srl]
M.U.S.T. Pedicle Screw System2018-10-26
Gammatom S.r.l. [GAMMATOM Srl]
MySpine Pedicle Screw Placement Guides - LP2018-10-26
Gammatom S.r.l. [GAMMATOM Srl]
MasterLoc Stem2018-10-26
Gammatom S.r.l. [GAMMATOM Srl]
Mpact Double Mobility System2018-10-26
Gammatom S.r.l. [GAMMATOM Srl]
Mecta-C TiPEEK2018-10-26
Gammatom S.r.l. [GAMMATOM Srl]
GMK EXTENSION2018-10-26
Gammatom S.r.l. [GAMMATOM Srl]
M.U.S.T PEDICLE SCREW SYSTEM2018-10-26
Gammatom S.r.l. [GAMMATOM Srl]
M.U.S.T. EXTENSION2018-10-26
Gammatom S.r.l. [GAMMATOM Srl]
GMK SPHERE EXTENSION2018-10-26
Gammatom S.r.l. [GAMMATOM Srl]
META-C CERVICAL PLATE2018-10-26
Gammatom S.r.l. [GAMMATOM Srl]
GMK SHORT STEM2018-10-26
Gammatom S.r.l. [GAMMATOM Srl]
MECTALIF TIPEEK2018-10-26
Gammatom S.r.l. [GAMMATOM Srl]
MPACT EXTENSION2018-10-26
Gammatom S.r.l. [GAMMATOM Srl]
M.U.S.T. EXTENSION2018-10-26
Gammatom S.r.l. [GAMMATOM Srl]
MYSPINE PEDICLE SCREW PLACEMENT GUIDES2018-10-26
Gammatom S.r.l. [GAMMATOM Srl]
MECTALIF2018-10-26
Gammatom S.r.l. [GAMMATOM Srl]
MECTACER BIOLOX OPTION HEADS2018-10-26
Gammatom S.r.l. [GAMMATOM Srl]
MPACT DM LINER CONVERTER2018-10-26
Gammatom S.r.l. [GAMMATOM Srl]
GMK HINGE2018-10-26
Gammatom S.r.l. [GAMMATOM Srl]
MECTALIF ANTERIOR2018-10-26
Gammatom S.r.l. [GAMMATOM Srl]
GMK REVISION EXTENSION2018-10-26
Gammatom S.r.l. [GAMMATOM Srl]
VERSAFITCUP CC TRIO EXTENSION2018-10-26
Gammatom S.r.l. [GAMMATOM Srl]
MPACT EXTENSION2018-10-26
Gammatom S.r.l. [GAMMATOM Srl]
GMK NARROW2018-10-26
Gammatom S.r.l. [GAMMATOM Srl]
GMK SPHERE2018-10-26
Gammatom S.r.l. [GAMMATOM Srl]
M.U.S.T PEDICLE SCREW SYSTEM2018-10-26
Gammatom S.r.l. [GAMMATOM Srl]
AMISTEM AND QUADRA - LINE EXTENSION2018-10-26
Gammatom S.r.l. [GAMMATOM Srl]
GMK - LINE EXTENSION2018-10-26
Gammatom S.r.l. [GAMMATOM Srl]
MECTALIF TRANSFORAMINAL2018-10-26
Gammatom S.r.l. [GAMMATOM Srl]
MECTA-C2018-10-26
Gammatom S.r.l. [GAMMATOM Srl]
MECTACER BIOLOX(R) DELTA FEMORAL HEADS2018-10-26
Gammatom S.r.l. [GAMMATOM Srl]
ENDO HEAD2018-10-26
Gammatom S.r.l. [GAMMATOM Srl]
MECTALIF2018-10-26
Gammatom S.r.l. [GAMMATOM Srl]
MPACT ACETABULAR SYSTEM2018-10-26
Gammatom S.r.l. [GAMMATOM Srl]
VERSAFITCUP CC TRIO2018-10-26
Gammatom S.r.l. [GAMMATOM Srl]
MEDACTA TOTAL HIP PROSTHESIS SYSTEM - AMISTEM C & QUADRA C SHORT NECK2018-10-26
Gammatom S.r.l. [GAMMATOM Srl]
GMK REVISION KNEE SYSTEM2018-10-26
Gammatom S.r.l. [GAMMATOM Srl]
MEDACTA TOTAL HIP PROTHESIS SYSTEM-AMISTEN H QUADRA H QUADRA S2018-10-26
Gammatom S.r.l. [GAMMATOM Srl]
MYKNEE CUTTING BLOCKS2018-10-26
Gammatom S.r.l. [GAMMATOM Srl]
MEDACTA BONE SCREWS - EVOLIS AND VERSAFIT2018-10-26
Gammatom S.r.l. [GAMMATOM Srl]
GMK TOTAL KNEE SYSTEM2018-10-26
Gammatom S.r.l. [GAMMATOM Srl]
MEDACTA TOTAL HIP PROSTHESIS SYSTEM - QUADRA C2018-10-26
Gammatom S.r.l. [GAMMATOM Srl]
VERSAFIT CUP DOUBLE MOBILITY SYSTEM2018-10-26
Gammatom S.r.l. [GAMMATOM Srl]
MEDACTA TOTAL HIP PROSTHESIS SYSTEM - QUADRA H AND R FEMORAL STEMS2018-10-26
Gammatom S.r.l. [GAMMATOM Srl]
EVOLIS TOTAL KNEE SYSTEM2018-10-26
Gammatom S.r.l. [GAMMATOM Srl]
MEDACTA TOTAL HIP PROSTHESIS SYSTEM - LINE EXTENSION2018-10-26
Gammatom S.r.l. [GAMMATOM Srl]
MECTACER BIOLOX FORTE-FEMORAL HEADS2018-10-26
Gammatom S.r.l. [GAMMATOM Srl]
TOTAL HIP PROSTHESIS SYSTEM QUADRA S + COCRMO FEMORAL BALL HEAD + APRICOT2018-10-26
Gammatom S.r.l. [GAMMATOM Srl]
PVC - Free Empty IV Mixing Container2018-05-31
Gammatom S.r.l. [GAMMATOM Srl]
Rayon Fiber Swab, Sterile2013-09-10
Gammatom S.r.l. [GAMMATOM Srl]
Polyester Fiber Swab, Sterile2013-09-10
Gammatom S.r.l. [GAMMATOM Srl]
Nylon Fiber Swab, Sterile2013-09-10
Gammatom S.r.l. [GAMMATOM Srl]
Cotton Fiber Swab, Sterile2013-09-10
Gammatom S.r.l. [GAMMATOM Srl]
CLASSIQSwab2013-09-10
Gammatom S.r.l. [GAMMATOM Srl]
dressing, wound, drug2013-06-26

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