Monique Costanza Lazzarini

FDA Filings

This page includes the latest FDA filings for Monique Costanza Lazzarini. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3000976525
FEI Number3000976525
NameMonique Costanza-Lazzarini
Owner & OperatorPhilips Medical Systems International BV
Contact AddressTussendiepen 4
Drachten NL-NOTA 9206 AD NL
US Agent
Importing Logistics Registration
ImporterDHL Express
Address1210 Pine Island Rd
Plantation, FL 33324 UNITED STATES
Importer TypeAgent
Importing Logistics Registration
ImporterExpeditors International of Washington Inc
Address1015 Third Ave 12th Floor
Seattle, WA 98104 UNITED STATES
Importer TypeAgent
Importing Logistics Registration
ImporterFedEx Trade Networks
Address3800 Forest Hill-Irene Road
Hickory Hill, TN 38125 UNITED STATES
Importer TypeBroker
Importing Logistics Registration
ImporterPanalpina
Address67 Park Place
Morristown, NJ 07960 UNITED STATES
Importer TypeAgent
Importing Logistics Registration
ImporterUPS Supply Chain Solutions
Address12380 Morris Road
Alpharetta, GA 30005 UNITED STATES
Importer TypeAgent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address4430 Rosewood Drive Suite 200
Pleasanton, CA 94588 US
Establishment Type
  • Complaint File Establishment per 21 CFR 820.198
  • Manufacture Medical Device
  • Export Device to the United States But Perform No Other Operation on Device

Registration Number3015763655
FEI Number3015763655
NameMonique Costanza-Lazzarini
Owner & OperatorPhilips Medical Systems International BV
Contact AddressTussendiepen 4
Drachten NL-NOTA 9206 AD NL
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address4430 Rosewood Drive Suite 200
Pleasanton, CA 94588 US
Establishment TypeDevelop Specifications But Do Not Manufacture At This Facility

Registration Number3014128039
FEI Number3014128039
NameMonique Costanza-Lazzarini
Owner & OperatorPhilips Medical Systems International BV
Contact AddressTussendiepen 4
Drachten NL-NOTA 9206 AD NL
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address4430 Rosewood Drive Suite 200
Pleasanton, CA 94588 US
Establishment TypeDevelop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device
Company
DeviceDate
Monique Costanza-Lazzarini [Philips Medical Systems International BV]
CAAS workstation2020-03-12
Monique Costanza-Lazzarini [Philips Medical Systems International BV]
CAAS workstation2020-03-12
Monique Costanza-Lazzarini [Philips Medical Systems International BV]
CAAS workstation2019-12-16
Monique Costanza-Lazzarini [Philips Medical Systems International BV]
CAAS workstation2019-12-16
Monique Costanza-Lazzarini [Philips Medical Systems International BV]
CSMC Cardiac Suite2019-12-16
Monique Costanza-Lazzarini [Philips Medical Systems International BV]
QLAB Advanced Quantification Software2019-06-24
Monique Costanza-Lazzarini [Philips Medical Systems International BV]
TomTec-Arena2018-12-07
Monique Costanza-Lazzarini [Philips Medical Systems International BV]
QLAB Advanced Quantification Software2018-06-08
Monique Costanza-Lazzarini [Philips Medical Systems International BV]
Illumeo2018-03-21
Monique Costanza-Lazzarini [Philips Medical Systems International BV]
Illumeo v2.x2018-03-21
Monique Costanza-Lazzarini [Philips Medical Systems International BV]
Illumeo2018-03-21
Monique Costanza-Lazzarini [Philips Medical Systems International BV]
Illumeo v2.x2018-03-21
Monique Costanza-Lazzarini [Philips Medical Systems International BV]
QLAB Advanced Quantification Software2017-05-31
Monique Costanza-Lazzarini [Philips Medical Systems International BV]
IntelliSpace Portal V9.x2016-11-15
Monique Costanza-Lazzarini [Philips Medical Systems International BV]
IntelliSpace Portal V11.x2016-11-15
Monique Costanza-Lazzarini [Philips Medical Systems International BV]
IntelliSpace Portal V10.x2016-11-15
Monique Costanza-Lazzarini [Philips Medical Systems International BV]
IntelliSpace Cardiovascular2016-05-02
Monique Costanza-Lazzarini [Philips Medical Systems International BV]
Xper Information Management System2011-06-29
Monique Costanza-Lazzarini [Philips Medical Systems International BV]
Xper Information Management System2011-06-29
Monique Costanza-Lazzarini [Philips Medical Systems International BV]
Xper Flex Cardio Physiomonitoring System2011-06-29
Monique Costanza-Lazzarini [Philips Medical Systems International BV]
Xper Flex Cardio Physiomonitoring System2011-06-29
Monique Costanza-Lazzarini [Philips Medical Systems International BV]
4 Lead Set Grabber, IEC, 16 Lead Hemo - 989803174241/A2011-06-29
Monique Costanza-Lazzarini [Philips Medical Systems International BV]
4 Lead Set Grabber, IEC, 16 Lead Hemo - 989803174241/A2011-06-29
Monique Costanza-Lazzarini [Philips Medical Systems International BV]
4 Lead Set Grabber, AAMI, 16 Lead Hemo - 989803174231/A2011-06-29
Monique Costanza-Lazzarini [Philips Medical Systems International BV]
4 Lead Set Grabber, AAMI, 16 Lead Hemo - 989803174231/A2011-06-29
Monique Costanza-Lazzarini [Philips Medical Systems International BV]
Xper Information Management System2011-06-29
Monique Costanza-Lazzarini [Philips Medical Systems International BV]
Xper Information Management System2011-06-29
Monique Costanza-Lazzarini [Philips Medical Systems International BV]
Xper Flex Cardio Physiomonitoring System2011-06-29
Monique Costanza-Lazzarini [Philips Medical Systems International BV]
Xper Flex Cardio Physiomonitoring System2011-06-29
Monique Costanza-Lazzarini [Philips Medical Systems International BV]
4 Lead Set Grabber, IEC, 16 Lead Hemo - 989803174241/A2011-06-29
Monique Costanza-Lazzarini [Philips Medical Systems International BV]
4 Lead Set Grabber, IEC, 16 Lead Hemo - 989803174241/A2011-06-29
Monique Costanza-Lazzarini [Philips Medical Systems International BV]
4 Lead Set Grabber, AAMI, 16 Lead Hemo - 989803174231/A2011-06-29
Monique Costanza-Lazzarini [Philips Medical Systems International BV]
4 Lead Set Grabber, AAMI, 16 Lead Hemo - 989803174231/A2011-06-29
Monique Costanza-Lazzarini [Philips Medical Systems International BV]
Xcelera2009-09-03
Monique Costanza-Lazzarini [Philips Medical Systems International BV]
IntelliSpace Cardiovascular2009-09-03
Monique Costanza-Lazzarini [Philips Medical Systems International BV]
IntelliSpace Portal2009-03-23
Monique Costanza-Lazzarini [Philips Medical Systems International BV]
Extended Brilliance Workspace (EBW)2009-03-23

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