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Cortex

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30078426723007842672CORTEX DENTAL IMPLANTS INDUSTRIES LTD.1N2026-01-01Yaara Street 26, P.O. Box 125, Old Industrial area Shlomi Northern IL 2283202
30087067073008706707CORTEX MANUFACTURING, LLC1N2026-01-017753 Highway 72 Byhalia MS US 38611
30136279703013627970Cortex, Inc.1N2026-01-012755 Great America Way Ste 401 Santa Clara CA US 95054
30142939553014293955Cortex USA Inc.1Y2026-01-0130 Two Bridges road Suite 370 Fairfield NJ US 07004
30378738643037873864CORTEX METABOLIC INC.1Y2026-01-01126 Cuscowilla Dr Eatonton GA US 31024

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3497331983044086K993641METALYZER, MODEL 2; METALYZER, MODEL 3BTY2000-12-14
3374321985661219K253205OptiMap Catheter - 50mm (OPTI-CATH2-50)MTD2026-03-13
3374322057359194K251344OptiMap™ SystemDQK2025-05-28
3374321947407564K230008Ablamap® SystemDQK2023-06-08
3374321587374106K223666Ablacath™ Mapping CatheterMTD2023-03-17
1075051822558891K181580Cortex CAD/CAM AbutmentsNHA2019-01-29
1075052035205472K163385Cortex Dental Implant SystemDZE2017-08-29
1075051370584631K131258SATURN DENTAL IMPLANTDZE2014-03-17
1226681783612768K102506MIXED MEDIA MARKERNEU2011-01-12
1226681933419815K100267FLEXIMARC, MODEL CM-0.9-2-10-GG-LIYE2010-02-24
1075051732125506K090709CORTEX DENTAL IMPLANT SYSTEMDZE2009-07-07
3497331550996527K001631CORTEX METAMAXBZC2001-02-22
1075051009543388
1075051298450020
1075051146821977
3374321348999970
1226681466753415
3374321847900217

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DZE62017-08-29
MTD22026-03-13
DQK22025-05-28
NEU22011-01-12
IYE22010-02-24
NHA12019-01-29
BZC12001-02-22
BTY12000-12-14

PMN#

GUDID#

CORTEX CPET System - The CORTEX CPET systems are intended for use in CPET, Spirometric, and Basal-/Resting Metabolic Rate Tests for the purpose to objectify the ventilatory, cardio-circulatory and metabolic capacity. With the following indications, they support the user in finding or confirming diagnoses, determining therapy programs and monitoring therapies.In a CPET test, a patient undergoes a period of defined physical stress (normally 10-20 minutes). Hereby data is measured about ventilation, gas exchange and heart rate. On basis of these measured data, further data is calculated and displayed, in order to depict the performance of the cardio-respiratory system.In a spirometry test, the patient performs defined breathing maneuvers (VC, FVC, MVV). Thereby measurement data of the respiratory strength and volume is collected and displayed, in order to show the mechanical capacity of the respiratory system.In a Basal-/Resting Metabolic Rate Test the patient performs a rest test (normally 15-20 minutes). Thereby measurement data of the gas exchange is collected and displayed, in order to estimate the Basal-/Resting Metabolic Rate.

Cortex Biophysik GmbH

2020-09-24

CORTEX CPET system - The CORTEX CPET systems are intended for use in CPET, Spirometric, and Basal-/Resting Metabolic Rate Tests for the purpose to objectify the ventilatory, cardio-circulatory and metabolic capacity. With the following indications, they support the user in finding or confirming diagnoses, determining therapy programs and monitoring therapies.In a CPET test, a patient undergoes a period of defined physical stress (normally 10-20 minutes). Hereby data is measured about ventilation, gas exchange and heart rate. On basis of these measured data, further data is calculated and displayed, in order to depict the performance of the cardio-respiratory system.In a spirometry test, the patient performs defined breathing maneuvers (VC, FVC, MVV). Thereby measurement data of the respiratory strength and volume is collected and displayed, in order to show the mechanical capacity of the respiratory system.In a Basal-/Resting Metabolic Rate Test the patient performs a rest test (normally 15-20 minutes). Thereby measurement data of the gas exchange is collected and displayed, in order to estimate the Basal-/Resting Metabolic Rate.

Cortex Biophysik GmbH

2020-09-24

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