Pulmodyne Inc

FDA Filings

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

FDA Registration(s)
Registration Number1832562
FEI Number1832562
NamePulmodyne Inc.
Owner & OperatorENGINEERED MEDICAL SYSTEMS
Contact Address2055 EXECUTIVE DR. --
INDIANAPOLIS IN 46241 US
Official Correspondent
  • TAMARA - LEFEVERS
  • x-317-2465500-x
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address2055 Executive Dr
Indianapolis, IN 46241 US
Establishment Type
  • Manufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility
  • Repack or Relabel Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)



FDA Filings

Device
Company
DeviceDate
PULMODYNE INC
VT Select 2023-04-18
PULMODYNE INC
VT Select 2023-04-18
PULMODYNE INC
VT Select 2023-04-18
PULMODYNE INC
VT Select 2023-04-18
PULMODYNE INC
VT Select 2023-04-18
PULMODYNE INC
BiTrac SE Select 2022-04-05
PULMODYNE INC
Aero-Sat Filter Compact Angled 2022-04-04
PULMODYNE INC
Aero-Sat Filter Compact Angled 2022-04-04
PULMODYNE INC
Aero-Sat Filter Compact Straight 2022-04-04
PULMODYNE INC
Aero-Sat Filter Compact Straight 2022-04-04
PULMODYNE INC
Aero-Sat Filter Pedi 2022-04-04
PULMODYNE INC
Aero-Sat Filter Small Straight 2022-04-04
PULMODYNE INC
Aero-Sat HEPA 2022-04-04
PULMODYNE INC
Aero-Sat HEPA 2022-04-04
PULMODYNE INC
Aero-Sat Micro+ 3.0 2022-04-04
PULMODYNE INC
Aero-T+ 2022-04-04
PULMODYNE INC
Aero-T 2022-04-04
PULMODYNE INC
Aero-Pro HEPA Small Angled 2022-04-04
PULMODYNE INC
Aero-Pro HEPA Small Straight 2022-04-04
PULMODYNE INC
Aero-Pro HEPA Light w/Port 2022-04-04
PULMODYNE INC
Aero-Pro HEPA Light 2022-04-04
PULMODYNE INC
BiTrac SE Select 2022-04-04
PULMODYNE INC
BiTrac SE Select 2022-04-04
PULMODYNE INC
DART 2022-04-04
PULMODYNE INC
DART-Reach 2022-04-04
PULMODYNE INC
DART-Reach 2022-04-04
PULMODYNE INC
DART-Reach 2022-04-04
PULMODYNE INC
DART 2022-04-04
PULMODYNE INC
DART 2022-04-04
PULMODYNE INC
Aero-Pro Filter Small Angled 2022-04-04
PULMODYNE INC
Aero-Sat Filter Small Angled 2022-04-04
PULMODYNE INC
Aero-Pro S Filter 2022-04-04
PULMODYNE INC
Aero-Sat Micro+ 3.5 2022-04-04
PULMODYNE INC
Aero-Pro Filter Compact Angled 2022-04-04
PULMODYNE INC
Aero-Pro HEPA Small Angled 2022-04-04
PULMODYNE INC
Aero-Pro HEPA Small Straight 2022-04-04
PULMODYNE INC
Aero-Pro Filter Small Straight 2022-04-04
PULMODYNE INC
Control-Cric 2021-10-08
PULMODYNE INC
DART 2021-07-06
PULMODYNE INC
O2-MAX 2020-12-24
PULMODYNE INC
O2-MAX 2020-12-24
PULMODYNE INC
O2-MAX 2020-12-24
PULMODYNE INC
O2-MAX 2020-12-24
PULMODYNE INC
O2-MAX 2020-12-24
PULMODYNE INC
O2-MAX 2020-12-24
PULMODYNE INC
O2-MAX 2020-12-24
PULMODYNE INC
O2-MAX 2020-12-24
PULMODYNE INC
O2-MAX 2020-12-24
PULMODYNE INC
O2-MAX 2020-12-24
PULMODYNE INC
O2-MAX 2020-12-24
PULMODYNE INC
O2-CPAP Valve 2020-12-11
PULMODYNE INC
Aero-Pro 2020-09-02
PULMODYNE INC
Aero-Sat 2020-08-04
PULMODYNE INC
Aero-Sat 2020-08-04
PULMODYNE INC
Aero-Sat 2020-08-04
PULMODYNE INC
Aero-Sat 2020-07-16
PULMODYNE INC
Areo-Pro 2020-05-18
PULMODYNE INC
Aero-Pro HEPA Light Machine 2020-05-04
PULMODYNE INC
Bacterial/Viral Depth Filter no Port 2020-04-27
PULMODYNE INC
BiTrac 2019-11-27
PULMODYNE INC
BiTrac 2019-11-27
PULMODYNE INC
BiTrac 2019-11-27
PULMODYNE INC
BiTrac 2019-11-27
PULMODYNE INC
ValueTrac 2019-11-27
PULMODYNE INC
BiTrac 2019-11-27
PULMODYNE INC
BiTrac 2019-11-27
PULMODYNE INC
BiTrac 2019-11-27
PULMODYNE INC
O2-MAX 2019-11-11
PULMODYNE INC
O2-MAX 2019-11-11
PULMODYNE INC
O2-MAX 2019-11-11
PULMODYNE INC
O2-MAX 2019-11-11
PULMODYNE INC
O2-MAX 2019-11-11
PULMODYNE INC
O2-MAX 2019-11-11
PULMODYNE INC
O2-MAX 2019-11-11
PULMODYNE INC
O2-MAX 2019-11-11
PULMODYNE INC
O2-MAX 2019-11-11
PULMODYNE INC
O2-MAX 2019-11-11
PULMODYNE INC
O2-MAX 2019-11-11
PULMODYNE INC
O2-MAX 2019-11-11
PULMODYNE INC
O2-MAX 2019-11-11
PULMODYNE INC
O2-MAX 2019-11-11
PULMODYNE INC
O2-MAX 2019-11-11
PULMODYNE INC
O2-MAX 2019-11-11
PULMODYNE INC
O2-MAX 2019-11-11
PULMODYNE INC
O2-MAX 2019-11-11
PULMODYNE INC
O2-MAX 2019-11-11
PULMODYNE INC
O2-MAX 2019-11-11
PULMODYNE INC
O2-MAX 2019-11-11
PULMODYNE INC
O2-MAX 2019-11-11
PULMODYNE INC
O2-MAX 2019-11-11
PULMODYNE INC
O2-MAX 2019-11-11
PULMODYNE INC
O2-MAX 2019-11-11
PULMODYNE INC
O2-MAX 2019-11-11
PULMODYNE INC
O2-MAX 2019-11-11
PULMODYNE INC
O2-MAX 2019-11-11
PULMODYNE INC
O2-MAX 2019-11-11
PULMODYNE INC
02-MAX 2019-11-11
PULMODYNE INC
02-MAX 2019-11-11
PULMODYNE INC
02-MAX 2019-11-11
PULMODYNE INC
02-MAX 2019-11-11
Pulmodyne Inc. [ENGINEERED MEDICAL SYSTEMS]
Aero-T2018-06-19
Pulmodyne Inc. [ENGINEERED MEDICAL SYSTEMS]
Aero-T+2018-06-19
Pulmodyne Inc. [ENGINEERED MEDICAL SYSTEMS]
Aero-Sat2018-06-19
Pulmodyne Inc. [ENGINEERED MEDICAL SYSTEMS]
Control Cric2016-01-11
Pulmodyne Inc. [ENGINEERED MEDICAL SYSTEMS]
Blom Tracheostomy Tube Kits & Accessories2014-04-01
Pulmodyne Inc. [ENGINEERED MEDICAL SYSTEMS]
ElectroLarynx2013-01-15
Pulmodyne Inc. [ENGINEERED MEDICAL SYSTEMS]
Valved T2013-01-15
Pulmodyne Inc. [ENGINEERED MEDICAL SYSTEMS]
Silicone Adapter - eValueMed2013-01-15
Pulmodyne Inc. [ENGINEERED MEDICAL SYSTEMS]
BiTrac2013-01-15
Pulmodyne Inc. [ENGINEERED MEDICAL SYSTEMS]
Valved T2013-01-15
Pulmodyne Inc. [ENGINEERED MEDICAL SYSTEMS]
BiTrac2013-01-15
Pulmodyne Inc. [ENGINEERED MEDICAL SYSTEMS]
Swirler2012-12-12
Pulmodyne Inc. [ENGINEERED MEDICAL SYSTEMS]
ResQGARD 7.02012-11-29
Pulmodyne Inc. [ENGINEERED MEDICAL SYSTEMS]
ResQGARD 7.02012-11-29
Pulmodyne Inc. [ENGINEERED MEDICAL SYSTEMS]
O2-MAX2008-12-09
Pulmodyne Inc. [ENGINEERED MEDICAL SYSTEMS]
O2 Resq2008-12-09
Pulmodyne Inc. [ENGINEERED MEDICAL SYSTEMS]
Go-PAP2008-12-09
Pulmodyne Inc. [ENGINEERED MEDICAL SYSTEMS]
AccuPAP2008-12-09
Pulmodyne Inc. [ENGINEERED MEDICAL SYSTEMS]
APV2007-12-04
Pulmodyne Inc. [ENGINEERED MEDICAL SYSTEMS]
SealFlex2007-12-04
Pulmodyne Inc. [ENGINEERED MEDICAL SYSTEMS]
BiTrac2007-12-04
Pulmodyne Inc. [ENGINEERED MEDICAL SYSTEMS]
BiTrac Select2007-12-04
Pulmodyne Inc. [ENGINEERED MEDICAL SYSTEMS]
BiTrac HC2007-12-04
Pulmodyne Inc. [ENGINEERED MEDICAL SYSTEMS]
VentiSure22007-12-04
Pulmodyne Inc. [ENGINEERED MEDICAL SYSTEMS]
FENEM2007-12-04
Pulmodyne Inc. [ENGINEERED MEDICAL SYSTEMS]
Pertrach2007-12-04
Pulmodyne Inc. [ENGINEERED MEDICAL SYSTEMS]
Percussor2007-12-04
Pulmodyne Inc. [ENGINEERED MEDICAL SYSTEMS]
SealFlex2007-12-04
Pulmodyne Inc. [ENGINEERED MEDICAL SYSTEMS]
Profit2007-12-04
Pulmodyne Inc. [ENGINEERED MEDICAL SYSTEMS]
BiTrac2007-12-04
Pulmodyne Inc. [ENGINEERED MEDICAL SYSTEMS]
BiTrac Select2007-12-04
Pulmodyne Inc. [ENGINEERED MEDICAL SYSTEMS]
BiTrac HC2007-12-04
Pulmodyne Inc. [ENGINEERED MEDICAL SYSTEMS]
Pulmonary Function Filter2007-12-04
Pulmodyne Inc. [ENGINEERED MEDICAL SYSTEMS]
eValueMed2007-12-04
Pulmodyne Inc. [ENGINEERED MEDICAL SYSTEMS]
DPM2007-12-04
Pulmodyne Inc. [ENGINEERED MEDICAL SYSTEMS]
SealFlex2002-11-27
Pulmodyne Inc. [ENGINEERED MEDICAL SYSTEMS]
COBRA PLA2002-11-27

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