Engineered Medical Systems

FDA Filings

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

Engineered Medical Systems holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number3011503227
FEI Number3011503227
NameEngineered Medical Systems Malaysia sdn. Bhd.
Owner & OperatorENGINEERED MEDICAL SYSTEMS
Contact Address2055 EXECUTIVE DR. --
INDIANAPOLIS IN 46241 US
Official Correspondent
  • TAMARA - LEFEVERS
  • x-317-2465500-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address993,Lorong Perindustrian Bukit Minyak 11 Taman Perindustrian Bukit Minyak
Simpang Ampat Pulau Pinang, 14000 MY
Establishment TypeManufacture Medical Device for Another Party (Contract Manufacturer)

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)

Registration Number3015259858
FEI Number3015259858
NameEngineered Medical Systems Baltimore
Owner & OperatorENGINEERED MEDICAL SYSTEMS
Contact Address2055 EXECUTIVE DR. --
INDIANAPOLIS IN 46241 US
Official Correspondent
  • TAMARA - LEFEVERS
  • x-317-2465500-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address101 West Dickman St. Suite 900
Baltimore, MD 21230 US
Establishment TypeManufacture Medical Device for Another Party (Contract Manufacturer)

FDA Owner/Operator Registration

FDA Filings

Device
Company
DeviceDate
Engineered Medical Systems Baltimore [ENGINEERED MEDICAL SYSTEMS]
SAVeII2018-12-17
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
Engineered Medical Systems Malaysia sdn. Bhd. [ENGINEERED MEDICAL SYSTEMS]
Aero-T2018-06-19
Engineered Medical Systems Malaysia sdn. Bhd. [ENGINEERED MEDICAL SYSTEMS]
Aero-T+2018-06-19
Engineered Medical Systems Malaysia sdn. Bhd. [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
Engineered Medical Systems Malaysia sdn. Bhd. [ENGINEERED MEDICAL SYSTEMS]
O2-MAX2008-12-09
Engineered Medical Systems Malaysia sdn. Bhd. [ENGINEERED MEDICAL SYSTEMS]
O2 Resq2008-12-09
Engineered Medical Systems Malaysia sdn. Bhd. [ENGINEERED MEDICAL SYSTEMS]
Go-PAP2008-12-09
Engineered Medical Systems Malaysia sdn. Bhd. [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
Engineered Medical Systems Malaysia sdn. Bhd. [ENGINEERED MEDICAL SYSTEMS]
VentiSure22007-12-04
Engineered Medical Systems Malaysia sdn. Bhd. [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
Engineered Medical Systems Malaysia sdn. Bhd. [ENGINEERED MEDICAL SYSTEMS]
Aero-Sat2007-12-04
Engineered Medical Systems Malaysia sdn. Bhd. [ENGINEERED MEDICAL SYSTEMS]
Aero-Pro2007-12-04
Pulmodyne Inc. [ENGINEERED MEDICAL SYSTEMS]
DPM2007-12-04
Engineered Medical Systems Malaysia sdn. Bhd. [ENGINEERED MEDICAL SYSTEMS]
DPM2007-12-04
ENGINEERED MEDICAL SYSTEMS
MULTI-STRAP FULL FACE MASK2003-12-01
Pulmodyne Inc. [ENGINEERED MEDICAL SYSTEMS]
SealFlex2002-11-27
Pulmodyne Inc. [ENGINEERED MEDICAL SYSTEMS]
COBRA PLA2002-11-27
ENGINEERED MEDICAL SYSTEMS
TRACH VOX2002-07-30
ENGINEERED MEDICAL SYSTEMS
EMS ELECTROSTATIC FLITER AND HME COMBINATION2002-04-19
ENGINEERED MEDICAL SYSTEMS
EMS PULMONARY FUNCTION TESTING FILTER2002-03-14
ENGINEERED MEDICAL SYSTEMS
EMS HEPA FILTER AND HME COMBINATIONS2002-03-14
ENGINEERED MEDICAL SYSTEMS
DISPOSABLE PRESSURE MONITOR2000-11-30
ENGINEERED MEDICAL SYSTEMS
SWIVEL ELBOW2000-05-26
ENGINEERED MEDICAL SYSTEMS
INCENTIVE SPIROMETER2000-04-12
ENGINEERED MEDICAL SYSTEMS
MODIFICATION TO ENGINEERED MEDICAL SYSTEMS DISPOSABLE MANUAL RESUSCITATOR WITH CO2 DETECTION1999-07-06
ENGINEERED MEDICAL SYSTEMS
MODIFICATION TO ENGINEERED MEDICAL SYSTEMS DISPOSABLE MANUAL RESUSCITATOR WITH CO2 DETECTION1999-07-01
ENGINEERED MEDICAL SYSTEMS
EMS MOUTH TO MASK RESUSCITATORS1999-04-07
ENGINEERED MEDICAL SYSTEMS
EMS PEEP VALVES- ADJUSTABLE1999-01-22
ENGINEERED MEDICAL SYSTEMS
EMS NASAL CPAP MASK1998-01-28
ENGINEERED MEDICAL SYSTEMS
SINGLE USE MANUAL RESUSCITATOR PEEP VALVE1993-09-03
ENGINEERED MEDICAL SYSTEMS
PRESSURE LIMITING ELBOW1993-09-03
ENGINEERED MEDICAL SYSTEMS
EMS BIOPSY INSTRUMENT1993-04-21
ENGINEERED MEDICAL SYSTEMS
BAXTER ADULT/PEDI INFANT SINGLE/USE MAN RESUSCIT1993-04-21
ENGINEERED MEDICAL SYSTEMS
BAXTER ADULT/PEDI/INFANT SINGLE USE MAN RESUSCIT1993-04-06
ENGINEERED MEDICAL SYSTEMS
EMS SINGLE USE MANUAL RESUSCITATORS1991-11-13
ENGINEERED MEDICAL SYSTEMS
EMS PERCUSSOR1991-10-23
ENGINEERED MEDICAL SYSTEMS
SEALFLEX MASK1987-12-21
ENGINEERED MEDICAL SYSTEMS
RIBBED CUSHION MASK1987-06-08

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Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020091770891Shanghai ,China (Mainland) -> Los Angeles, CaliforniaAIR FILTER PLASTIC FITTINGS SILICONE FITTINGS3048 CTN
2020091770891Shanghai ,China (Mainland) -> Los Angeles, CaliforniaAIR FILTER PLASTIC FITTINGS SILICONE FITTINGS3048 CTN
2020091792492Port Swettenham,Malaysia -> Los Angeles, CaliforniaMEDICAL DEVICE982 CTN
2020091792492Port Swettenham,Malaysia -> Los Angeles, CaliforniaMEDICAL DEVICE982 CTN
202009077542Port Swettenham,Malaysia -> New York/Newark Area, Newark, New JerseyMEDICAL DEVICE877 CTN
2020090720693Port Swettenham,Malaysia -> New York/Newark Area, Newark, New JerseyMEDICAL DEVICE306 CTN
202009074173Port Swettenham,Malaysia -> New York/Newark Area, Newark, New JerseyMEDICAL DEVICE971 CTN
2020083172037Shanghai ,China (Mainland) -> Los Angeles, CaliforniaAIR FILTER PLASTIC FITTINGS SILICONE FITTINGS2425 CTN
2020082081339Nagoya Ko ,Japan -> Los Angeles, CaliforniaHEROS ASSENBLY/SCISSORS STAINLESS STELL WITH PO0035792 .34 CTN
202008115458Shanghai ,China (Mainland) -> Los Angeles, CaliforniaAIR FILTER PLASTIC FITTINGS2700 CTN
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