47 results
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133ms
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Sources: EU EUDAMED, US FDA
Pressure Products Medical Device Manufacturing LLC.
Manufacturer
🇺🇸 United States·1 Basic UDI-DI·1 Device·3 Importers·INTERTEK SEMKO AB and INTERTEK SEMKO AB
SafeSept Transseptal Guidewire
Device
EU MDD
·
Eu Md Class 3
·Pressure Products Medical Device Manufacturing LLC.·On the market·32 countries
PRESSURE PRODUCTS MEDICAL DEVICE MANUFACTURING LLC
FDA registration
PRESSURE PRODUCTS MEDICAL DEVICE MANUFACTURING LLC·3 products·🇺🇸 United States
SafeSept Transseptal Guidewire
Basic UDI-DI
EU MDD
·
Eu Md Class 3
·Pressure Products Medical Device Manufacturing LLC.·1 device
SAFESEPT TRANSSEPTAL GUIDEWIRE
FDA Adverse Event
Malfunction
·PRESSURE PRODUCTS MEDICAL DEVICE MANUFACTURING LLC·Product code DRC·June 1, 2021
SAFESHEATH II
FDA Adverse Event
Malfunction
·PRESSURE PRODUCTS MEDICAL DEVICE MANUFACTURING LLC·Product code DYB·July 9, 2024
SAFESEPT TRANSSEPTAL GUIDEWIRE
FDA Adverse Event
Death
·PRESSURE PRODUCTS MEDICAL DEVICE MANUFACTURING LLC·Product code DRC·May 22, 2026
SAFESEPT NEEDLE FREE TRANSSEPTAL GUIDEWIRE
FDA Adverse Event
Injury
·PRESSURE PRODUCTS MEDICAL DEVICE MANUFACTURING LLC·Product code DRC·December 21, 2018
SAFESEPT TRANSSEPTAL GUIDEWIRE
FDA Adverse Event
Injury
·PRESSURE PRODUCTS MEDICAL DEVICE MANUFACTURING LLC·Product code DRC·May 15, 2026
SAFESEPTTM TRANSSEPTAL NEEDLE
FDA Adverse Event
Injury
·PRESSURE PRODUCTS MEDICAL DEVICE MANUFACTURING LLC.·Product code DRC·October 8, 2024
SAFESEPT NEEDLE FREE TRANSSEPTAL GUIDEWIRE
FDA Adverse Event
Malfunction
·PRESSURE PRODUCTS MEDICAL DEVICE MANUFACTURING LLC·Product code DRC·January 29, 2020
PRESSURE PRODUCTS 6FR. SAFE SHEATH
FDA Adverse Event
Malfunction
·PRESSURE PRODUCTS MEDICAL DEVICE MANUFACTURING LLC·Product code DYB·January 6, 2021
DUAL INTRODUCER
FDA Adverse Event
Malfunction
·PRESSURE PRODUCTS MEDICAL DEVICE MANUFACTURING LLC·Product code DYB·January 6, 2021
SAFESEPT NEEDLE FREE TRANSSEPTAL GUIDEWIRE
FDA Adverse Event
Malfunction
·PRESSURE PRODUCTS MEDICAL DEVICE MANUFACTURING LLC·Product code DRC·September 9, 2019
Bisping Medizintechnik GmbH
Authorized representative
🇩🇪 Germany·2 Manufacturers·1 Device
413106295
Certificate
MDD Annex II (excluding section 4)·Pressure Products Medical Device Manufacturing LLC.·INTERTEK SEMKO AB·1 Basic UDI-DI
413106296
Certificate
MDD Annex II Section 4·Pressure Products Medical Device Manufacturing LLC.·INTERTEK SEMKO AB·1 Basic UDI-DI
ALLIED HEALTHCARE PRODUCTS INC.
FDA Adverse Event
Malfunction
·ALLIED HEALTHCARE PRODUCTS INC·Product code BTL·October 27, 2023
ALLIED HEALTHCARE PRODUCTS INC.
FDA Adverse Event
Malfunction
·ALLIED HEALTHCARE PRODUCTS INC.·Product code BTL·October 27, 2023
REMUNITYPRO PUMP FOR REMODULIN (TREPROSTINIL) INJECTION
FDA Adverse Event
Malfunction
·MILLYARD ADVANCED MEDICAL PRODUCTS, LLC·Product code FRN·February 19, 2026