1,027 results
·
38ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Buffer H EZ-001 Module L : 1000L Bag
FDA UDI
Lonza Verviers·05407010123883·
Buffer H EZ-001 Module L : 1L Bag SAMPLE
FDA UDI
Lonza Verviers·05407010129762·
FULL RING, 220MM, TL-HEZ STERILE
FDA Adverse Event
Malfunction
·ORTHOFIX SRL·Product code KTT·December 3, 2014
ENDURANT STENT GRAFT
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code MIH·September 25, 2025
8010047-1997-00015
FDA Adverse Event
Injury
·Product code HEZ·June 11, 1997
OLYMPUS ENDOSCOPE
FDA Adverse Event
Injury
·THE OLYMPUS OPTICAL CO.·Product code HEZ·June 11, 1997
FALLOPOSCOPE
FDA Adverse Event
Other
·CONCEPTUS, INC.·Product code HEZ·December 24, 1996
FALLOPOSCOPE
FDA Adverse Event
Other
·CONCEPTUS, INC.·Product code HEZ·December 24, 1996
ENDURANT STENT GRAFT
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·September 25, 2025
PIPELINE
FDA Adverse Event
Injury
·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·September 14, 2023
UNKENTERPRISE2
FDA Adverse Event
Death
·MEDOS INTERNATIONAL SARL·Product code NJE·May 15, 2024
STENT - VASCULAR RECONSTRUCTION
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code NJE·May 17, 2023
PIPELINE
FDA Adverse Event
Injury
·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·September 14, 2023
PIPELINE
FDA Adverse Event
Death
·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·January 27, 2023
PIPELINE
FDA Adverse Event
Injury
·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·January 27, 2023
EZ Derm Porcine Xenograft, labeled as the following: a. EZ Derm 3x4 (8x10 cm) Non-Perforated, Part Number: 131703-03; b. EZ Derm 7 x 18 (17 x 46 cm) Non-Perforated, Part Number: 131704-03; c. EZ Derm 2 x 2 (5 x 5 cm) Non-Perforated, Part Number: 131705-03; d. EZ Derm 3 x 48 (8 x 122 cm) Perforated, Part Number: 131710-03; e. EZ Derm 3 x 24 (8 x 61 cm) Perforated, Part Number: 131711-03; f. EZ Derm 3 x 12 (8 x 30 cm) Perforated, Part Number: 131712-03; g. EZ Derm 3 x 4 (8 x 10 cm) Perforated, Part Number: 131713-03; h. EZ Derm 7 x 18 (17 x 46 cm) Perforated, Part Number: 131714-03; i. EZ Derm 2 x 2 (5 x 5 cm) Perforated. Part Number: 131715-03 Product Usage: EZ Derm is a porcine derived xenograft in which the collagen has been cross linked with an aldehyde. EZ Derm (porcine xenograft) can be used for partial thickness skin loss injuries. Use of EZ Derm for burns, donor sites and chronic vascular ulcers reduces pain and fluid loss. EZ Derm can also be used as a temporary cover, or test graft, prior to auto grafting and as a protective covering over perforated auto grafts.
FDA Recall
Terminated
·Molnlycke Health Care, Inc·Product code KGN·March 26, 2019
EZ Derm Porcine Xenograft, labeled as the following: a. EZ Derm 3x4 (8x10 cm) Non-Perforated, Part Number: 131703-03; b. EZ Derm 7 x 18 (17 x 46 cm) Non-Perforated, Part Number: 131704-03; c. EZ Derm 2 x 2 (5 x 5 cm) Non-Perforated, Part Number: 131705-03; d. EZ Derm 3 x 48 (8 x 122 cm) Perforated, Part Number: 131710-03; e. EZ Derm 3 x 24 (8 x 61 cm) Perforated, Part Number: 131711-03; f. EZ Derm 3 x 12 (8 x 30 cm) Perforated, Part Number: 131712-03; g. EZ Derm 3 x 4 (8 x 10 cm) Perforated, Part Number: 131713-03; h. EZ Derm 7 x 18 (17 x 46 cm) Perforated, Part Number: 131714-03; i. EZ Derm 2 x 2 (5 x 5 cm) Perforated. Part Number: 131715-03 Product Usage: EZ Derm is a porcine derived xenograft in which the collagen has been cross linked with an aldehyde. EZ Derm (porcine xenograft) can be used for partial thickness skin loss injuries. Use of EZ Derm for burns, donor sites and chronic vascular ulcers reduces pain and fluid loss. EZ Derm can also be used as a temporary cover, or test graft, prior to auto grafting and as a protective covering over perforated auto grafts.
FDA Enforcement
Class II
·Terminated·Molnlycke Health Care, Inc·May 8, 2019
Endoscope, Transcervical (Amnioscope)(And Accessories)
FDA classification
FDA Class 2
·Endoscope, Transcervical (Amnioscope)(And Accessories)
RETRACT EEZ, INC.
FDA registration
RETRACT EEZ, INC.·1 product·🇺🇸 United States
ELECSYS HE4, ELECSYS HE4 CALSET, ELECSYS PRECICONTROL HE4, ELECSYS HE4 CALCHECK 5
FDA 510(k)
FDA Class 2
·Immunology