1,027 results · 38ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

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