2,344 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Buffer D EZ-001 Module L : 1000L Bag
FDA UDI
Lonza Verviers·05407010123852·
Buffer D EZ-001 Module L : 1L Bag SAMPLE
FDA UDI
Lonza Verviers·05407010129724·
SUTURE ANCHOR, BIO- COMPOSITE PUSHLOCK
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code MAI·December 21, 2021
REVERS LEVER-LOCKING BROACH HANDLE
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code LXH·December 6, 2024
ICOTEC PEDICLE SYSTEM, SCREW, CARBON/PEEK
FDA Adverse Event
Injury
·ICOTEC AG·Product code NKB·November 30, 2023
FASTPASS SCORPION SL-MF WITH FLUSHPORT
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code LXH·December 15, 2025
UNIVERS REVERS VERSION ROD
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code LXH·November 27, 2024
UNKNOWN ATIS ABUTMENT
FDA Adverse Event
Injury
·DENTSPLY IMPLANTS MANUFACTURING GMBH·Product code DZE·October 26, 2022
ADIN DENTAL IMPLANTS
FDA Adverse Event
Injury
·ADIN DENTAL IMPLANTS LTD.·Product code DEZ·May 1, 2026
SEVEN XD INT. HEX. IMPLANT D4.2 L8MM, SP
FDA Adverse Event
Injury
·MIS IMPLANTS TECHNOLOGIES LTD.·Product code DEZ·September 15, 2025
SEVEN XD INT. HEX. IMPLANT D3.75 L8MM SP
FDA Adverse Event
Injury
·MIS IMPLANTS TECHNOLOGIES LTD.·Product code DEZ·February 4, 2025
DW ARTHROSCOPY FLUID MANAGEMENT DEV
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code HRX·November 13, 2023
RESTORE ULTRA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·March 21, 2014
2.7/3.5 TI VA-LCP POSTLAT DHP- LAT SUPT 4H/RT/88MM-MED-STER
FDA Adverse Event
Malfunction
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HRS·April 21, 2020
BOLT FOR FEMORAL NECK SYSTEM 85MM LENGTH-STERILE
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code KTT·May 26, 2020
DRILL BIT Ø1.8 W/MARKING L110/85 2FLUTE
FDA Adverse Event
Malfunction
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HTW·March 9, 2018
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
Igm, Rhodamine, Antigen, Antiserum, Control
FDA classification
FDA Class 2
·Igm, Rhodamine, Antigen, Antiserum, Control
Power Dental U.S.A., Inc.
FDA UDI
Power Dental U.S.A. Inc.·D943N28034EZ00·B27/29 (3.1/1.6mm) 4EZ