30 results · 25ms · Sources: EU EUDAMED, US FDA

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Savaria SL-1000 Stairlift

FDA Enforcement
Class II ·Terminated·Savaria Concord Lifts, Inc.·May 17, 2017

TIBIAL TRAY , SIZE 3, REF 90-SRK-200300, QTY: 1, STERILE R, total knee replacement

FDA Enforcement
Class II ·Terminated·Medtronic Sofamor Danek USA Inc·August 31, 2016

TIBIAL TRAY , SIZE 2, REF 90-SRK-200200, QTY: 1, STERILE R, total knee replacement .

FDA Enforcement
Class II ·Terminated·Medtronic Sofamor Danek USA Inc·August 31, 2016

RESPONSIVE, KNEE: FEMORAL COMPONENT CR/CS, SIZE 3R, REF 90-SRK-311300, QTY: 1, STERILE R,

FDA Enforcement
Class II ·Terminated·Medtronic Sofamor Danek USA Inc·August 31, 2016

TIBIAL TRAY , SIZE 5, REF 90-SRK-200500, QTY: 1, STERILE R, Responsive Orthopedics, total knee replacement

FDA Enforcement
Class II ·Terminated·Medtronic Sofamor Danek USA Inc·August 31, 2016

TIBIAL TRAY , SIZE 4, REF 90-SRK-200400, QTY: 1, STERILE R, Responsive Orthopedics, total knee replacement

FDA Enforcement
Class II ·Terminated·Medtronic Sofamor Danek USA Inc·August 31, 2016

RESPONSIVE, KNEE: FEMORAL total knee replacement COMPONENT CR/CS, SIZE 4R, REF 90-SRK-311400, QTY: 1, STERILE R,

FDA Enforcement
Class II ·Terminated·Medtronic Sofamor Danek USA Inc·August 31, 2016

RESPONSIVE, KNEE: FEMORAL total knee replacement COMPONENT CR/CS, SIZE 5R, REF 90-SRK-311500, QTY: 1, STERILE R,

FDA Enforcement
Class II ·Terminated·Medtronic Sofamor Danek USA Inc·August 31, 2016

RESPONSIVE, KNEE: FEMORAL total knee replacement COMPONENT CR/CS, SIZE 3L, REF 90-SRK-312300, QTY: 1, STERILE R,

FDA Enforcement
Class II ·Terminated·Medtronic Sofamor Danek USA Inc·August 31, 2016

Omega Incline Platform Lift

FDA Enforcement
Class II ·Terminated·Savaria Concord Lifts, Inc.·May 3, 2017

Bariatric Bed Frame System The Citadel Plus Bariatric Bed Frame System is intended for the acute and post-acute care environments. It is not intended for use in the home care environment.

FDA Enforcement
Class II ·Terminated·ARJOHUNTLEIGH POLSKA Sp. z.o.o.·August 26, 2020

Perkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 06198900. The PerkinElmer 226 Sample Collection Devices are intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory, in newborn screening. The device includes a tear-apart form for the collection of demographic information.

FDA Enforcement
Class II ·Terminated·Perkin Elmer Health Sciences, Inc.·October 30, 2013

TrueDent White, TDM110, Model No. OBJ-09168 Light-curable methacrylate-based resin that enables fabrication of dental appliances

FDA Enforcement
Class III ·Completed·STRATASYS LTD·July 16, 2025

TrueDent Yellow, TDM140, Model No. OBJ-09169 Light-curable methacrylate-based resin that enables fabrication of dental appliances

FDA Enforcement
Class III ·Completed·STRATASYS LTD·July 16, 2025

TrueDent Magenta, TDM130, Model No. OBJ-09166 Light-curable methacrylate-based resin that enables fabrication of dental appliances

FDA Enforcement
Class III ·Completed·STRATASYS LTD·July 16, 2025

TrueDent Cyan, TDM 120, Model No. OBJ-09165 Light-curable methacrylate-based resin that enables fabrication of dental appliances

FDA Enforcement
Class III ·Completed·STRATASYS LTD·July 16, 2025

TrueDent Clear, TDM 100, Model No. OBJ-09164 Light-curable methacrylate-based resin that enables fabrication of dental appliances

FDA Enforcement
Class III ·Completed·STRATASYS LTD·July 16, 2025

O.B. Pack, Catalog number 900-645. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

FDA Enforcement
Class I ·Terminated·Customed, Inc·December 10, 2014

O.B. Pack, Catalog number 900-012. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

FDA Enforcement
Class I ·Terminated·Customed, Inc·December 10, 2014

O.B. PK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

FDA Enforcement
Class II ·Terminated·Customed, Inc·September 9, 2015