22 results
·
24ms
·
Sources: EU EUDAMED, US FDA
Osteotomy Wedge System
FDA 510(k)
FDA Class 2
·Orthopedic
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704283938·
NA
FDA UDI
aap Implantate AG·04042409193224·Juxta-articular Radiusplate WSP 2.5, 5/4-Hole, ...
MYTIS ARROW XXXX
FDA 510(k)
FDA Class 2
·Dental
DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa)
FDA 510(k)
FDA Class 2
·Radiology
T:SLIM G5 SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OYC·May 13, 2020
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·April 14, 2021
INGEVITY+
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code NVN·May 12, 2025
IVT DISPOSABLE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MALTA·Product code KPE·September 16, 2011
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·November 14, 2014
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 29, 2013
VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAM·March 9, 2018
GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
FDA Adverse Event
Malfunction
·COOK INC·Product code MMX·August 20, 2024
GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
FDA Adverse Event
Malfunction
·COOK INC·Product code MMX·November 18, 2024
UNKNOWN
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FCG·April 11, 2024
UNKNOWN
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FCG·April 16, 2024
VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAM·March 9, 2018
MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 710001B2
FDA Enforcement
Class II
·Ongoing·Getinge Usa Sales Inc·November 20, 2024
Nussloch GmbH ASP6025 Tissue Processor
FDA Enforcement
Class II
·Ongoing·Leica Microsystems, Inc.·July 12, 2017
Leica ASP6025 Vacuum Tissue Processor The Leica ASP6025 is a modular tissue processor for the following laboratory applications: fixation, dehydration, infiltration with intermedium, and the paraffin infiltration of histological tissue specimens.
FDA Enforcement
Class II
·Terminated·Leica Microsystems, Inc.·August 7, 2013