27 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Neodent Implant System - CM Pro PEEK Abutment
FDA 510(k)
FDA Class 2
·Dental
RUSCH
FDA UDI
TELEFLEX INCORPORATED·04026704319596·SLICK SET CUFFED STERILE
OsteoMed
FDA UDI
OSTEOMED LLC·00845694016070·Spectrum Assembly Block
Mariner Cortical
FDA UDI
Seaspine Orthopedics Corporation·10889981168759·CORTICAL SHANK, Cannulated, 7.0 X 80
Mariner Cortical
FDA UDI
Seaspine Orthopedics Corporation·10889987168753·CORTICAL SHANK, Cannulated, 7.0 X 80
RUSCH Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 170050 b) 170055 c) 170060 d) 170065 e) 170070 f) 170075 g) 170080 h) 170085 i) 170090 j) 170095
FDA Recall
Open, Classified
·Teleflex Medical Europe Ltd Ida Business Park Athlone Ireland·Product code BTR·July 16, 2021
Ø3.5mm x 80mm Precontoured Cervical Rods
FDA UDI
XENCO MEDICAL LLC·B064XM21700801·
RUSCH Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 170050 b) 170055 c) 170060 d) 170065 e) 170070 f) 170075 g) 170080 h) 170085 i) 170090 j) 170095
FDA Enforcement
Class II
·Completed·Teleflex Medical Europe Ltd·August 25, 2021
Ø3.5mm X 80mm PRECONTOURED CERVICAL RODS
FDA UDI
XENCO MEDICAL LLC·B064XMPH21700802·
INTELEPACS
FDA 510(k)
FDA Class 2
·Radiology
REPROCESSED TROCARS, MODEL B5LT AND CB5LT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
AGILIA VP MC RO
FDA Adverse Event
Malfunction
·FRESENIUS VIAL S.A.S.·Product code FRN·November 8, 2024
AGILIA VP MC RO
FDA Adverse Event
Malfunction
·FRESENIUS VIAL S.A.S.·Product code FRN·November 8, 2024
RAPIDLAB 1265
FDA Adverse Event
SIEMENS HEALTHCARE DIAGNOSTICS·Product code CHL·October 14, 2014
IUNI G2
FDA Adverse Event
Injury
·CONFORMIS·Product code HSX·June 5, 2013
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL MANUFACTURING CORPORATION·Product code MVK·October 23, 2015
OSTEO-SITE BONE BIOPSY NEEDLE
FDA Adverse Event
Malfunction
·COOK INC·Product code KNW·July 18, 2019
OSTEO-SITE BONE BIOPSY NEEDLE
FDA Adverse Event
Malfunction
·COOK INC·Product code KNW·June 17, 2019
OSTEO-SITE BONE BIOPSY NEEDLE
FDA Adverse Event
Malfunction
·COOK INC·Product code KNW·January 23, 2019
OSTEO-SITE BONE BIOPSY NEEDLE
FDA Adverse Event
Malfunction
·COOK INC·Product code KNW·July 16, 2019