48 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AUTO SUTURE ENDO CLIP III5MM CLIP ADAPTER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Marienfeld Superior
FDA UDI
Paul Marienfeld GmbH & Co. KG·04250317300119·
COOLEY VASCULAR CLAMP
FDA UDI
SONTEC INSTRUMENTS, INC.·B09921002420·COOLEY VASCULAR CLAMP
LEONE SPA
FDA UDI
LEONE SPA·08033707092841·BKT 42 F1000 SELF LIGATING 22
METZENBAUM SCISSORS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896046788·METZENBAUM SCISSORS CURVED BLADE
COOLEY VASCULAR CLAMP
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896002081·COOLEY VASCULAR CLAMP
ACUMATCH A-SERIES CORUNDUM ACETABULAR COMPONENT AND ACUMATCH A-SERIES CORUNDUM ACETABULAR COMPONENT WITH HYDROXYAPATITE
FDA 510(k)
FDA Class 2
·Orthopedic
COOK ZILVER BILIARY STENT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·November 25, 2019
T:FLEX INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code LZG·September 6, 2019
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 8, 2013
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·September 18, 2014
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 16, 2011
THORATEC® HEARTMATE 3® LVAS IMPLANT KIT
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·October 7, 2024
THORATEC® HEARTMATE 3® LVAS IMPLANT KIT
FDA Adverse Event
Death
·THORATEC CORPORATION·Product code DSQ·October 8, 2024
SURSHIELD PUR SAFETY I.V. CATHETER
FDA Adverse Event
Injury
·TERUMO CORPORATION - KOFU·Product code FOZ·December 22, 2017
M2A-MAGNUM 42-50MM TPR INSRT-3
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·March 13, 2012
Oxygen Mask, Standard (Under the Lip) Infant, High Concentration Non-Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-All Oxygen Connector Check Valve, Two Side Valves, Product Code 3266-E
FDA Enforcement
Class II
·Terminated·ConvaTec, Inc·June 14, 2017
SOMATOM Confidence -Computed tomography systems Model 10590100
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·January 19, 2022
SOMATOM Confidence with software syngo.CT VB20 Model #10590100
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·December 1, 2021