19 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Cediflo Enteral Feeding Tubes & Cediflo Junior Enteral Feeding Tubes
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Oticon
FDA UDI
Oticon A/S·05707131330925·GENIE 2 2017.1
DUOLINK II
FDA 510(k)
FDA Class 2
·Dental
CAMLAB CRANIAL ORTHOSIS HELMET
FDA 510(k)
FDA Class 2
·Neurology
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 28, 2011
PAINSMART IOD
FDA Adverse Event
Malfunction
·MOOG DEVICE GROUP·Product code FRN·June 6, 2013
SILICONE ADVANCED OPTIC-VIOLET SHIELD
FDA Adverse Event
Malfunction
·BAUSCH & LOMB·Product code HQL·September 30, 2008
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN916549), cardiac pump
FDA Enforcement
Class I
·Ongoing·ARROW INTERNATIONAL Inc.·December 21, 2022
GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
FDA Adverse Event
Malfunction
·COOK INC·Product code MMX·March 17, 2022
GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
FDA Adverse Event
Injury
·COOK INC·Product code MMX·September 29, 2021
GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
FDA Adverse Event
Malfunction
·COOK INC·Product code MMX·June 3, 2022
GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
FDA Adverse Event
Malfunction
·COOK INC·Product code MMX·August 15, 2022
GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
FDA Adverse Event
Malfunction
·COOK INC·Product code MMX·January 30, 2023
GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
FDA Adverse Event
Injury
·COOK INC·Product code MMX·February 6, 2023
GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
FDA Adverse Event
Malfunction
·COOK INC·Product code MMX·July 27, 2021
GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
FDA Adverse Event
Malfunction
·COOK INC·Product code MMX·November 4, 2022
GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
FDA Adverse Event
Malfunction
·COOK INC·Product code MMX·March 28, 2022
GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
FDA Adverse Event
Injury
·COOK INC·Product code MMX·August 18, 2022
PENUMA IMPLANT
FDA Adverse Event
Injury
·INTERNATIONAL MEDICAL DEVICES, INC.·Product code MIB·October 7, 2019