18 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 Series
FDA 510(k)
FDA Class 2
·Anesthesiology
24M - Tampa Electric Co.
FDA UDI
Certified Safety Manufacturing, Inc.·00766588013497·24M Tampa Electric Co.
PEDIATRIC BODY-CARDIAC COIL, MODEL: 5000012601
FDA 510(k)
FDA Class 2
·Radiology
FULCRUM
FDA 510(k)
FDA Class 2
·Radiology
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 27, 2014
ATTAIN OTW
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011
STRETCHER CHAIR
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FPO·July 2, 2013
UNK 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE
FDA Adverse Event
Injury
·TERUMO MEDICAL CORPORATION·Product code MGB·January 8, 2020
UNK 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE
FDA Adverse Event
Injury
·TERUMO MEDICAL CORPORATION·Product code MGB·January 8, 2020
ULTRAPRO HERNIA SYSTEM UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code FTL·February 19, 2021
DEXCOM G4 PLATINUM PEDIATRIC CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·February 29, 2016
UNK - PLATES: 4.5MM VA LCP CONDYLAR PLATE
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HRS·September 24, 2021
UNK - PLATES: DHS/DCS
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HRS·September 24, 2021
UNK - PLATES: 4.5MM VA LCP CONDYLAR PLATE
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HRS·September 24, 2021
UNK - CONSTRUCTS: DHS/DCS
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HRS·September 24, 2021
UNK - PLATES: 4.5MM VA LCP CONDYLAR PLATE
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HRS·September 24, 2021
EXCOR BLOOD PUMP PU VALVES,15 ML IN/OUT Ø9 MM
FDA Adverse Event
Malfunction
·BERLIN HEART GMBH·Product code DSQ·July 17, 2019
EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021