18 results · 27ms · Sources: EU EUDAMED, 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