11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Augmento
FDA 510(k)
FDA Class 2
·Radiology
BD Difco™ Salmonella H Antiserum Z4 Complex
FDA UDI
BECTON, DICKINSON AND COMPANY·00382902227816·BD Difco™ Salmonella H Antiserum Z4 Complex, 3 mL
MIDAS TOUCH PURPLE NITRILE EXAMINATION GLOVES-POLYMER COATED, POWDER FREE
FDA 510(k)
FDA Class 1
·General Hospital
RELIAMAX GASTROINTESTINAL ANASTOMOSIS AND RELOAD
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BD ANGIOCATH
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·May 12, 2025
BD ANGIOCATH
FDA Adverse Event
Malfunction
·BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.·Product code FOZ·May 2, 2025
SHUNT SENSOR SYS500
FDA Adverse Event
TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·August 9, 2011
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE REHABILITATION EQUIP·Product code CAW·November 4, 2014
NON AC-POWERED PATIENT LIFT
FDA Adverse Event
LAND AMERICA HEALTH & FITNESS·Product code FSA·July 12, 2013
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025