17 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MICROLIFE UPPER ARM MANUAL BLOOD PRESSURE MONITOR, MODEL BP3MR1-H (BP A50)
FDA 510(k)
FDA Class 2
·Cardiovascular
BD BBL¿ MACCONKEY II AGAR
FDA Adverse Event
Malfunction
·BECTON DICKINSON GMBH·Product code JSI·June 26, 2023
COLLES C SERIES FRAME STERILE PACK
FDA 510(k)
FDA Class 2
·Orthopedic
PACIFIC HEMOSTASIS REFERENCE EMULSION
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BD BBL¿ MACCONKEY II AGAR
FDA Adverse Event
Malfunction
·BECTON DICKINSON GMBH·Product code JSI·August 26, 2025
BD BBL¿ MACCONKEY II AGAR
FDA Adverse Event
Malfunction
·BECTON DICKINSON GMBH·Product code JSI·August 26, 2025
BD BBL¿ MACCONKEY II AGAR
FDA Adverse Event
Malfunction
·BECTON DICKINSON GMBH·Product code JSI·August 26, 2025
BD BBL¿ MACCONKEY II AGAR
FDA Adverse Event
Malfunction
·BECTON DICKINSON GMBH·Product code JSI·August 26, 2025
WAVEWRITER ALPHA 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 8, 2022
PINNACLE MTL INS NEUT36IDX64OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·April 23, 2013
ARCHITECT TOTAL PSA
FDA Adverse Event
Injury
·ABBOTT LABORATORIES·Product code LTJ·May 1, 2011
TENDRIL ST
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·July 11, 2008
25 G X 5/8 IN. BD ECLIPSE¿ NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMI·March 1, 2016
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022