12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BELRAY II
FDA 510(k)
FDA Class 2
·Dental
BIOMET EXTERNAL WRIST PLATE
FDA 510(k)
FDA Class 2
·Orthopedic
ST AIA-PACK CA 19-9
FDA 510(k)
FDA Class 2
·Immunology
BD INSYTE AUTOG BC
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·August 23, 2024
BD INSYTE AUTOGUARD BC 20GA
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY·Product code FOZ·November 20, 2024
BD INSYTE AUTOG BC
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·July 17, 2024
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·May 5, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Death
·ANIMAS CORPORATION·Product code LZG·September 16, 2014
MINICAP TRANSFER SET
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·May 18, 2011
BD INSYTE AUTOG BC
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·December 9, 2024
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
Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633 Product Usage: Partial Shoulder Replacement.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·December 4, 2019