12 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VITOSS SCAFFOLD FOAM BONE GRAFT MATERIAL
FDA 510(k)
FDA Class 2
·Orthopedic
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032288·Baltic Denture System BDLoad Lm6 PLSEbil2DFl A1...
ARNDT PEDIATRIC ENDOBRONCHIAL BLOCKER
FDA 510(k)
FDA Class 2
·Anesthesiology
COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
MOSAIC AORTIC BIOPROSTHETIC HEART VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code DYE·April 9, 2026
NAVITOR VISION
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code NPT·September 12, 2024
EON MINI
FDA Adverse Event
Injury
·ST JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 29, 2013
XENO IV
FDA Adverse Event
Injury
·DENTSPLY CAULK·Product code KLE·March 23, 2011
VOYAGER RX CORONARY DILATATION CATHETER
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code LOX·April 21, 2008
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 Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·March 23, 2016
cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014