12 results · 30ms · Sources: EU EUDAMED, 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