17 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CRP (II) CALIBRATORS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496030546·VENERE 70, SIZE XXL, CHAMPAGNE, GRADUATED COMPR...
BUSCH®, BNA®
FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120305461·Diamond, cone flat, medium grit
POWDER FREE LATEX EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
FUSION 7D
FDA 510(k)
FDA Class 2
·Radiology
LINER NEUTRAL 36 MM I.D. SIZE F FOR USE WITH G7 ACETABULAR SYSTEM ONLY
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·September 29, 2020
LINER NEUTRAL 36 MM I.D. SIZE F
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·October 5, 2020
PROCEED* MULTI-LAYER LAMINATE MESH
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·April 2, 2013
7700
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·March 9, 2011
SWAN-GANZ CONTINUOUS CARDIAC OUTPUT CATHETER
FDA Adverse Event
Malfunction
·EDWARD LIFESCIENCES, PR·Product code DYG·April 14, 2008
ECHO B-MTRC MP FP SO 11
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·September 25, 2020
G7 OSSEOTI 4 HOLE SHELL 54MM F 4MM F
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·September 25, 2020
G7 OSSEOTI 4 HOLE SHELL 54MM F 4MM F
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·October 5, 2020
ECHO B-MTRC MP FP SO 11
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·October 5, 2020
superDimension Systems AAS00016-xx with Software Version 4.0-4.9. Indicated for use for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools or catheters in the pulmonary tract and to enable marker placement within soft lung tissue. It does not make a diagnosis and is not an endoscopic tool. Not for pediatric use.
FDA Enforcement
Class II
·Terminated·superDimension, Inc·July 18, 2012
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
Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013