11 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GERATHERM UNIQUERESC
FDA 510(k)
FDA Class 2
·Cardiovascular
NIDEK ADVANCED VISION INFORMATION SYSTEM (NAVIS)
FDA 510(k)
FDA Class 2
·Radiology
BIO-MARK RESORBABLE BIOPSY SITE MARKER AND BIO-MARK PERMANENT BIOPSY SITE MARKER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VELA VENTILATOR
FDA Adverse Event
Malfunction
·CAREFUSION·Product code CBK·July 21, 2015
ROUND FILTER POLYPROVPYLENE
FDA Adverse Event
Malfunction
·SPS MEDICAL SUPPLY CORP·Product code FRG·June 25, 2013
VELA VENTILATOR
FDA Adverse Event
Malfunction
·CAREFUSION·Product code CBK·February 19, 2015
ZIMMER M/L TAPER FEMORAL STEM
FDA Adverse Event
Injury
·ZIMMER INC·Product code LZO·May 1, 2013
CODMAN EXTERNAL DRAINAGE SYSTEM III
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF, INC.·Product code JXG·September 16, 2014
PINNACLE MTL INS NEUT40IDX58OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·May 12, 2011
BD PEGASUS PNK 20GAX1.16IN PRN-CAPY NON-PVC
FDA Adverse Event
Injury
·BD SUZHOU (MDS)·Product code FOZ·February 20, 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