10 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ROYAL GUARD
FDA 510(k)
FDA Class 1
·General Hospital
NPS2 Hellige
FDA UDI
RAUMEDIC AG·04057834025774·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450282779·
JOSTRA ARTERIAL PERFUSION CANNULAE, MODEL A...
FDA 510(k)
FDA Class 2
·Cardiovascular
PERIFORM PERINEOMETRIC PROBE, MODEL 8300
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
RX CYTOLOGY BRUSH
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SPENCER·Product code FDX·May 3, 2013
NELLCOR OXIMAX N-65
FDA Adverse Event
Malfunction
·SANMINA-SCI SYSTEMS·Product code DQA·August 19, 2014
GENTLEPOWER LUX WINKELSTUCK 25LP
FDA Adverse Event
Injury
·KAVO DENTAL GMBH·Product code EFB·May 9, 2011
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
Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025