17 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CENEFOM PVA SURGICAL SPEAR
FDA 510(k)
FDA Class 2
·Ophthalmic
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B16740824600·
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B1674082460060·
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X0824600·8mm H x 24mm W x 60mm L x 0 degrees XLIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X08246080·8mm H x 24mm W x 60mm L x 8 degrees XLIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X082460120·8mm H x 24mm W x 60mm L x 12 degrees XLIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587L082460120·8mm H x 24mm W x 60mm L XLIF Trial 12 degree Lo...
V60 VENTILATOR
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, INC·Product code MNT·July 9, 2015
MODEL 6495 BIPOLAR TEMPORARY MYOCARDIAL PACING LEAD
FDA 510(k)
FDA Class 2
·Cardiovascular
LIQUICHEK LIPIDS CONTROL, MODEL 641, 642
FDA 510(k)
FDA Class 1
·Clinical Chemistry
V60 VENTILATOR
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, INC·Product code MNT·August 3, 2015
NEEVA BABY FETAL DOPPLER
FDA Adverse Event
Injury
·CONTEC MEDICAL SYSTEM CO., LTD.·Product code KNG·October 27, 2020
SONOLINE B (FETAL DOPPLER)
FDA Adverse Event
Injury
·BABY DOPPLER / DAGAMMA INC.·Product code HGM·January 17, 2019
CHARGING SYSTEM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·April 16, 2013
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·May 10, 2011
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORP.·Product code MKJ·July 22, 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