17 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MASIMO RAINBOW SET RAD 87 PULSE CO-OXIMETER AND ACCESSORIES
FDA 510(k)
FDA Class 2
·Cardiovascular
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496073024·STRIPE GAME CRONO, SIZE M, NERO, GRADUATED COMP...
AutoPulse®Resuscitation System
FDA UDI
Zoll Circulation, Inc.·00849111000659·The AutoPulse System consists of 4 primary comp...
TRANSVAGINAL DOPPLER PROBE, MODEL 09-0006-02
FDA 510(k)
FDA Class 2
·Radiology
SELECTIVA GUIDEWIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
INFINION CX
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 29, 2020
AutoPulse®Resuscitation System
FDA UDI
Zoll Circulation, Inc.·00849111000918·The AutoPulse System consists of 4 primary comp...
SILCONE COATED I/A 45 HANDHELD INSTRUMENT
FDA Adverse Event
Injury
·BAUSCH + LOMB·Product code HQC·May 7, 2019
GRAFTYS BCP (510K NUMBER: K073064)
FDA Adverse Event
Injury
·GRAFTYS·Product code MQV·July 11, 2013
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·April 8, 2013
ATLAS VR
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2008
HEAD/NECK 24 STRETCH
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·April 21, 2011
MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·June 10, 2021
MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·May 28, 2022
PROFILE 3D
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·July 30, 2021
MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·July 22, 2021
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