11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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31P/1H HEADCOIL FOR MAGNETOM ALLEGRA
FDA 510(k)
FDA Class 2
·Radiology
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496042617·IMBRULIA 70, SIZE XL, OTTANIO, GRADUATED COMPRE...
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809866339·FOR MEN 30-40 MM HG THIGH MICRO DOT BAND OPEN T...
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
GEMSTR 7 THPY ALT ST
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·April 4, 2013
CONTAK RENEWAL TR
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code NKE·May 8, 2008
PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code NIQ·April 6, 2011
Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs.
FDA Enforcement
Class I
·Terminated·Smiths Medical ASD Inc.·December 18, 2019
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
Aespire View. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.
FDA Enforcement
Class I
·Ongoing·Datex-Ohmeda, Inc.·October 30, 2024