11 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HDC SPIDER SCREW
FDA 510(k)
FDA Class 2
·Dental
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809848427·FOR MEN 15-20 MM HG KNEE HIGH OPEN TOE EXTRA LA...
JETCAN HUBER NEEEDLE SET
FDA 510(k)
FDA Class 2
·General Hospital
TYTRON C-500IR CLINICAL INFRARED IMAGING SYSTEM
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
EASYTRAK HEAVYWEIGHT GUIDE WIRE
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS·Product code DTB·November 9, 2006
CONTOUR THREAD OR CONTOUR THREADS
FDA Adverse Event
Other
·SURGICAL SPECIALTIES (DBA ANGIOTECH)·Product code GAW·April 3, 2008
LIGAMAX-5MM ENDO CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·April 11, 2013
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·March 16, 2011
LIFESHIELD EXT SET WITH LOCKING LUER 'T'
FDA Adverse Event
Malfunction
·HOSPIRA, LTD·Product code FPA·May 22, 2008
FilmArray BCID Panel, IVD, Rx Only, BioFire Diagnostics, REF: RFIT-ASY-0126, and RFIT-ASY-0127, when used with the following blood culture bottles: Bottle Description/Part Number: BACT/ALERT FA Plus/410851; BACT/ALERT FN Plus/410852; BACT/ALERT PF Plus/410853
FDA Enforcement
Class II
·Terminated·BioFire Diagnostics, LLC·April 24, 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