11 results
·
18ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
INO THERAPEUTICS INOBLENDER, MODEL 10004
FDA 510(k)
FDA Class 2
·Anesthesiology
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809846140·FOR MEN 20-30 MM HG KNEE HIGH OPEN TOE EXTRA LA...
HARDYDISK NETILMICIN, 30MCG
FDA 510(k)
FDA Class 2
·Microbiology
EASY MOVING MOBILE X-RAY UNIT (MODEL SM-HF)
FDA 510(k)
FDA Class 2
·Radiology
ACUITY
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code OJX·April 11, 2013
UNKNOWN DEPUY PATELLA
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code HTG·April 7, 2011
SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA
FDA Adverse Event
Injury
·STAAR SURGICAL CO.·Product code HQL·May 22, 2008
BACT/ALERT® 3D INSTRUMENT
FDA Adverse Event
Malfunction
·BIOMERIEUX, INC.·Product code MDB·December 27, 2019
COLONOVIDEOSCOPE
FDA Adverse Event
Malfunction
·AIZU OLYMPUS CO., LTD.·Product code FDF·February 4, 2025
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