11 results · 18ms · Sources: EU EUDAMED, US FDA

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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